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news.A phase III trial of Depomed's Glumetza, a once-daily metformin tablet for the treatment of type 2 diabetes mellitus, has shown that adding the drug to a sulfonylurea treatment regimen provided more effective glycemic control than the use of the sulfonylurea alone.
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“This is very important data that further support Glumetza as a potential first line choice for controlling diabetes,” said Dr Bret Berner, vice president, product development and chief scientific officer of Depomed. “We feel that Glumetza is a unique formulation of metformin that increases the potential of what this drug can offer. Glumetza leverages Depomed's AcuForm drug delivery technology, which is designed to enhance tolerability and reduce the gastrointestinal side effects associated with oral medications.”
The results, which were included in the company's new drug application approved by the FDA in June 2005, were published in a journal of the American diabetes association.
The trial involved 575 adult patients who were randomized to receive one of three treatment options with sulfonylurea in combination with Glumetza at varying doses or sulfonylurea alone.
There were significant decreases in mean HbA1c levels, a common measure of glycemic control, by week eight with each of the Glumetza/sulfonylurea combination regimens. Most importantly, the mean change from baseline to study endpoint at 24 weeks in the Glumetza/sulfonylurea combination regimen was significantly different from the sulfonylurea only treatment group.