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QUESTION: Is glyburide as effective and safe as insulin in women with gestational diabetes mellitus?
Design
Randomised (allocation concealed*), unblinded,* controlled trial.
Setting
Maternal health clinics in San Antonio, Texas, USA.
Patients
404 women (mean age 29.5 y) who were between 11 and 33 weeks of gestation with a singleton pregnancy and who had gestational diabetes and fasting blood glucose concentrations ≥5.3 mmol/l and <7.8 mmol/l. Follow up was 100%.
Intervention
404 women were allocated to receive glyburide (n=201) or insulin (n=203). Glyburide was started at an oral dose of 2.5 mg and increased to 20 mg as needed. Insulin was started at a dose of 0.7 U/kg of actual body weight, given subcutaneously 3 times/day, and increased as needed. …
Footnotes
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Source of funding: not stated.
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For correspondence: Dr O Langer, Department of Obstetrics and Gynecology, St Luke's-Roosevelt Hospital Center, 1000 10th Avenue, New York, NY 10019, USA. Fax +1 212 523 8066.