Metformin in Women with Type 2 Diabetes in Pregnancy Trial (MiTy) is a multicentre, double masked, randomized placebo-controlled trial of metformin or placebo in addition to their usual insulin regimen, in women with type 2 diabetes in pregnancy, between 6 and 22 weeks gestation.
The primary research question of MiTy is: Among pregnant women with diagnosed type 2 diabetes mellitus, does the addition of metformin to a standard regimen of insulin increase or decrease the incidence of adverse perinatal outcomes as defined by a composite of: pregnancy loss, preterm birth, birth injury, respiratory distress, neonatal hypoglycemia, and NICU admission >24 hours, compared with women treated with insulin plus placebo?
The secondary research questions of MiTy are: Among pregnant women with type 2 diabetes mellitus, does the addition of metformin to a standard regimen of insulin increase or decrease the risk of: LGA infants , cord blood gases
The sample size for MiTy is 500 pregnant women, to be recruited from 25 centres across Canada.
Click here to visit the MiTy blog.