Amylin, Eli Lilly and Alkermes have announced that a long-term study using exenatide, an investigational therapy for type 2 diabetes just once a week showed sustained glucose control with weight loss, as well as improvements in systolic blood pressure and triglycerides.
The outcome was observed during a duration-1 study over two years of treatment with exenatide once a week.
During the study, patients received exenatide once weekly or a Byetta (exenatide) injection for 30 weeks, followed by 74 weeks of treatment with exenatide once weekly for all patients.
The results showed that 65% of patients achieved an A1C level of 7% or less. Body weight was significantly reduced, with patients losing an average of 5.8lb. Serum lipid profiles were also significantly improved, and there was a significant reduction in systolic blood pressure.
Amylin senior vice president of research and development Orville Kolterman said that the two-year duration-1 data showed that maintenance of steady state concentrations of exenatide may result in sustained improvements in glycaemic control, with potential weight loss.”
"If approved, this therapy could fill an important unmet need for treating patients with type 2 diabetes with just one dose per week," said Kolterman.
The companies have now submitted a New Drug Application for exenatide to the US Food and Drug Administration.