Comparative study between two recombinant human NPH insulin formulations for the treatment of type 2 diabetes mellitus.

Nelson Rassi,Fernanda Cruvinel De Abreu,Salvador Rassi,Karini Bruno Bellório,Paulo Roberto Mendonça Prata,Adriana Ganam Alves,Sandra Maria Campos Teixeira De Moraes,Josianny Mesquita Moreira,Leonardo De Souza Teixeira,Daniela Cunha Cavalheiro

doi:10.1590/2359-3997000000140

Abstract

To compare the effects of the neutral protamine Hagedorn (NPH) recombinant human insulin formulations Gansulin and Humulin N® on the glycemic control of patients with type 2 diabetes mellitus (T2DM). Prospective, double-blind, randomized, parallel, single-center study of 37 individuals with T2DM treated with NPH insulin formulations. The Tukey-Kramer test for multiple comparisons, the Wilcoxon paired comparison test and the Chi-Square test were used for the statistical analyses. The significance level was set at 5% (p < 0.05). The NPH insulin formulations Humulin and Gansulin similarly reduced the HbA1c levels observed at the end of the study compared with the values obtained at the beginning of the study. In the Humulin group, the initial HbA1c value of 7.91% was reduced to 6.56% (p < 0.001), whereas in the Gansulin group, the reduction was from 8.18% to 6.65% (p < 0.001). At the end of the study, there was no significant difference between the levels of glycated hemoglobin (p = 0.2410), fasting plasma glucose (FG; p = 0.9257) and bedtime plasma glucose (BG; p = 0.3906) between the two insulin formulations. There was no nt difference in the number of hypoglycemic events between the two insulin formulations, and no severe hyp episodes were recorded. This study demonstrated similar glycemic control by NPH insulin Gansulin compared with human insulin Humulin N® in patients with T2DM.

Highlights

P rojections by the World Health Organization (WHO) indicate that the prevalence of diabetes worldwide will exceed 300 million in 12 years and that developing countries will contribute significantly to these numbers [1,2]
The mean time living with a diabetes diagnosis was over 10 years (145 ± 73.65 months for females and 130.20 ± 74.21 months for males); for glycemic control, females presented the following clinical parameters: HbA1c–8.14 ± 0.86%, fasting plasma glucose (FG)–144.45 ± 61.24 mg.dL-1 and bedtime plasma glucose (BG)–96.75 ± 35.03 mg.dL-1; and males presented the following clinical parameters: Hba1c–7.95 ± 0.63%, FG–93.20 ± 26.71 mg.dL-1 and BG–131.5 ± 45.16 mg.dL-1
To the best of our knowledge, this is the first randomi zed controlled trial comparing the efficacy and safety of a new brand of neutral protamine Hagedorn (NPH) insulin, Gansulin, which is not available in Brazil, with Humulin, which is an NPH in sulin that has been available in Brazil for decades

Summary

Introduction

P rojections by the World Health Organization (WHO) indicate that the prevalence of diabetes worldwide will exceed 300 million in 12 years and that developing countries will contribute significantly to these numbers [1,2].

Results

Conclusion