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

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 (HbA_1c) 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.