Studies Show Effect of BYDUREON on A1C and Weight for Up to Three Years
DURATION-1 Three-Year and DURATION-3 84-Week Data Presented at ADA 2011
SAN DIEGO, June 24, 2011 /PRNewswire/ -- Amylin Pharmaceuticals, Inc. (Nasdaq:AMLN - News), Eli Lilly and Company (NYSE:LLY - News) and Alkermes, Inc. (Nasdaq:ALKS - News) today announced results from long-term extensions of the DURATION-1 and 3 studies evaluating BYDUREON™ (exenatide extended-release for injectable suspension), an investigational medication for type 2 diabetes. The studies will be presented at the 71st Scientific Sessions of the American Diabetes Association.
Data from the DURATION-1 study showed that after three years, patients receiving BYDUREON experienced a significant reduction in A1C (1.6 percentage points), a measure of average blood sugar over three months, and weight (5.1 pounds) compared to baseline. (BYDUREON is not being studied as a weight-loss product.) BYDUREON-treated patients also experienced improvements from baseline in several cardiometabolic risk markers, including systolic blood pressure (-2.1 mmHg), total cholesterol (-9.9 mg/dL), LDL cholesterol (-7.0 mg/dL) and triglycerides (-12 percent).
Separately, results from the DURATION-3 study showed that at 84 weeks, patients treated with BYDUREON experienced significantly greater A1C reduction from baseline, sustained weight loss and a lower risk of hypoglycemia than patients treated with Lantus® (insulin glargine). A1C reduction was 1.2 percentage points for BYDUREON compared with 1.0 percentage points for Lantus. Also, significantly more patients taking BYDUREON achieved an A1C of less than or equal to 6.5 percent. Patients on BYDUREON lost an average of 4.5 pounds while those on Lantus gained an average of 5.3 pounds, a difference of 9.8 pounds between the treatments.