title: Insulin aspart improves meal time glycaemic control in patients with Type 2 diabetes: a randomized, stratified, double-blind and cross-over trial.
abstract: OBJECTIVE
  This randomized, multi-centre, double-blind, stratified, two period, cross-over trial was undertaken to assess the pharmacokinetics and pharmacodynamics of insulin aspart injected immediately before compared with regular human insulin injected 30 min before a Mediterranean-style meal in 37 (23 M, 14 F) patients with Type 2 diabetes.
  
  
  METHODS
  Insulin aspart or regular human insulin was given subcutaneously (0.15 U/kg) in random sequence, using a double-dummy technique (at one visit: human regular insulin at t=-30 min and placebo at t=0; at the other visit: placebo at t=-30 min and aspart insulin at t=0). Serum glucose and insulin concentrations (15 points) were measured after each meal for 240 min.
  
  
  RESULTS
  Post-prandial glycaemic excursions were 20% lower with insulin aspart (IAsp) compared with regular human insulin (HI) treatment [ratio (Iasp/HI)=0.80, CI=(0.66-0.98), P=0.034]. The maximum serum glucose (SG) concentration was similar for the two treatments (P=NS). The (median) time to maximum SG was 25 min shorter for IAsp compared with HI (P=0.048). Maximum serum insulin concentration was higher after IAsp compared with HI (P=0.023) as well as the area under the 4-h serum insulin curve (P=0.006). Furthermore, the time to maximum serum insulin concentration was 27 min shorter after IAsp (P=0.039), even though IAsp was injected 30 min after HI. No adverse events occurred during the trial.
  
  
  CONCLUSIONS
  In patients with Type 2 diabetes a more favourable insulin profile and a better glycaemic control were found with IAsp injected immediately before compared with HI injected 30 min before a Mediterranean-style meal.
authors.affiliation: Section of Internal Medicine, Endocrinology and Metabolism, Department of Internal Medicine, University of Perugia, Italy. gabriele@dimisem.med.unipg.it
authors.forename: G
authors.initials: G
authors.lastname: Perriello
authors.forename: S
authors.initials: S
authors.lastname: Pampanelli
authors.forename: F
authors.initials: F
authors.lastname: Porcellati
authors.forename: A
authors.initials: A
authors.lastname: Avogaro
authors.forename: E
authors.initials: E
authors.lastname: Bosi
authors.forename: G
authors.initials: G
authors.lastname: Petrella
authors.forename: S
authors.initials: S
authors.lastname: Squatrito
authors.forename: S
authors.initials: S
authors.lastname: Furneri
authors.forename: G
authors.initials: G
authors.lastname: Marra
authors.forename: L
authors.initials: L
authors.lastname: Vitali
authors.forename: M
authors.initials: M
authors.lastname: Previti
authors.forename: D
authors.initials: D
authors.lastname: Cucinotta
mesh_terms: D000368:Aged; D001786:Blood Glucose / Q000378:metabolism*; D003924:Diabetes Mellitus, Type 2 / Q000097:blood / Q000188:drug therapy*; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D007004:Hypoglycemic Agents / Q000627:therapeutic use*; D007328:Insulin / Q000031:analogs & derivatives* / Q000627:therapeutic use*; D061267:Insulin Aspart; D008297:Male; D008875:Middle Aged; D019518:Postprandial Period / Q000502:physiology; D013997:Time Factors
chemical_list: D001786:Blood Glucose; D007004:Hypoglycemic Agents; D007328:Insulin; D061267:Insulin Aspart