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Positive Phase II Data Reported for Delayed-Release Metformin (NewMet) in Diabetes Patients

Efficacy comparable with that of Glucophage XR (October 21)

A 12-week phase IIb study has evaluated a delayed-release formulation of metformin (NewMet, Elcelyx Therapeutics) for the treatment of patients with type 2 diabetes. Previously, it was reported that the study had met its primary endpoint of a statistically significant reduction in fasting plasma glucose after 4 weeks of treatment with delayed-release metformin compared with placebo. The new 12-week data confirm the effect observed at 4 weeks.

The randomized, double-blind, dose-finding trial evaluated once-daily doses of delayed-release metformin (600, 800, and 1,000 mg) compared with placebo in 240 patients. Two unblinded reference arms consisted of Glucophage XR (metformin extended-release tablets, Bristol-Myers Squibb) dosed once-daily at 1,000 and 2,000 mg.

All delayed-release metformin arms showed efficacy comparable with or greater than that of Glucophage XR 1,000 mg. The metformin 1,000-mg dose was approximately 50% more effective than 1,000 mg of Glucophage XR and approximately 70% as effective as 2,000 mg of Glucophage XR. All doses of extended-release metformin and Glucophage XR prevented the increase in hemoglobin A1c (HbA1c) seen with placebo due to the washout of previous antidiabetic medications.

In previous studies, extended-release metformin, which is targeted to the lower bowel, reduced systemic exposure by as much as 65% compared with immediate-release metformin.

Source: Elcelyx Therapeutics; October 21, 2013.

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