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June 9, 2008
By: Tim Wright
Editor-in-Chief, Contract Pharma
Amylin Pharmaceuticals, Lilly and Alkermes announced results from a 30-week study comparing the efficacy of exenatide once weekly (a long-acting release formulation of exenatide) to Byetta (the injectable version of exenatide), in type 2 diabetes. Patients treated with exenatide once weekly, an investigational therapy, showed statistically significant improvements in A1c and fasting plasma glucose from baseline compared with Byetta. Patients in both treatment groups also reported significant weight loss (average of 8 pounds) and 77% of patients treated with exenatide achieved an A1c of 7% or less. 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. The 30-week study was randomized, open-label study of 295 patients with type 2 diabetes who were treated with exenatide once weekly 2.0 mg or Byetta twice daily subcutaneously. Patients in both groups who completed the randomized portion of the study continued in an open-ended portion of the study to receive exenatide once weekly. Exenatide once weekly uses a technology for long-acting medications developed by Alkermes, which encapsulates active medication into polymer-based microspheres that are injected into the body where they degrade slowly, gradually releasing the drug in a controlled manner to provide continuous therapeutic concentrations.
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