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Grand Rounds

MeDiGes RCT Results: Metformin vs Insulin for GDM

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BACKGROUND AND PURPOSE:

  • While some recent GDM studies have shown that metformin can achieve comparable pregnancy outcomes vs insulin, not all clinical guidelines currently endorse the use of metformin in this setting
  • Picón-César et al. (AJOG, 2021) compared metformin vs insulin in women with GDM who did not achieve glycemic control with lifestyle changes alone

METHODS:

  • Multicenter, open-label, parallel arms, randomized clinical trial
  • Participants
    • Women with GDM
    • 18 to 45 years
    • Second or third trimesters of pregnancy
  • Interventions
    • Metformin
    • Insulin (Detemir and/or Aspart)
  • GDM screening
    • Selective screening in first and third trimester
    • Universal screening at 24 to 28th gestational weeks: 50g oral glucose tolerance (O’Sullivan test) screening
    • Positive screen at 24 to 28 weeks followed by 100g OGTT diagnostic test        
  • Study design
    • Analysis based on intention to treat
  • Power analysis
    • Non-inferiority margin of 25%
    • Power 80% | Alpha error 0.05
    • Sample size: Total 231 (82 patients per group)
  • Primary outcomes
    • Glycemic control (mean glycemia, pre-prandial and postprandial) and hypoglycemic episodes
    • Obstetric and perinatal results and complications
      • Hypertensive disorders | Sort of labor | Prematurity | Macrosomia | LGA | NICU stay | RDS | Hypoglycemia | Jaundice

RESULTS:

  • 100 women in insulin group | 100 women in metformin group
  • Mean fasting and postprandial glycemia did not differ between groups
  • Postprandial glycemia was significantly better after lunch and/or dinner in the metformin group
  • Hypoglycemic episodes were significantly more common in the insulin group
    • Insulin: 55.9%
    • Metformin: 17.7%
    • OR 6.118 (95% CI, 3.134 to 11.944; P=0.000)
  • Women who received metformin gained less weight in between the enrollment and the pre-partum visit (36 to 37 weeks)
    • Insulin: 3.87±3.50 Kg
    • Metformin: 1.35±3.21 Kg
    • P=0.000
  • The metformin group also experienced significantly fewer
    • Labor inductions
      • Insulin: 62.5%
      • Metformin: 45.7%
      • OR 0.506 (95% CI, 0.283 to 0.903; P=0.029)
    • Cesarean deliveries
      • Insulin: 52.6%
      • Metformin: 27.6%
      • OR 0.345 (95% CI, 0.187 to 0.625; P=0.001)
  • There were no differences between the groups for the following
    • Mean birth weight
    • Macrosomia and LGA
    • Neonatal complications
  • The lower cesarean delivery rate for women treated with metformin was not associated with
    • Macrosomia
    • LGA or SGA
    • Any other complications of pregnancy

CONCLUSION:

  • Compared with insulin, treatment of GDM with metformin led to
    • Better glycemic control after meals
    • Lower risk of hypoglycemic episodes
    • Less maternal weight gain
  • Women in both groups had mostly similar obstetric and perinatal outcomes

Learn More – Primary Sources:

MeDiGes Study. Metformin versus insulin in gestational diabetes: Glycemic control, and obstetrical and perinatal outcomes. Randomized prospective trial.

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Related ObG Topics:

ACOG and SMFM Both Release Guidance on Gestational Diabetes – Insulin vs Metformin for First-Line Therapy?
MiTy RCT Results: Is Metformin Use in Pregnancy Associated with Better Maternal and Neonatal Outcomes?
Metformin in Pregnancy
Metformin vs. Insulin for GDM: How Do Neonatal and Childhood Growth Rates Compare?
The MiG-TOFU Study: Gestational Diabetes, Metformin and Metabolic Outcomes in Offspring 7 Years Later

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