There were 15 major congenital malformations with insulin detemir and 17 with other basal insulins.
There were 6 perinatal deaths with insulin detemir and 13 with other insulins, and 1 and 0 neonatal deaths, respectively.
The composite primary endpoint of no major congenital malformations and no perinatal or neonatal deaths was 97.0% for insulin detemir and 95.5% for other basal insulins (adjusted risk difference -0.003, 95% CI -0.03, 0.03).
There were 14 induced abortions due to major congenital malformations: 5 with insulin detemir and 9 with other basal insulins.
How does this study impact clinical practice?
The study was designed in collaboration with the European Medicines Agency and collected real-world data covering many nationalities with broad inclusion criteria.
In pregnant women with pre-existing diabetes, insulin detemir was not associated with excess risk of major congenital malformations, or perinatal or neonatal deaths compared with other basal insulins.
This is a highlights summary of an oral session given at the EASD 2020 Virtual Meeting and presented by:
Elisabeth Mathiesen, MD
Center for Pregnant Women with Diabetes, Faculty of Health and Medical Sciences, University of Copenhagen, Denmark; On behalf of the EVOLVE study group
The presenting authors of the original session had no part in the creation of this conference highlights summary.
The content is produced by Infomedica. The summary text was drafted by Patrick Moore, PhD, and reviewed by Marco Gallo, MD, an independent external expert, and approved by Florian Toti, MD, the scientific editor of the program.