New Time-Released Brand of Metformin Well-Tolerated in Clinical Trials

DepoMed of Menlo Park, California, reported a second set of positive phase I data for its oral anti-diabetic drug Metformin GR. Data from a five-day trial enrolling 14 healthy volunteers suggest that 1000 mg of Metformin GR once per day is as well-tolerated as two doses per day of 500 mg Glucophage.

Metformin GR, an extend-release product, is still in its development stage. It is designed to provide an alternative to Bristol-Myers Squibb’s leading diabetes drug Glucophage, which requires twice-daily dosing.

Glucophage is scheduled to lose its patent this month.

Metformin GR is formulated using the company’s Gastric Retention (GR) delivery technology. Using normal physiological processes where the stomach retains large objects for further digestion, the GR System swells following ingestion and is retained in the stomach for a number of hours. Once in the stomach, the drug is released at a controlled rate.

A larger phase II trial of Metformin GR is scheduled to begin in the third quarter.

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