TY - JOUR
T1 - Metformin in women with type 2 diabetes in pregnancy (MiTy)
T2 - A multi-center randomized controlled trial
AU - MiTy Collaborative Group
AU - Feig, Denice S.
AU - Murphy, Kellie
AU - Asztalos, Elizabeth
AU - Tomlinson, George
AU - Sanchez, Johanna
AU - Zinman, Bernard
AU - Ohlsson, Arne
AU - Ryan, Edmond A.
AU - Fantus, I. George
AU - Armson, Anthony B.
AU - Lipscombe, Lorraine L.
AU - Barrett, Jon F.R.
AU - Donat, Diane
AU - Gandhi, Shital
AU - Cleave, Barbara
AU - Strom, Michele
AU - Qureshi, Asma
AU - Tobin, Siobhan
AU - Rylance, Heather
AU - Sample, Dory
AU - Carson, George
AU - Williams, Suzanne
AU - Kelly, Sheila
AU - Clark, Heather
AU - Donovan, Lois
AU - Oldford, Carolyn
AU - Young, Catherine
AU - Galway, Brenda
AU - Parsons, Minnie
AU - Godbout, Ariane
AU - Mahone, Michele
AU - Weber, Florence
AU - Bedard, Marie Josee
AU - Wo, Bi Lan
AU - Daigle, Sylvie
AU - Hanna, Amir
AU - Wolfs, Maria
AU - De Souza, Leanne D.
AU - Houlden, Robyn
AU - Breen, Adriana
AU - Kader, Tina
AU - Cefis, Luca
AU - Keely, Erin
AU - Champagne, Josee
AU - Klinke, Jennifer
AU - Lee, Julie
AU - Subrt, Peter
AU - Carr, Francina
AU - Young, Sharon
AU - Ransom, Thomas
N1 - Funding Information:
This study was funded by the Canadian Institute for Heath Research MOP 106678.
Funding Information:
This trial is funded by the Canadian Institute of Health Research MOP 106678. The metformin and placebo tablets have been donated by Apotex Inc.
Publisher Copyright:
© 2016 The Author(s).
PY - 2016/7/19
Y1 - 2016/7/19
N2 - Background: The incidence of type 2 diabetes in pregnancy is rising and rates of serious adverse maternal and fetal outcomes remain high. Metformin is a biguanide that is used as first-line treatment for non-pregnant patients with type 2 diabetes. We hypothesize that metformin use in pregnancy, as an adjunct to insulin, will decrease adverse outcomes by reducing maternal hyperglycemia, maternal insulin doses, maternal weight gain and gestational hypertension/pre-eclampsia. In addition, since metformin crosses the placenta, metformin treatment of the fetus may have a direct beneficial effect on neonatal outcomes. Our aim is to compare the effectiveness of the addition of metformin to insulin, to standard care (insulin plus placebo) in women with type 2 diabetes in pregnancy. Methods: The MiTy trial is a multi-centre randomized trial currently enrolling pregnant women with type 2 diabetes, who are on insulin, between the ages of 18-45, with a gestational age of 6 weeks 0 days to 22 weeks 6 days. In this randomized, double-masked, parallel placebo-controlled trial, after giving informed consent, women are randomized to receive either metformin 1,000 mg twice daily or placebo twice daily. A web-based block randomization system is used to assign women to metformin or placebo in a 1:1 ratio, stratified for site and body mass index. The primary outcome is a composite neonatal outcome of pregnancy loss, preterm birth, birth injury, moderate/severe respiratory distress, neonatal hypoglycemia, or neonatal intensive care unit admission longer than 24 h. Secondary outcomes are large for gestational age, cord blood gas pH < 7.0, congenital anomalies, hyperbilirubinemia, sepsis, hyperinsulinemia, shoulder dystocia, fetal fat mass, as well as maternal outcomes: maternal weight gain, maternal insulin doses, maternal glycemic control, maternal hypoglycemia, gestational hypertension, preeclampsia, cesarean section, number of hospitalizations during pregnancy, and duration of hospital stays. The trial aims to enroll 500 participants. Discussion: The results of this trial will inform endocrinologists, obstetricians, family doctors, and other healthcare professionals caring for women with type 2 diabetes in pregnancy, as to the benefits of adding metformin to insulin in this high risk population. Trial registration: ClinicalTrials.gov Identifier: no. NCT01353391. Registered February 6, 2009.
AB - Background: The incidence of type 2 diabetes in pregnancy is rising and rates of serious adverse maternal and fetal outcomes remain high. Metformin is a biguanide that is used as first-line treatment for non-pregnant patients with type 2 diabetes. We hypothesize that metformin use in pregnancy, as an adjunct to insulin, will decrease adverse outcomes by reducing maternal hyperglycemia, maternal insulin doses, maternal weight gain and gestational hypertension/pre-eclampsia. In addition, since metformin crosses the placenta, metformin treatment of the fetus may have a direct beneficial effect on neonatal outcomes. Our aim is to compare the effectiveness of the addition of metformin to insulin, to standard care (insulin plus placebo) in women with type 2 diabetes in pregnancy. Methods: The MiTy trial is a multi-centre randomized trial currently enrolling pregnant women with type 2 diabetes, who are on insulin, between the ages of 18-45, with a gestational age of 6 weeks 0 days to 22 weeks 6 days. In this randomized, double-masked, parallel placebo-controlled trial, after giving informed consent, women are randomized to receive either metformin 1,000 mg twice daily or placebo twice daily. A web-based block randomization system is used to assign women to metformin or placebo in a 1:1 ratio, stratified for site and body mass index. The primary outcome is a composite neonatal outcome of pregnancy loss, preterm birth, birth injury, moderate/severe respiratory distress, neonatal hypoglycemia, or neonatal intensive care unit admission longer than 24 h. Secondary outcomes are large for gestational age, cord blood gas pH < 7.0, congenital anomalies, hyperbilirubinemia, sepsis, hyperinsulinemia, shoulder dystocia, fetal fat mass, as well as maternal outcomes: maternal weight gain, maternal insulin doses, maternal glycemic control, maternal hypoglycemia, gestational hypertension, preeclampsia, cesarean section, number of hospitalizations during pregnancy, and duration of hospital stays. The trial aims to enroll 500 participants. Discussion: The results of this trial will inform endocrinologists, obstetricians, family doctors, and other healthcare professionals caring for women with type 2 diabetes in pregnancy, as to the benefits of adding metformin to insulin in this high risk population. Trial registration: ClinicalTrials.gov Identifier: no. NCT01353391. Registered February 6, 2009.
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U2 - 10.1186/s12884-016-0954-4
DO - 10.1186/s12884-016-0954-4
M3 - Article
C2 - 27435163
AN - SCOPUS:84978793015
SN - 1471-2393
VL - 16
JO - BMC Pregnancy and Childbirth
JF - BMC Pregnancy and Childbirth
IS - 1
M1 - 173
ER -