Published data from post-marketing studies have not reported a clear association with metformin and major birth defects, miscarriage, or adverse maternal or fetal outcomes when metformin was used during pregnancy.

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a 29-week, double-blind, placebo-controlled study of glycomet gp metformin hydrochloride hydrochloride tablets and glyburide, alone and in combination, was conducted in obese patients with type 2 diabetes who had failed to achieve adequate glycemic control while on maximum doses of glyburide baseline fpg of approximately 250 mg dl see table 3 .

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a phase 4 trial mandated by the us food and drug administration fda and specifically designed to study adverse events of metformin use did not identify any cases from among 7227 patients.

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