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Exenatide Once Weekly Provided Superior Glucose Control With Weight Loss Compared to Sitagliptin or Pioglitazone in Head-to-Head DURATION-2 Study
Date:3/31/2009

therapy that helps patients achieve A1C targets, with the added benefits of weight loss and no major hypoglycemia, could provide patients with an important option to improve their diabetes care."

"Together with our collaboration partners Lilly and Alkermes, we are pleased that exenatide once weekly met the primary endpoint of this superiority study and showed greater reduction in A1C than sitagliptin or pioglitazone. Additionally, from an average baseline of 193 pounds, at the end of the study patients on exenatide once weekly weighed an average of 14 pounds less than patients on pioglitazone and 4 pounds less than patients on sitagliptin," stated Orville G. Kolterman, M.D., senior vice president of research and development at Amylin Pharmaceuticals. "These data continue to build the value proposition for a once-weekly treatment that, if approved, has the potential to help patients improve their diabetes management."

"The results of this study provide us with more insight into the potential profile that may be achieved with exenatide once weekly," said Dr. Jim Malone, global medical director for exenatide, Eli Lilly and Company. "As we continue to progress through the series of DURATION studies, our goal is to clearly understand how exenatide once weekly compares to other diabetes therapies and be able to articulate, through the data, these differences to patients and their healthcare providers."

Over 80% of patients completed the study, and there was one withdrawal due to nausea in each treatment arm. There was no major hypoglycemia in any treatment group. The most frequently reported adverse events among exenatide once weekly and sitagliptin users were nausea and diarrhea. Upper respiratory tract infection and peripheral edema were the most frequently reported events by patients receiving pioglitazone.

Study Design

The 26-week double-blind, superiority study included 491
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SOURCE Amylin Pharmaceuticals, Inc.
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