Interindividual Variability in the Pharmacodynamic and Pharmacokinetic Characteristics of Recombinant Human Insulin and Insulin Aspart

Purpose: The present study compared the interindividual variability in the pharmacodynamic (PD) and pharmacokinetic (PK) properties of a short-acting recombinant human insulin to those of insulin aspart through manual euglycemic glucose clamp tests. Methods: Sixty healthy Chinese male volunteers were randomly assigned to receive human insulin or insulin aspart, administered via SC injection (0.2 U/kg). For the evaluation of interindividual variability in PD and PK properties (glucose infusion rate [GIR], insulin concentration [INS]) through euglycemic clamp studies, %CVs were calculated, and PK/PD interindividual variability was compared between the 2 groups. Findings: The differences between the human insulin and insulin aspart groups in interindividual variabilities in total AUCs of the GIR (19% vs 21%) and INS (14% vs 17%) were not significant. The interindividual variabilities in AUC(GIR0-120min), early T-max50%, and AUC(INS0-120min) were lower in the insulin aspart group than in the human insulin group (22% vs 44%, 21% vs 35%, and 22% vs 28%, respectively; all, P < 0.05), while the interindividual variabilities in the AUCs of GIR(120-600min) and INS120-600min were higher with insulin aspart than with human insulin (29% vs 20%, 51% vs 30%; both, P < 0.05). (C) 2021 Elsevier Inc.