近日，华领医药Li Chen等研究人员合作完成Dorzagliatin对2型糖尿病患者二甲双胍附加治疗的3期临床试验。2022年5月12日，《自然—医学》杂志在线发表了这项成果。

Author: Yang, Wenying, Zhu, Dalong, Gan, Shenglian, Dong, Xiaolin, Su, Junping, Li, Wenhui, Jiang, Hongwei, Zhao, Wenjuan, Yao, Minxiu, Song, Weihong, Lu, Yibing, Zhang, Xiuzhen, Li, Huifang, Wang, Guixia, Qiu, Wei, Yuan, Guoyue, Ma, Jianhua, Li, Wei, Li, Ziling, Wang, Xiaoyue, Zeng, Jiaoe, Yang, Zhou, Liu, Jingdong, Liang, Yongqian, Lu, Song, Zhang, Huili, Liu, Hui, Liu, Ping, Fan, Kuanlu, Jiang, Xiaozhen, Li, Yufeng, Su, Qing, Ning, Tao, Tan, Huiwen, An, Zhenmei, Jiang, Zhaoshun, Liu, Lijun, Zhou, Zunhai, Zhang, Qiu, Li, Xuefeng, Shan, Zhongyan, Xue, Yaoming, Mao, Hong, Shi, Lixin, Ye, Shandong, Zhang, Xiaomei, Sun, Jiao, Li, Ping, Yang, Tao, Li, Feng, Lin, Jingna, Zhang, Zhinong, Zhao, Ying, Li, Ruonan, Guo, Xiaohui, Yao, Qi, Lu, Weiping, Qu, Shen, Li, Hongmei, Tan, Liling, Wang, Wenbo, Yao, Yongli, Chen, Daoxiong, Li, Yulan, Gao, Jialin, Hu, Wen, Fei, Xiaoqiang, Wu, Tianfeng, Dong, Song, Jin, Wenlong, Li, Chenzhong, Zhao, Dong, Feng, Bo, Zhao, Yu, Zhang, Yi

Issue&Volume: 2022-05-12

Abstract: Metformin, the first-line therapy for type 2 diabetes (T2D), decreases hepatic glucose production and reduces fasting plasma glucose levels. Dorzagliatin, a dual-acting orally bioavailable glucokinase activator targeting both the pancreas and liver glucokinase, decreases postprandial glucose in patients with T2D. In this randomized, double-blind, placebo-controlled phase 3 trial, the efficacy and safety of dorzagliatin as an add-on therapy to metformin were assessed in patients with T2D who had inadequate glycemic control using metformin alone. Eligible patients with T2D (n=767) were randomly assigned to receive dorzagliatin or placebo (1:1 ratio) as an add-on to metformin (1,500mg per day) for 24weeks of double-blind treatment, followed by 28weeks of open-label treatment with dorzagliatin for all patients. The primary efficacy endpoint was the change in glycated hemoglobin (HbA1c) levels from baseline to week 24, and safety was assessed throughout the trial. At week 24, the least-squares mean change from baseline in HbA1c (95% confidence interval (CI)) was 1.02% (1.11, 0.93) in the dorzagliatin group and 0.36% (0.45, 0.26) in the placebo group (estimated treatment difference, 0.66%; 95% CI: 0.79, 0.53; P<0.0001). The incidence of adverse events was similar between groups. There were no severe hypoglycemia events or drug-related serious adverse events in the dorzagliatin and metformin combined therapy group. In patients with T2D who experienced inadequate glycemic control with metformin alone, dorzagliatin resulted in effective glycemic control with good tolerability and safety profile (NCT03141073).

DOI: 10.1038/s41591-022-01803-5

Source: https://www.nature.com/articles/s41591-022-01803-5