BioChaperone Lispro versus faster aspart and insulin aspart in patients with type 1 diabetes using continuous subcutaneous insulin infusion: A randomized euglycemic clamp study

Diabetes Obes Metab. 2019 Apr;21(4):1066-1070. doi: 10.1111/dom.13621. Epub 2019 Jan 17.


We investigated the pharmacodynamics (PD) and pharmacokinetics (PK) of BioChaperone insulin Lispro (BCLIS), faster insulin aspart (FIA) and insulin aspart (ASP) in patients with type 1 diabetes using an insulin pump. In this randomized, double-blind, three-way crossover glucose clamp study, 43 patients received a bolus dose of each insulin (0.15 U/kg) in addition to a basal rate (0.01 U/kg/h), delivered via an insulin pump. With BCLIS, the AUC-GIR,0-60 minutes (primary endpoint) was improved compared to ASP (least square means ratio, 1.63; 95% CI, 1.44-1.88; P < 0.0001) and was similar compared to FIA (least square means ratio, 1.06; 95% CI, 0.94-1.18; P = 0.4609). BCLIS showed faster-on PD (tearly0.5GIRmax ) than ASP and faster-off PD (tlate0.5GIRmax ) than both FIA and ASP. BCLIS also demonstrated significantly higher early exposure (AUCins, 0-60 minutes) and lower late exposure (AUCins,120-600 minutes) than both other insulins. In patients with type 1 diabetes using an insulin pump, BCLIS better mimics prandial insulin secretion and action than ASP and shows a faster off-PD than FIA.

Keywords: insulin analogs; insulin pump therapy; pharmacodynamics; pharmacokinetics; type 1 diabetes.

Publication types

  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Blood Glucose / metabolism
  • Cross-Over Studies
  • Diabetes Mellitus, Type 1 / drug therapy*
  • Diabetes Mellitus, Type 1 / metabolism
  • Dosage Forms
  • Double-Blind Method
  • Excipients / pharmacokinetics
  • Female
  • Glucose Clamp Technique
  • Humans
  • Hypoglycemic Agents / administration & dosage
  • Hypoglycemic Agents / pharmacokinetics*
  • Infusions, Subcutaneous
  • Insulin Aspart / administration & dosage
  • Insulin Aspart / pharmacokinetics*
  • Insulin Infusion Systems
  • Insulin Lispro / administration & dosage
  • Insulin Lispro / pharmacokinetics*
  • Male
  • Middle Aged


  • Blood Glucose
  • Dosage Forms
  • Excipients
  • Hypoglycemic Agents
  • Insulin Lispro
  • Insulin Aspart