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Research Article
23 December 2020

Efficacy and safety of GP40021 insulin lispro biphasic compared with Humalog Mix 25 in Type 2 diabetes mellitus patients

Authors: Alexandr Y Mayorov https://orcid.org/0000-0001-5825-3287, Anna A Mosikian https://orcid.org/0000-0002-2863-270X [email protected], Diana N Alpenidze, Igor E Makarenko https://orcid.org/0000-0003-2308-0608, Valeria L Orlova, Ivan S Lunev, Maria V Verbovaya, Bella R Zinnatulina, Alexander L Khokhlov https://orcid.org/0000-0002-0032-0341, and Roman V Drai https://orcid.org/0000-0003-4594-6097Author Info & Affiliations
Volume 10, Number 1
https://doi.org/10.2217/cer-2020-0064
PDFFormats

Abstract

Aim: To compare safety (immunogenicity) and efficacy of a biosimilar insulin GP-Lis25 and a reference insulin Ly-Lis25 (Humalog Mix 25) in Type 2 diabetes mellitus (T2D) patients. Materials & methods: This randomized open-label, 26-week clinical trial enrolled 210 T2D patients, randomized 1:1 to twice-daily GP-Lis25 or Ly-Lis25. The primary end point was immune response at 26th week. Noninferiority margin for HbA1c was 0.4%. Results: Immune response frequency was similar in GP-Lis25 and Ly-Lis25 groups both at week 12 (p = 0.651) and 26 (p = 0.164). The difference of HbA1c change at week 26 was (95% CI) 0.01 (-0.27–0.28)%. Fasting plasma glucose, seven-point glucose profile and insulin dose were similar between groups. Safety did not differ between groups. Conclusion: GP-Lis25 and Ly-Lis25 demonstrated similar safety and efficacy.

Supplementary Material

File (suppl_file.docx)

References

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