Pooled Analysis of Clinical Trials Investigating the Pharmacokinetics (PK) of Ultra-rapid Insulin BioChaperone Lispro (BCLIS) vs. Lispro (LIS) in Subjects with Type 1 (T1D) and Type 2 (T2D) Diabetes

BCLIS is an ultra-rapid insulin lispro formulation designed to accelerate the time-action profile vs. conventional short-acting insulin analogs. PK characteristics of single doses of BCLIS and LIS were characterized in four randomized, double-blind, crossover studies in altogether 112 T1D and 51 T2D subjects who received BCLIS and LIS (0.2 U/kg in studies 1 and 2, individualized doses in studies 3 and 4) subcutaneously by syringe. Insulin absorption was consistently faster with BCLIS than with LIS as indicated by reaching early half-maximum insulin levels (early t50%max) 8.4 (95% confidence interval [-9.6;-7.2]) and time to maximum levels (tmax) 10.0 [-14.3;-5.8] min earlier (p