Hod, Moshe2; Mathiesen, Elisabeth R3; Jovanovič, Lois2; McCance, David R2; Ivanisevic, Marina2; Durán-Garcia, Santiago2; Brøndsted, Lise2; Nazeri, Avideh2; Damm, Peter3
1 Department of Clinical Medicine, Department of Clinical Medicine, Faculty of Health and Medical Sciences, Københavns Universitet2 unknown3 Department of Clinical Medicine, Department of Clinical Medicine, Faculty of Health and Medical Sciences, Københavns Universitet
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
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