Amylin, Eli Lilly, and Alkermes have announced long-term, interim results from the Duration-1 study that showed sustained glucose control with weight loss, as well as improvements in systolic blood pressure and triglycerides. The outcome was observed through two years of treatment with exenatide once weekly, an investigational therapy for type 2 diabetes.
A New Drug Application (NDA) for exenatide once weekly was recently submitted to the FDA.
In the study, patients received exenatide once weekly or Byetta (exenatide) injection for 30 weeks, followed by 74 weeks of treatment with exenatide once weekly for all patients.
65% of patients achieved an A1C of 7% or less. Body weight was significantly reduced, with patients losing an average of 5.8 pounds. Serum lipid profiles were significantly improved, and there was a significant reduction in systolic blood pressure (SBP).
Orville Kolterman, Senior Vice President of research and development at Amylin, said: “These two-year Duration-1 data showed that maintenance of steady state concentrations of exenatide may result in sustained improvements in glycemic control, with potential weight loss.”
“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,” he added.