172-LB: Risk of Major Congenital Malformations, Perinatal or Neonatal Death with Insulin Detemir Compared with Other Basal Insulins in Pregnant Women with Preexisting Diabetes: The EVOLVE Study

Abstract

Aim: The EVOLVE study examined the risk of major congenital malformations and perinatal or neonatal deaths when using insulin detemir (IDet) versus other basal insulins in pregnant women with pre-existing diabetes. Materials and Methods: A prospective, non-interventional, multinational study in pregnant women with type 1 or type 2 diabetes treated with IDet or other insulin treatment. In the present analysis, 727 women using IDet during pregnancy were compared with 730 women using other basal insulin, mainly insulin glargine. The primary endpoint was the number of women completing ≥22 weeks of gestation without any of the following events: major congenital malformations, perinatal or neonatal deaths. Results: At enrolment 86% of subjects had type 1 diabetes (mean age: 31 years; BMI: 26 kg/m2) and mean A1C was 7.1%. There was no difference between treatment groups in crude or adjusted risk difference for pregnancies without major congenital malformations, perinatal or neonatal deaths (Table). Conclusion: In pregnant women with pre-existing diabetes, IDet was not associated with excess risk of major congenital malformations, perinatal or neonatal deaths vs. other basal insulin. Disclosure E.R. Mathiesen: Advisory Panel; Self; Novo Nordisk A/S. Consultant; Self; Novo Nordisk A/S. Speaker’s Bureau; Self; Lilly Diabetes, Novo Nordisk A/S, Sanofi-Aventis. A. Alibegovic: Employee; Self; Novo Nordisk A/S. L.N. Husemoen: Employee; Self; Novo Nordisk A/S. Stock/Shareholder; Self; Novo Nordisk A/S. P. Kelkar: Employee; Self; Novo Nordisk Service Centre India Private Ltd. D.R. McCance: None. H.W. de Valk: None. P. Damm: Advisory Panel; Self; Novo Nordisk A/S. Funding Novo Nordisk A/S