title: U-100, pH-Neutral formulation of VIAject(®) : faster onset of action than insulin lispro in patients with type 1 diabetes.
abstract: OBJECTIVE
  VIAject® is a formulation of human insulin with a very fast onset of action. Previous studies used VIAject in a concentration of 25 U/ml and a pH of 4 [VIAject 25 (VJ25)]. Objective of this double blind, three-way crossover study was to compare the pharmacodynamic/pharmacokinetic properties of a novel formulation of VIAject with a concentration of 100 U/ml and a neutral pH [VIAject 7 (VJ7)] with VJ25 and insulin lispro (LIS).
  
  
  METHODS
  Forty-three patients with type 1 diabetes [aged 43 (21-65) years, BMI 24.1 (20-28) kg/m(2) and HbA1c 7.5 (5.7-9.5) %] participated in this study. They received subcutaneous injections of 12 U of each insulin formulation under euglycaemic glucose clamp conditions.
  
  
  RESULTS
  VJ7 was bioequivalent to VJ25 [90% confidence interval (CI) of the ratios for total insulin AUCs and maximum insulin concentration (C(INS max) ) was within 0.80-1.25]. VJ7 showed a faster absorption compared to LIS [time to C(INS max) 23 vs. 60 min; difference (CI) -30 (-35 to -23)] and faster onset of action [time to early half-maximal glucose infusion rate (GIR) 25 vs. 44 min; -18 (-26 to -10)], and a higher AUC of glucose infusion rate (AUC(GIR) ) in the first 60 min after injection [176 vs. 107 mg/kg; ratio 1.65 (1.27 to 2.14)], contributing to a slightly higher value for AUC(GIR 0-480) [1263 vs. 1095 mg/kg; 1.15 (1.06 to 1.26)]. Maximum GIR was similar between VJ7 and LIS [6.1 vs.6.6 mg/kg/min; ratio 0.93 (0.86 to 1.01)], whereas the duration of action (t(GIR50%-late) ) was longer with VJ7 [274 vs. 228 min; 50 (25 to 73)].
  
  
  CONCLUSIONS
  This formulation of VIAject is bioequivalent to the previously used formulation and has a faster absorption/onset of action than LIS.
authors: Profil Institut für Stoffwechselforschung, Hellersbergstrasse 9, Neuss, Germany.
authors: L
authors: L
authors: Heinemann
authors: L
authors: L
authors: Nosek
authors: F
authors: F
authors: Flacke
authors: K
authors: K
authors: Albus
authors: A
authors: A
authors: Krasner
authors: P
authors: P
authors: Pichotta
authors: T
authors: T
authors: Heise
authors: S
authors: S
authors: Steiner
mesh_terms: D000328:Adult; D000368:Aged; D019540:Area Under Curve; D001786:Blood Glucose / Q000187:drug effects / Q000378:metabolism; D018592:Cross-Over Studies; D003922:Diabetes Mellitus, Type 1 / Q000097:blood / Q000188:drug therapy*; D004311:Double-Blind Method; D005215:Fasting; D005260:Female; D015309:Glucose Clamp Technique; D006801:Humans; D007004:Hypoglycemic Agents / Q000493:pharmacokinetics* / Q000494:pharmacology; D007279:Injections, Subcutaneous; D007328:Insulin / Q000031:analogs & derivatives / Q000493:pharmacokinetics* / Q000494:pharmacology; D061268:Insulin Lispro / Q000493:pharmacokinetics* / Q000494:pharmacology; D008297:Male; D008875:Middle Aged; D019518:Postprandial Period; D013810:Therapeutic Equivalency
chemical_list: D001786:Blood Glucose; D007004:Hypoglycemic Agents; D007328:Insulin; D061268:Insulin Lispro