Emerge-2: placebo-controlled RCT of the Effectiveness of MEtformin in addition to usual care in the Reduction of Gestational diabetes mellitus Effects

Diabetes (high blood sugars) developing during pregnancy is called Gestational Diabetes Mellitus (GDM). GDM is increasing, affecting one-in-eight pregnant women in Ireland. Women with GDM have an increased risk of complications including delivery by Caesarean section and more blood pressure problems. Women with GDM have a 7-fold increased risk of diabetes long-term. Infants of mothers with GDM have a greater risk of being born overweight and more likely to require admission to neonatal intensive care units because of low blood sugars, and other medical complications. The first line of managing high blood sugar levels is diet change and exercise. However, at least 40% of women with GDM will require insulin to maintain normal blood sugar levels. While insulin is effective at keeping blood sugars in the normal range, it has important side effects and limitations for the mother (e.g. excessive weight gain, low blood sugars, more likely to have a delivery by Caesarean section) and baby (tendency to excess weight at birth). A potential other treatment is a tablet called metformin used for 30 years in diabetes and fertility treatment. In a GDM trial in New Zealand, metformin was shown to work as well as insulin and be safe during pregnancy in obese women. Metformin might also reduce the chance of women with GDM developing long-term diabetes after pregnancy. A trial examining metformin in overweight women without diabetes is complete and no new safety issues were identified. We wish to see if metformin is effective for managing all women with GDM (not just those who are obese) if given at the time of a GDM diagnosis in addition to diet and exercise management. We want to see also if metformin is associated with less excessive weight gain, less need for insulin and is more cost-effective for women with GDM.

Award Date: 04 December 2020
Award Value: €€736,569.51
Principal Investigator: Professor Fidelma Dunne
Host Institution: National University of Ireland, Galway
Scheme: DIFA 2020