Bioequivalence between two human insulin analogs in Chinese population: Glulisine and Lispro.

Intensive insulin therapy for diabetic patients has been demonstrated as an appropriate treatment. Regular fast-acting insulin can hardly mimic the efficiency of endogenous meal-activated insulin secretion. Glulisine is a new rapid-acting insulin analog for mealtime insulin supplementation. We compared the pharmacokinetics and pharmacodynamics end points between the two rapid-acting insulin analogs Glulisine and Lispro. Twenty healthy adult males age ranging from 22 to 32 years were included in a randomized, open-label, cross contrast research. Two long duration hyperinsulinemic euglycemic clamp tests, one with Glulisine and the other with Lispro, were conducted on two separate days for all the participants. The two rapid-acting insulin analogs were administrated randomly to each participant. Glucose infusion rate (GIR) began to increase 20 min after injection in both Glulisine and Lispro groups. GIR increased sharply during the first 150 min and reached a peak at 6.23 ± 1.35 mg/(kg min) in the Glulisine group and 6.02 ± 1.27 mg/(kg min) in the Lispro group. It returned to the initial level at hour 5. The Area Under Curve (AUC(0-clamp end)) in Glulisine and Lispro groups were 1455.04 ± 381.88 mg/kg and 1356.25 ± 287.30 mg/kg (P > 0.05), respectively. However, AUC(0-1h) between the two groups showed significant difference, with Glulisine showed greater AUC(0-1h) in the first hour after injection. Other parameters showed no significant difference between the two groups. Insulin analogs Glulisine and Lispro were proved to have equivalent pharmacokinetic and pharmacodynamic parameters when administered to healthy Chinese adults, but with Glulisine showing greater AUC(0-1h) after injection.

RCT Entities:   Population Interventions Outcomes