RCT Metformin for Reduction of Gestational Diabetes Mellitus Effects

PHASE3CompletedINTERVENTIONAL
Enrollment

535

Participants

Timeline

Start Date

June 6, 2017

Primary Completion Date

January 12, 2023

Study Completion Date

April 13, 2023

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.

Trial Locations (2)

Unknown

Portiuncula University Hospital, Ballinasloe

University Hospital Galway, Galway

Sponsors
All Listed Sponsors
collaborator

Health Research Board, Ireland

OTHER

collaborator

HRB Clinical Research Facility Galway

OTHER

collaborator

University College Hospital Galway

OTHER

collaborator

Portiuncula University Hospital

UNKNOWN

collaborator

University Hospital of Limerick

OTHER

collaborator

University Maternity Hospital Limerick

UNKNOWN

collaborator

Clinical Research Support Unit, University of Limerick

UNKNOWN

lead

National University of Ireland, Galway, Ireland

OTHER