Positive Ph II results for Metformin GR

DepoMed has announced positive interim results in a double-blind,positive-controlled Phase II study which compares its GR (Gastric Retention System) formulation of metformin to Bristol-Myers Squibb/Merck KGaA's Glucophage brand of the drug in type 2 diabetes.

The GR technology is designed to improve absorption and bioavailability of oral drugs through controlled release high in the gastrointestinal tract. Metformin GR was administered once-daily to patients with type 2 diabetes and compared to Glucophage, an immediate-release formulation of metformin, which was administered twice-daily. Analysis of the results showed that there was no statistical difference between the two products, but found comparable trends in all measures of glycemic control and tolerance and seemed to support the use of Metformin GR as a once-daily product for antidiabetic treatment. DepoMed's vice president of product development, Bret Berner, said: "we are very encouraged and now anticipate moving ahead rapidly with planning Phase a III program." The company expects to complete the study in July this year.