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 BYETTA® (exenatide) injection added to Lantus® (insulin glargine), which showed patients with type 2 diabetes achieved glucose targets without weight gain or increasing their risk of hypoglycemia. 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 BYETTA or placebo in addition to aggressive insulin titration. After 30 weeks of treatment, A1C decreased by 1.7 percentage points in patients adding BYETTA, compared with a decrease of 1.0 percentage point in patients treated with insulin alone. Weight decreased in patients adding BYETTA by 4 pounds, compared with an increase of 2 pounds in patients treated with insulin alone. Fasting plasma glucose and hypoglycemia were similar between treatment groups.
"Even in this population of patients who were poorly controlled on insulin therapy, the addition of BYETTA 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 hypoglycemia 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 BYETTA may provide a complementary addition to basal insulin for these hard-to-treat type 2 diabetes patients."
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: 208 pounds; A1C: 8.4 percent; diabetes duration: 12 years; insulin dose 48 units) who were randomized to BYETTA 10 microgramss A1C was < 8 percent or maintained if a patient's A1C was > 8 percent for five weeks, then titrated to achieve a target fasting glucose of < 100 mg/dL. Primary endpoint was change in A1C, a measure of average blood sugar over three months. Continuous glucose monitoring>
Nausea was the most common event during the 30-week treatment period and decreased over time. Nausea occurred in 41 percent of patients treated with BYETTA compared with 8 percent of patients treated with insulin alone. Hypoglycemia was similar for both groups; major hypoglycemia occurred twice in one patient receiving insulin alone.
Amylin Pharmaceuticals, Inc.