MeDiGes Study. Metformin versus insulin in gestational diabetes: Glycemic control, and obstetrical and perinatal outcomes. Randomized prospective trial
Abstract
BACKGROUND
Gestational diabetes not properly controlled with diet has been commonly treated with insulin. In recent years several studies have published that metformin can lead to, at least, similar obstetrical and perinatal outcomes as insulin. Nevertheless, not all clinical guidelines endorse its use, and clinical practice is heterogeneous.
OBJECTIVES
The aim of this study was to test if metformin could achieve the same glycemic control as insulin and similar obstetrical and perinatal results, with a good safety profile, in women with gestational diabetes not properly controlled with lifestyle changes.
STUDY DESIGN
The MeDiGes study was a multicenter, open-label, parallel arms, randomized clinical trial performed at two hospitals in Málaga (Spain), enrolling women with GDM who needed pharmacological treatment. Women aged 18-45 years, in the second or third trimesters of pregnancy, were randomized to receive metformin or insulin (Detemir and/or Aspart). The main outcomes were: 1. glycemic control (mean glycemia, pre-prandial and postprandial) and hypoglycemic episodes, and 2. obstetrical and perinatal outcomes and complications (hypertensive disorders, type of labor, prematurity, macrosomia, large for gestational age, neonatal care unit admissions, respiratory distress syndrome, hypoglycemia, jaundice). Outcomes were analyzed on an intention-to-treat basis.
RESULTS
Between 2016-October and 2019-June 200 women were randomized, 100 to the insulin-treated group and 100 to the…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 200 participants or records.
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