There was no difference in the composite neonatal outcome between the groups
Metformin: 71% | Placebo: 74%
Adjusted odds ratio (aOR) 0.86 (95% CI, 0.63 to 1.19)
The study was halted at 75% accrual for futility in detecting a significant difference in the primary outcome
The most common adverse events in both groups were
Preterm birth | Neonatal hypoglycemia | Large for gestational age
Prespecified secondary outcomes and subgroup analyses were similar between groups
For the individual components of the composite outcome, metformin-exposed neonates had a lower odds of large for gestational age
aOR 0.63 (95% CI, 0.46 to 0.86)
For pregnant patients with preexisting diabetes or diabetes diagnosed early in pregnancy, the addition of metformin to insulin treatment had no effect on the risk of a composite adverse neonatal outcome
There was a reduction in large for gestational age associated with metformin
The authors state
Using metformin plus insulin to treat preexisting type 2 or gestational diabetes diagnosed early in pregnancy did not reduce a composite neonatal adverse outcome
The effect of reduction in odds of a large for gestational age infant observed after adding metformin to insulin warrants further investigation
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