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A correction has been published: N Engl J Med 2008;359(1):106.
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Background Metformin is a logical treatment for women with gestational diabetes mellitus, but randomized trials to assess the efficacy and safety of its use for this condition are lacking.
Methods We randomly assigned 751 women with gestational diabetes mellitus at 20 to 33 weeks of gestation to open treatment with metformin (with supplemental insulin if required) or insulin. The primary outcome was a composite of neonatal hypoglycemia, respiratory distress, need for phototherapy, birth trauma, 5-minute Apgar score less than 7, or prematurity. The trial was designed to rule out a 33% increase (from 30% to 40%) in this composite outcome in infants of women treated with metformin as compared with those treated with insulin. Secondary outcomes included neonatal anthropometric measurements, maternal glycemic control, maternal hypertensive complications, postpartum glucose tolerance, and acceptability of treatment.
Results Of the 363 women assigned to metformin, 92.6% continued to receive metformin until delivery and 46.3% received supplemental insulin. The rate of the primary composite outcome was 32.0% in the group assigned to metformin and 32.2% in the insulin group (relative risk, 0.99; 95% confidence interval, 0.80 to 1.23). More women in the metformin group than in the insulin group stated that they would choose to receive their assigned treatment again (76.6% vs. 27.2%, P<0.001). The rates of other secondary outcomes did not differ significantly between the groups. There were no serious adverse events associated with the use of metformin.
Conclusions In women with gestational diabetes mellitus, metformin (alone or with supplemental insulin) is not associated with increased perinatal complications as compared with insulin. The women preferred metformin to insulin treatment. (Australian New Zealand Clinical Trials Registry number, 12605000311651.)
Source Information
From National Women's Health, Auckland City Hospital, Auckland (J.A.R.); the National Institute of Public Health and Mental Health Research, Faculty of Health and Environmental Sciences, Auckland University of Technology, Auckland (W.G.); the Department of Pediatrics, University of Auckland, Auckland City Hospital, Auckland (M.R.B.); and the Diabetes Centre, Christchurch Hospital, Christchurch (M.P.M.) — all in New Zealand; and the Department of Obstetrics, Women's and Children's Hospital, University of Adelaide, Adelaide, Australia (W.M.H.).
Address correspondence to Dr. Rowan at National Women's Health, SMO Room, 9th Floor Support Bldg., Auckland City Hospital, Grafton, Auckland, New Zealand, or at jrowan{at}internet.co.nz.
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