A randomized trial comparing perinatal outcomes using insulin detemir or neutral protamine Hagedorn in type 1 diabetes

• Published in: The journal of maternal-fetal & neonatal medicine Vol. 27; no. 1; pp. 7 - 13
• Main Authors: Hod, Moshe, Mathiesen, Elisabeth R., Jovanovič, Lois, McCance, David R., Ivanisevic, Marina, Durán-Garcia, Santiago, Brøndsted, Lise, Nazeri, Avideh, Damm, Peter
• Format: Journal Article
• Language: English
• Published: England Taylor & Francis 01.01.2014
• Subjects: Abortion, Induced - statistics & numerical data; Abortion, Spontaneous - epidemiology; Congenital Abnormalities - epidemiology; Congenital malformations; Diabetes Mellitus, Type 1 - drug therapy; Drug Combinations; Female; Fetal Death - epidemiology; Gestational Age; Humans; Hypoglycemic Agents - therapeutic use; Insulin Aspart - therapeutic use; Insulin Detemir; Insulin, Isophane - therapeutic use; Insulin, Long-Acting - therapeutic use; Live Birth - epidemiology; perinatal outcomes; Pregnancy; Pregnancy in Diabetics - drug therapy; Pregnancy Outcome; Pregnancy, Ectopic - epidemiology; type 1 diabetes
• ISSN: 1476-7058; 1476-4954
• DOI: 10.3109/14767058.2013.799650

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.