Fetal and perinatal outcomes in type 1 diabetes pregnancy: a randomized study comparing insulin aspart with human insulin in 322 subjects

• Published in: American journal of obstetrics and gynecology Vol. 198; no. 2; pp. 186.e1 - 186.e7
• Main Authors: Hod, Moshe, Damm, Peter, Kaaja, Risto, Visser, Gerard H.A., Dunne, Fidelma, Demidova, Irina, Hansen, Anne-Sofie Pade, Mersebach, Henriette
• Format: Journal Article
• Language: English
• Published: Philadelphia, PA Mosby, Inc 01.02.2008; Elsevier
• Subjects: Adult; Denmark; Diabetes Mellitus, Type 1; Diabetes, Gestational - blood; Diabetes, Gestational - drug therapy; Diabetes, Gestational - mortality; Female; Glycated Hemoglobin A; human insulin; Humans; Hypoglycemic Agents - administration & dosage; Hypoglycemic Agents - therapeutic use; Infant, Newborn; Insulin - administration & dosage; Insulin - analogs & derivatives; Insulin - therapeutic use; Insulin Aspart; Male; Obstetrics and Gynecology; perinatal outcomes; Pregnancy; Pregnancy Outcome; Stillbirth; Treatment Outcome; type 1 diabetes; type 1 diabetes; perinatal outcomes; human insulin; insulin aspart; pregnancy
• ISSN: 0002-9378; 1097-6868; 1097-6868
• DOI: 10.1016/j.ajog.2007.08.005

The objective of the study was a comparison of insulin aspart (IAsp) with human insulin (HI) in basal-bolus therapy with neutral protamine Hagedorn for fetal and perinatal outcomes of type 1 diabetes in pregnancy. This was a randomized, parallel, open-label, controlled, multicenter, multinational study. Subjects were pregnant (gestational age; <10 weeks) or planning pregnancy at enrollment. Three hundred twenty-two women with type 1 diabetes received IAsp (n = 157) or HI (n = 165). For IAsp and HI, respectively, there were 137 and 131 live births and 14 and 21 fetal losses. Perinatal mortality was 14 and 22 per 1000 births; number of congenital malformations were 6 and 9; mean (SEM) birthweight corrected for gestational age was 3438 g (71.5) and 3555 g (72.9; P = .091). Mean gestational age was 37.6 vs 37.4 weeks. Preterm delivery occurred in 20.3% (IAsp) and 30.6% (HI) of pregnancies ( P = .053). The fetal outcome using IAsp was comparable with HI with a tendency toward fewer fetal losses and preterm deliveries.