Gestational diabetes & diabetes in pregnancy
Oral Glucose-Lowering Agents vs Insulin for Gestational Diabetes: A Randomized Clinical Trial
Primary result · Infants born large for gestational ageResult — go to the resultAbsolute risk difference 4.0% 95% CI −1.7% to 9.8%Authors' conclusion
Treatment of gestational diabetes with metformin and additional glyburide, if needed, did not meet criteria for noninferiority compared with insulin with respect to the proportion of infants born large for gestational age.
Study context
- Population
- Individuals with GDM and singleton pregnancies at 16–34 weeks of gestation with insufficient glycemic control after 2 weeks of dietary changes; 25 Dutch centers, June 2016–November 2022; mean age 33.2 (SD, 4.7) years
- Participants
- 820 individuals
- Comparison
- Oral glucose-lowering agents vs insulin
- Oral agentsn = 409
- Insulinn = 411reference
- Primary endpoint
- Between-group difference in the percentage of infants born large for gestational age (birth weight >90th percentile for gestational age and sex)
Methodological detailsopen-label, noninferiority, multicentre (25 Dutch centers)
- Open-label
- Noninferiority
- Multicentre (25 Dutch centers)
Primary result
Infants born large for gestational age
Absolute risk difference
4.0%
95% CI −1.7% to 9.8%
P = 0.09 for noninferiority
Events by treatment group
As reported in the abstract
Secondary outcomes
- Glycemic control maintained without insulin (oral agents) — Oral agents
- 79%
Other secondary outcomes (cesarean delivery, pregnancy-induced hypertension, preeclampsia, maternal weight gain, preterm delivery, birth injury, neonatal hypoglycemia, neonatal hyperbilirubinemia, neonatal ICU admission)
- All other secondary outcomes did not differ between groups
Safety
| Outcome | Oral agents | Insulin | Absolute risk difference (95% CI) | |
|---|---|---|---|---|
| Maternal hypoglycemia | 20.9% | 10.9% | 10.0% (3.7%–21.2%) | |
| −100102030Difference (linear scale) |
Original publication
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