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ORIGINAL RESEARCH article
Front. Endocrinol.
Sec. Clinical Diabetes
Volume 15 - 2024 |
doi: 10.3389/fendo.2024.1407829
This article is part of the Research Topic Non-insulin pharmacotherapies for the treatment of type 2 diabetes and obesity - old and new players View all articles
A comparative evaluation of bioequivalence of Gan & Lee glargine U300 and Toujeo ® in Chinese healthy male participants
Provisionally accepted- 1 The first affiliated hospital of Bengbu medical university, Bengbu, China
- 2 Gan & Lee Pharmaceuticals, Beijing, China
- 3 Bengbu Medical University, Bengbu, Anhui Province, China
Background: To assess the bioequivalence between Gan & Lee (GL) glargine U300 and Toujeo ® regarding pharmacokinetics (PK), pharmacodynamics (PD), and safety in Chinese healthy male participants.Methods: A single-center, randomized, double-blind, single-dose, two-preparation, two-sequence, four-cycle repeated crossover design study was performed to compare GL glargine U300 and Toujeo ® in 40 healthy participants. The primary PK endpoints were the area under the curve of glargine metabolites, M1 concentration from 0 to 24 hours (AUC0-24h), and the maximum glargine concentration within 24 hours post-dose (Cmax). The primary PD endpoints were the area under the glucose infusion rate (GIR) curve from 0 to 24 hours (AUCGIR.0-24h) and the maximum GIR within 24 hours post-dose (GIRmax).Results: GL Glargine U300 demonstrated comparable PK parameters (AUC0-24h, Cmax, AUC0-12h, and AUC12-24h of M1) and PD responses [AUCGIR.0-24h, GIRmax, AUCGIR.0-12h, and AUCGIR.12-24h] to those of Toujeo ® , as indicated by 90% confidence intervals ranging from 80% to 125%. No significant disparities in safety profiles were observed between the two treatment groups, and there were no reported instances of serious adverse events.The PK, PD, and safety of GL glargine U300 were bioequivalent to that of Toujeo ® .
Keywords: diabetes, Insulin glargine U300, Bioequivalence, biosimilar, pharmacokinetics, Pharmacodynamics
Received: 27 Mar 2024; Accepted: 22 Jul 2024.
Copyright: © 2024 Li, He, Liu, Jiang, Shan, Zhu, Li, Xie, Li, Chen, Su, Zhang, Li, Cheng, Chen, Wang, Su, Xu, Li, Zhou, Chen and Liu. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) or licensor are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.
* Correspondence:
Xiaoli Li, The first affiliated hospital of Bengbu medical university, Bengbu, China
Bingyan Liu, The first affiliated hospital of Bengbu medical university, Bengbu, China
Qian Jiang, Gan & Lee Pharmaceuticals, Beijing, China
Rongfang Shan, Bengbu Medical University, Bengbu, Anhui Province, China
Juan Zhu, Bengbu Medical University, Bengbu, Anhui Province, China
Xiaoyue Li, The first affiliated hospital of Bengbu medical university, Bengbu, China
Tian Xie, Gan & Lee Pharmaceuticals, Beijing, China
Mengmeng Chen, The first affiliated hospital of Bengbu medical university, Bengbu, China
He Su, The first affiliated hospital of Bengbu medical university, Bengbu, China
Chaoyang Zhang, The first affiliated hospital of Bengbu medical university, Bengbu, China
Lufeng Li, The first affiliated hospital of Bengbu medical university, Bengbu, China
Dongmei Cheng, The first affiliated hospital of Bengbu medical university, Bengbu, China
Juan Chen, The first affiliated hospital of Bengbu medical university, Bengbu, China
Ying Wang, Bengbu Medical University, Bengbu, Anhui Province, China
Yuanyuan Xu, Bengbu Medical University, Bengbu, Anhui Province, China
Zhuoran Li, Gan & Lee Pharmaceuticals, Beijing, China
Wei Chen, Gan & Lee Pharmaceuticals, Beijing, China
Yuanyuan Liu, The first affiliated hospital of Bengbu medical university, Bengbu, China
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