Exenatide Once Weekly Provided Sustained Improvements in Glycemic Control With Weight Loss Over Two Years: DURATION-1 Interim Long-Term Data Presented a...(ult in sustained improvements in glycemi...),Health

Date:6/7/2009

ult in sustained improvements in glycemic control, with potential weight loss," said Orville G. Kolterman, M.D., senior vice president of research and development at Amylin. "In DURATION-1, exenatide once weekly has been shown to provide superior glycemic control, with weight loss, compared to BYETTA. If approved, this therapy could fill an important unmet need for treating patients with type 2 diabetes with just one dose per week."

Study Design and Findings

The study enrolled 295 patients, with nearly 75 percent completing the two years of treatment. Baseline characteristics for these patients were: A1C 8.2+/-1.0%, FPG 168+/-43 mg/dL, body weight 223+/-41 pounds, BMI 34.8+/-4.8 kg/m squared, diabetes duration 7.1+/-5.3 years. Significant improvements in both A1C [-1.7+/-0.1%] and FPG [-40+/-3 mg/dL] were maintained after two years of treatment, body weight was significantly reduced [-5.8+/-1.2 pounds], serum lipid profiles were significantly improved [total cholesterol -8.6+/-2.8 mg/dL; LDL cholesterol -4.5+/-2.2 mg/dL; triglycerides -15+/-3 percent], and there was a significant reduction in SBP [-3.0+/-1.0 mmHg for all participants and -9.4+/-1.5 mmHg for those with abnormal baselines].

Safety Profile

Nausea was the most common event during the 30-week treatment period and decreased over time, occurring in 12 percent of patients during the 74-week assessment period when all patients were receiving exenatide once weekly. No severe hypoglycemia was observed. The safety profile of patients treated in this study was consistent with the previously reported profiles of BYETTA and exenatide once weekly.

About Diabetes

Diabetes affects more than 23 million people in the United States and an estimated 246 million adults worldwide.(i,ii) Approximately 90-95 percent of those affected have type 2 diabetes. Diabetes is the fifth leading cause of death by disease in the United Stat
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SOURCE Amylin Pharmaceuticals, Inc. Copyright©2009 PR Newswire. All rights reserved

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