THE ACTION PROFILE OF HUMAN INSULIN: AN EUGLYCEMIC CLAMP TEST APPROACH TO COMPARE TWO COMMERCIAL BIOSYNTHETIC INSULIN BRANDS

The aim of this study was to compare time action profile of regular human Insulin produced by Exir pharmaceutical Co. and Actrapid® HM produced by Novo Nordisk with euglycemic clamp technique for the first time in Iran. Euglycemic glucose clamps were performed with two Insulin brands in a single-center, randomized, double-blind, and crossover study on 6 healthy male volunteers. Glucose disposal kinetics including metabolic clearance rate of glucose (MCRg) and metabolic clearance rate of insulin (MCRi) were determined during a 2-h predetermined intravenous Insulin infusion while blood glucose levels were maintained steady using variable continues intravenous glucose infusions based on method of De Fronzo. There were no differences in glucose kinetics or time action profile with respect to glucose infusion rates (688.4 vs. 664.6 mg/kg per 120min), MCRg (0.63±0.19 vs. 0.62±0.25 ml/kg), and MCRi(110 % vs110%) between Exir and Novo Nordisk regular human Insulin preparations. Serum insulin levels increased and serum C-peptide levels decreased with both exogenous Insulin infusions which were statistically the same for both preparations. Time action profile and bioavailability of regular human insulin produced by Exir Pharmaceutical Corporation is comparable with commonly used Novo Nordisk preparation demonstrated by 2 hour euglycemic clamp study.