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After One Year, Type 2 Diabetes Patients Taking Exenatide Once Weekly Sustained Improvements in Glycemic Control and Weight; DURATION-1 Presented at ADA 2008
Date:6/9/2008

tion (ADA) in San Francisco.

BYETTA is indicated as adjunctive therapy to improve glycemic control in patients with type 2 diabetes mellitus who are taking metformin, a sulfonylurea, a thiazolidinedione, a combination of metformin and a sulfonylurea, or a combination of metformin and a thiazolidinedione, but have not achieved adequate glycemic control.

"Diabetes is a lifelong condition that requires constant management of blood glucose or blood sugar as well as weight. In DURATION-1 trial, patients significantly reduced their blood glucose levels and, on average, lost a total of over nine pounds. These improvements were sustained for a year," said John B. Buse, M.D., Ph.D., Professor of Medicine, Director of the Diabetes Care Center, and Chief of the Division of Endocrinology at the University of North Carolina School of Medicine in Chapel Hill. "Importantly, the study results also showed that steady-state levels of exenatide may result in improvements in a variety of glucose parameters. If approved, exenatide once weekly may provide patients with a treatment option that is on board 24 hours a day, seven days a week, helping to manage their blood sugar and, secondarily, their weight."

Study Design and Findings

The Diabetes Therapy Utilization: Researching Changes in A1C, Weight and Other Factors Through Intervention with Exenatide ONce Weekly (DURATION-1) study was a 30-week, randomized, open-label study of 295 patients with type 2 diabetes (baseline values: A1C 8.3%+/-1.0, FPG 169+/-43 mg/dL, weight 225+/-44lbs., BMI 35+/-5.0 kg/m2, diabetes duration 6.7+/-5.0 years; mean+/-SD) who were treated with exenatide once weekly 2.0 mg or BYETTA twice daily as outlined in the approved label subcutaneously. Following the first 30 weeks of treatment, 258 patients entered an open-label treatment with exenatide once weekly. Patients either remained on exenatide once weekly or switched from BYETTA to exenatide once weekly for an additional 22 weeks.
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SOURCE Eli Lilly and Company
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