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news.Amylin Pharmaceuticals, Eli Lilly and Company and Alkermes have reported positive results from a phase II study evaluating a once-monthly injectable suspension formulation of exenatide on glycemic control in patients with type II diabetes.
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The randomised, open-label, phase II study evaluated the efficacy, safety and tolerability of three different doses of exenatide once monthly.
It also evaluated once weekly (exenatide extended-release for injectable suspension, proposed brand name Bydureon), another investigational type II diabetes therapy.
The study enrolled 121 adults who were randomised to receive 2mg weekly subcutaneous injections of Bydureon or subcutaneous injections of exenatide once monthly at a low, medium or high dose.
After 20 weeks of treatment, patients receiving exenatide once monthly treatment arms experienced average reductions in A1C ranging between 1.3 and 1.5 percentage points from baseline.
Patients in once-weekly Bydureon treatment arm, experienced a reduction of 1.5 percentage points.
A1C is defined as a measure of average blood sugar over three months.
Amylin, Lilly and Alkermes have collaborated to develop extended-release formulations of exenatide, including once-weekly Bydureon and exenatide once monthly.
Bydureon and exenatide once monthly are not currently approved by any regulatory agency.