OBJECTIVE: This randomized controlled trial aimed to compare the efficacy and safety of insulin detemir (IDet) with neutral protamine Hagedorn (NPH), both with insulin aspart, in pregnant women with type 1 diabetes. The perinatal and obstetric pregnancy outcomes are presented. METHODS: Subjects were randomized to IDet (n = 152) or NPH (n = 158) ≤12 months before pregnancy or at 8-12 gestational weeks. RESULTS: For IDet and NPH, there were 128 and 136 live births, 11 and 9 early fetal losses, and two and one perinatal deaths, respectively. Gestational age at delivery was greater for children from the IDet arm than the NPH arm (treatment difference: 0.49 weeks [95% CI 0.11;0.88], p = 0.012, linear regression). Sixteen children had a malformation (IDet: n = 8/142, 5.6%; NPH: n = 8/145, 5.5%). The incidence of adverse events was similar between treatments. CONCLUSION: IDet is as well tolerated as NPH as regards perinatal outcomes in pregnant women with type 1 diabetes and no safety issues were identified.
Journal of Maternal - Fetal and Neonatal Medicine, 2014, Vol 27, Issue 1, p. 7-13
Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't; Abortion, Induced; Abortion, Spontaneous; Congenital Abnormalities; Diabetes Mellitus, Type 1; Drug Combinations; Female; Fetal Death; Gestational Age; Humans; Hypoglycemic Agents; Insulin Aspart; Insulin, Isophane; Insulin, Long-Acting; Live Birth; Pregnancy; Pregnancy Outcome; Pregnancy in Diabetics; Pregnancy, Ectopic