Efficacy and safety of GP40021 insulin lispro biphasic compared with Humalog Mix 25 in Type 2 diabetes mellitus patients-Reference-Cited by-同舟云学术

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

Published:2021-01 Issue:1 Volume:10 Page:55-66
ISSN:2042-6305
Container-title:Journal of Comparative Effectiveness Research
language:en
Short-container-title:Journal of Comparative Effectiveness Research

Author:

Mayorov Alexandr Y¹^ORCID,Mosikian Anna A²^ORCID,Alpenidze Diana N³,Makarenko Igor E²^ORCID,Orlova Valeria L⁴,Lunev Ivan S²,Verbovaya Maria V⁵,Zinnatulina Bella R²,Khokhlov Alexander L⁶^ORCID,Drai Roman V²^ORCID

Affiliation:

1. Diabetes institution, Endocrinology Research Centre, Moscow, Russia

2. Department of Clinical trial, OOO GEROPHARM, Saint Petersburg, Russia

3. Department of Endocrinology, City Outpatient Clinic No. 117, Saint Petersburg, Russia

4. Department of Endocrinology, City Hospital No. 2, Saint Petersburg, Russia

5. Department of Endocrinology, Diabetes Center Ltd, Samara, Russia

6. The Chair of Clinical Pharmacology, Yaroslavl State Medical University, Yaroslavl, Russia

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. ClincalTrials.gov identifier: NCT04023344 .

Publisher

Future Medicine Ltd

Subject

Health Policy

Link

https://www.futuremedicine.com/doi/pdf/10.2217/cer-2020-0064

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