A study comparing oral glucose-lowering agents to insulin for gestational diabetes found no non-inferiority in preventing large-for-gestational-age infants.
By Vijay Kumar MalesuReviewed by Danielle Ellis, B.Sc.Jan 9 2025 23.9% of infants were large for gestational age with oral medications compared to 19.9% with insulin, falling short of noninferiority criteria
However, concerns about their placental transfer and long-term safety in offspring persist, leading to varying guidelines globally. While metformin and glyburide are widely used, their effectiveness compared to insulin and the potential benefits of sequential combination therapies remain unclear. Participants were pregnant individuals aged over 18 years with singleton pregnancies between 16 and 34 weeks of gestation who failed to achieve glycemic control after approximately two weeks of dietary intervention.
If glycemic control remained inadequate, glyburide was added, and insulin was introduced if necessary. Insulin dosing followed local clinical practices. Outcomes were assessed for primary and secondary measures, including maternal and neonatal health indicators. In the oral agents group, 55% maintained glycemic control with metformin alone, and an additional 24% achieved control with glyburide, resulting in 79% maintaining control without insulin. However, 7.7% required insulin despite oral agents, and adverse effects prompted 3.7% to switch to insulin. Supply issues with glyburide further excluded nine participants from per-protocol analysis.
Exploratory analyses indicated no subgroup differences for secondary outcomes. Neonatal intravenous glucose therapy was more frequent in the oral agents group . Patient satisfaction was comparable across groups, though oral agent participants more often recommended their treatment. The time between randomization and delivery was similar. Overall, no significant differences in secondary outcomes were observed between groups in per-protocol analyses.
Gestational Diabetes Insulin Clinical Trial Glucose Hypoglycemia Metformin
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