Gestational diabetes & diabetes in pregnancy

Metformin Versus Insulin and Risk of Major Congenital Malformations in Pregnancies With Type 2 Diabetes: A Nordic Register-Based Cohort Study

Diabetes CarePublished Register-based cohort study

Authors' conclusion

No evidence of an increased malformation risk with metformin versus insulin in the first trimester was found. Results should be interpreted with caution since information on glycemic control was missing.

Study context

Population
Live and stillborn singleton infants exposed to metformin or insulin during first trimester organogenesis in pregnancies with T2D; excluded T1D, PCOS, fertility treatment, other diabetes drugs4,023 singleton infants included
Participants
3,145 / 2,852 / 293 / 878
Exposure
Metformin vs insulin in first trimester
  • Any metforminn = 3,145
  • Metformin alonen = 2,852
  • Metformin + insulinn = 293
  • Insulin alonen = 878reference
Outcome
Any major congenital malformation
Methodological detailsnationwide registers, four Nordic countries
  • Nationwide registers
  • Four Nordic countries

Main finding

As reported in the abstract

Any malformation
Each group vs insulin aloneEstimate (95% CI)
Any metformin
RR 0.84(0.46–1.54)
Metformin alone
adjusted RR 0.83(0.44–1.58)
Metformin + insulin
adjusted RR 0.98(0.56–1.69)

Observational data: associations, not effects.

Further findings

OutcomeRR (CI)
Cardiac malformationsAny metforminvs Insulin alone1.01 (0.55–1.84)
Cardiac malformationsMetformin alonevs Insulin alone0.92 (0.47–1.81)
Cardiac malformationsMetformin + insulinvs Insulin alone1.72 (0.76–3.91)

Original publication

Metformin Versus Insulin and Risk of Major Congenital Malformations in Pregnancies With Type 2 Diabetes: A Nordic Register-Based Cohort Study. Diabetes Care. Published 21 June 2023. doi:10.2337/dc23-0256

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