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
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
| Outcome | RR (CI) | |
|---|---|---|
| Cardiac malformationsAny metforminvs Insulin alone | 1.01 (0.55–1.84) | |
| Cardiac malformationsMetformin alonevs Insulin alone | 0.92 (0.47–1.81) | |
| Cardiac malformationsMetformin + insulinvs Insulin alone | 1.72 (0.76–3.91) | |
| 0.20.5125Relative risk (log scale) |
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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