open access

Vol 3, No 3 (2014)
Original articles (submitted)
Published online: 2014-07-10
Get Citation

The immunogenicity of Polhumin® insulin — the results of a six-month comparative, multicenter, randomized, controlled clinical trial conducted in the double-blind conditions

Przemysław Mrozikiewicz, Krzysztof Strojek, Jarosław Opiela, Janusz Kamiński
Diabetologia Kliniczna 2014;3(3):100-107.

open access

Vol 3, No 3 (2014)
Original articles (submitted)
Published online: 2014-07-10

Abstract

Background. Long-term use of insulin leads to a number of side effects, including the formation of specific insulin antibodies which can give immunological complications.

Aim. Randomized, double-blind, multicenter phase IV clinical trial comparing the immunogenicity of two formulations of human insulin: Polhumin® (Tarchominskie Pharmaceutical Plant “POLFA” S.A.) and Humulin® (Lilly France S.A.) used in the treatment of diabetes.

Material and methods. After initial screening in thegroup of 751 subjects, 502 patient were qualified to the study who were treated for 28 weeks with recombinant human insulin (Polhumin®) or reference (Humulin®). The main inclusion criteria were diabetes type 1 or 2 for at least 6 months not treated with either Polhumin® or Humulin® preparations and the absence of anti-insulin antibodies.

Results. The proportion of patients with new anti-insulinantibodies were 15% in the test group and 14% in the reference group. There were no statistically significant differences in the number of newly established insulin antibodies between the groups receiving thestudy drug and a reference drug. The percentage of glycated hemoglobin (HbA1c) decreased in the group treated with Polhumin® from 7.8 ± 1.5% to 7.1 ± 1.2% (p < 0.001) and in the group treated with Humulin® from 7.7 ± 1.5% to 7.0 ± 1.0% (p < 0.001). The body weight remained comparable between both treatment groups for the entire duration of treatment: 84 ± 14 kg in the test group vs. 85 ± 12 kg in the reference group at screening; 84.0 ± 15 kg in the test group vs. 85 ± 12 kg in the reference group after 28 weeks of treatment. The total number of 155 patients reported 276 adverse events. There were no differences in the frequency of adverse events between the two groups.

Conclusions. Polhumin® is comparable to the reference product — Humulin® regarding its immunogenicity and clinical efficacy.

Abstract

Background. Long-term use of insulin leads to a number of side effects, including the formation of specific insulin antibodies which can give immunological complications.

Aim. Randomized, double-blind, multicenter phase IV clinical trial comparing the immunogenicity of two formulations of human insulin: Polhumin® (Tarchominskie Pharmaceutical Plant “POLFA” S.A.) and Humulin® (Lilly France S.A.) used in the treatment of diabetes.

Material and methods. After initial screening in thegroup of 751 subjects, 502 patient were qualified to the study who were treated for 28 weeks with recombinant human insulin (Polhumin®) or reference (Humulin®). The main inclusion criteria were diabetes type 1 or 2 for at least 6 months not treated with either Polhumin® or Humulin® preparations and the absence of anti-insulin antibodies.

Results. The proportion of patients with new anti-insulinantibodies were 15% in the test group and 14% in the reference group. There were no statistically significant differences in the number of newly established insulin antibodies between the groups receiving thestudy drug and a reference drug. The percentage of glycated hemoglobin (HbA1c) decreased in the group treated with Polhumin® from 7.8 ± 1.5% to 7.1 ± 1.2% (p < 0.001) and in the group treated with Humulin® from 7.7 ± 1.5% to 7.0 ± 1.0% (p < 0.001). The body weight remained comparable between both treatment groups for the entire duration of treatment: 84 ± 14 kg in the test group vs. 85 ± 12 kg in the reference group at screening; 84.0 ± 15 kg in the test group vs. 85 ± 12 kg in the reference group after 28 weeks of treatment. The total number of 155 patients reported 276 adverse events. There were no differences in the frequency of adverse events between the two groups.

Conclusions. Polhumin® is comparable to the reference product — Humulin® regarding its immunogenicity and clinical efficacy.

Get Citation

Keywords

diabetes, insulin human, immunogenicity

About this article
Title

The immunogenicity of Polhumin® insulin — the results of a six-month comparative, multicenter, randomized, controlled clinical trial conducted in the double-blind conditions

Journal

Clinical Diabetology

Issue

Vol 3, No 3 (2014)

Pages

100-107

Published online

2014-07-10

Bibliographic record

Diabetologia Kliniczna 2014;3(3):100-107.

Keywords

diabetes
insulin human
immunogenicity

Authors

Przemysław Mrozikiewicz
Krzysztof Strojek
Jarosław Opiela
Janusz Kamiński

Important: This website uses cookies. More >>

The cookies allow us to identify your computer and find out details about your last visit. They remembering whether you've visited the site before, so that you remain logged in - or to help us work out how many new website visitors we get each month. Most internet browsers accept cookies automatically, but you can change the settings of your browser to erase cookies or prevent automatic acceptance if you prefer.

 

Wydawcą serwisu jest  "Via Medica sp. z o.o." sp.k., ul. Świętokrzyska 73, 80–180 Gdańsk

tel.:+48 58 320 94 94, faks:+48 58 320 94 60, e-mail:  viamedica@viamedica.pl