Abstract 6: Maternal efficacy, safety, and pregnancy outcomes with degludec versus detemir in the treatment of pregnant women with type 1 diabetes: An international, multicentre, randomised trial

BACKGROUND AND AIMS: To compare the efficacy and safety of insulin degludec (degludec) versus insulin detemir (detemir) in pregnant women with type 1 diabetes (T1D). MATERIALS AND METHODS: EXPECT was an open-label, randomised trial of women aged ≥18 years with T1D and previously treated with insulin, who were at 8-13 weeks’ gestation or planned to become pregnant within 52 weeks. Women were randomised to degludec once daily or detemir 1- 2 times daily, both with insulin aspart 2-4 times daily. The primary analysis aimed to demonstrate the non-inferiority (margin of 0.4%) of degludec to detemir with respect to the last planned glycated haemoglobin (HbA1c) measurement prior to delivery (>16 weeks’ gestation) using ANCOVA. Secondary endpoints were maternal efficacy, safety, and pregnancy outcomes. RESULTS: In total, 225 women (degludec: 111; detemir: 114) were randomised including 144 who were, and 81 who planned to become pregnant. Mean (±SD) HbA1c at treatment baseline was 6.8% (±0.7%) and 6.7% (±0.8%) with degludec and detemir, respectively. Over the trial, 188 women (degludec: 92; detemir: 96) with singleton pregnancies were included and there were 171 live-born infants (degludec: 86; detemir: 85), with no perinatal deaths (between ≥20 week's gestation and and <1 week after delivery). Estimated mean HbA1c prior to delivery was 6.23% with degludec and 6.34% with detemir (estimated treatment difference: −0.11% [−0.31; 0.08]95% CI, confirming non-inferiority). See Table for supportive maternal safety and pregnancy outcomes. Conclusion: In pregnant women with T1D, degludec was non-inferior to detemir with respect to HbA1c prior to delivery. Hypoglycaemia rates and pregnancy outcomes were comparable between insulins.