title: Comparable efficacy and safety of insulin glulisine and insulin lispro when given as part of a Basal-bolus insulin regimen in a 26-week trial in pediatric patients with type 1 diabetes.
abstract: BACKGROUND
  We compared the efficacy and safety of insulin glulisine with insulin lispro as part of a basal-bolus regimen in children and adolescents with type 1 diabetes.
  
  
  METHODS
  Overall, 572 children and adolescents (4-17 years old) using insulin glargine or neutral protamine Hagedorn insulin as basal insulin were enrolled in a 26-week, multicenter, open, centrally randomized, parallel-group, noninferiority study. Subjects were randomized to receive glulisine (n = 277) or lispro (n= 295) 0-15 min premeal.
  
  
  RESULTS
  Baseline-to-endpoint hemoglobin A1c changes were similar between the two insulins: adjusted mean change (glulisine vs. lispro), 0.10% versus 0.16%; between-treatment difference (glulisine-lispro), &minsu;0.06, 95% confidence interval (-0.24; 0.12); and prespecified noninferiority margin, 0.4%. Overall, for all age groups together, the percentage of patients achieving American Diabetes Association age-specific A1c targets at endpoint was significantly higher (P = 0.039) with glulisine (38.4%) versus lispro (32.0%). From Month 4 to endpoint, both "all" and "severe" symptomatic hypoglycemia rates were similar (3.10 vs. 2.91 and 0.06 vs. 0.07 events/patient-month, respectively). Frequency and type of adverse events, serious adverse events, or hypoglycemia reported as serious adverse events were similar between both groups.
  
  
  CONCLUSIONS
  Glulisine was as effective as lispro in baseline-to-endpoint A1c change, and both treatments were similarly well tolerated.
authors.affiliation: University of Cape Town Diabetes Clinical Trials Unit, New Groote Schuur Hospital, Cape Town, South Africa. aphilotheou@iafrica.com
authors.forename: Areti
authors.initials: A
authors.lastname: Philotheou
authors.forename: Silva
authors.initials: S
authors.lastname: Arslanian
authors.forename: László
authors.initials: L
authors.lastname: Blatniczky
authors.forename: Valentina
authors.initials: V
authors.lastname: Peterkova
authors.forename: Elisabeth
authors.initials: E
authors.lastname: Souhami
authors.forename: Thomas
authors.initials: T
authors.lastname: Danne
mesh_terms: D000293:Adolescent; D002648:Child; D002675:Child, Preschool; D003922:Diabetes Mellitus, Type 1 / Q000097:blood / Q000188:drug therapy*; D005260:Female; D006442:Glycated Hemoglobin / Q000032:analysis; D006801:Humans; D007003:Hypoglycemia / Q000517:prevention & control; D007004:Hypoglycemic Agents / Q000008:administration & dosage*; D007328:Insulin / Q000008:administration & dosage / Q000031:analogs & derivatives*; D061268:Insulin Lispro; D016015:Logistic Models; D008297:Male
chemical_list: D006442:Glycated Hemoglobin; D007004:Hypoglycemic Agents; D007328:Insulin; D061268:Insulin Lispro; C479079:insulin glulisine