Category: Diabetes 101

Mutinational pharmaceutical company Novartis recently announced at the 47th annual Meeting of the European Association for the Study of Diabetes that results from a recent study demonstrated that Galvus® (vidagliptin) is similar in safety profile to placebo when it is used in conjunction with other anti-diabetic therapies in patients who have Type 2 diabetes and moderate to several renal impairment. The study, sponsored by Novartis, also showed that vidagliptin significantly improved glycemic control when it was added to current therapies.

Vidagliptin, a dipeptidyl peptidase-4 (DDP-4) inhibitor, is the largest of its type. It is used to treat patients with Type 2 diabetes with moderate to severe renal impairment, a condition known to be difficult to treat.

The study was randomized, double-blind, parallel-group, and placebo-controlled. It was conducted across multiple facilities and lasted 24 weeks. The study tested vidagliptin 50mg qd for safety and tolerability among 294 patients who had moderate renal impairment and 221 who had severe renal impairment. The groups were randomized, receiving either vidagliptin or placebo.

Researchers used glomerular filtration rate (GFR) to measure the renal function of the patients. Moderate renal impairment was defined as < 30 mL/min/1.73m while severe impairment was defined as 30 to < 50.

The data produced by the study showed that safety and tolerability of vidagliptin 50mg in patients with both moderate and severe renal impairment was typically similar to placebo.

Adverse events in patients with moderate renal impairment were similar in those receiving placebo and vidagliptin (68% and 73%, respectively), while serious adverse events registered at 9% in both groups. Only 3% of the patients on vidagliptin developed adverse effects leading to discontinuation of the medication compared to 5% on placebo; 1% of both groups died during the course of the study.

Adverse effects in patients with severe renal impairment were similar to moderate renal impairment patients at 73% on vidagliptin and 74% on placebo. 19% of the serious renal impairment patients taking vidagliptin experienced serious adverse effects compared to 21% on placebo; 2% of the vidagliptin patients died compared with 4% of the placebo patients.

Patients in the moderate renal impairment group who were treated with vidagliptin showed slightly higher rates of hypoglycemia, comparable to those in the severe renal impairment and placebo groups; this confirms a previous report that vidagliptin is associated with a low risk of hypoglycemia.

“Safety is the primary concern in the treatment of patients with renal impairment and this study demonstrated strong safety results with vidagliptin, without compromising on efficacy,” said Ameet Nathwani, M.D., Global Head of Cardiovascular and Metabolism Development Franchise with Novartis Pharmaceuticals. “Renally-impaired patients are a particularly vulnerable and high-risk T2DM population3 with limited therapeutic options.”

Patients with severe renal impairment who took vidagliptin displayed a higher rate of infections and infestations than patients taking placebo. Most of the adverse effects reported in the study were mild or moderate.

Patients showed a statistically significant decrease in blood glucose levels when vidagliptin was added to other anti-diabetic therapies — 0.7% from baseline in patients with moderate renal impairment and 0.9% in patients with severe renal impairment. The once-daily 50mg dose of vidagliptin was most effective in patients with average renal impairment; patients with normal renal function saw maximum efficacy from taking two daily doses of vidagliptin 50mg.

Vidagliptin is a DPP-4 inhibitor that prevents the breakdown of incretin hormones, which are responsible for stimulating insulin production in the pancreas. It targets the dysfunction in islet alpha and beta cells in the pancreas that causes increased blood sugar levels for those with Type 2 diabetes.

A Phase III investigation of linagliptin (trade name Trajenta® in Europe) that lasted 102 weeks has shown significantly lowered blood glucose levels in adults who have been diagnosed with Type 2 diabetes. The results of the study were presented at the 47th yearly meeting of the European Association for the Study of Diabetes (EASD) by Boehringer Ingelheim and Eli Lilly and Company. The findings demonstrated that linagliptin, a DPP-4 inhibitor, showed a positive safety profile in addition to reducing HbA1c levels by 0.8% over a long term period in patients who were treated with the medication for the entire duration of the study.

The results showed not only the effectiveness of linagliptin, but its usefulness in the long term. “These results show that the efficacy achieved by linagliptin is reliable and meaningful in a clinical setting, but also that it is durable over the long term,” said Professor David Owens, Clinical Professor with the Department of Medicine at the Cardiff University School of Medicine in Wales, U.K. “This is especially important in chronic conditions such as type 2 diabetes.”

The data provided by the study demonstrates the effectiveness of linagliptin as well as the patients’ ability to tolerate it as a medication for Type 2 diabetes over a period of 102 weeks. Linagliptin was tested as a treatment by itself, as a dual treatment with metformin or pioglitazone, or as part of a multiple medication treatment along with metformin and sulphonylurea. After 24 weeks of blinded treatment, patients showed a reduction in HbA1c level of 0.8%; those results were durable, lasting throughout the remaining 78 weeks of the investigation. On average, the participants experienced a low incidence of hypoglycemic events while their body weight stayed about the same.

A separate investigation lasting 12 weeks demonstrated linagliptin’s effectiveness and durability when used as a dual medication in combination with metformin. The test used a group of patients who had been diagnosed with Type 2 diabetes and were taking uncontrolled metformin twice daily, a dose of 1500mg per day. The group was further split into two separate groups; one group took linagliptin 2.5mg twice daily — to simplify dosing, as the patients were already taking metformin twice daily — while the other group received linagliptin 5mg approved doses once daily. After adjusting for placebo, the results indicated that the two groups showed a comparable reduction in HbA1c, at 0.74% for the group taking linagliptin twice daily and 0.8% for the group taking the medication once daily.

“Linagliptin is a new treatment that is primarily excreted unmetabolised via the bile and gut, and so delivers reliable HbA1c reductions at one dosage strength for all patients, even for those with declining hepatic or renal function,” said Professor Anthony Barnett, a consultant physician with the Heart of England NHS Foundation Trust as well as Emeritus Professor of Medicine at the University of Birmingham in the U.K. “One dosage strength for all patients will help make the process of prescribing easier and more straightforward for physicians.”

The findings of the investigation demonstrate meaningful effectiveness of linagliptin, with good safety and tolerability markers, across patients with all types of Type 2 diabetes — from those who have been newly diagnosed with the disease to those with significant renal impairment.

Linagliptin was developed by Boehringer Ingelheim and is being marketed by Eli Lilly. Linagliptin inhibits DPP-4, an enzyme that degrades glucagon-like peptide 1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP).

The U.S. Department of Agriculture has long held the food pyramid in high esteem as a recommendation for the types of foods we should be eating and their ratios to other foods. Within recent months, however, the USDA has redesigned its nutritional recommendations in the form of a plate, with portions of vegetables, grains, protein, fruit, and dairy represented as “slices of the pie.” The new dietary recommendations, detailed by the USDA at www.myplate.gov, was praised by some and criticized by others.

The Harvard School of Public Health and Harvard Health Publications are two of the groups that have leveled criticism against the new “plate” initiative. In response, they have created the “Healthy Eating Plate,” their own version of the USDA’s food plate.

According to Walter Willett, professor of epidemiology and nutrition as well as chair of Harvard School of Public Health’s department of nutrition, the USDA’s “My Plate” initiative is “simple,” but it might be “too simple.”

“It doesn’t have the details necessary to make healthy food choices,” said Willett. The lack of detail in the types of foods that we should aim for mean that you could follow the advice from My Plate and still eat a “horrible diet,” according to Willett. “It’s pretty useless.” In response to the perceived lack of detail in the USDA’s My Plate, Harvard’s Healthy Eating Plate is more specific about the types of food that are being recommended.

As with the USDA’s plate, half of Harvard’s plate is made up of fruits and vegetables, with slightly more vegetables than fruit. However, the Harvard plate specifically notes that potatoes don’t count as vegetables in this situation — Harvard researchers recently conducted a study that associated potato consumption with increased weight gain over a long period of time.

The “grain” section is more clearly defined to mean “whole grains” such as brown rice, whole wheat bread and whole grain pasta instead of refined and processed grains such as white rice and bread. The “protein” area of the plate is also more specifically defined as “healthy proteins,” including poultry, beans, fish, and nuts, which limits consumption of red meat and recommends cutting out processed meats, bacon, and cold cuts entirely.

A glass of milk has long been held as a healthy drink, but the Harvard Healthy Eating Plate eliminates the serving of dairy that the USDA’s plate recommends, instead encouraging people to drink a glass of water, tea, or lightly-sugared coffee. According to Willett, the Healthy Eating Plate only has room for one or two servings of dairy per day.

The Harvard diet includes a bottle of oil to the side of the plate to represent the healthy unsaturated fats found in foods like olive oil. According to the Harvard plate, we should limit butter while trans fats should be eliminated completely. According to Willett, the USDA plate does not provide enough detail about “the type of fat that should be used when we put something on our bread, on our vegetables [or] when we bake or cook,” says Willett.

The Myplate.gov initiative seeks to simply the sometimes complicated process of choosing a healthy diet. Among the no-nonsense recommendations are eating less and avoiding oversized portions, eating at least half of your grains as whole grains, and drinking water instead of sugary drinks.

A registry analysis reports that patients who had been diagnosed with Type 2 diabetes and used insulin therapy to manage the disease were 19% more likely to die after a percutaneous coronary intervention than were diabetics who managed the disease through oral antiglycemic medication or with diet.

Even after researchers adjusted the results to account for the severity of the diabetes, the results remained the same. The findings were reported by Dr. Anna Norhammar with the Karolinska Institute of Sweden at the yearly meeting of the European Association for the Study of Diabetes.

“Patients with type 2 diabetes who are taking insulin are at a very high risk after cardiac angiography, especially if they have a history of previous myocardial infarction or renal complications,” said Dr. Norhammar. “We need to give these patients special attention and intensive handling.”

Dr. Norhammar’s research team used data on patients from two Swedish registries: the Swedish Coronary Angiography and Angioplasty Register (SCARR), which indexes all patients who have undergone those procedures, and the National Diabetes Registry, which holds data on about 70% of the Swedes diagnosed with diabetes. The research team identified 14,079 patients who had been indexed in both registries from 2001 through 2009; these patients were used to find the results of the study.
Patients were separated into four groups according to the type of treatment they received: those treated with diet alone, those treated with oral medications alone, those treated with insulin and oral medications, and those treated only with insulin.

The mean age of the patients was 69 years. The patients taking insulin only had the disease for an average of 15 years, while the patients who were being treated with therapies other than insulin had the disease for an average of 6 years.

Mean hemoglobin A1c in the patients rose along with the intensity of the treatment, from 6.5% in the group treated with diet to 7% in the group treated with oral medication to 7.8% in the groups treated with only insulin or with oral medication and insulin. The diet-only group had a 13% chance of developing retinopathy, compared to a 54% chance in the insulin-only group.
The insulin-only group also saw increased rates of heart failure (24%) compared to the other groups; the diet-only group was at 14% while the oral medication-only group was at 12% and the combination therapy group was at 17%. A significant number of the insulin-only group (39% of the patients) had suffered heart attacks while 29% of the diet-only group had such heart failure.

About 70% of the patients had been diagnosed with hypertension. The group treated with only insulin had a greater chance of developing renal insufficiency and peripheral artery disease, but the numbers were not statistically significant.

The patients’ angiographic results also varied according to the type of treatment they received. Of the patients treated with diet only, 22% had normal angiographic results; 17% of the insulin-only group had normal results. The insulin-only group had a higher rate of three-vessel disease, with 30% of the group developing the disease while only 23% of the diet-only group did the same.

After six months of treatment, the mortality rate was higher for the insulin-only group at 9%. Less intensive therapies indicated lower mortality rates, with the diet-only and oral medication group experiencing a 5% mortality rate and 7% for the combination therapy group.

By the four year mark, mortality in the insulin-only group was at 22% while the diet only group was at 15%; at the eight year mark, the insulin-only group’s mortality rate was over 50% while only 38% of the diet-only group had died.

Dr. Norhammar says it is unclear whether insulin-only treatment is directly responsible for the greater risks of disease and mortality or if it is simply a sign that the patient has a more advanced disease, which is likely to cause more complications and mortality.

That energy drink or the next can of soda you drink may not seem like it’s doing that much harm, but people are getting an enormous amount of calories from drinks today. While mankind lived for thousands of years on water alone, we now have a huge array of tasty (and sometimes seemingly healthy) beverages available every day, from fruit juices to soda to cappuccinos, and they all have the potential to flood our bodies with an enormous number of excess calories.

“It’s a huge problem,” says Katie Warwick, dietitian with the Toronto Western Hospital who works with patients who have received a recommendation for bariatric surgery. “A lot of our patients aren’t aware of how many calories they’re actually drinking. There’s the misperception that if it’s healthy, such as milk or juice, the calories don’t cause weight gain.” In other words, fruit juice may provide vitamin C and other important nutrients, but it also provides lots of energy in the form of calories, just as any other food does. And that extra energy can induce a caloric excess that causes your body to store fat.
Canadian beverage companies are beginning a two-year initiative that will emphasize the amount of calories contained in a drink right on the packaging. Similar companies in the U.S. have started a similar campaign.

Not only are we consuming more sugary and high-calorie drinks, but we’re consuming more of them in a single sitting. “For years the beverage industry considered 591-mL a multi-serve portion,” says Justin Sherwood, the president of the Canadian Beverage Association. “But our research shows that many consumers are now drinking it in one sitting.”

Data from Statistics Canada shows that middle-aged Canadian men in their 30s and 40s receive 16% of their daily caloric intake from liquids, while women receive 14.3% of their intake in liquids. In younger generations, it’s even higher: men in their 20s receive 20.4% of their calories from beverages and women 17.9%.

Those numbers are far out of line with what is considered healthy. According to Barry Popkin, a professor of nutrition at the University of North Carolina at Chapel Hill and leading obesity researcher, people should gain more like “between five and ten percent” of their daily calories from beverages.

It’s so easy to consume an excessive number of calories from beverages because they don’t activate the satiety mechanisms in our bodies the way solid foods do. The hormonal process from the gut signaling that we’re full is not fully realized when we consume calories in liquid form. Since we don’t feel full, we can consume hundreds of calories from a liquid and still feel like we need to eat some solid food.

According to Barry Popkin, “Our thirst mechanism developed separately from hunger so we could constantly drink water but eat only when food was available.” For thousands of years, mankind relied only on water; this evolutionary advantage has turned into a disadvantage as we have been exposed to tasty beverages that flood our bodies with extra calories.

Most of the offending beverages consist of simple sugars. These sugars move quickly through the gastrointestinal tract; they do not promote satiety or provide the fiber and fats that slow down digestion the way solid food does.

A recent study published in the New England Journal of Medicine found that the foods most responsible for contributing to the obesity problem include potatoes, potato chips, and high-sugar sweetened beverages.

The Juvenile Diabetes Research Foundation (JDRF) recently announced on September 14 that it is sponsoring a $100,000 Challenge, calling for the development of new methods for discovering and creating a glucose-responsive insulin medication for treating insulin-dependent diabetes. The JDRF is a global leader in promoting research and development in prevention and medication for Type 1 diabetes. The challenge is open to the public; it can be found at InnoCentive.com, a website that allows the global community to work together in solving problems across a wide variety of fields.

The JDRF is utilizing InnoCentive’s base of “problem solvers” to encourage the development of a transformative and sophisticated insulin medication for diabetics. The JDRF hopes that the drug will improve glucose control, reduce or eliminate the need for frequent blood sugar testing, and decrease the chances of long-term complications arising from diabetes.

The ultimate goal of the challenge is the development of a glucose-responsive insulin medication; such as a medication would only activate when the body requires it, releasing the proper amount of insulin into the bloodstream upon the detection of high blood glucose levels. It will also regulate blood glucose levels in diabetics while requiring only a single dose each day, or even less if possible.

According to Aaron Kowalski, Ph.D., assistant Vice President of Treatment Therapies at the JDRF, modern insulin treatments and blood sugar monitoring technologies place an unnecessary burden on diabetics. “Today, insulin treatment requires diligent monitoring and burdensome administration, often several times a day, every day,” says Dr. Kowalski. This remains the only way to regulate blood sugar levels for the millions of individuals with insulin-dependent diabetes worldwide. Although research has propelled the development of better and faster-acting insulins, the disease is still hard to control because of the way insulin is administered to patients.

What we need is sophisticated insulin that will take the guesswork out of managing diabetes by developing a novel insulin that works in the same way insulin works in people without diabetes. By fostering novel approaches from diverse problem Solvers within and outside the diabetes field, we hope this Challenge with InnoCentive will help speed progress toward the development of glucose-responsive insulin- progress urgently needed by people with diabetes.”

Dwayne Spradlin, CEO and president of InnoCentive, commented on the new project.

“JDRF is an organization that recognizes the importance of innovation in the healthcare industry,” said Spradlin. “This approach of looking beyond traditional researchers to gain new insights, ideas, and solutions illustrates their commitment to finding a better way to treat diabetes. We are excited to be partnering with JDRF finding new ways to enhance the quality of life for patients while helping patients better manage their disease.”

InnoCentive.com is a platform for connecting businesses or organizations looking for solutions (“seekers”) with interdisciplinary scientists and research groups who have the resources and capabilities to offer solutions (“problem solvers”). The platform is an “open source” model that encourages scientists from all over the world to offer their own solutions to the problems. Cash rewards are offered for the best solutions, typically in the $10,000 to $100,000 range. Solutions have come from countries all over the world, including the United States, Europe, Russia, India, China, and Argentina.

InnoCentive is based in Waltham, Massachusetts. The idea for the company came to its founders in 1998 and it officially launched in 2001.

Josefina Hernandez didn’t think that eating a bag of chips to prevent her blood sugar from dropping would be cause for getting fired. But Hernandez, who worked at a Walgreens in San Francisco, found her employment terminated when she did just that.

Hernandez, who has worked at Walgreens for 18 years as a cashier, was fired for eating a bag of chips so that her blood sugar wouldn’t drop too low. According to her attorney, Cindy O’Hara, Hernandez is a diabetic. “She reached for a piece of candy in her pocket. She didn’t have one so she grabbed a $1.39 bag of chips and ate some to raise her blood sugar to avoid an emergency,” said O’Hara.

According to O’Hara, the assistant manager of the Walgreens store noticed Hernandez grabbing the bag of chips. Hernandez was suspended for three days following the incident, then went on vacation.

But after returning from vacation, Hernandez said she was pulled aside, brought into the office, and terminated as an employee. She said that the management fired her because she ate the chips before she paid for them. However, she says she did pay the $1.39 that before the end of her shift.

O’Hara is an attorney with the U.S. Equal Employment Opportunity Commission. The Commission filed the lawsuit because it believes that incident is a clear case of discrimination against someone with a disability — in this case, diabetes.

“An employer has a duty to accommodate people who have disabilities and take that into account and in this case it was clear that the action that Ms. Hernandez took was because of a disability,” says O’Hara. Thus far, Walgreens has not offered any comment on the lawsuit.

According to the Americans with Disabilities Act, or ADA, employers are prohibited from discriminating against individuals with disabilities. The ADA recognizes diabetes as a disability, citing figures that nearly 17 million Americans over the age of 20 have been diagnosed with diabetes while over one million new cases of the disease are diagnosed each year. Individuals with diabetes can perform a variety of job functions, but according to the ADA, diabetics still receive discrimination from employers due to myths and stereotypes — such as the beliefs that diabetics are unable to drive, will require substantial sick leave, or will require frequent breaks. However, many diabetics work without restrictions or changes to normal schedules so employers typically aren’t even aware that employees have diabetes. Any accommodations that a diabetic may request, such as meal breaks, regular work schedules, and rest areas typically do not add any extra cost for the employer.

The Americans with Disabilities Act considers diabetes to be a “disability” when it “substantially limits one or more of a person’s major life activities” — activities that an average person can carry out with little or no difficulty, such as eating. Further, the ADA considers diabetes a disability when it causes adverse side effects that significantly limit a major life activity of the diabetic, even if the disease is currently being treated through diet, exercise, and insulin treatment and is no longer a limiting factor on those activities. Lastly, the ADA considers diabetes a disability if it does not affect the major life activities of an individual, but the individual’s employer treats him or her as if it does.

The ADA determines whether an individual’s diabetes is classified as a disability on a case-by-case basis.

Dr. Neal Barnard, president of the Physicians Committee for Responsible Medicine (PCRM) and author of “The 21-Day Weight Loss Kickstart,” believes that many of our modern-day problems such as obesity and diabetes can be traced to the high concentration of animal products and dietary fat to which we are exposed. A known author on vegan nutrition and vocal opponent of the high-fat Atkins diet, Dr. Barnard has been encouraging individuals to reduce their dependence on animal products and fat. With over two million books sold, Dr. Barnard is an often-quoted figurehead in the vegan community.

Dr. Barnard’s newest book is called “The 21-Day Weight Loss Kickstart,” and it’s based on the principles that the doctor has been promoting for years: switching to a plant-based diet and cutting out cooking oil, which Dr. Barnard claims will boost metabolism, reduce cholesterol, fight diabetes, and offer a slew of overall health benefits. The book is a 21-day guide to switching to a plant-based diet, offering recipes and tips for making the transition.

“The 21-Day Weight Loss Kickstart” is focused on making long-term, healthy changes to one’s dietary lifestyle. The diet isn’t concerned so much with counting calories or cardio as it is with simply eating healthy foods all the time. “If you look at other diets, they’re very short-term and artificial. If you go on the Atkins diet, which says don’t eat any fruit, no pasta, no cookies, no bread, it’s not realistic and it’s not healthy,” says Dr. Barnard. “Or if you go on a starvation regimen of eating just 800 calories a day, you just can’t [sustain that], and the weight inevitably comes back. But if you’re eating truly healthful foods, you don’t need to limit calories, carbohydrates or portions, and it becomes a one-way street towards weight loss.”

The vegan diet isn’t just good for reducing obesity, according to Dr. Barnard. He believes that it’s also an effective tool in fighting obesity and metabolic disorders such as diabetes, and that diabetes is caused by small amounts of dietary fat that build up in muscles and reduce the effect of insulin. “…the people who are the slimmest and live the longest and have the least occurrence of diabetes are people who are basing their diets on plant foods,” says Dr. Barnard. “In our research studies, it really does improve people’s diabetes, blood pressure and cholesterol. When it comes to diabetes, it’s fairly simple. The cause of type 2 diabetes is microscopic amounts of fat that build up in the muscle cells and stops insulin from working.” Since the plant-based diet advocated by The 21-Day Weight Loss Kickstart contains very little fat, any fat remaining in the muscle cells will “drain out” and allow glucose to enter the muscle cells where it can be used for energy, causing blood sugar levels to fall.

Dr. Barnard’s carbohydrate-heavy recommendation for a healthy diet might seem strange to most diabetics. In his description of a typical day’s diet, he describes eating several pancakes with syrup for breakfast then salad and pasta for dinner.

The 21-day diet plan is effective because it’s a long enough period of time for dieters to begin seeing the benefits of the plan. Beyond weight loss, Dr. Barnard says dieters could expect to see lowered cholesterol and blood pressure, increased energy, and increasing interest in the vegan diet as the days pass.

Amylin Pharmaceuticals, a biopharmaceutical company based in San Diego, CA, recently announced the results of clinical trials of its new medication, Bydureon. The medication was shown to encourage significant improvements in cardiovascular risk factors compared to patients who were prescribed other typical diabetes medications. Patients who had Type 2 diabetes and were treated with Bydureon showed improvements in body weight, blood pressure, and lipid levels. The results of the study will be presented at the annual meeting European Association for the Study of Diabetes (EASD) in Lisbon, Portugal. It will be the 47th meeting of the EASD.

“Patients with diabetes are at least twice as likely as people without the disease to have heart disease or a stroke. Having other chronic conditions including obesity, high blood pressure or high cholesterol further increases this risk,” says James Malone, M.D., global exenatide medical director for Lilly Diabetes. Commenting on the necessity of treating patients for complications often related to diabetes, Malone continued: “These data underscore the need to consider not only glycemic control but also the important role played by other medical conditions that are common among patients with type 2 diabetes.”

In one phase of the trial, patients received either Bydureon or Lantus in addition to metformin, or metformin plus sulfonylurea. After 84 weeks of this medication, the patients taking Bydureon showed improvements in several key areas. They had a significant reduction in body weight (9.8 pounds more than did the patients taking Lantus). They also met a composite endpoint of A1C less than 7% plus target systolic blood pressure (at less than 130mmHg) and LDL cholesterol (at less than 100mg/dL).

In another phase of the trial, participants were divided into groups and treated with one of four drug therapies: Bydureon, metformin, Actos, or Januvia. After analyzing the data, researchers found that participants taking Bydureon or metformin had a better chance of achieving composite goals than the patients treated with Actos or Januvia.

Among the side effects reported in the participants taking Bydureon, gastrointestinal events were the most commonly reported. However, the number of reported cases declined as the trial continued. In another phase of the study, patients taking Bydureon reported nausea and diarrhea as the most common side effects, which falls in line with previously reported adverse side effects of the drug.

Bydureon is the tentative name for exenatide extended-release, an injectable medication for Type 2 diabetes that delivers continuous therapeutic doses of exenatide with one weekly dose. Exenatide is the active ingredient in Byetta, which has been in use since 2005 in the U.S. and in 70 countries around the world as a medication for Type 2 diabetes. Byetta is also an injectable medication typically used in concert with a diet and exercise program to improve glycemic control in adults with Type 2 diabetes. It is also used in combination with metformin or a thiazolidinedione. The drug has been associated with some significant adverse side effects, including fatal and non-fatal hemorrhagic or necrotizing pancreatitis. It has been used by over 1.8 million patients since it was introduced.

Bydureon was granted marketing authorization in the European Union in June 2011. It is currently under review in the United States and is due for a Prescription Drug user Fee Action update in January of next year. The drug is already available in the United Kingdom and will be launching shortly in other European countries.

New research shows that there may be a good reason why you should chew your food thoroughly. According Masaaki Eto, M.D., a professor of clinical pharmacology and medicine with Ohu University in Koriyama, Japan, thoroughly chewing food stimulates the release of two intestinal peptides that serve a function in lowering appetite and reducing food intake in obese individuals. Dr. Eto presented the findings of the research at the 47th annual meeting of the European Association for the Study of Diabetes (EASD).

The study, performed on non-diabetic, obese individuals, demonstrated that when participants chewed their food thoroughly, they experienced postprandial increases in plasma glucagon-like peptide, known as GLP-1, as well as in peptide YY, known as PYY. Both peptides are released by L cells in the intestines.

According to Dr. Eto, the study was the first to analyze this occurrence in obese individuals. Dr. Eto presented a similar study at last year’s meeting of the EASD; however, that study was performed on normal-weight individuals.

GLP-1 stimulates the glucose-dependent secretion of insulin and encourages reduced food intake. GLP-1 and PYY are thought to be associated with regulation of triglyceride levels and plasma glucose as well as body weight. Plasma insulin and plasma levels of both peptides rise after a meal in normal-weight individuals, while plasma glucose stays about the same.

The newer study analyzed data from nine subjects (five male, four female); the mean age was 41 years. The mean body mass index (BMI) across the participants was 27.2 ± 0.4 kg/m2, which is considered obese in Japan: a BMI of 25 or over falls into “obese” territory in that country, while 25 would be considered “overweight” in the United States. The mean fasting plasma glucose level of the participants was 99 ± 2 mg/dL while mean blood pressure was 124/77 mm Hg.

The study required the participants to fast for 12 hours, after which they ate an early-morning breakfast consisting of steamed vegetables, a boiled egg, bread, margarine, a banana, and milk. The participants were instructed to stretch the meal out to 20 minutes by chewing each mouthful of food five times. Another test on a different day required them to chew each mouthful 30 times. The researchers measured plasma levels of GLP-1 and PYY before the meal and then one hour after.

According to Dr. Eto, the results showed that postprandial plasma levels of the two peptides were significantly higher when the participants chewed 30 times instead of five. He suggested that the thorough chewing of food could be an effective obesity control measure in overweight individuals.

Dr. Eto based his study on old advice from the Japanese government about chewing food thoroughly.

“In [Japan], 30 times chewing is recommended by the government to prevent obesity,” said Dr. Eto. “Increased incidence of obesity is a very, very [big] problem, so since the old days in my country, 30 times chewing was recommended.” He believes that well-chewed food acts on the intestine to encourage the release of the hormones, rather than the peptides being released by the mechanical action of chewing, as some suggested.

Session moderator Leszek Czupryniak, M.D., Ph.D., of the Medical University of Lodz in Poland, said that “what is interesting here is that if you eat something slowly and chew it slowly, the rate of absorption is much slower, and actually, the meal becomes longer. That probably changes the way any hormones are secreted.” Dr. Czupryniak continued on to say that the study’s results were useful in that the technique could be used in everyday life to help control weight in obese individuals.