ORLANDO, Fla.--28 Jun--PRNewswire-AsiaNet/ InfoQuest
Study Presented at ADA 2010
Amylin Pharmaceuticals, Inc. (Nasdaq: AMLN) and Eli Lilly and Company (NYSE: LLY) today announced results from the first double-blind, placebo-controlled clinical study to evaluate exenatide injection added to insulin glargine, which showed patients with type 2 diabetes achieved glucose targets without weight gain or increasing their risk of hypoglycaemia. These findings were presented at the 70th Annual Scientific Sessions of the American Diabetes Association (ADA) in Orlando, Fla.
In the study, patients receiving insulin glargine, with or without oral agents, were randomized to receive exenatide or placebo in addition to aggressive insulin titration. After 30 weeks of treatment, HbA1c decreased by 1.7 percentage points in patients adding exenatide, compared with a decrease of 1.0 percentage point in patients treated with insulin alone. Weight decreased in patients adding exenatide by 1.81 kilograms, compared with an increase of 0.90 kilograms in patients treated with insulin alone. Fasting plasma glucose and hypoglycaemia were similar between treatment groups.
"Even in this population of patients who were poorly controlled on insulin therapy, the addition of exenatide to optimized basal insulin therapy provided exactly what we hoped for - improved control of blood sugar throughout the day, weight loss and no increased risk of hypoglycaemia as compared to optimized basal insulin treatment alone," said John Buse, M.D., Ph.D., Professor of Medicine, Director of the Diabetes Care Center, and Chief of the Division of Endocrinology at the University of North Carolina School of Medicine in Chapel Hill. "This study showed exenatide may provide a complementary addition to basal insulin for these hard-to-treat type 2 diabetes patients."
Exenatide is not currently approved for this dosing regimen. Results from this study will form the basis for a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA). The filing is planned for the end of 2010.
Study Design and Findings
The double-blind, placebo-controlled study enrolled 261 patients (mean age: 59 years old; weight: 93.89 kilograms; HbA1c: 8.4 percent; diabetes duration: 12 years; insulin dose 48 units) who were randomized to exenatide 10 micrograms (n=137) or placebo (n=122). Groups were generally comparable at baseline. Insulin dose was decreased by 20 percent if a patient's HbA1c was < / = 8 percent or maintained if a patient's HbA1c was >8 percent for five weeks, then titrated to achieve a target fasting glucose of