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Once-Weekly BYETTA (Exenatide) LAR Improves Glucose Control in Patients with Type 2 Diabetes

Posted: Thursday, June 15, 2006

Reduces A1c by 2 points and average weight lose of 8 pounds in 15 weeks.

Amylin Pharmaceuticals, Inc. and Eli Lilly and Company (NYSE: LLY) and Alkermes, Inc. announced detailed results from a safety and efficacy study of the long-acting release (LAR) formulation of BYETTA(R) (exenatide) injection. Data from the study demonstrated that 86 percent of patients using the higher of two doses of the once-weekly formulation of exenatide were able to achieve recommended levels of glucose control, as measured by hemoglobin A1C (A1C) with an average improvement of approximately 2 percent compared to placebo.

The study was conducted in 45 patients with type 2 diabetes unable to achieve adequate glucose control with metformin or a diet and exercise regimen. The patients received a once-weekly subcutaneous injection of exenatide LAR (either 0.8 mg or 2.0 mg) or placebo. After 15 weeks of treatment there was a 12-week safety monitoring period during which no study medication was administered.

Dose-dependent improvements in A1C and weight loss were observed at 15 weeks. At the beginning of the study, the average A1C of study participants was approximately 8.5 percent. In subjects receiving the 2.0 mg dose of exenatide LAR, the average reduction in A1C was 1.7 percent compared to an increase of 0.4 percent in the placebo group. Those receiving the 0.8 mg dose improved with an average decrease in A1C of 1.4 percent.

In patients administered 0.8 mg or 2.0 mg of exenatide LAR, 33 percent and 86 percent achieved A1C levels of 7 percent or less, respectively. None of the patients given placebo achieved this target level of glucose control.

Fasting blood glucose levels were reduced by an average of 39 mg/dL in the 2.0 mg arm and 43 mg/dL in the 0.8 mg arm compared to an average increase of 18 mg/dL in the placebo group at week 15. Average fasting blood glucose level at the beginning of the study was 179 mg/dL. Patients who received 2.0 mg of exenatide LAR also experienced average reductions in body weight of 8.4 pounds at week 15 with no evidence of plateau at this point in time; body weight remained essentially unchanged for the 0.8 mg and placebo groups. The most frequent adverse event was mild nausea, experienced by 27 percent of subjects in the 2.0 mg dose group and 19 percent of subjects in the 0.8 mg dose group compared to 15 percent in the placebo group. No severe hypoglycemia was observed, and no subjects receiving either dose of exenatide LAR withdrew because of adverse events.

Exenatide LAR uses the proprietary Medisorb(R) drug-delivery technology developed by Alkermes. The technology encapsulates active medication into polymer-based microspheres that are injected into the body, where they degrade slowly -- gradually releasing the drug at a carefully controlled rate.

Exenatide LAR has not been approved by the FDA for marketing in the United States.

Source: Diabetes In Control: These study findings were presented at the 66th Annual Scientific Sessions of the American Diabetes Association (ADA) in Washington, D.C.