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DURATION-6 Top-Line Study Results Announced
Date:3/3/2011

SAN DIEGO, INDIANAPOLIS and WALTHAM, Mass., March 3, 2011 /PRNewswire/ -- Amylin Pharmaceuticals, Inc. (Nasdaq: AMLN), Eli Lilly and Company (NYSE: LLY) and Alkermes, Inc. (Nasdaq: ALKS) today announced top-line results from DURATION-6, a head-to-head study designed to compare weekly BYDUREON™ (exenatide extended-release for injectable suspension), an investigational type 2 diabetes therapy, to daily Victoza® (liraglutide (rDNA origin) injection). Both drugs are members of the class of type 2 diabetes medications known as glucagon-like peptide-1 (GLP-1) receptor agonists.

This open-label 26-week, multicenter clinical study compared BYDUREON (2 mg weekly) to Victoza administered at the maximum approved dose of 1.8 mg daily. The study was designed to measure A1C, an assessment of average blood sugar, and to evaluate safety and tolerability.

Results showed that patients receiving BYDUREON experienced a reduction in A1C of 1.3 percentage points from baseline, compared to a reduction of 1.5 percentage points for Victoza. BYDUREON did not meet the pre-specified primary endpoint of non-inferiority to Victoza.

More than 85 percent of patients in both treatment arms completed the study. Gastrointestinal adverse events occurred more frequently among Victoza patients (nausea reported among 20 percent of patients, vomiting 11 percent, diarrhea 13 percent) compared with BYDUREON patients (nausea 9 percent, vomiting 4 percent, diarrhea 6 percent).  Injection site nodule occurred more frequently among BYDUREON users (10 percent) compared with Victoza users (1 percent). There were no major hypoglycemia events in either treatment group.  

Further evaluation of this data set is
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SOURCE Amylin Pharmaceuticals, Inc.; Eli Lilly and Company; Alkermes, Inc.
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