Diabetes and Life – You have Chance?

2015-03-25 / Diabetes / 0 Comments

I have worked as a bus driver all my working life. I first got diabetes five years ago and have been well controlled till about six months ago. My doctor tells me that tablets are no longer working and that I must go onto insulin. This means I will lose my job, my source of income and probably my house. Diabetes and Life

This tragic situation is all too common. Some people in your situation have no difficulty in finding another way of earning money and paying the mortgage. However, others find it hard to give up their driving and believe no other job will match their present salary. There is no easy solution when you are faced with deciding between your health and your job. The choice becomes easier if you are feeling unwell, perhaps with symptoms of high sugars such as thirst and tiredness. We know some people in your situation who feel perfectly fit and cannot believe that there is a problem with their health. This makes their decision particularly difficult as they have to take their doctor’s word that they need to have insulin.

I recently read a newspaper article that implied that people with diabetes who are breathalysed can produce a positive reading even though they have not been drinking alcohol. What does this mean?

Diabetes has no effect on breathalyser tests for alcohol even if acetone is present on the breath. However, the Lion Alcolmeter, widely used by the police, does also measure ketones, though this does not interfere with the alcohol measurement. Anyone breathalysed by the police may also be told that they have ketones and that they should consult their own doctor. These ketones may be caused either by diabetes that is out of control or by a long period of fasting. Awc Canadian Pharmacy believes that we should not give up and succumb to the disease, more info here.


My husband likes a pint of beer in the evening. He has now been found to have diabetes and has to stick to a diet. Does this mean he will have to give up drinking beer?

No. He can still drink beer but, if he is trying to lose weight, he will need to reduce his overall calorie intake and, unfortunately, all alcohol contains calories. There are about 180 calories in a pint of beer and this is equivalent to a large bread roll. Special ‘diabetic’ lager contains less carbohydrate but more alcohol so in the end it contains the same number of calories, with the drawback of being more expensive and more potent. He should probably also avoid the ‘strong’ brews, which are often labelled as being low in carbohydrate, as these are higher in alcohol and calories than the ordinary types of beer and lager. Low-alcohol and alcohol-free beers and lagers often contain a lot of sugar, so, if he decides to change to these, he should look for the ones also labelled as being low in sugar.

Overall your husband is probably better off drinking ordinary beer, but if he is overweight he should restrict the amount he drinks.

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Blood Glucose testing

2014-12-04 / Diabetes / 0 Comments


I have Type 2 diabetes and have just started tablets. I am testing my urine but would prefer to test my blood sugar. Why does my CP not seem keen to prescribe blood testing strips for me?

Blood glucose monitoring for people with Type 2 diabetes is a controversial area. Some healthcare professionals feel that there is no proof that blood testing helps people improve their diabetic control. Blood testing is reasonably costly and it can be argued that if it doesn’t improve things then the expense is not justified. However, you may feel that home blood glucose monitoring may help you to understand your diabetes better. For example, it can tell you what happens if you take exercise or eat a big meal. Blood testing may give you a sense of being more in control. You may wish to discuss with your doctor or nurse how you think you could benefit from testing your blood glucose.

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Are the blood glucose meters accurate enough for daily use?

Most results obtained when you are using a meter will be slightly different from the clinic laboratory results or even from different makes of meters because different technological methods are used. These slight differences do not matter and the strips and meters are quite accurate enough for home use provided your technique is correct. If you are concerned that your results may not be accurate you can check the meter yourself by using the quality control solution provided with the meter. Phone the meter company helpline for advice or contact your diabetes specialist nurse who can check both your meter and your technique.

I have heard that there is a watch you can wear that measures the blood sugar automatically. Is this right?

You are thinking about the ClucoWatch, developed by a Californian company called Cygnus Inc. Unfortunately there were many technological problems and so the GlucoWatch is currently unavailable in the UK. This device is worn like a wristwatch and measures blood glucose from interstitial fluid every 10-20 minutes depending on the model. The watch had to be fitted with a sensor which only lasted for 12 hours and was expensive to buy.

I have heard that it is now possible to obtain a meter, which can measure the blood glucose constantly without the need for repeated fingerpricks. How do I get hold of one?

Meters which provide a continuous read-out of blood glucose levels are available for research purposes and for short-term use. The eventual aim is to connect these meters to an insulin pump allowing the dose of insulin to be controlled by the level of blood glucose – a true ‘artificial pancreas’. The technology is promising but not fully developed.

At present the Minimed Medtronic can record the blood glucose continuously for three days and many diabetes centres will own such a meter. They can be loaned to people who are having problems with their diabetes control and are used to identify patterns of either high or low blood sugars. They do not produce an immediate reading but can be downloaded to a computer to print out a three-day blood glucose curve. Unfortunately the three-day probes are expensive and are not yet practical for long term use.

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Diabetes – Monitoring and Control in Canadian Health and Care Mall

2014-11-03 / Diabetes / 0 Comments

The key to a successful life with diabetes is achieving good blood glucose control. Your degree of success can be judged only by measurements of your body’s response to treatment. If you have diabetes, the fact that you feel well does not necessarily mean that your blood glucose is well controlled. It is only when control goes badly wrong that you may be aware that something is amiss. If your blood glucose is too low, you may be aware of hypo symptoms -if left untreated this may progress to unconsciousness (hypoglycaemic coma). At the other end of the spectrum, when the blood glucose concentration rises very steeply, you may be aware of increased thirst and passing urine excessively – left untreated, this may progress to nausea, vomiting, weakness, and eventual clouding of consciousness and coma (a condition called ketoacidosis). It has long been apparent that relying on how you feel is too imprecise, even though some people may be able to ‘feel’ subtle changes in their control. Diabetes - Monitoring

For this reason, many different tests have been developed to allow precise measurement of control and, as the years go by, these tests become more efficient and accurate.

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The involvement of the person with diabetes in monitoring and control of their own condition has always been essential for successful treatment. With the development of blood glucose monitoring, this has become even more apparent: it allows you to measure precisely how effective you are at balancing the conflicting forces of diet, exercise and insulin, and to make adjustments in order to maintain this balance with. In the early days after the discovery of insulin, urine tests were the only tests available and it required a small laboratory even to do these. Urine tests have always had the disadvantage that they are only an indirect indicator of what you really need to know, which is the level of glucose in the blood. Blood glucose monitoring first became available to people with diabetes in 1977 and is now widely accepted. As anyone who has monitored glucose levels in the blood will know, these vary considerably throughout the day as well as from day to day. For this reason, a single reading at a twice yearly visit to the local diabetes clinic is of limited value in assessing long-term success or failure with control.

The introduction of haemoglobin Ale (glycosylated haemoglobin or HbA1c) has provided a very reliable test for longer-term monitoring of average blood glucose levels (taking into account the peaks and troughs) over an interval of two to three months. Someone with diabetes should aim at a target HbA1c of 7%, which indicates that the blood glucose has been contained within the near normal range. Provided there have been no troublesome hypoglycaemic attacks, this means that balance of diabetes has been excellent and no further changes are required. Achieving a normal HbA1c level and maintaining it as near normal as possible is an important goal. Not everyone can achieve this, but it is undoubtedly the most effective way of eliminating the risk of long-term complications.

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Diabetes Mellitus News: Diabetes Mellitus Cases Hit 366 Million

2011-09-21 / Diabetes / 0 Comments

Diabetes Mellitus Cases Hit 366 Million

The number of people now living with diabetes mellitus has reached 36 million, healthcare experts said at a United Nations meeting Tuesday. According to Reuters, the disease kills one person every seven seconds and poses a “massive challenge” to global healthcare systems.

Of these millions of cases, most have diabetes Type 2—one that is linked to a poor diet, obesity and lack of exercise. The problem is spreading as more and more people worldwide begin to adopt Western lifestyles.

The disease, once contracted, causes diabetics to have inadequate blood sugar control, leading to heart disease and stroke, damage to the kidneys and nerves, and even blindness. According to Reuters, worldwide deaths from diabetes now number at about 4.6 million every year.

“The IDF’s latest Atlas data are proof indeed that diabetes is a massive challenge the world can no longer afford to ignore,” said IDF President Jean Claude Mbanya. “In 2011, one person is dying from diabetes every seven seconds.”

Mbanya recommended more research that would seek to find a way to strengthen global health systems in dealing with the disease. Older classes of diabetes drugs are becoming available, also helping diabetics worldwide manage their condition in a more cost-effective manner.

According to IMS Health, global sales of diabetes medication totaled $35 billion last year alone. By 2015, that number could be $48 billion.

Onglyza reduces blood sugar levels: study

Pharmaceutical companies Bristol-Myers Squibb and AstraZeneca have announced results from an investigational phase 3b clinical study of use of Onglyza (saxagliptin) in diabetic patients.

The study was based on the addition of Onglyza (saxagliptin) 5mg to ongoing insulin therapy (with or without metformin) to maintain reductions in blood sugar levels (glycosylated hemoglobin levels, or HbA1c) in adult patients with type 2 diabetes compared to the addition of placebo (with or without metformin) from 24 to 52 weeks.
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These results, presented at the 47th European Association for the Study of Diabetes (EASD) Annual Meeting in Lisbon, Portugal, are from an extension of a 24-week trial, the results of which were presented at the 71st American Diabetes Association (ADA) Scientific Sessions in San Diego, CA in June 2011.

In the 52-week analysis, change from baseline in HbA1c in patients taking Onglyza 5 mg added to insulin was -0.75% compared to -0.38% for those taking placebo added to insulin, a statement from the company said.

There was also a greater increase from baseline mean daily insulin dose in patients who received placebo compared to patients who received Onglyza 5 mg.

It is unknown whether increased insulin doses by patients in the placebo group could have affected the magnitude of differences seen between the two treatment groups in the efficacy analyses, it said.

The proportion of patients in each treatment group who experienced at least one adverse event over the 52-week treatment period was similar. The most common events included hypoglycemia, urinary tract infection, nasopharyngitis, upper respiratory tract infection, headache and bronchitis.

“Since many patients with type 2 diabetes will eventually require insulin, it is important to assess a compound’s ability to be used in combination with insulin to manage blood glucose control over the long term,” said Anthony Barnett, MD, University of Birmingham and Heart of England NHS Foundation Trust and principal investigator of the study.

“This is the first longer-term study to report that Onglyza 5 mg, used with insulin, maintains improvement in glucose control over 24 to 52 weeks in adult patients with type 2 diabetes”, he said.

In Europe, Onglyza is indicated as a once-daily 5 mg oral tablet dose in adult patients with type 2 diabetes mellitus to improve glycemic control – in combination with metformin.

When metformin alone, with diet and exercise, does not provide adequate glycemic control; in combination with a sulphonylurea, when sulphonylurea alone, with diet and exercise, does not provide adequate glycemic control in patients for whom use of metformin is considered inappropriate; or in combination with a thiazolidinedione, when the thiazolidinedione alone, with diet and exercise, does not provide adequate glycemic control in patients for whom use of a thiazolidinedione is considered appropriate.

Onglyza is currently not indicated in combination with insulin therapy, the statement said.

In the United States, Onglyza is indicated as an adjunct to diet and exercise to improve blood sugar (glycemic) control in adults with type 2 diabetes mellitus in multiple clinical settings.

Diabetes Mellitus Type 2 Risk Reduced By Regular Exercise: Study

Diabetes mellitus type 2 may be largely preventable, after new research has shown that physical inactivity has a direct impact on a person’s ability to control their blood sugar levels.

University of Missouri researchers showed that after just three days of limiting their physical activity, participants had significantly impaired post-meal glucose control.

However, these changes were reversed after just moderate exercise, Medical Daily reports.

Lead author John Thyfault said, “A single bout of moderate exercise can improve the way the body maintains glucose homeostasis (blood glucose regulation) and reduce post-prandial glucose.”

But he warned that “becoming inactive for a short period of time quickly disrupts glucose homeostasis.”

“This study shows that physical activity directly impacts health issues that are preventable,” Thyfault said, reports Medical Daily.

“Even in the short term, reducing daily activity and ceasing regular exercise causes acute changes in the body associated with diabetes that can occur before weight gain and the development of obesity,” he said.

Due to escalating type 2 diabetes rates, he added that more needs to be done to prevent the condition.

According to the Centers for Disease Control and Prevention, 79 million people in the U.S. suffer from prediabetes.

The condition, which often develops into type 2 diabetes, is characterized by abnormal glucose levels.

The findings suggest that encouraging people to become more physically active may be a good starting point, Medical Daily reports.

“It is recommended that people take about 10,000 steps each day. Recent evidence shows that most Americans are only taking about half of that, or 5,000 steps a day,” Thyfault said.

“This chronic inactivity leads to impaired glucose control and increases the risk of developing diabetes,” he pointed out, Medical Daily reports.

The study, “Lowering Physical Activity Impairs Glycemic Control in Healthy Volunteers,” will be published in Medicine & Science in Sports & Exercise.

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Diabetes Treatment News: The American Diabetes Association Announces New Editors for Diabetes Care

2011-08-16 / Diabetes / 0 Comments

The American Diabetes Association Announces New Editors for Diabetes Care

The American Diabetes Association announces the appointment of William T. Cefalu, MD, of the Pennington Biomedical Research Center and the Louisiana State University Health Science Center (LSUHSC) School of Medicine, as the Editor-in-Chief of Diabetes Care. Diabetes Care is the Association’s premier peer-reviewed journal dedicated to diabetes care, prevention, and treatment.

The Association also announced the appointment of the following Associate Editors to the editorial team of Diabetes Care:
George Bakris, MD, University of Chicago Medical Center
Lawrence Blonde, MD, FACP, Ochsner Clinic and Alton Ochsner Medical Foundation
Andrew J. M. Boulton, MD, University of Manchester and the University of Miami
Mary de Groot, PhD, Indiana University School of Medicine
Eddie L. Greene, MD, Mayo Clinic
R. Robert Henry, MD, VA San Diego Healthcare System and the University of California, San Diego
Sherita Hill Golden, MD, MHS, FAHA, Johns Hopkins University
Frank Hu, MD, MPH, PhD, Harvard School of Public Health
Derek LeRoith, MD, PhD, Mount Sinai School of Medicine
Robert G. Moses, MD, South Eastern Sydney & Illawarra Area Health Service
Eric Ravussin, PhD, Pennington Biomedical Research Center
Stephen Rich, PhD, University of Virginia
Matthew C. Riddle, MD, Oregon Health & Science University
Julio Rosenstock, MD, Dallas Diabetes and Endocrine Center
William V. Tamborlane, MD, Yale Center for Clinical Investigation
Katie Weinger, EdD, RN, Joslin Diabetes Center
Judith Wylie-Rosett, EdD, RD, Albert Einstein College of Medicine

The team will serve a three-year term, for the 2012 to 2014 volume years, with an optional two-year extension.

As the incoming Editor-in-Chief of Diabetes Care, Cefalu brings a wealth of professional and scholarly experience to the journal. Cefalu is Director of the Joint Diabetes, Endocrinology and Metabolism Program of the LSUHSC School of Medicine and Pennington Biomedical Research Center, as well as the Douglass L. Manship Sr., Professor of Diabetes at Pennington Biomedical Research Center.

The American Diabetes Association, the Pennington Biomedical Research Center, and the LSUHSC are proud to come together to support Cefalu and the publication of high-impact diabetes-related research in Diabetes Care.

“The appointment of Dr. Cefalu brings great honor to the Pennington Biomedical Research Center,” said Steven Heymsfield, MD, Executive Director. “The peer-reviewed Diabetes Care will continue under his editorship to provide timely, insightful, in-depth information on this profoundly important health topic.”

Likewise, Steve Nelson, MD, Dean of the LSUHSC School of Medicine, applauds the appointment of Cefalu as the next Editor-in-Chief of Diabetes Care. “This is well-deserved recognition for the stature that Dr. Cefalu has attained professionally. He is an accomplished physician scientist. We are proud to have him on our LSU School of Medicine faculty and honored that our school will be working closely with the American Diabetes Association in the dissemination of the latest in research findings for the care of patients with diabetes.”

Cefalu’s research is active at both the clinical and basic levels. On a clinical level, he is interested in clinical interventions to improve the metabolic state of individuals with insulin resistance and type 2 diabetes. On a basic level, he is interested in cellular mechanisms for insulin resistance. In addition, Cefalu also serves as Director for a National Institutes of Health-funded Center for the Study of Botanicals and Metabolic Syndrome at Pennington Biomedical Research Center.

Cefalu has published widely in journals, books, and book chapters and has edited several textbooks on the management of diabetes. He is a past Associate Editor for Diabetes Care and is currently an Associate Editor for Diabetes. He lectures both nationally and internationally.

Cefalu and his editorial team will succeed current Editor-in-Chief Vivian A. Fonseca, MD, and his current editorial team, which convened in July 2006 and will complete its term at the end of 2011:
Edward J. Boyko, MD
Antonio Ceriello, MD
Charles M. Clark, Jr., MD
Samuel Dagogo-Jack, MD, FRCP
Lawrence Fisher, PhD
Todd P. Gilmer, PhD
Carla J. Greenbaum, MD
James B. Meigs, MD, MPH
Richard E. Pratley, MD
Aaron I. Vinik, MD
Ruth S. Weinstock, MD, MPH
Bernard Zinman, MD

Current Associate Editors Andrew M. Boulton, MD; Robert G. Moses, MD; Katie Weinger, EDD, RN; and Judith Wylie-Rosset, EDD, RD, will continue with Cefalu’s team.

“My colleagues and I are extremely excited to oversee the future editorial direction of Diabetes Care, the top clinical journal for diabetes care and management in the world,” stated Cefalu. “Our goal is to ensure the journal continues to address the changing health care and research landscape, as well as provide health care professionals with the information they need to better manage people with diabetes.”

Diabetes Care is the highest-ranked journal devoted exclusively to diabetes prevention and treatment. The journal publishes original research about topics that are of interest to clinically oriented physicians, researchers, epidemiologists, psychologists, diabetes educators, and other health professionals. Diabetes Care is published 12 times a year and is received by American Diabetes Association Category I Professional Members.

How fatty food triggers diabetes: Scientists believe discovery paves way for Type 2 ‘cure’

Fatty food trips a genetic switch in the body that can trigger diabetes, a study has found.

Understanding the biological pathway could lead to a potential cure for the disease, say scientists.

The discovery helps explain why Type 2 diabetes is so often linked to obesity.

n studies of mice and humans, researchers found that high levels of fat disrupted two key proteins that turn genes on and off.

The ‘transcription factors’ FOXA2 and HNF1A activate a pancreatic enzyme that in healthy people prevents diabetes developing.

When the proteins stop working, the enzyme is shut down, which in turn upsets the ability of insulin-secreting beta cells in the pancreas to monitor blood sugar levels. Without this glucose sugar-sensing mechanism, blood sugar cannot be regulated properly.

Study leader Dr Jamey Marth, from the Sanford-Burnham Medical Research Institute in the U.S., said: ‘Now that we know more fully how states of over-nutrition can lead to Type 2 diabetes, we can see more clearly how to intervene.

‘The identification of the molecular players in this pathway to diabetes suggests new therapeutic targets and approaches towards developing an effective preventative or perhaps curative treatment.

‘This may be accomplished by beta cell gene therapy or by drugs that interfere with this pathway in order to maintain normal beta cell function.’

The research is published in the journal Nature Medicine.

Experiments in mice showed that preserving the function of the enzyme affected by FOXA2 and HNF1A blocked the onset of diabetes, even in obese animals.

Diminished glucose sensing by beta cells was an important factor in both the development and severity of the disease.

Dr Marth and his team are now looking at ways to augment the enzyme’s activity in humans.

More than two million people in the UK have Type 2 diabetes, the most common form of the disease.

Insulin-dependent, or Type 1 diabetes is a quite different condition caused by an autoimmune disorder.

Leon Medical Centers Earns Coveted American Diabetes Association Certification for Centro de Diabetes Education* Program

Leon Medical Centers, a leading healthcare service provider for the Medicare community in Miami-Dade County, has earned the prestigious American Diabetes Association (ADA) Education Recognition Certificate for its quality diabetes self-management education program. This Recognition was recently awarded to the LMC’s “Centro de Diabetes” at Flagler Center on July 6, 2011 for offering high-quality education* that is essential for effective diabetes treatment.

“It is an honor to be recognized by such a prestigious association because the process gives professionals a national standard by which to provide patients with comprehensive quality education”

The ADA Education Recognition effort for LMC which begun in the fall of 2010, is a voluntary process, which assures that approved education programs have met the National Standards for Diabetes Self-Management Education Programs. These Standards were developed and tested under the auspices of the National Diabetes Advisory Board in 1983 and were revised by the diabetes community in 1994, 2000 and 2007. Programs that achieve Recognition status have a staff of knowledgeable health professionals who can provide comprehensive information about diabetes management for participants. Education Recognition status is verified by an official certificate from ADA and awarded for four years.

“The American Diabetes Association Certification reinforces Leon Medical Centers’ commitment to continually enhance care to our patients and the community. By providing a level of care that meets the highest national standards we are able to maintain patients’ health and improve their quality of life,” said Rafael Mas, M.D., Chief Medical Officer, Leon Medical Centers.

Self-management education is an essential component of diabetes treatment. By meeting the National Standards we ensure greater consistency in the quality of education offered to people with diabetes. Assuring high-quality education for patient self-care is one of the primary goals of the Education Recognition program. Unnecessary hospital admissions and some of the acute and chronic complications of diabetes may be prevented through self-management.

According to the ADA, there are 25.8 million people or 8.5% of the population in the United States who have diabetes; 11.8% are Hispanics. While an estimated 18.8 million have been diagnosed, unfortunately, 7.0 million people are not aware that they have the disease. Each day approximately 5,205 people are diagnosed with diabetes. Many will first learn that they have diabetes when they are treated for one of its life-threatening complications – heart disease and stroke, kidney disease, blindness, nerve disease and amputation. About 1.9 million new cases of diabetes were diagnosed in people aged 20 years or older in 2010 in the US. Diabetes contributed to 231,404 deaths in 2007, making it the seventh leading cause of death in the US. Overall, the risk of death among people with diabetes is about twice that of people of similar age but without diabetes.

“It is an honor to be recognized by such a prestigious association because the process gives professionals a national standard by which to provide patients with comprehensive quality education,” said Janet Martinez, ARNP, BC, Director of Disease Management, Leon Medical Centers.

About Leon Medical Centers:

Leon Medical Centers, established in 1996, is a healthcare service provider that offers medical services exclusively to Medicare patients in Miami-Dade County. LMC operates seven Super Medical Centers located in Miami, Westchester, East Hialeah, Bird Road, West Hialeah, Kendall and Flagler and offers state-of-the-art technology such as CT scan, Digital X-rays, Ultrasound, Echocardiogram, and other diagnostics, in addition to a range of medical services that includes primary care, specialties, dental, on-site pharmacy, vision, hearing, physical therapy and laboratory.

Fat ‘disrupts sugar sensors causing type 2 diabetes’

US researchers say they have identified how a high-fat diet can trigger type 2 diabetes, in experiments on mice and human tissue.

Writing in the journal Nature Medicine, they say that fat interferes with the body’s sugar sensors.

The authors argue that a deeper understanding of the processes involved could help them develop a cure.

Diabetes UK said the study was interesting and a “theory worth investigating further”.

One of the main risk factors for type 2 diabetes is being overweight – rising obesity levels have contributed to a doubling of diabetes cases in the last 30 years.
Fat and sugar

Sugar in the blood is monitored by pancreatic beta cells. If sugar levels are too high then the cells release the hormone insulin, which tells the body to bring the levels back down.

Key to this is the enzyme GnT-4a. It allows the cells to absorb glucose and therefore know how much is in the blood.
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The identification of the molecular players in this pathway to diabetes suggests new therapeutic targets and approaches towards developing an effective preventative or perhaps curative treatment”
Dr Jamey Marth
Lead researcher

Researchers at the University of California and the Sanford-Burnham Medical Research Institute say they have shown how fat disrupts the enzyme’s production.

Experiments on mice showed that those on a high-fat diet had elevated levels of free fatty acids in the blood.

These fatty acids interfered with two proteins – FOXA2 and HNF1A – involved in the production of GnT-4a.

The result: fat effectively blinded cells to sugar levels in the blood and the mice showed several symptoms of type 2 diabetes.

The same process also took place in samples of human pancreatic cells.

Lead researcher Dr Jamey Marth said: “The observation that beta cell malfunction significantly contributes to multiple disease signs, including insulin resistance, was unexpected.”

He suggested that boosting GnT-4a levels could prevent the onset of type 2 diabetes: “The identification of the molecular players in this pathway to diabetes suggests new therapeutic targets and approaches towards developing an effective preventative or perhaps curative treatment.

“This may be accomplished by beta cell gene therapy or by drugs that interfere with this pathway in order to maintain normal beta cell function.”

Dr Iain Frame, Director of Research at Diabetes UK, said: “This is a well-executed study into possible factors responsible for the events that lead to type 2 diabetes.

“The researchers have linked their results in mice to the same pathways in humans and although they did not show they could prevent or cure type 2 diabetes they have shown it is a theory worth investigating further.

“We will watch this with great interest and hope this early work will eventually lead to some benefit to people with type 2 diabetes.”

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Diabetes Treatment News: Drugmakers angle for advantage in treating diabetes

2011-07-07 / Diabetes / 0 Comments

Drugmakers angle for advantage in treating diabetes

Obesity and longevity have helped make diabetes an epidemic in much of the world, and drugmakers are jockeying to make sure their medicines are used early and often.

Companies including Sanofi and Eli Lilly aim to introduce new classes of drugs that could further extend treatment options, and potentially their market share.

Once diagnosed, people with type 2 diabetes are commonly treated with generic drugs, followed by several different classes of branded pills, injected medicines and eventually insulin.

Some major pharmaceutical players are trying to gain an earlier foothold in that succession of treatment as the market for such drugs has grown dramatically, with global incidence of diabetes reaching nearly 350 million cases over the last 30 years.

At the American Diabetes Association meeting in San Diego this week, Boehringer Ingelheim Pharmaceuticals and Lilly promoted their new oral drug, Tradjenta, as a better option for a patient’s next line of defense after generics. Tradjenta, also known as linagliptin, is a member of a class of oral drugs known as DPP-4 inhibitors.

“Our focus is to be the first product to be added to metformin,” said John Smith, head of clinical development and medical affairs at Boehringer. Metformin is the generic pill initially prescribed for many diabetes patients.

That goal may be helped by the fact that another class of branded diabetes drugs may be falling out of favor. Since patients now live for decades with diabetes, the safety profile of treatments has become even more important. Drugmakers face increased scrutiny of cardiovascular and cancer risks.

“Patients with type 2 diabetes are living longer, so there is a higher incidence of other problems,” said Dr. Joel Zonszein, director of the clinical diabetes center at Montefiore Medical Center in New York.


Top-selling diabetes drug Actos, marketed by Takeda Pharmaceutical Co , is a high-profile example of the safety concerns. Recent data on the drug, with nearly $5 billion in annual sales, linked it to increased risk of bladder cancer if used for more than a year.

U.S. health officials added that information to the drug’s label, while France and Germany suspended Actos sales.

Actos is a thiazolidinedione — shortened to TZD or glitazone — designed to lower the body’s insulin resistance, the underlying problem for people with type 2 diabetes.

Earlier versions of glitazones caused serious liver damage for some people and were withdrawn from the market. Avandia, a member of the same class sold by GlaxoSmithKline , has been linked to heart risks.

For Actos, “it is too early to say” whether the preliminary findings have had an impact on sales, said Dr. Robert Spanheimer, Takeda’s vice president, medical and scientific affairs. He said full results from the Actos safety trial will be available in 2013.


Global sales of diabetes medicines totaled $35 billion last year and could rise to as much as $48 billion by 2015, according to research firm IMS Health, driven by increased prevalence and treatment, especially in countries such as China, India, Mexico and Brazil.

“There is a large amount of people who don’t know they have diabetes,” said Dr. Stuart Weinerman, chief of endocrinology at North Shore-Long Island Jewish Health System in New Hyde Park, New York. “There is an even larger group of people that have diabetes and don’t control it adequately.”

IMS also forecast growing use of oral diabetes medicines due to their convenience and efficacy.

“The aim is to preserve the option of oral therapy for as long as possible,” said Boehringer’s Smith.

Boehringer is also developing a member of a new class of drugs known as SGLT2 inhibitors, which are designed to block glucose from being absorbed into the bloodstream through the kidneys, allowing more sugar to be excreted with urine.

New data on another experimental SGLT2 inhibitor, dapafliglozin from Bristol-Myers Squibb and AstraZeneca , showed that it was effective in a two-year study. But more bladder and breast cancers were found in patients treated with the drug.

“The probability of these drugs causing cancer is very, very low … the duration of the trials was too short,” said Zonszein.

Lilly also featured information on Byetta, an injectable GLP-1 drug co-marketed with Amylin Pharmaceuticals , which is suing Lilly over its deal with Boehringer.

Amylin presented data at the conference showing no significant link between use of Byetta and heart rhythms, which is important since U.S. regulators have asked for a heart risk trial of the company’s once-weekly GLP-1 drug, Bydureon.

That data is expected soon and Amylin said it plans to refile for U.S. regulatory approval of Bydureon in the second half of this year.

Drugmakers are also working on improved versions of insulin, the blood-sugar controlling hormone that is missing in people with type 1 diabetes and can be needed by patients with the more common type 2 diabetes.

Novo Nordisk , the world’s biggest insulin producer, showed that its experimental long-acting insulin, degludec, lowered blood sugar levels with less risk of hypoglycemia, compared with Sanofi’s Lantus.

Degludec is formulated with spacer molecules to provide a more steady rate of absorption than current insulins, said Alan Moses, Novo Nordisk’s chief medical officer.

“It lines up like pearls on a string … the insulin just basically drops off one molecule at a time from the ends,” he explained.

Sanofi’s diabetes division head, Dennis Urbaniak, said the French drugmaker aims to hold its market share with Lantus.

“Lots of other folks are trying to change that position,” he said.

ADA: Intensive Tx No Better than Good Routine Diabetes Care

SAN DIEGO — Screening and early intensive management of type 2 diabetes may hold little benefit beyond usual care, perhaps because of more aggressive routine practice, researchers suggested.

Intense managment of glucose, lipids, and blood pressure for screen-detected cases in the randomized ADDITION trial modestly reduced cardiovascular events by 12% and raised overall survival by 9% over roughly five years, Simon J. Griffin, MD, of Addenbrooke’s Hospital at the University of Cambridge, England, and colleagues found.

But neither advantage reached statistical significance compared with the outcomes of routine primary care by Dutch, Danish, and British clinicians, the group reported here at the American Diabetes Association meeting and simultaneously online in The Lancet.

The first cardiovascular event incidence rate was 7.2% with intensive treatment versus 8.5% with usual care (HR 0.83, 95% confidence interval 0.65 to 1.05); all-cause mortality occurred in 6.2% and 6.7%, respectively (HR 0.91, 95% CI 0.69 to 1.21).

These results, reiterating those presented at the European Association for the Study of Diabetes meeting last fall, were again seen as an overall positive for early diabetes treatment regardless of intensity.

“Any form of early therapy seems to pay dividends when compared with either later detection or delayed diagnosis and intervention,” David Kendall, MD, the ADA’s chief scientific and medical officer, told MedPage Today.

The trial couldn’t be definitive about the clinical benefit of screen detection of diabetes in the context of current clinical practice, David Preiss, MRCP, and Naveed Sattar, PhD, both of the University of Glasgow, Scotland, cautioned in a commentary accompanying the Lancet paper.

“However, the substantial improvements in blood pressure and cholesterol observed in the routine care group suggest that early diagnosis and treatment of diabetes according to current guidelines is likely to be beneficial,” they wrote in the commentary.

The usual care group achieved an 11.7 mm Hg reduction in systolic blood pressure and 1.2 mmol/L lower LDL with treatment by standard European guidelines, reductions that were nearly as good as the 13.7 mm Hg and 1.3 mmol/L reductions with intensive management although reaching statistical significance for a difference.

European guidelines don’t recommend routine screening for diabetes, unlike ADA guidelines, which recommend screening every three years for all adults over age 45 or regardless of age for those overweight, obese, or with at least one risk factor.

But national guidelines in the three northern European countries involved got more aggressive on treatment for diabetes patients during the trial.

Thresholds for antihypertensive treatment dropped from a systolic blood pressure of 140 to 155 mm Hg in 2001 at baseline to 130 to 140 mm Hg at follow-up; cholesterol treatment thresholds fell from 5.0 to 6.0 mmol/L to 4.5 mmol/L.

Diabetes treatment goals changed to include 6.5% in the A1c target range in some countries, although remaining largely stable overall.

Those unexpected changes may have undermined the trial’s ability to detect significant benefits from intensive managment, Preiss and Sattar suggested.

By the end of the trial, “the treatment groups were similar in terms of allocated treatments (such as statins) and had similar prevalence of glycemia and cardiovascular risk factors, with the result that achieving the target of a 30% reduction in cardiovascular events with intensive therapy became unlikely,” they wrote in the Lancet.

ADDITION — the Anglo-Danish-Dutch study of Intensive Treatment in People with Screen Detected Diabetes in Primary Care — included 3,057 patients (age 40 to 69) who screened positive for diabetes at primary care practices in Britain, the Netherlands, and Denmark.

Patients randomized to intensive treatment received:
Antihypertensive treatment starting with an ACE inhibitor at a blood pressure of 120/80 mm Hg or higher, with directions to intensify treatment for blood pressures of 135/85 mm Hg or greater
Lipid-lowering medication at an LDL of 3.5 mmol/L (135 mg/dL) or higher with intensification for those at or above 4.5 mmol/L (174 mg/dL)
Diabetes medications targeting a hemoglobin A1c of 6.5% or less

At the mean 5.3 years of follow-up, all the individual components of the primary cardiovascular event outcome (cardiovascular death, MI, stroke, and revascularization) tended to favor intensive therapy numerically, although without statistical significance.

The researchers pointed to the apparent divergence of cardiovascular event rates beyond four years, suggesting that five years of follow-up may be insufficient if the benefits of more intensive therapy accrue over the long term as in the UKPDS study.

But Griffin’s group cautioned that they could not rule out chance findings.

The low event rates in both groups — half what had been expected — left the trial underpowered, potentially obscuring benefit from intensive therapy, the commentary noted.

Also, participating primary care practices may have been those more motivated to improve their quality of diabetes care, “such that the routine care delivered in the trial might not be representative of routine care elsewhere,” it added.

The quality of care in the routine primary practice group may just have been too good, the researchers agreed.

Diet, Metformin Cut Medical Cost for Prediabetes Patients

People with prediabetes can save thousands of dollars in medical costs by taking the diabetes drug metformin or making lifestyle changes, a new study shows.

Treatment with the inexpensive drug metformin, which lowers blood sugar levels, reduced costs by $1,700 over a decade, the researchers say. Intensive lifestyle changes, such as participating in tailored weight loss and exercise programs, saved $2,600 per person.

The study also showed that people who ate right and exercised had the highest scores on quality-of-life questionnaires that measure physical and mental functioning.

The cost savings are in line with other standard prevention strategies such as childhood immunizations and beta-blocker treatment in people who have had a heart attack, says William Herman, MD, professor of internal medicine at the University of Michigan, Ann Arbor.

The interventions should be offered to all people at high risk of developing diabetes, he tells WebMD. About 79 million Americans have prediabetes and are at high risk, according to the CDC.

Herman presented the study here at the annual meeting of the American Diabetes Association.

The cost-savings analysis comes from seven years of follow-up to the three-year study called he Diabetes Prevention Program (DPP). The study was halted early when both metformin and lifestyle changes far outperformed placebo.

The DPP showed that 10 years of treatment with metformin lowered the risk of developing diabetes by 18%, while lifestyle changes reduced the chance by 34%.

The economic analysis showed that lifestyle strategies were more expensive to implement, costing about $4,500 per person over 10 years. Metformin cost about $2,000 over a decade.

The increased cost of lifestyle programs was offset by the $2,600 savings in medical care, which included money spent on doctor and hospital visits as well as on drugs, Herman says.

When dollars spent were weighed against money saved, metformin saved $30 per person over 10 years and the lifestyle intervention cost $1,500.

While no price tag can be placed on improved physical and mental well-being, the researchers also weighed in the finding that lifestyle changes were associated with better quality-of-life scores than metformin, Herman says.

“Compared to doing nothing, the metformin intervention is cost-saving for diabetes prevention, and the intensive lifestyleintervention, though not saving dollars over 10 years, is extremely cost-effective,” he says.
New Approach for Diabetes Prevention

The new analysis “is important because as soon as DPP was published, people said, ‘This is great but we don’t have the resources,’” Herman says.

Only one in 10 common prevention strategies — prenatal care and flu shots, for example — actually saves money, he says.

The cost savings in the new study included lower costs for doctor and hospital visits as well as for drugs.

“I’m really stunned by these findings,” says James Meigs, MD, of Massachusetts General Hospital in Boston. “They could revolutionize the way we approach diabetes prevention.”

Most people prefer making exercise and dietary changes to taking a drug, says Meigs, who was not involved with the research.

In the study, the focus of the lifestyle intervention program was on losing and maintaining a 7% loss in body weight and 30 minutes a day of brisk walking, five times a week, or its equivalent, according to Herman.

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Diabetes Prevention News: Diabetes forum on Rota draws crowd

2011-06-01 / Diabetes / 0 Comments

Diabetes forum on Rota draws crowd

A total of 110 residents of Sinapalo and Songsong Villages on Rota took part in the third CNMI-Wide Diabetes Health Community Forum: Highway to Better Health held at the Mayor’s Office on May 19.

Organized by the Commonwealth Diabetes Coalition in collaboration with the Diabetes Prevention and Control Program of the Department of Public Health and the Ayuda Network, the event was part of a six-part series of community-wide forums that aims to educate the public about diabetes health and prevention.

The goal of the community-wide forums is to involve the “taro roots” to address the need for systems changes, and combat the prevalence of diabetes, non-communicable diseases, obesity, cancer, and poor health lifestyle choices in high-risk populations through targeted social and behavioral strategies.

“The participants were very active in the group discussions and activities,” said Vinycia Seman, Coalition Education and Outreach Committee chair.

Seman said the Rota presenters were Dr. David Hardt, Dr. Jang Ho Kim, Jonathan Kiyoshi of the Northern Marianas College CREES Food Science Program, and Rosa Palacios of the Hinemlo Familia Network.

According to Seman, they gave away incentives to participants such as backpacks, T-shirts, pens, and safety kits as well as healthy lunches.

Seman added that they raffled off prizes, including $20 gas certificates, T-shirts, flash drives, Coral Ocean Point golf passes, PIC Water Park passes, and gift certificates from Herman’s Modern Bakery and Serenity Salon.

“We hope that the people of Rota can instill what they have learned from this community forum and live a better and healthier life. Diabetes can be prevented if we live healthier lifestyles by eating healthier foods and staying active,” she told Saipan Tribune.

Seman said the coalition thanks all the exhibitors, sponsors and supporters, including Ike Mendiola of the local Channel 5 for airing the interview about the event, who all made the forum a successful event.

Diabetes research shows promise

In the past two weeks, we have been considering some of the challenges that people with type 1 or 2 diabetes face on a daily basis. I was, therefore, most interested to attend a lecture on “Nutrition in the Prevention and Treatment of Diabetes: Science and Mythology”, arranged by the Academy of Science of South Africa (ASSAf) a few weeks ago. The lecture was presented by Jim Mann, Professor in Human Nutrition and Medicine, University of Otago, Dunedin, in New Zealand. Prof Mann, is one of the world’s leading experts in nutrition and its effects on diseases of lifestyle, including diabetes. Prof Mann was visiting South Africa as a guest of North-West University, who have bestowed an Honorary Doctorate on him for his contributions to nutrition.

Historical background

In his introduction, Prof Mann briefly outlined the history of diabetes and its treatment. This disease was known as far back as 400 BC and is mentioned in ancient Chinese texts. In 1889, a Dr Schmée diagnosed type 1 diabetes for the first time and prescribed a low carbohydrate diet for his patients, an approach that persisted for the next 100 years. From what my readers report to me, many doctors and healthcare professionals still only say, “Cut out all sugars and carbohydrates” when they counsel their diabetic patients.

In the 1970’s, a researcher called Hugh Trowell, for the first time suggested that diabetics could eat carbohydrates provided they were rich in dietary fibre. Dr Trowell based his recommendations on the observation that populations eating traditional diets which were rich in plant fibre and relatively high in carbohydrate, had a low incidence of diabetes compared to populations eating western diets containing an excess of highly processed low-fibre foods.

Subsequently a number of scientific studies have produced results showing that diabetics can use carbohydrates in their diet, provided such carbohydrates have a high dietary fibre content and are of the correct type (see below).

Finnish Study

Prof Mann also described the Finnish Diabetes Prevention Study (DPS), which was conducted with 522 middle-aged, overweight subjects with impaired glucose tolerance. The study achieved significant results that can be applied in everyday life (Lindström et al, 2003) . The goals of the DPS were as follows:
to decrease the body weight of the participants by 5% or more
to get participants to do moderate physical activity of 30 or more minutes a day
to reduce the subjects’ intakes of dietary fat and saturated fat significantly
to increase their dietary fibre intake to 15 g or more per 1000 kcal (a man consuming 2000 kcal per day, would thus be expected to eat 30 g of fibre a day)

The subjects in the DPS were divided into two groups – an experimental group that received intensive lifestyle interventions (individual dietary counselling from a dietician, circuit-training and exercise advice) and a control group who received standard medical care (Lindström et al, 2003).

Prof Mann emphasised the success of this Finnish study, where those subjects who had achieved at least 3 of the above mentioned goals, did not develop type 2 diabetes even 15 years after the initial intervention. The two most important interventions were identified as weight loss and increasing dietary fibre intake.

Perhaps the most encouraging result of the DPS was the finding that type 2 diabetes is the most preventable of all the lifestyle diseases!

What type of carbs should diabetics eat?

According to Prof Mann, it is important for diabetics to eat the right kind of carbohydrate, such as legumes (cooked or canned dry beans, peas, lentils, soya) and pulses, chickpeas, low-GI (glycaemic index) bread, and low-GI vegetables.

In other words, the old idea that all so-called “complex” carbohydrates benefit diabetics by keeping their blood sugar and insulin levels low and steady, such as high-fibre carbohydrates (wholewheat bread, high-bran breakfast cereals, etc), is no longer valid. Prof Mann pointed out that the idea that complex carbs are “good” and simple carbs are “bad”, has been disproved with the introduction of the glycaemic index (GI). So if you are diabetic, it is important to select carbohydrates with a low-GI-value, such as the ones listed above.

Australian study

Other aspects of the dietary treatment of patients with diabetes or insulin resistance, are also being investigated. It has been suggested that the type of fat used in the diet (saturated, polyunsaturated or monounsaturated), can also have an important effect on insulin reactions.

Researchers working in Australia, have investigated the effect of substituting carbohydrates with either monounsaturated fat or protein (Luscombe-Marsh et al, 2005). In this study, 57 overweight or obese subjects with insulin resistance were either given a low-fat, high-protein diet or a high-fat (mainly monounsaturated fat), low-protein diet for 12 weeks, to study the effects of the 2 diets on weight loss, blood fats, appetite regulation and energy output after each test meal.

The results showed that there was no significant difference between the amounts of weight the two groups lost – the low-fat, high-protein subjects lost 9.7 kg, while the high-monounsaturated fat, low-protein subjects managed to lose an average of 10.2 kg in the 12-week study period. However, the low-fat, high-protein diet did suppress appetite to a greater extent than the high-fat, low-protein diet.

The researchers concluded that the weight loss and improvements in insulin resistance and other risk factors (e.g. risk of heart disease due to increased blood fat levels), were similar on both diet treatments and that neither diet affected bone turnover or kidney function negatively (Luscombe-Marsh et al, 2005).

It may thus be a good idea for diabetics to use monounsaturated fats in their diets to replace other sources of fat. Avocados, nuts and olives; olive, canola, grapeseed, peanut, sesame, safflower and avocado oils, as well as foods made with these oils, are rich sources of monounsaturated fats.

Different population GI responses to foods
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Prof Mann also cautioned that different populations may exhibit different blood sugar and insulin reactions to foods. A study which compared the glycaemic response of people of European and Chinese ethnicity, found that on average the GI of parboiled rice in the Chinese subjects was 20% higher than in the Caucasian group: an average GI of 72 was obtained with the Chinese subjects, compared to an average GI-value of 57 with the European subjects, which would make parboiled rice a high-GI food for the Chinese subjects, while it can still be regarded as a low-GI food for the subjects of European descent.

This indicates that it is important to determine the GI of foods in different populations, particularly staple foods that are used as the basis of a specific population’s diet (rice in China and other Eastern countries, maize meal in large parts of Africa, including South Africa).

It is good to know that scientific researchers are hard at work trying to improve the lives of patients with insulin resistance, and types 1 and 2 diabetes. The most encouraging news is that type 2 diabetes can to a large extent be prevented by losing weight, increasing the intake of dietary fibre from legumes, pulses and low-GI foods, and doing some physical exercise as often as possible.

Camp held for youth at risk of diabetes

Qatar Diabetes Association has organised an “At Risk Camp” for students and overweight teenagers with first degree family history of diabetes.
Some 20 overweight teenagers took part in the event.
QDA is at the forefront of efforts in Qatar and the Middle East to promote the prevention, care and management of diabetes.
The association’s effort in prevention field has increased in recent years due to the dramatic increase in the incidence of obesity and diabetes in Qatar, the region and worldwide.
QDA executive director Dr Abdullah al-Hamaq said: “Our aim is to influence young people and youth to take small steps so they can get big rewards. These steps include ‘eating healthy’ by focusing on eating less and making healthy food choices like eating more vegetables and fruits, cutting down on fatty and fried foods.”
Other steps such as “move more” by walking, swimming or playing ball also matter, he said.
“We want to help them achieve their full potential, set goals they can meet and have the power to cut their chances of getting diabetes as well as to spread awareness about diabetes prevention among their families,” Dr al-Hamaq said.
QDA senior dietitian Katie Nahas said: “The camping programmes consisted providing the participants with a healthy diet with reduced calorie accompanied with an active exercise schedule aimed at initiating weight loss.”
In addition, Nahas mentioned that counselling sessions were also included to assist the adolescents in their difficulties to initiate and maintain behavioural changes.
She added that QDA will maintain a monthly follow up with few of the participants who were at risk group.
Camp manager Mohamed Saadi mentioned that the camp was run by a team of professionals made up of various committees that include medical, nutrition, activities and programmes, public relations and safety personnel.

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Diabetes Treatment News

2011-04-28 / Diabetes / 0 Comments

MU researchers pioneer animal diabetes treatment

Studies show the incidence of diabetes in dogs has increased 200 percent over the past 30 years. Now, University of Missouri veterinarians have changed the way veterinarians treat diabetes in animals by adapting a device used to monitor glucose in humans.

Dogs are susceptible to type 1, insulin-dependent diabetes. Affected animals are unable to utilize sugar in their bloodstream because their bodies do not produce enough insulin, a hormone that helps cells turn sugar into energy. Veterinarians treat animals with this type of diabetes similarly to the way humans are treated, with insulin injections and a low-carbohydrate diet.

Amy DeClue, assistant professor of veterinary internal medicine, and Charles Wiedmeyer, assistant professor of veterinary clinical pathology, have been studying the use of a “continuous glucose monitor” (CGM) on animals since 2003. A CGM is a small flexible device that is inserted about an inch into the skin, to constantly monitor glucose concentrations.

“Continuous glucose monitoring is much more effective and accurate than previous glucose monitoring techniques and has revolutionized how veterinarians manage diabetes in dogs,” said DeClue. “The CGM gives us a complete view of what is happening in the animal in their natural setting. For example, it can show us if a pet’s blood glucose changes when an owner gives treats, when the animal exercises or in response to insulin therapy.”

CGMs have become more commonly used in dogs with diabetes that are not responding well to conventional treatment. The monitor provides detailed data for glucose concentrations throughout the course of three days in a dog’s usual environment, so veterinarians can make better treatment decisions. Previously, veterinarians would have created an insulin regimen based on a glucose curve by taking blood from the animal in the veterinary hospital every two hours over the course of a single day. The glucose curve was often inaccurate due to increased stress from the animals being in an unnatural environment.

Dogs show clinical signs of diabetes similar to humans. Clinical signs include increased urination, thirst, hunger and weight loss. Typically, no direct cause is found for diabetes in dogs, but genetic disposition and obesity are thought to play a role in causing diabetes, according to DeClue. Just like people, dogs suffering with diabetes must be medically managed or complications can arise.

“Typically, dogs that are treated properly for diabetes go on to live a long, full life,” said Wiedmeyer.

“Actually, dogs with diabetes are similar to young children with diabetes but somewhat easier to manage. Dogs will eat what their owners give them at the same time each day and they won’t ask for a cupcake at a friend’s birthday party. With tools like the continuous glucose monitor to assist with disease management, the outlook is very good for a dog with diabetes.”

In the future Wiedmeyer projects that the device will become smaller and less invasive. In addition, he hopes device manufacturers develop a device that would monitor blood sugar levels remotely.

DeClue and Wiedmeyer’s most recent article on methods for monitoring and treating diabetes in dogs was published in the journal, Clinic in Laboratory Medicine.

Hospital to pioneer new diabetes treatment

Doctors from Hackensack University Medical Center hope to find a cure for diabetes as they embark on a partnership with one of the world’s leading researchers for the disease.

The hospital will be the first to try a procedure on humans with diabetes that is currently being tested on monkeys in Florida — a collaborative effort with Dr. Camillo Ricordi, a pioneer in the field and the scientific director and chief academy officer of the University of Miami Diabetes Research Institute.

“Dr. Ricordi wants to find a cure for diabetes, and he doesn’t care how many people are involved in the process or share in the credit,” said Dr. Michael Shapiro, Hackensack’s chief of organ transplantation and leader of the diabetes partnership. “This collaboration will do great things for diabetes research.”

Diabetes occurs when the body cannot produce or properly use insulin, a hormone that helps the body metabolize glucose into energy and control blood sugar levels.

With Type 1 diabetes, sometimes called juvenile diabetes and the most serious form of the disease, the body’s immune system destroys the cells from the pancreas that make insulin, called islets. People with Type 2 diabetes make insulin, but their body doesn’t utilize it correctly and production of it typically declines as they age. More than 25 million Americans have diabetes, and about 3 million of those suffer with Type 1.

Health care experts expect the number of diabetics to increase dramatically, as obesity can trigger Type 2 diabetes and Americans continue to get heavier.

Living for years with unregulated blood sugar levels can cause a myriad of symptoms, some as severe as blindness, poor circulation that leads to limb amputation, and kidney failure.

Typical treatment for diabetic patients includes insulin pumps, injections and oral medications. Transplanting islets from deceased donors is sometimes effective, but it frequently triggers other complications because the islets need to be implanted in the liver. The number of organ donors also falls way short of the number of diabetics who would benefit from a transplant.

In this latest study with monkeys, Ricordi loads islets on a disc and then implants them in the abdomen, rather than in the liver.

“The challenge is we’re dealing with an autoimmune disease so we have to replace or get cells to regenerate that were destroyed,” Ricordi told dozens of HUMC executives, physicians and health care workers this week. “And the key is to do this without a lifelong regimen of autoimmune rejection drugs.”

Based on the success with the primates, Shapiro is hoping to have four patients undergo the procedure in early 2012, though recruitment hasn’t begun. The ideal patients will be those who aren’t responding to other treatments.

Physicians attending the announcement highlighted Ricordi’s expertise and advances in treatment of the disease.

His creation, the Ricordi Chamber, is so well-known in the field that it was mentioned in a recent episode of the medical drama “Grey’s Anatomy.” Critical for a transplant, it is able to efficiently separate islets from the pancreas.

But successfully transplanting the islets will only be part one of the cure. Researchers need to figure out how to create islets in the lab so there will be enough to treat all diabetic patients who need them. Another research team is working on that endeavor in the Miami institute.

Still, the partnership has hospital executives determined and diabetic patients hopeful.

“I’m absolutely sure we’ll find a cure,” said Robert Garrett, president and chief executive of HUMC.

Stephanie Stone, who was diagnosed with diabetes at 10 and is now 18, attended the announcement with her Franklin Lakes, N.J., family.

“I’m optimistic for the future,” Stephanie said. “If this isn’t a cure, it sounds like it’s a better treatment before a cure is found.”

CeQur Develops Diabetes Compliance Device

An important drawback of current diabetes treatment regimens is patient compliance, particularly for insulin injections that are painful and must also be timely administered. CeQur has developed an innovative technological platform to address this concern, actualizing a minimally invasive wearable drug patch infuser that provides relatively painless, continuous subcutaneous delivery of insulin in basal doses, as well on-demand doses at the push of a button. The company’s minimally invasive subcutaneous route of drug administration precludes the use of the existing injection-based insulin regimens that are burdensome to patients due to their painful nature, which can significantly lower patient compliance. The company has shown through clinical trials that its technology accurately delivers insulin while improving patient comfort and compliance, and is currently waiting health board approvals.

Jim Peterson, CeQur President and CEO contends that insulin delivery devices and technologies are coming and will be a major help for people with Type II diabetes, a major help for them in overcoming the barriers to taking insulin properly and consequently living longer and healthier lives. “People have always known that there are four times as many Type II diabetics taking insulin as Type 1, and 80 percent of all insulin in the world is consumed by Type II diabetics,” he said in an interview for Mass Device last year. “However, the Type II diabetic population has been very under-served as far as technologies helping them with that struggle. It’s estimated that the market is easily a $2 billion marketplace for this new generation of products.”

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Diabetes Prevention Today

2011-04-14 / Diabetes / 0 Comments

State effort targets diabetes

Insurers and the Centers for Disease Control and Prevention aren’t willing to wait for Georgians to get a diabetes diagnosis before they change their lifestyles.

A leading cause of kidney failure and heart disease, diabetes costs the U.S. more than $170 billion annually, according to the CDC. Insurers across the country are experimenting with ways to prevent the chronic disease in those most at risk — hoping to curb the ballooning cost of care.

In Georgia, insurance giant UnitedHealth Group is partnering with the YMCA, the CDC and local pharmacists — a sometimes underutilized resource — to help its members lower their risk of developing Type 2 diabetes: by eating healthy, exercising and losing weight.

It’s part of a larger effort by the CDC to lay the groundwork for a nationwide diabetes prevention system it hopes other insurers and nonprofits eventually will join. Even those not at risk of diabetes could see a benefit if the effort lowers escalating health care costs for everyone.

“Lifestyle changes — even those that are modest — can make a dent,” said Dr. Catherine Palmier, chief medical director for UnitedHealthcare’s Southeast region. “As little as 10 pounds can make a difference.”

Nationwide, 25.8 million people — 7 million of them undiagnosed — suffer from the disease, and one-third of Americans could have it by 2050, according to the CDC.

When the new health care law goes into full effect in 2014, insurers will have to cover more people with chronic illnesses, giving them more of a stake in curbing the epidemic, experts say.

Insurers such as Aetna offer diabetes management programs, and Blue Cross Blue Shield of Georgia has bumped up its diabetes prevention efforts, which include health coaches, in recent years.

The cost involved in treating diabetes is unsustainable for society and is a natural area for health care organizations to build partnerships, said Rick Elliott, CEO of UnitedHealthcare of Georgia. “We’ve got to get people to live healthier.”

The disease is especially prevalent in the Southeast; 9.7 percent of Georgians had diagnosed diabetes in 2009, CDC data show.

UnitedHealth, which has 1.4 million Georgia members, is encouraging those most at risk of developing the disease to join the 16-week YMCA program, which is free to the insurer’s members. It will pay the nonprofit and Walgreens pharmacists for members they help. Delta Air Lines already has signed on to the program, which UnitedHealth also is working on in other states.

The effort is based on a prevention program tested by the National Institutes of Health and the CDC that showed people who lost 5 to 7 percent of their body weight could prevent or delay the onset of Type 2 diabetes — which is less severe than Type 1 — by 58 percent.

Pharmacists track blood work, cholesterol and other indicators, said Amy Elkareh, a local Walgreens pharmacist. “We also talk with patients about what they’re struggling with and what areas they feel like they need help with controlling.”

UnitedHealth also is tapping Walgreens pharmacists to counsel patients who already have diabetes on how to better manage it by properly using medications, monitoring blood glucose levels and other methods.

Insurers are increasingly focused on controlling chronic illnesses in part because employers are demanding it, said Tony Holmes, a partner in global consulting firm Mercer’s Atlanta office.

A survey by the firm showed companies that put a heavy focus on health management activities, such as wellness programs, had a 2 percent lower increase in year-over-year health care costs than those that didn’t, Holmes said.

UnitedHealth, which has 75 million members worldwide, has launched its diabetes programs in 10 states so far.

The CDC hopes bringing other insurers on board will help give 15 million Americans access to diabetes prevention programs by 2020, said Dr. Ann Albright, who heads the Division of Diabetes Translation.

The agency has invested $3 million in the project to get it started, but a sustainable funding source from third parties will be key to its success, Albright said. Other insurers and health care providers can contract with UnitedHealth or develop their own programs, she said. So far, Minnesota-based insurer Medica has signed on through an agreement with UnitedHealth.

It’s a complicated problem, she said. “It’s going to take a lot of us to do this.”


A YMCA program is a key element of UnitedHealth Group’s partnership with the Centers for Disease Control and Prevention. Here’s how it works:

— Participants meet one hour a week for 16 weeks, followed by monthly check-ins for a year. The program trains people to eat healthier and find ways to incorporate exercise into their day, such as taking the stairs instead of the elevator, said Kristin McEwen, Metro Atlanta YMCA group vice president. “We run through the day, and if it’s not scheduled, we can’t find time for it.”

— The program is free to UnitedHealth members. Non-UnitedHealth members can participate at a cost of $142 for YMCA members and $299 for nonmembers with financial assistance available.

Data Showing Use Of Tethys’ PreDx(R) Diabetes Risk Score Improves Medical Management And Outcomes In Patients At High Risk For Type 2 Diabetes

Data were presented today showing that utilization of the PreDx® Diabetes Risk Score (DRS) to accurately assess a patient’s risk of developing type 2 diabetes within five years results in more aggressive treatment and follow-up for diabetes prevention among patients whose test scores indicate high risk levels, as well as statistically significant improvements in their cardiometabolic risk factors, compared to patients with lower test scores and those not tested with PreDx DRS. The strong correlation among accurate risk assessment, risk reduction and improved medical outcomes suggests that utilization of PreDx DRS contributes to more careful diabetes risk monitoring and more effective preventive and therapeutic intervention than reliance upon traditional risk assessments.

The data were presented at the Fourth International Congress on Prediabetes and the Metabolic Syndrome, held in Madrid, Spain, in a presentation titled, “A Comparative Study of the Use of the Diabetes Risk Score (DRS) in Primary Care: How Are Medical Management and Patient Outcomes Affected?” authored by S. E. Conard, et al.

PreDx Diabetes Risk Score (DRS) is a multi-marker fasting blood test that assesses markers of inflammation, fat cell function, and glucose metabolism. The DRS categorizes individuals as low, moderate, or high risk for diabetes conversion within 5 years, and has been shown to be significantly more accurate than HbA1c or fasting glucose. Medical Edge Healthcare Group in Dallas, Texas, conducted the retrospective observational study using electronic medical records in order to evaluate the impact of PreDx DRS on clinical practice and patient care in a natural primary care practice setting.

“Today we face several challenges in diabetes prevention. Use of evidence-based interventions before disease diagnosis has been traditionally low, and with 79 million Americans already considered pre-diabetic, we have too many patients to treat effectively. This study provides strong evidence that PreDx DRS is not only a powerful risk assessment tool, but also an important prevention tool, enabling physicians to more effectively direct resources to patients with the greatest need for intervention, and motivating physicians and patients to employ preventive measures,” said Mickey S. Urdea, PhD, chairman and chief executive officer of Tethys.

“Careful monitoring of risk factors is essential to patient behavioral change and effective medical management,” said Scott Conard, MD, chief medical officer of Medical Edge. “PreDx DRS captures essential information about the physiology of our patients, and provides an easy-to-understand diabetes risk score which can contribute to enhanced monitoring of diabetes risk and the use of more appropriate preventive therapy for higher-risk individuals. The evidence showing that patients with high diabetes risk scores were more aggressively treated for risk factor control strongly suggests that these patients and physicians were more engaged in reducing risk factors when this test was applied.”

About the Observational Study and Results

The Tethys sponsored study included data on 696 patients age 30 or older who received the PreDx DRS test between June and December 2010 with valid test results and no prior diagnosis of diabetes. A total of 35 physicians ordered the PreDx test for at least one patient during this period. A control un-tested group was randomly selected in a 3:1 ratio to DRS-tested patients to match gender and age distributions from those who had at least one measurement of LDL, blood pressure, and weight in the 18 months prior to the reference date, and had no record of visiting a physician known to be ordering PreDx DRS tests. Biometric, diagnosis, and prescription records of all selected patients were extracted for the 18 months prior to the reference date of October 1, 2010 and all dates afterwards (mean follow-up 4 months).

Biometric measures included blood pressure, LDL, HDL, weight, HbA1c, triglycerides, fasting glucose, and HbA1c. Per-patient means were computed for the periods before and after the reference date. Diagnoses examined were hypercholesterolemia and hypertension. Prescriptions for anti-hypertensives, lipid-lowering agents, anti-diabetic agents, and aspirin written after the reference date were compiled. Differences in intensity of care between controls, and low, moderate, and high scoring DRS patients were evaluated by subsequent risk factor monitoring rates, use of pharmacological agents, and improvement in risk-factor control. P-values were computed using a two-tailed chi-square test.

Results showed:

– Patients who received the PreDx DRS test were more likely to have follow-up monitoring of biometric risk factors by a physician relative to similar patients who did not receive the test, including measurements of lipid and glucose control (p<0.001).

– Patients with high PreDx DRS diabetes risk scores were more aggressively treated for risk factor control than those with lower PreDx scores or no test, including use of aspirin, antihypertensive agents, lipid lowering therapies and other agents (p<0.01)

– There was significant improvement of risk-factors in patients who received the PreDx test, including weight, blood pressure, and cholesterol measures (p<0.001).

About Type 2 Diabetes

Type 2 diabetes mellitus is a major public health epidemic. According to the United States Centers for Disease Control and Prevention, diabetes affects nearly 26 million people in the United States or 8.3% of the population. Diabetes is the seventh leading cause of mortality in the US, a major cause of heart disease and stroke, and the leading cause of kidney failure, nontraumatic lower-limb amputations and new cases of blindness among adults in the US. The direct and indirect costs of diabetes in the U.S. exceeded $174 billion in 2007, including $58 billion in indirect costs (disability, work loss, premature mortality). Medical expenditures for people with diabetes are more than two times higher than for people without diabetes. Worldwide, in 2000, diabetes affected an estimated 171 million people and this figure is projected to rise to 366 million by 2030, propelled by increases in age, obesity, and urbanization of the world’s population.

In 2005-2008, based on fasting glucose or A1c levels, 35% of US adults aged 20 years or older had prediabetes (50% of those aged 65 years or older), In 2010, it is estimated that 79 million Americans aged 20 years or older had prediabetes. The Diabetes Prevention Program (DPP), a large prevention study of people at high risk for diabetes, showed that lifestyle intervention to lose weight and increase physical activity reduced the development of type 2 diabetes by 58% during a 3-year period. The reduction was even greater, 71%, among adults aged 60 years or older.

About PreDx® Diabetes Risk Score

The PreDx Diabetes Risk Score (DRS) provides enhanced risk stratification through the measurement of multiple biomarkers linked to pathways of diabetes progression. PreDx DRS was developed using a unique approach to quantifying biomarkers suspected of playing roles in diabetes development. Tethys methodology enabled evaluation of many biomarkers utilizing very small amounts of blood from select and well-characterized large study cohorts with known diabetes outcomes. The company then determined the combination of these biomarkers with an algorithm that best identified an individual’s risk of developing type 2 diabetes within five years. PreDx DRS has been validated by the Tethys Clinical Laboratory (TCL) in several large populations. The test uses standard immunoassay and clinical chemistry formats, sample collection and shipment methods. Currently performed exclusively by the CLIA-certified TCL, the test generates a Diabetes Risk Score between 1 and 10 that corresponds to an absolute percentage risk of developing disease within five years.

Tethys Snags U.S. Air Force Support for Big Diabetes Prevention Study

Tethys Bioscience is making a big bet as a company that it can help prevent people from getting diabetes. Now it has got some critical support to help it prove that idea.

Emeryville, CA-based Tethys is announcing today it has secured a partnership with the U.S. Air Force to see if the company’s PreDx test can help people avoid getting full-blown diabetes that can lead to a range of complications like blindness, heart attacks, and limb amputations. Air Force physicians, led by Lt. Col. Mark True, plan to enroll 600 pre-diabetic patients at six domestic Air Force bases. Half of the patients will get information on their diabetes risk at the beginning of a 12-week study, while the other half won’t. Researchers want to see whether this trial supports the idea that the Tethys test essentially scares patients into really changing their behavior, and improving their diet and exercise habits as a way of staving off diabetes.

The company isn’t disclosing the budget for the study, and isn’t saying when it expects to have results—although the study will require patients be followed for six months. It’s safe to say, though, that if this confirms some of the anecdotal reports that suggest Tethys is helping motivate some patients, then the findings could be a powerful new tool for Tethys, as it seeks to convince insurers that the test’s list price of $585 is justified.

Tethys has had some success already in the marketplace, based on data that says its test can identify who among the nation’s 79 million “pre-diabetics” who are likely to worsen over five years, and join the much riskier group of 25 million people with diabetes. Anything to reduce the number of diabetics could have huge implications for the U.S. health system. The total cost of diabetes in the U.S. is estimated at about $3.4 trillion in the 10 years through 2020, according to UnitedHealth, the nation’s largest health insurer.

Tethys, as I described in a feature earlier this month, has already had some success in its early days, selling about 27,000 of its tests in its first year and a half on the market. Last week, the company said it has sold 35,000 tests, meaning it sold about 8,000 tests in the first two and a half months of this year. We’ll see how big that number can go if Tethys can present hard evidence to insurers that its test changes behavior and can prevent a chronic, expensive ailment like diabetes.

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Diabetes Treatment News

2011-04-01 / Diabetes / 0 Comments

Bariatric Surgery coming into its own

Earlier this week the International Diabetes Federation (IDF) released a position statement regarding bariatric surgery as an option for Type 2 Diabetes and obesity. According to their distinguished panel of experts, bariatric surgery should now be considered an appropriate treatment option for people with Type 2 diabetes and obesity if treatment goals are not being met by the traditional medical therapies. But, having said that, if you have diabetes and are overweight, don’t rush out to book your surgery just yet. Do your homework on the subject, research your options and seek the advice of your endocrinologist prior to scheduling surgery. There are guidelines and criteria that should be met to be an eligible candidate for bariatric surgery.

Bariatric surgery is not one specific type of surgery, but rather a group of surgeries, all of which are used to treat obesity. Bariatrics is defined as the field of medicine that study’s and treats obesity. Three of the most common types of bariatric surgeries include: Gastric Bypass surgery, Adjustable Gastric Band surgery and Gastric Sleeve surgery (also referred to as Sleeve Gastrectomy).

Gastric Bypass surgery is the oldest of the group and therefore, is the type of bariatric surgery most people are aware of. It involves sectioning off a part of the stomach and rerouting the intestine to that segment of the stomach. Reduction in the stomach’s capacity results in a rapid weight-loss. However, one of the main drawbacks is that the procedure is permanent (non-reversible). Another major complication is nutritional deficiencies that are often associated with this type of surgery.

Adjustable Gastric Band surgery is another type of bariatric surgery that is performed macroscopically. It sections off a small pouch of the upper stomach using an inflatable band that can be adjusted to maximize the person’s weight-loss. The initial weight-loss is slower than with bypass surgery, but is also considered a less invasive procedure. A major benefit is that this type of surgery is reversible. Initial studies found gastric band surgery to be considered very successful. But complaints of weight regain and band complications have led to many people reversing the procedure and or being dissatisfied with the outcome. Band erosion and band slippage are common complications found in several long-term studies.

The final of the three is Gastric Sleeve Surgery. It is a relatively new procedure and is receiving a lot of attention, especially from dissatisfied gastric band patients. The procedure involves either removing part of the stomach (gastrectomy) or folding and suturing of part of the stomach (plication). The result is a smaller sleeve like stomach that holds less food and allows the patient to feel full with decreased caloric intake, which results in weight-loss. The plication technique has the advantage of being reversible, whereas, the gastrectomy approach is of course permanent.

All three of the procedures have received mixed reviews, but obviously the IDF experts feel it is a viable intervention for morbidly obese patients with type 2 diabetes. But, the patient must remember there is no magic bullet (or surgery) regarding weight-loss. Along with the surgery, a commitment to change one’s eating habits; exercise patterns and general lifestyle are crucial to long-term weight-loss success.

These surgical procedures are tools that may help a person lose weight and manage their diabetic condition, but it is imperative that the patient work closely with his or her medical team prior to surgery and during the post-surgical process. If you feel you fit the criteria (outlined by the IDF), make an appointment to see your endocrinologist regarding bariatric surgical options. The experts have stated their position: bariatric surgery is now a viable option in the treatment of type 2 diabetes and obesity, under certain circumstances!

Could the Treatment For Depression Be the Same As the Treatment For Diabetes?

For decades, physicians, mental health experts and individuals have struggled to find answers to the crippling problems of depression. Now, researchers have posed an interesting new theory: insulin.

Researchers at the University of Toronto stated Monday that intriguing new research seems to suggest that insulin has much more impact on the brain and mood disorders than previously thought.

A trial completed in early March at Mount Sinai Hospital in Toronto saw patients with depression being treated with nasal insulin rather than traditional methods. While it’s in the very early days, the results appear to be positive.

The issue with treating mental health is that even the most recent advances in pharmaceutical treatments are no more effective at treating or controlling depression than the drugs on the market in the 1950s. This new research seems to suggest that perhaps a wholesale alteration to treatment approaches are necessary. Part of the urge to point research in this direction was the fact that 50% to 75% of depression and bi-polar patients are either diabetic, obese or overweight. Other research has shown that insulin plays a significant role in the development of the brain and other neurological functions, said Dr. Roger McIntyre, a psychiatrist and University of Toronto researcher.

“If you step out of psychiatry and you look into another area, like diabetes, a condition defined by insulin problems, those individuals on the surface have many of the same problems that our patients have,” he said in the National Post. “They have lots of mood disturbances and cognitive changes and their brains are as affected as our patients.”

Given that this research is in its infancy, it will be years before enough trials can be run to determine a scientifically proven link, and even longer before effective treatments can be based on the research. Still, it’s a hopeful line of attack and one that could bode well for treatments in the future.

Omni Bio Pharmaceutical, Inc’s. CEO Issues Letter to Shareholders

DENVER, March 31, 2011 /PRNewswire/ — Omni Bio Pharmaceutical, Inc. (OTC BB: OMBP), today issued the following letter to shareholders of the Company:

To the Shareholders of Omni Bio Pharmaceutical, Inc.:

I am writing to you having completed my first month as the Chief Executive Officer of Omni Bio Pharmaceutical, Inc., (“Omni”). With our 2011 Fiscal year coming to a close, this is an appropriate juncture to update our shareholders on the basis for my optimism in your Company’s prospects, and to advise you of my initiatives to increase shareholder value. I intend to keep you updated periodically going forward, the timing of which will be dictated by substantive scientific or business developments.

As you may be aware, I served on the Scientific Advisory Board (“SAB”) of Omni for approximately two years prior to accepting the role as CEO of the Company, and I would like to provide you with my observations about the magnitude of this business opportunity and our progress. During my involvement with Omni’s SAB, I became aware of scientific research in animal models related to the potential uses of Alpha 1 antitrypsin (“AAT”) in numerous disease classifications. I believe the results of these animal models are compelling in terms of their potential significance if similar results can be obtained in a human population.

These studies, which were largely conducted by investigators not associated with Omni, but where Omni controls intellectual property, made it clear to me that the opportunity for Omni to advance its intellectual property into a number of additional disease classifications was significant and persuasive. When I was approached by your Board of Directors to assume the Chief Executive Officer role, I believed that Omni’s science had the potential to have a significant impact on human disease.

At this point in my career, I am interested in developing life changing therapies and I believe Omni’s opportunity provides that situation for me.

Omni is involved with the development of intellectual property related to methods of use patent applications and issued patents related to AAT, a human biological that is FDA-approved for the treatment of chronic obstructive pulmonary disease (“COPD”) and emphysema in AAT deficient patients. Because of the approximately 20 year history of AAT being used to treat COPD and Emphysema, AAT has a solid established safety record, and this assisted us in obtaining FDA clearance to begin our trial in Type 1 diabetes within 12 months of its submission to the FDA. We believe that our method of use patent applications will control the treatment of Type 1 diabetes utilizing AAT, should we obtain the requisite FDA approval.

Our most advanced program is our Phase I/II human clinical trial in Type 1 diabetes involving AAT in recently diagnosed patients at the Barbara Davis Center for Childhood Diabetes in Denver at the Anschutz Medical Campus of the University of Colorado Denver. For this trial, we are using a branded formulation of AAT which is being provided by an existing manufacturer. We initiated this clinical trial this past October, and are approaching completion of the young adult population’s infusion stage, before we move into pediatric patients.

Type 1 diabetes is a large market, there are over two million individuals with Type 1 diabetes in the United States, and we believe that 25-30,000 that have been recently diagnosed have residual islet function. There is no effective form of therapy currently available to the market to block this debilitating and life shortening disease. Based on the addressable market size and anticipated cost of the drug, this would approximate a potential US market of $700 million annually, which is larger than the existing market for AAT for the treatment of COPD and emphysema. Our plan is to sublicense our intellectual property rights for diabetes and our other intellectual property disease classifications to one or more of the existing manufacturers of AAT, hence avoiding the capital intensive investment in plant, equipment and associated sales force.

Although there is optimism about our study’s prospects within Omni, we are not alone in our optimism. The Immune Tolerance Network (“ITN”) has initiated a similar trial of AAT utilizing Aralast NP in Type 1 diabetics (http://www.retainstudy.org/). The ITN is a non-profit, government-funded consortium of researchers working together to establish new treatments for diseases of the immune system. The ITN was founded in 1999 by the National Institute of Allergy and Infectious Diseases (a part of the National Institutes of Health ) and receives support from the National Institute of Diabetes and Digestive and Kidney Diseases and the Juvenile Diabetes Research Foundation (“JDRF”). The ITN study follows on the heels of two failed Type 1 diabetes studies that had been funded by ITN utilizing other drugs. I consider the Immune Tolerance Network’s decision to invest their resources in this trial as an important endorsement of our concept that AAT is a promising therapy for Type I Diabetes.

In addition to the recently commenced ITN study, Israel’s Kamada, LTD recently filed for an IND utilizing their formulation of AAT on Type 1 diabetes. Kamada received FDA approval for its formulation of AAT this past summer and has become aware of our clinical trial in Type 1 diabetes over the past 15 months. We believe their filing an IND with the FDA is a clear indication that they believe the potential for AAT to treat Type 1 diabetes is significant.

Over the course of the past 12 months Omni has been invited to attend and/or present at a number of conferences which have included the Jefferies 2010 Global Healthcare Conference (New York), the 2011 JP Morgan Healthcare Conference (San Francisco), and the Biotech Showcase-2011 (San Francisco). These conferences have provided us with opportunities to meet with research analysts, investment bankers and potential industry collaborators for Omni. We intend to continue to pursue the regular attendance of investment conference opportunities in our next fiscal year.

In addition, I believe our intellectual property pipeline gives Omni other opportunities for commercialization. During the course of this year, we may initiate additional clinical trials, which are contingent upon the receipt of additional financing. Each of these trials addresses significant disease classifications with potentially larger markets than Type 1 diabetes. Indications such as transplant rejection and the prevention of graft vs host disease are likely to be areas that will gather the most impetus from Omni due to the ability to generate clinically relevant data in short periods of time.

I am enthusiastic about our prospects and look forward to reporting to you periodically on our progress.


James D. Crapo, MD

Chief Executive Officer

Omni Bio Pharmaceutical, Inc.

About Omni Bio Pharmaceutical, Inc.

Omni Bio Pharmaceutical, Inc. (www.omnibiopharma.com) is an emerging biopharmaceutical company formed to acquire, license, and develop existing therapies for indications with substantial commercialization potential. Omni Bio’s core technology and pipeline are based on issued and pending patents licensed from the University of Colorado Denver (“UCD”) and a privately held corporation surrounding the broader therapeutic potential of currently marketed therapies. One of Omni Bio’s lead development programs is evaluating an FDA-approved, off-patent drug, AAT, for the treatment of Type 1 diabetes. Novel discoveries made at UCD indicate that AAT has the potential to address a variety of indications in the areas of bacterial and viral disorders, biohazards, diabetes and transplant rejection. For additional information, please visit www.omnibiopharma.com.

Forward-Looking Statements

Some of the statements made in this press release are forward-looking statements that reflect management’s current views and expectations with respect to future events, including the expansion and commencement of clinical trials and the outcome and expenses of such trials. These forward-looking statements are not a guarantee of future events and are subject to a number of risks and uncertainties, many of which are outside our control, which could cause actual events to differ materially from those expressed or implied by the statements. These risks and uncertainties are based on a number of factors, including but not limited to receipt of adequate funding to expand and commence clinical trials; receipt of applicable regulatory approvals for clinical trials, the risks related to the ownership and enforceability of our licensed intellectual property necessary to conduct the clinical trials and the business risks disclosed in our SEC filings, especially the section entitled “Risk Factors” in our Annual Report on Form 10-K for the fiscal year ended March 31, 2010. We undertake no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.

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