Efficacy and safety of PEGylated exenatide injection (PB-119) in treatment-naive type 2 diabetes mellitus patients: a Phase II randomised, double-blind, parallel, placebo-controlled study.

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Glucagon-like peptide 1 receptor agonists (GLP-1 RA) such as exenatide are used as monotherapy and add-on therapy for maintaining glycaemic control in patients with type 2 diabetes mellitus. The current study investigated the safety and efficacy of once-weekly PB-119, a PEGylated exenatide injection, in treatment-naive patients with type 2 diabetes.In this Phase II, randomised, placebo-controlled, double-blind study, we randomly assigned treatment-naive Chinese patients with type 2 diabetes in a 1:1:1:1 ratio to receive subcutaneous placebo or one of three subcutaneous doses of PB-119 (75, 150, and 200 μg) for 12 weeks. The primary endpoint was the change in HbA1c from baseline to week 12, and other endpoints were fasting plasma glucose, 2 h postprandial glucose (PPG), and proportion of patients with HbA1c 


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Authors: Linong Ji, Ying Du, Min Xu, Xiangjun Zhou, Zhaohui Mo, Jianhua Ma, Jiarui Li, Yufeng Li, Jingna Lin, Yanjun Wang, Jing Yang, Weihong Song, Hui Jin, Shuguang Pang, Hui Liu, Ping Li, Jie Liu, Minxiu Yao, Wenhui Li, Xiaohong Jiang, Feixia Shen, Houfa Geng, Haifeng Zhou, Jianmin Ran, Minxiang Lei, Yinghong Du, Shandong Ye, Qingbo Guan, Wenshan Lv, Huiwen Tan, Tao Chen, Jinkui Yang, Guijun Qin, Shiyun Li, Lei Chen

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