Marie-Victoire Sénat, M.D., Ph.D., from the University of Paris-Sud, and colleagues compared oral glyburide with subcutaneous insulin for prevention of perinatal complications in newborns of women with gestational diabetes in a multicenter noninferiority randomized trial. A total of 914 women with singleton pregnancies and gestational diabetes diagnosed between 24 and 34 weeks of gestation who required pharmacologic treatment after 10 days of dietary intervention were randomized to glyburide or insulin (460 and 454 participants, respectively). The noninferiority margin was set at 7 percent.
In a per-protocol analysis, 367 women randomized to glyburide and 442 to insulin and their neonates were analyzed. The researchers found that the frequency of the primary outcome of a composite criterion, including macrosomia, neonatal hypoglycemia, and hyperbilirubinemia, was 27.6 and 23.4 percent in the glyburide and insulin groups, respectively (difference, 4.2 percent; one-sided 97.5 percent confidence interval, −∞ to 10.5 percent; P =.19).
“This study of women with gestational diabetes failed to show that use of glyburide compared with subcutaneous insulin does not result in a greater frequency of perinatal complications,” the authors write. “These findings do not justify the use of glyburide as a first-line treatment.”
One author disclosed financial ties to Ferring Laboratories.