drugset / Trial / NCT02980276
RCT Metformin for Reduction of Gestational Diabetes Mellitus Effects
Phase 3
Completed
535 enrolled
National University of Ireland, Galway, Ireland
Clinical Research Support Unit, University of Limerick · collabHRB Clinical Research Facility Galway · collabHealth Research Board, Ireland · collabPortiuncula University Hospital · collabUniversity College Hospital Galway · collabUniversity Hospital of Limerick · collabUniversity Maternity Hospital Limerick · collab
RandomizedParallel-groupQuadruple-blindTreatment
Summary
The overall objective of the EMERGE trial is to determine whether metformin + usual care, compared to placebo + usual care (introduced at the time of initial diagnosis of GDM), reduces a) the need for insulin use, or hyperglycemia (primary outcome measure); b) excessive maternal weight gain; c) maternal and neonatal morbidities and, d) cost of treatment for women with Gestational Diabetes Mellitus.
Timeline
- Start
- 2017-06-06
- Primary completion
- 2023-01-12
- Completion
- 2023-04-13
Publications
- Dunne F, Newman C, Alvarez-Iglesias A, O'Shea P, Devane D, Gillespie P, Egan A, O'Donnell M, Smyth A. Metformin and small for gestational age babies: findings of a randomised placebo-controlled clinical trial of metformin in gestational diabetes (EMERGE). Diabetologia. 2024 Dec;67(12):2660-2666. doi: 10.1007/s00125-024-06252-y. Epub 2024 Aug 31.
- Dunne F, Newman C, Alvarez-Iglesias A, Ferguson J, Smyth A, Browne M, O'Shea P, Devane D, Gillespie P, Bogdanet D, Kgosidialwa O, Egan A, Finn Y, Gaffney G, Khattak A, O'Keeffe D, Liew A, O'Donnell M. Early Metformin in Gestational Diabetes: A Randomized Clinical Trial. JAMA. 2023 Oct 24;330(16):1547-1556. doi: 10.1001/jama.2023.19869.
- Dunne F, Newman C, Devane D, Smyth A, Alvarez-Iglesias A, Gillespie P, Browne M, O'Donnell M. A randomised placebo-controlled trial of the effectiveness of early metformin in addition to usual care in the reduction of gestational diabetes mellitus effects (EMERGE): study protocol. Trials. 2022 Sep 21;23(1):795. doi: 10.1186/s13063-022-06694-y.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Metformin | Small molecule | 2500 mg | — |