The effect of metformin on perinatal outcomes in pregnant women with type 2 diabetes differs by baseline insulin requirements
Abstract
BACKGROUND: Metformin works by increasing insulin sensitivity, which may aid in the management of insulin-treated type 2 diabetes in pregnancy. However, large trials have found that adjunctive metformin did not reduce composite adverse neonatal outcomes in this population.
OBJECTIVE: Our objective was to determine if baseline insulin requirements modified the effect of metformin on adverse neonatal and maternal outcomes.
STUDY DESIGN: We performed a secondary analysis of the Medical Optimization and Management of Pregnancies with Overt Type 2 Diabetes trial, a randomized controlled trial of metformin vs placebo in insulin-treated type 2 diabetes or diabetes diagnosed in early pregnancy. We included participants who took ≥1 dose of study drug and had baseline insulin data available. Our primary outcome was a composite of adverse neonatal outcomes, as defined by the parent trial. Secondary outcomes included cesarean delivery, maternal gestational weight gain, and change in insulin requirements during pregnancy, among others. Total daily dose of insulin at randomization was evaluated as an effect modifier of the relationship between metformin and the primary outcome using a likelihood ratio test with P60 U, and >90 U using multivariable Poisson regression with robust error variance and ordinary least squares regression.
RESULTS: Of the 794 participants included in the parent trial analysis, 785 (99%) met criteria for our study. The median total daily dose at randomization was…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 794 participants or records.
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