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Volume 334:1612-1613 June 13, 1996 Number 24
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Metformin-Associated Mortality in U.S. Studies

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 by DeFronzo, R. A.
To the Editor: 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.

Six hundred two of these patients chose to enroll in the open study to receive . . . [Full Text of this Article]

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