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Original Article
Volume 343:1134-1138 October 19, 2000 Number 16
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A Comparison of Glyburide and Insulin in Women with Gestational Diabetes Mellitus
Oded Langer, M.D., Deborah L. Conway, M.D., Michael D. Berkus, M.D., Elly M.-J. Xenakis, M.D., and Olga Gonzales, R.N.

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ABSTRACT

Background Women with gestational diabetes mellitus are rarely treated with a sulfonylurea drug, because of concern about teratogenicity and neonatal hypoglycemia. There is little information about the efficacy of these drugs in this group of women.

Methods We studied 404 women with singleton pregnancies and gestational diabetes that required treatment. The women were randomly assigned between 11 and 33 weeks of gestation to receive glyburide or insulin according to an intensified treatment protocol. The primary end point was achievement of the desired level of glycemic control. Secondary end points included maternal and neonatal complications.

Results The mean (±SD) pretreatment blood glucose concentration as measured at home for one week was 114±19 mg per deciliter (6.4±1.1 mmol per liter) in the glyburide group and 116±22 mg per deciliter (6.5±1.2 mmol per liter) in the insulin group (P=0.33). The mean concentrations during treatment were 105± 16 mg per deciliter (5.9±0.9 mmol per liter) in the glyburide group and 105±18 mg per deciliter (5.9±1.0 mmol per liter) in the insulin group (P=0.99). Eight women in the glyburide group (4 percent) required insulin therapy. There were no significant differences between the glyburide and insulin groups in the percentage of infants who were large for gestational age (12 percent and 13 percent, respectively); who had macrosomia, defined as a birth weight of 4000 g or more (7 percent and 4 percent); who had lung complications (8 percent and 6 percent); who had hypoglycemia (9 percent and 6 percent); who were admitted to a neonatal intensive care unit (6 percent and 7 percent); or who had fetal anomalies (2 percent and 2 percent). The cord-serum insulin concentrations were similar in the two groups, and glyburide was not detected in the cord serum of any infant in the glyburide group.

Conclusions In women with gestational diabetes, glyburide is a clinically effective alternative to insulin therapy.


Source Information

From the Department of Obstetrics and Gynecology, St. Luke's–Roosevelt Hospital Center, New York (O.L.); and the Department of Obstetrics and Gynecology, University of Texas Health Science Center at San Antonio, San Antonio (D.L.C., M.D.B., E.M.-J.X., O.G.).

Address reprint requests to Dr. Langer at the Department of Obstetrics and Gynecology, St. Luke's–Roosevelt Hospital Center, 1000 10th Ave., New York, NY 10019, or at olanger{at}slrhc.org.

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