Studies of pharmacokinetic, pharmacodynamic properties and bioequivalence of recombinant insulin glargine injection in healthy man

Objective: To study the pharmacokinetic and pharmacodynamic properties of the subcutaneously injected long-acting insulin analog-recombinant insulin glargine injections in comparison with those of reference preparation-NPH insulin injection (Novolin (R) N) in healthy volunteers, and to evaluate the bioequivalence of domestic (Basalin (R)) and imported (Lantus (R)) recombinant insulin glargine injection preparation. Methods: This single center, randomized, single-blind, three-period, crossover design study was carried out by an euglycemic glucose clamp test. 16 healthy male volunteers received single subcutaneous injection of 0.4 U/kg body weight of Basalin administration. Results: The two injections of insulin glargine did not induce the pronounced peak in metabolic activity (P < 0.01) and neous injection of Basalin (R), Lantus (R) or Novolin (R) N. Plasma insulin concentrations (P < 0.05) showed a constant metabolic activity over 24-hour study period, which were different from NPH insulin. The statistic analysis of variance, two one-sided tests and 90% confidence interval were calculated. There were no significant differences in INS-AUC0 similar to 24h, INS-Cmax and INS-Tmax between the two glargine insulin preparations (P > 0.05). The 90% confidence interval of BasalinTM -Ln(AUC0 similar to 24h) was 0.82 to 1.05 in the range of 0.8 to 1.25, the 90% confidence interval of Basalin (R)- Ln (Cmax) was 0.789 to 1.077 in the range of 0.7 to 1.43, which were in accordance with those of Lantus (R). Conclusions: The subcutaneously injected long-acting insulin analog-recombinant insulin glargine injections (Basalin (R) and Lantus (R)) induce a smoother metabolic effect and more stable plasma insulin concentrations than the NPH insulin injection (Novolin (R) N). The results of pharmacokinetic and pharmacodynamic properties demonstrate that the domestic (Basalin (R)) and imported (Lantus (R)) insulin glargine injection preparations were bioequivalent.