Metformin use during pregnancy for T2DM tied to better maternal and neonatal outcomes: Lancet
Researchers have found in a prospective, multicentre, international, randomised trial that Metformin use during pregnancy for T2DM is associated with better outcomes for mother and child including various maternal glycaemic and neonatal adiposity benefits.
The trial details were published on The LANCET Diabetes & Endocrinology in October 2020.
Insulin is the standard treatment for the management of type 2 diabetes in pregnancy, but for women who have insulin resistance, gestational diabetes worsens the pregnancy, by increasing their insulin requirements, leading to weight gain, painful injections, high cost, and noncompliance.
As there is much less information on metformin's benefits and risks in pregnancy, the MiTy trial (Metformin in women with type 2 diabetes in pregnancy) was conducted with an aim to investigate the effects of the addition of metformin to a standard regimen of insulin on neonatal morbidity and mortality in pregnant women with type 2 diabetes.
It was a prospective, multicentre, international, randomised, parallel, double-masked, placebo-controlled trial. Researchers recruited 502 women from 29 sites in Canada and Australia who had type 2 diabetes prior to pregnancy or were diagnosed during pregnancy, before 20 weeks' gestation. Participants were randomly assigned to metformin 1 g twice daily or placebo, in addition to their usual insulin regimen, at between 6 and 28 weeks of gestation. The mean A1c level at randomization was 47 mmol/mol (6.5%) in both groups. Participants with type 2 diabetes with single viable pregnancy between 6 and 22 weeks plus 6 days' gestation and who were on insulin were included in the trial. Participants were asked to check their fasting blood glucose level before the first meal of the day, before the last meal of the day, and 2 hours after each meal. Follow up visits were scheduled monthly and the participants were seen every 1–4 weeks and when ever needed for standard clinical care. Blood pressure was monitored during the study visit and the researchers asked participants about tolerance to pills, hospitalisations, insulin doses, and severe hypoglycaemia events. The glucometer readings were recorded and stored in the central coordinating centre. Researchers determined a composite of fetal and neonatal outcomes as a primary outcome of the trial. Secondary outcomes included several relevant maternal and neonatal outcomes.
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