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Metformin in Women with Type 2 Diabetes in Pregnancy Trial (MiTy)

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 <7.0, cord blood c-peptide levels, sepsis, hyperbilirubinemia, or fetal fat mass compared to women treated with insulin plus placebo?  Among pregnant women with type 2 diabetes mellitus, does the addition of metformin to a standard regimen of insulin increase or decrease: maternal weight gain; maternal insulin doses; maternal glycemic control; rates of maternal hypoglycemia; the incidence of pre-eclampsia and/or pregnancy-induced hypertension; the duration of hospital stay for mother; the duration of hospital stay for infant; or the incidence of caesarean section compared to women treated with insulin plus placebo?

The sample size for MiTy is 500 pregnant women, to be recruited from 25 centres across Canada.

For more information on the MiTy trial, please contact: mity@sunnybrook.ca.

Mity blog

For recent updates on the MiTy trial, visit our blog.