Metformin in Women with Type 2 Diabetes in Pregnancy (MiTy) Trial: A randomized controlled trial
Description: The incidence of type 2 diabetes is rising at a remarkable rate, and with it we see a rise in type 2 diabetes in pregnancy. Insulin is the standard of care for the management of women with type 2 diabetes in pregnancy. However, despite treatment with insulin, these women continue to face high rates of poor maternal and fetal outcomes. Mothers have high blood pressure, preeclampsia, high rates of cesarean section, while infants have preterm birth, low blood sugar, they are large, can get stuck during delivery leading to birth injury, and often require the NICU. Metformin is an oral hypoglycemic agent presently being used in patients with type 2 diabetes outside of pregnancy and in other pregnant populations, with some benefit. Our aim is to see whether the addition of metformin to standard therapy of insulin alone, will improve these poor pregnancy outcomes by conducting a multicentre, randomized trial, randomizing 500 pregnant women with type 2 diabetes to receive either metformin or placebo, in addition to their usual insulin regimen. We hypothesize that metformin use, when added to the treatment with insulin, will improve pregnancy outcomes by reducing high maternal blood sugars, high maternal insulin doses, excessive maternal weight gain and pregnancy-induced high blood pressure, all of which should reduce poor outcomes in the baby. Our primary outcome will be the reduction of a composite outcome, which will include pregnancy loss, preterm birth, birth injury, respiratory distress, low blood sugar, and neonatal intensive care admissions over 24 hours. Our MiTy Kids study (separately funded) aims to follow these children for up to 2 years of age, to see if metformin reduces the risk of childhood obesity. This study will provide critical insight into an important treatment, which will impact standard of care and clinical practice, with the potential to benefit the health of pregnant mothers with diabetes and their children, immediately and in the long-term.
Amount: CA$436,700
Funding type: research
Funder scheme: Project Grant
Start date: 2018-04-01
End date: 2020-12-31
Investigator: Denice Feig
Institution: Lunenfeld-Tanenbaum Research Institute (Toronto)
Subfield: Obstetrics and Gynecology
Field: Medicine
Domain: Health Sciences
Funded outputs count: 0
Funder award ID: 156313_1
OpenAlex ID: G1124047121