title: Maternal efficacy and safety outcomes in a randomized, controlled trial comparing insulin detemir with NPH insulin in 310 pregnant women with type 1 diabetes.
abstract: OBJECTIVE
  This randomized, controlled noninferiority trial aimed to compare the efficacy and safety of insulin detemir (IDet) versus neutral protamine Hagedorn (NPH) (both with prandial insulin aspart) in pregnant women with type 1 diabetes.
  
  
  METHODS
  Patients were randomized and exposed to IDet or NPH up to 12 months before pregnancy or at 8-12 weeks gestation. The primary analysis aimed to demonstrate noninferiority of IDet to NPH with respect to A1C at 36 gestational weeks (GWs) (margin of 0.4%). The data were analyzed using linear regression, taking several baseline factors and covariates into account.
  
  
  RESULTS
  A total of 310 type 1 diabetic women were randomized and exposed to IDet (n = 152) or NPH (n = 158) up to 12 months before pregnancy (48%) or during pregnancy at 8-12 weeks (52%). The estimated A1C at 36 GWs was 6.27% for IDet and 6.33% for NPH in the full analysis set (FAS). IDet was declared noninferior to NPH (FAS, -0.06% [95% CI -0.21 to 0.08]; per protocol, -0.15% [-0.34 to 0.04]). Fasting plasma glucose (FPG) was significantly lower with IDet versus NPH at both 24 GWs (96.8 vs. 113.8 mg/dL, P = 0.012) and 36 GWs (85.7 vs. 97.4 mg/dL, P = 0.017). Major and minor hypoglycemia rates during pregnancy were similar between groups.
  
  
  CONCLUSIONS
  Treatment with IDet resulted in lower FPG and noninferior A1C in late pregnancy compared with NPH insulin. Rates of hypoglycemia were comparable.
authors.affiliation: Center for Pregnant Women with Diabetes, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark. em@rh.dk
authors.forename: Elisabeth R
authors.initials: ER
authors.lastname: Mathiesen
authors.forename: Moshe
authors.initials: M
authors.lastname: Hod
authors.forename: Marina
authors.initials: M
authors.lastname: Ivanisevic
authors.forename: Santiago
authors.initials: S
authors.lastname: Duran Garcia
authors.forename: Lise
authors.initials: L
authors.lastname: Brøndsted
authors.forename: Lois
authors.initials: L
authors.lastname: Jovanovic
authors.forename: Peter
authors.initials: P
authors.lastname: Damm
authors.forename: David R
authors.initials: DR
authors.lastname: McCance
mesh_terms: D000328:Adult; D001786:Blood Glucose / Q000378:metabolism; D003922:Diabetes Mellitus, Type 1 / Q000188:drug therapy*; D005260:Female; D006442:Glycated Hemoglobin / Q000378:metabolism; D006801:Humans; D061267:Insulin Aspart / Q000627:therapeutic use; D000069057:Insulin Detemir; D007336:Insulin, Isophane / Q000627:therapeutic use*; D049528:Insulin, Long-Acting / Q000627:therapeutic use*; D011247:Pregnancy; D011254:Pregnancy in Diabetics / Q000188:drug therapy*
chemical_list: D001786:Blood Glucose; D006442:Glycated Hemoglobin; D061267:Insulin Aspart; D000069057:Insulin Detemir; D007336:Insulin, Isophane; D049528:Insulin, Long-Acting; C517652:hemoglobin A1c protein, human