FDAnews
www.fdanews.com/articles/75678-firms-announce-phase-ii-diabetes-study-results

FIRMS ANNOUNCE PHASE II DIABETES STUDY RESULTS

August 23, 2005

Amylin Pharmaceuticals, Eli Lilly and Alkermes have announced results from the ongoing Phase II multidose study of a long-acting release (LAR) formulation of Byetta (exenatide) injection in patients with Type 2 diabetes.

This Phase II, randomized, placebo-controlled, double-blind study includes 45 subjects with Type 2 diabetes who were not achieving adequate glucose control using diet and exercise with or without metformin. Subjects were randomized to receive 15 once-weekly subcutaneous injections of exenatide LAR at one of two doses or placebo. At this time, study participants have completed the active dosing period. Subjects will be observed for an additional 12 weeks with follow-up observations and data analyses ongoing. The companies anticipate that the full study results will be presented in a future scientific forum.