Trial results for the EMERGE study (NCT02980276) investigating metformin hydrochloride for the reduction of gestational diabetes mellitus effects were posted on ClinicalTrials.gov on 2025-03-17. The study found that treatment with metformin significantly reduced the need for insulin, showing a risk difference of -12.7% (95.0% CI: -21.2 to -4.3) with a p-value of 0.004.
Background
Gestational diabetes mellitus (GDM) is a condition where women without previously diagnosed diabetes develop high blood sugar levels during pregnancy. The EMERGE trial aimed to determine if metformin could reduce the need for insulin use or hyperglycemia, excessive maternal weight gain, and maternal and neonatal morbidities in women with GDM.
Trial design
The EMERGE trial (NCT02980276) was a Phase 3, randomized controlled trial that enrolled 535 participants with Gestational Diabetes. The study compared metformin hydrochloride plus usual care to placebo plus usual care, introduced at the time of initial GDM diagnosis. The overall objective included evaluating the reduction in the need for insulin use or hyperglycemia as a primary outcome measure.
Key results
The trial results indicated that metformin treatment led to a reduction in the need for insulin and hyperglycemia. For the primary composite outcome, 150 participants in the treatment group experienced the outcome compared to 167 in the control group. Specifically, 101 participants in the treatment group required insulin, compared to 134 in the control group. Similarly, 94 participants in the treatment group initiated insulin, versus 106 in the control group. Fasting hyperglycemia was observed in 94 participants in the treatment group and 106 in the control group.
Key analyses showed a statistically significant reduction in the need for insulin. One analysis reported a risk difference of -12.7% (95.0% CI: -21.2 to -4.3) with a p-value of 0.004. Another analysis using logistic regression showed an Odds Ratio (OR) of 0.56 (95.0% CI: 0.38 to 0.82) with a p-value of 0.003. A Log Rank test yielded a p-value of 0.001. The primary analysis, which was a two-sample comparison of reduction in the proportion of women needing insulin, showed a risk difference of -6.9% (95.0% CI: -15.1 to 1.4) with a p-value of 0.13.
Regarding time to insulin initiation, the mean time was 68 days (Standard Deviation: 38.1) for the treatment group and 58.7 days (Standard Deviation: 37) for the control group. For participants who required insulin, the mean insulin dose was 20.4 IU (Standard Deviation: 19.8) in the treatment group and 2.2 IU (Standard Deviation: 22.8) in the control group.
What this means
The findings from the EMERGE trial suggest that metformin hydrochloride can significantly reduce the need for insulin in women with gestational diabetes. The statistically significant risk difference and odds ratio for insulin requirement indicate that metformin offers a beneficial therapeutic option for managing GDM, potentially reducing the burden of insulin therapy for these patients. These results provide important evidence for clinical decision-making in the management of gestational diabetes.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for study NCT02980276, titled 'RCT Metformin for Reduction of Gestational Diabetes Mellitus Effects,' were posted on 2025-03-17 on clinicaltrials.gov.