Treatment of gestational diabetes with metformin, and glyburide if needed, does not meet noninferiority criteria versus insulin
By Elana Gotkine HealthDay Reporter
THURSDAY, Jan. 9, 2025 (HealthDay News) — With respect to the proportion of infants born large for gestational age, treatment of gestational diabetes with metformin and glyburide, if needed, does not meet the criteria for noninferiority versus insulin, according to a study published online Jan. 6 in the Journal of the American Medical Association.
Doortje Rademaker, M.D., from the Amsterdam University Medical Center, and colleagues examined whether a treatment strategy of oral glucose-lowering agents is noninferior to insulin for prevention of large-for-gestational-age infants in a randomized trial conducted at 25 Dutch centers. A total of 820 individuals with gestational diabetes and singleton pregnancies between 16 and 34 weeks of gestation, with insufficient glycemic control after two weeks of dietary changes, were randomly assigned to receive metformin or insulin (409 and 411 participants, respectively). Glyburide was added to metformin, and if needed to achieve glucose targets, insulin was then substituted for glyburide.
Overall, 79 percent of the participants randomly assigned to oral agents maintained glycemic control without insulin. The researchers found that 23.9 and 19.9 percent of infants were large for gestational age with oral agents and insulin, respectively (absolute risk difference, 4.0 percent; 95 percent confidence interval, −1.7 to 9.8 percent; P = 0.09 for noninferiority), with the confidence interval exceeding the absolute noninferiority margin of 8 percent.
“These findings contribute to existing trial data regarding the use of metformin and glyburide as alternatives for insulin to manage gestational diabetes,” the authors write.
Several authors disclosed ties to the pharmaceutical industry.
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