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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
Xiaoli Li Xiaoli Li 1*Anshun He Anshun He 2Bingyan Liu Bingyan Liu 1*Qian Jiang Qian Jiang 2*Rongfang Shan Rongfang Shan 3*Juan Zhu Juan Zhu 3*Xiaoyue Li Xiaoyue Li 1*Tian Xie Tian Xie 2*Yue Li Yue Li 2Mengmeng Chen Mengmeng Chen 1*He Su He Su 1*Chaoyang Zhang Chaoyang Zhang 1*Lufeng Li Lufeng Li 1*Dongmei Cheng Dongmei Cheng 1*Juan Chen Juan Chen 1*Ying Wang Ying Wang 3*Yue Su Yue Su 1Yuanyuan Xu Yuanyuan Xu 3*Zhuoran Li Zhuoran Li 2*Huan Zhou Huan Zhou 1Wei Chen Wei Chen 2*Yuanyuan Liu Yuanyuan Liu 1*
  • 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

The final, formatted version of the article will be published soon.

    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

    Disclaimer: All claims expressed in this article are solely those of the authors and do not necessarily represent those of their affiliated organizations, or those of the publisher, the editors and the reviewers. Any product that may be evaluated in this article or claim that may be made by its manufacturer is not guaranteed or endorsed by the publisher.