Conference Gives Researchers the Opportunity to Strut Their Stuff

The 65th Annual American Diabetes Association Scientific Sessions

| Sep 1, 2005

Diabetes professionals from all over the world descended on San Diego, California, this past June for the 65th Annual American Diabetes Association Scientific Sessions. Some brought with them the latest drugs, meters, pumps and software. Others came armed with research.

Each year, the Scientific Sessions gives the ‘independent’ as well as the pharmaceutical-sponsored researcher the opportunity to showcase his or her hypotheses, study designs, results and conclusions. We share with you here a sampling of that research.

Dual-Action Muraglitazar—Is It the Next Big Type 2 Med?

Every year at the ADA Scientific Sessions, new research is presented that puts a drug or technology “on the radar” and suggests it is the “next big thing.” This year, that drug was muraglitazar, a novel dual PPAR alpha/gamma agonist, a member of the new class of type 2 oral medications called the glitazars with action to improve both insulin resistance and diabetic lipid disorders.

Researchers say that long-term (two-year) monotherapy with muraglitazar at doses of 1.5 mg and 5 mg effectively reduced triglycerides while also reducing non-HDL-C (total cholesterol minus HDL cholesterol) and increasing HDL cholesterol in participants with type 2 diabetes. This study focused on the lipid-regulating effects of muraglitazar rather than the drug’s action potential in decreasing insulin resistance and improving blood glucose control in type 2 diabetes.

In this multicenter study, 985 patients with type 2 were given doses of either 1 mg or 5 mg of muraglitazar or 15 mg of Actos (pioglitazone, a PPAR gamma agonist). At the study’s outset, all participants had inadequate blood glucose control on a regimen of just diet and exercise alone.

For participants on 5-mg doses of muraglitazar, there was a 22.4 percent reduction in triglycerides, 28.9 percent increase in HDL cholesterol and an 11.3 percent decrease in non-HDL cholesterol. Participants on 15 mg of Actos had a 12.3 percent reduction in triglycerides, a 17.7 percent increase in HDL cholesterol and an 8.8 percent decrease in non-HDL cholesterol. Muraglitazar was generally well tolerated and no safety concerns were observed.

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Clinical adviser’s note: The current class of type 2 oral meds known as “glitazones” that includes Actos (pioglitazone) and Avandia (rosiglitazone) are PPAR gamma agonists, which primarily improve insulin sensitivity but also have some lipid-regulating action. Some studies indicate glitazones also have anti-inflammatory action and possibly have the potential to prevent the loss of beta cell insulin-producing action in type 2s.

Pargluva (muraglitazar) will probably be the first of the new glitazar class of medications with dual PPAR gamma and alpha action to be approved by the FDA to help control both glucose and cholesterol levels in type 2 diabetes. Pargluva is a product of Bristol-Meyers, Squibb and Merck.

At the ADA Scientific Sessions, there was an oral presentation of a clinical study of another promising glitazar called Galida (tesaglitazar) in development by AstraZeneca.

Both Pargluva and Galida show possible side effects of edema (fluid retention) and some degree of weight gain as is seen with the glitazones Actos and Avandia.


Lantus May Be Better Twice Daily for Type 1s

Although its indication is as a once-daily basal insulin, researchers suggest that twice-daily administration of Lantus (insulin glargine) with a mealtime bolus of NovoLog (insulin aspart) may improve blood glucose although nighttime blood glucose concentration was higher with the twice-daily regimen.

In an eight-week study, 20 type 1s were randomized to once-daily Lantus injection at dinnertime or twice-daily Lantus injection at breakfast and dinnertime. Mealtime insulin was NovoLog.

Post-breakfast, post-lunch and pre-dinner blood glucose levels were lower with twice-daily compared with once-daily Lantus.

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Early Intensive Insulin Therapy May Improve Beta Cell Function in Type 2s

Type 2s who utilize intensive insulin therapy at the outset of their diagnosis can significantly improve beta cell function and facilitate further long-term blood glucose control.

Sixteen newly diagnosed type 2 diabetic patients with A1Cs over 8.5% were treated with multiple daily injections or twice-daily injections for an average of 11.3 weeks. Average insulin intake was 0.5 units/kg/day.

A1C fell from an average of 10.1% to 6%. During the periods of intensive insulin therapy, body weight remained unchanged and there were no critical hypoglycemic episodes.

Researchers suggest that if long-term controlled studies are performed to establish the mechanism and effectiveness, “intensive insulin therapy may [be] considered as [an] initial approach in new-onset type 2 diabetes.”

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Avandia/Metformin Combo Improves Kidney Function

Adding Avandia (rosiglitazone) to an oral medication regimen of metformin demonstrated beneficial effects on urinary albumin/creatinine ratio in people with type 2 with elevated microalbuminuria (protein in the urine).

Participants were randomized to the addition of 4 mg per day of Avandia or 5 mg per day of glyburide for eight months. With the Avandia/metformin combo, urinary albumin/creatinine ratio decreased 22.8 percent compared to 7.1 percent in the glyburide/metformin group.

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Diabetics Sweat Differently Than Nondiabetics

In a pilot study, researchers found that abnormalities in perspiration function in patients with diabetes are location-specific rather than generalized during isometric exercise.

Seven participants with type 2 were matched against a control group. Before exercise, sweat level was lower in all areas in subjects with diabetes. But during exercise, sweat was significantly higher in the forehead of subjects with diabetes than in the controls. It was the same in the chest and lower in the arms and legs.

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Aspirin May Slow Development of Retinopathy

Nonsteroidal anti-inflammatory drugs (NSAIDs) like aspirin may inhibit the development of early stages of diabetic retinopathy, according to researchers.

In a study on diabetic rats, 25 mg of buffered aspirin, 25 mg of salicylate or 150 mg of sulfasalazine was given in either food or water.

“Administration of each of these salicylate derivatives significantly inhibited the diabetes-induced increase in retinal capillary cell death and formation of acellular capillaries,” write the researchers

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Fructose-Sweetened Beverages Make Things Worse for Overweight People

In overweight people who drink fructose-sweetened beverages, circulating insulin and leptin levels are lower and plasma triglycerides are higher than when glucose-sweetened drinks are consumed.

Researchers speculate that this may lead to increased caloric intake and thereby contribute to further weight gain as well as atherosclerosis.

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Insulin Resistance Peaks at Breakfast

Type 2s who are not treated with insulin have exaggerated plasma glucose excursions for the first meal of the day despite increased pancreatic beta cell secretory products. This promoted researchers in the United Kingdom to speculate that increased morning high blood glucose in the patient group may be primarily due to changes in insulin sensitivity rather than beta cell dysfunction.

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Fish Oil Supplementation Benefits Obese Pediatric Patients on Low GI Diets

Inflammation markers decreased in obese pediatric patients who supplemented their low glycemic index (GI) diets with long-chain omega-3 fatty acids.

Researchers enrolled 30 overweight pediatric patients (10 to 18 years in age) in an intervention program that emphasized exercise and a low glycemic load diet supplemented with fish oil. After six weeks, the fish-oil group saw a 19 percent decrease in the C-reactive protein inflammatory marker while the ratio of arachidonic acid to eicosapentaenoic acid decreased 73 percent.

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Fiber Supplements Improve Metabolic Profile in Type 2s

Type 2s looking for an improvement in blood glucose levels and plasma lipid concentrations may want to consider upping their intake of dietary fiber—particularly of the soluble variety.

Researchers measured the effects of supplementing a diet with the fiber drink BiosLife 2. Seventy-eight patients with an average age of 59 were given 5 grams of soluble fiber in a drink two to three times daily 5 to 10 minutes prior to a meal.

After 90 days, before-meal blood glucose levels decreased 9.8 percent, while after-meal BGs decreased 14.7 percent. In addition, total cholesterol decreased 14.4 percent, and LDL (bad) cholesterol decreased 28.7 percent. HDL (good) cholesterol increased 21.8 percent and A1C decreased by 0.9 percent points.

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Chromium Supplementation May Improve Control

A small, randomized study of 27 type 2s, average age 59 years, treated with a sulfonylurea plus chromium picolinate or a sulfonylurea plus placebo found that chromium supplementation improved insulin sensitivity and blood glucose control. In addition, chromium improved body-weight gain and visceral fat accumulation when compared to the placebo group.

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Type 1 Kids With Good Parental Communication Have Better Control

Researchers emphasize that parent-child communication regarding diabetes care responsibility is important “to promote self-care behaviors and prevent elements of care without clearly assigned responsibility.”

Boston researchers assessed 42 adolescents, looking at measures of problem-solving ability, self-care behavior, delegation of diabetes responsibility between parent and child and hypoglycemia frequency.

Adolescents with poor parental communication regarding responsibility for diabetes care had lower problem-solving ability and trends suggesting poorer adherence to self-care. Hypoglycemic episodes, however, were lower in the group that had poor parental communication, which the researchers attribute to “underlying adolescent desire to avoid hypoglycemia in order to minimize embarrassment.”

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Sep 1, 2005

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