NCT02980276

RCT Metformin for Reduction of Gestational Diabetes Mellitus Effects

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)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 535 (actual)
• Sponsor: National University of Ireland, Galway, Ireland · Academic / Other
• Sex: Female
• Age: 18 Years – 50 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Gestational Diabetes

Interventions

Type	Name	Description
DRUG	Metformin Hydrochloride	Women randomised to the metformin group will receive metformin 500mg once daily, with the dose titrated upwards every 2 days over 10 days increasing to a maximum of 2500mg Metformin daily (5 tablets) or maximum tolerated dose, in addition to usual care (exercise and MNT), and taken until delivery.
OTHER	Placebo	Women randomised to the placebo group will receive 1 placebo tablet once daily, with the dose titrated upwards every 2 days over 10 days increasing to a maximum of five placebo tablets daily, in addition to usual care (exercise and MNT), and taken until delivery.

Timeline

• Start date: 2017-06-06
• Primary completion: 2023-01-12
• Completion: 2023-04-13
• First posted: 2016-12-02
• Last updated: 2025-03-17
• Results posted: 2025-03-17

Locations

2 sites across 1 country: Ireland