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

Abstract

Background: 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.

Methods: 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.

Results: 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.

Conclusion: 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.