Metformin-Associated Mortality in U.S. Studies

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Abstract
The data submitted for the approval of metformin for use in the United States were from two 29-week clinical trials involving patients with non-insulin-dependent diabetes mellitus (NIDDM), reported by DeFronzo et al. (Aug. 31 issue),1 and one 2-year, unreported, open-enrollment study.2 One of the clinical trials was placebo-controlled, with 143 patients assigned to receive metformin and 146 to receive placebo. In the second trial, 210 patients were assigned to monotherapy with metformin, 213 to metformin plus glyburide, and 209 to glyburide alone.