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In a recent study published in the Journal of the American Medical Association (JAMA), researchers evaluated the efficacy of oral glucose-lowering agents as potential alternatives to insulin for the management of gestational diabetes mellitus (GDM). The findings suggest that while oral agents like metformin and glyburide can effectively control blood sugar in many patients, they may not be as effective as insulin in preventing large-for-gestational-age (LGA) infants.
The study, led by Dr. Doortje Rademaker from Amsterdam University Medical Center, was conducted across 25 Dutch medical centers and included 820 pregnant individuals with GDM and singleton pregnancies. Participants, who had insufficient glycemic control after two weeks of dietary modifications, were randomly assigned to receive either metformin or insulin (409 and 411 participants, respectively). Glyburide was added to metformin when necessary, and if glycemic targets were still unmet, insulin was introduced.
Results showed that 79% of participants assigned to oral agents successfully managed their blood sugar without requiring insulin. However, the proportion of infants born large for gestational age was 23.9% in the oral agents group compared to 19.9% in the insulin group. The absolute risk difference of 4.0% (95% confidence interval: −1.7 to 9.8%) failed to meet the pre-specified noninferiority margin of 8%.
“This indicates that treatment with oral agents did not achieve noninferiority compared to insulin regarding the prevention of large-for-gestational-age infants,” the authors stated.
The study contributes to ongoing research into the role of metformin and glyburide as alternatives to insulin in managing gestational diabetes. While oral agents are more convenient and less invasive, their limitations in specific clinical outcomes, such as infant size, may affect their suitability for certain patients.
An accompanying editorial by Camille E. Powe, M.D., underscores insulin’s continued primacy in gestational diabetes management, highlighting its established efficacy and safety profile.
For more details, refer to the full studies:
- Rademaker et al., Oral Glucose-Lowering Agents vs Insulin for Gestational Diabetes, JAMA (2025). DOI: 10.1001/jama.2024.23410
- Powe et al., For Gestational Diabetes Pharmacotherapy, Insulin Reigns Supreme, JAMA (2025). DOI: 10.1001/jama.2024.27148
