Metformin in women with type 2 diabetes in pregnancy (MiTy): a multi-center randomized controlled trial

Feig, Denice S., Murphy, Kellie, Asztalos, Elizabeth, Tomlinson, George, Sanchez, Johanna, Zinman, Bernard, Ohlsson, Arne, Ryan, Edmond A., Fantus, I. George, Armson, Anthony B., Lipscombe,Lorraine L., Barrett, Jon F. R., MiTy Collaborative Group, McIntyre, David and Tremellen, Anne (2016) Metformin in women with type 2 diabetes in pregnancy (MiTy): a multi-center randomized controlled trial. BMC Pregnancy and Childbirth, 16 1: . doi:10.1186/s12884-016-0954-4


Author Feig, Denice S.
Murphy, Kellie
Asztalos, Elizabeth
Tomlinson, George
Sanchez, Johanna
Zinman, Bernard
Ohlsson, Arne
Ryan, Edmond A.
Fantus, I. George
Armson, Anthony B.
Lipscombe,Lorraine L.
Barrett, Jon F. R.
MiTy Collaborative Group
McIntyre, David
Tremellen, Anne
Title Metformin in women with type 2 diabetes in pregnancy (MiTy): a multi-center randomized controlled trial
Journal name BMC Pregnancy and Childbirth   Check publisher's open access policy
ISSN 1471-2393
Publication date 2016-06-19
Sub-type Article (original research)
DOI 10.1186/s12884-016-0954-4
Open Access Status DOI
Volume 16
Issue 1
Total pages 8
Place of publication London, United Kingdom
Publisher BioMed Central
Collection year 2017
Language eng
Formatted abstract
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.
Keyword Diabetes Mellitus
Pregnancy
Pregnancy in diabetics
Metformin
Diabetes Mellitus Type 2
Q-Index Code CX
Q-Index Status Provisional Code
Institutional Status Non-UQ
Additional Notes Article number 173

Document type: Journal Article
Sub-type: Article (original research)
Collections: Mater Research Institute-UQ (MRI-UQ)
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Created: Thu, 18 Aug 2016, 21:08:16 EST by Julia McCabe on behalf of Learning and Research Services (UQ Library)