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


METHODS
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).


RESULTS
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).


CONCLUSIONS
The fetal outcome using IAsp was comparable with HI with a tendency toward fewer fetal losses and preterm deliveries.
Hod
Moshe
M
Perinatal Division, Helen Schneider Hospital for Women, Rabin Medical Center, Sackler Faculty of Medicine, Tel Aviv University, Petah-Tiqva, Israel. mhod@clalit.org.il
Damm
Peter
P
Kaaja
Risto
R
Visser
Gerard H A
GH
Dunne
Fidelma
F
Demidova
Irina
I
Hansen
Anne-Sofie Pade
AS
Mersebach
Henriette
H
D000328:Adult; D003718:Denmark; D003922:Diabetes Mellitus, Type 1; D016640:Diabetes, Gestational / Q000097:blood / Q000188:drug therapy* / Q000401:mortality; D005260:Female; D006442:Glycated Hemoglobin; D006801:Humans; D007004:Hypoglycemic Agents / Q000008:administration & dosage / Q000627:therapeutic use*; D007231:Infant, Newborn; D007328:Insulin / Q000008:administration & dosage / Q000031:analogs & derivatives* / Q000627:therapeutic use*; D061267:Insulin Aspart; D008297:Male; D011247:Pregnancy; D011256:Pregnancy Outcome; D050497:Stillbirth; D016896:Treatment Outcome
D006442:Glycated Hemoglobin; D007004:Hypoglycemic Agents; D007328:Insulin; D061267:Insulin Aspart