Amylin Pharmaceuticals, Eli Lilly and Alkermes have reported positive results from a Phase II study that evaluated the effect of a once-monthly injectable suspension formulation of exenatide on glycaemia control in patients with type 2 diabetes.
The randomised and open-label study evaluated the efficacy, safety and tolerability of three doses of exenatide once-monthly.
It also evaluated once-weekly doses of exenatide extended-release for injectable suspension (proposed brand name Bydureon), another investigational type 2 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 of between 1.3 and 1.5 percentage points from baseline.
Patients in the once-weekly Bydureon treatment arm experienced an average reduction of 1.5 percentage points.
A1C is defined as a measure of average blood-sugar over three months.
Amylin, Lilly and Alkermes are collaborating 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.
