RCT Metformin for Reduction of Gestational Diabetes Mellitus Effects

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

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.

Sponsors & Collaborators

• Health Research Board, Ireland

  collaborator OTHER

• HRB Clinical Research Facility Galway

  collaborator OTHER

• University College Hospital Galway

  collaborator OTHER

• Portiuncula University Hospital

  collaborator UNKNOWN

• University Hospital of Limerick

  collaborator OTHER

• University Maternity Hospital Limerick

  collaborator UNKNOWN

• Clinical Research Support Unit, University of Limerick

  collaborator UNKNOWN

• National University of Ireland, Galway, Ireland

  lead OTHER

Principal Investigators

• Prof. Fidelma Dunne · National University of Ireland, Galway, Ireland

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

50 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2017-06-06

Primary Completion

2023-01-12

Completion

2023-04-13

Countries

• Ireland

Study Locations