BioChaperone Lispro: Preliminary Phase IIb data

Preliminary data from 37 Type I diabetics in a double-blind, crossover, German Phase IIa trial showed that single doses of 0.1, 0.2 and 0.4 U/kg BioChaperone Lispro dose-proportionally increased total insulin exposure as measured by area under the curve (AUC) (112, 213 and 452 h*mU/L, respectively) and maximum insulin lispro concentration (Cmax) (55, 100 and 191 mU/L, respectively). Additionally, 0.1, 0.2 and 0.4 U/kg doses of BioChaperone Lispro led to a linear dose response for the total metabolic effect (726, 1,357 and 2,422 mg/kg, respectively) and maximum glucose infusion rate (4.8, 7.4 and 10.2 mg/kg/min, respectively).

Additionally, 0.2 U/kg BioChaperone Lispro led to a significantly faster rate of insulin lispro absorption as measured by AUC (25 vs. 12 h*mU/L, p<0.001) and a significantly lower median time to peak insulin concentration ( Tmax) (40 vs. 60 min, p=0.001) vs. Humalog insulin lispro. Furthermore, 0.2 U/kg BioChaperone Lispro significantly reduced time to half maximum insulin levels after peak insulin concentration (Tmax) vs. Humalog (132 vs. 163 min, p<0.001). During the first hour of administration, 0.2 U/kg BioChaperone Lispro significantly increased the early metabolic effect vs. Humalog (207 vs. 123 mg/kg, p<0.0001). Data will be presented at the European Association for the Study of Diabetes meeting in Vienna this month. ...