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Dorzagliatin in drug-naïve patients with type 2 diabetes: a randomized, double-blind, placebo-controlled phase 3 trial.
Zhu, Dalong; Li, Xiaoying; Ma, Jianhua; Zeng, Jiao'e; Gan, Shenglian; Dong, Xiaolin; Yang, Jing; Lin, Xiaohong; Cai, Hanqing; Song, Weihong; Li, Xuefeng; Zhang, Keqin; Zhang, Qiu; Lu, Yibing; Bu, Ruifang; Shao, Huige; Wang, Guixia; Yuan, Guoyue; Ran, Xingwu; Liao, Lin; Zhao, Wenjuan; Li, Ping; Sun, Li; Shi, Lixin; Jiang, Zhaoshun; Xue, Yaoming; Jiang, Hongwei; Li, Quanmin; Li, Zongbao; Fu, Maoxiong; Liang, Zerong; Guo, Lian; Liu, Ming; Xu, Chun; Li, Wenhui; Yu, Xuefeng; Qin, Guijun; Yang, Zhou; Su, Benli; Zeng, Longyi; Geng, Houfa; Shi, Yongquan; Zhao, Yu; Zhang, Yi; Yang, Wenying; Chen, Li.
Afiliación
  • Zhu D; Affiliated Drum Tower Hospital, Medical School of Nanjing University, Nanjing, China. zhudalong@nju.edu.cn.
  • Li X; Zhongshan Hospital, Fudan University, Shanghai, China.
  • Ma J; Nanjing First Hospital, Nanjing, China.
  • Zeng J; Jingzhou Hospital Affiliated to Yangtze University, Jingzhou, China.
  • Gan S; The First People's Hospital of Changde City, Changde, China.
  • Dong X; Jinan Central Hospital Affiliated to Shandong First Medical University, Jinan, China.
  • Yang J; The First Hospital of Shanxi Medical University, Taiyuan, China.
  • Lin X; Zhuzhou Central Hospital, Zhuzhou, China.
  • Cai H; The Second Hospital of Jilin University, Changchun, China.
  • Song W; Chenzhou First People's Hospital, Chenzhou, China.
  • Li X; Taihe Hospital, Hubei University of Medicine, Shiyan, China.
  • Zhang K; Tongji Hospital of Tongji University, Shanghai, China.
  • Zhang Q; The First Affiliated Hospital of Anhui Medical University, Hefei, China.
  • Lu Y; The Second Affiliated Hospital of Nanjing Medical University, Nanjing, China.
  • Bu R; Wuxi People's Hospital, Wuxi, China.
  • Shao H; Changsha Central Hospital, Changsha, China.
  • Wang G; The First Hospital of Jilin University, Changchun, China.
  • Yuan G; Affiliated Hospital of Jiangsu University, Zhenjiang, China.
  • Ran X; West China Hospital, Sichuan University, Chengdu, China.
  • Liao L; The First Affiliated Hospital of Shandong First Medical University & Shandong Provincial Qianfoshan Hospital, Jinan, China.
  • Zhao W; The Affiliated Hospital of Qingdao University, Qingdao, China.
  • Li P; Affiliated Drum Tower Hospital, Medical School of Nanjing University, Nanjing, China.
  • Sun L; Siping Hospital of China Medical University, Siping, China.
  • Shi L; The Affiliated Hospital of Guizhou Medical University, Guiyang, China.
  • Jiang Z; The 960th Hospital of the PLA Joint Logistics Support Force, Jinan, China.
  • Xue Y; Southern Medical University Nanfang Hospital, Guangzhou, China.
  • Jiang H; The First Affiliated Hospital, and College of Clinical Medicine of Henan University of Science and Technology, Luoyang, China.
  • Li Q; PLA Rocket Force Characteristic Medical Center, Beijing, China.
  • Li Z; Sanya Central Hospital, Sanya, China.
  • Fu M; The Second Affiliated Hospital of Hainan Medical University, Haikou, China.
  • Liang Z; Chongqing Red Cross Hospital, Chongqing, China.
  • Guo L; Chongqing University Three Gorges Central Hospital, Chongqing, China.
  • Liu M; Tianjin Medical University General Hospital, Tianjin, China.
  • Xu C; The Third Medical Center of PLA General Hospital, Beijing, China.
  • Li W; Peking Union Medical College Hospital, Beijing, China.
  • Yu X; Tongji Hospital, Tongji Medical College of HUST, Wuhan, China.
  • Qin G; The First Affiliated Hospital of Zhengzhou University, Zhengzhou, China.
  • Yang Z; Jiangxi Pingxiang People's Hospital, Pingxiang, China.
  • Su B; The Second Hospital of Dalian Medical University, Dalian, China.
  • Zeng L; The Third Affiliated Hospital, Sun Yat-sen University, Guangzhou, China.
  • Geng H; Xuzhou Central Hospital, Xuzhou, China.
  • Shi Y; Shanghai Changzheng Hospital, Shanghai, China.
  • Zhao Y; Hua Medicine, Shanghai, China.
  • Zhang Y; Hua Medicine, Shanghai, China.
  • Yang W; China-Japan Friendship Hospital, Beijing, China. ywying_1010@126.com.
  • Chen L; Hua Medicine, Shanghai, China. lichen@huamedicine.com.
Nat Med ; 28(5): 965-973, 2022 05.
Article en En | MEDLINE | ID: mdl-35551294
Improving glucose sensitivity remains an unmet medical need in treating type 2 diabetes (T2D). Dorzagliatin is a dual-acting, orally bioavailable glucokinase activator that enhances glucokinase activity in a glucose-dependent manner, improves glucose-stimulated insulin secretion and demonstrates effects on glycemic control in patients with T2D. We report the findings of a randomized, double-blind, placebo-controlled phase 3 clinical trial to evaluate the efficacy and safety of dorzagliatin in patients with T2D. Eligible drug-naïve patients with T2D (n = 463) were randomly assigned to the dorzagliatin or placebo group at a ratio of 2:1 for 24 weeks of double-blind treatment, followed by 28 weeks of open-label treatment with dorzagliatin for all patients. The primary efficacy endpoint was the change in glycated hemoglobin from baseline to week 24. Safety was assessed throughout the trial. At week 24, the least-squares mean change in glycated hemoglobin from baseline (95% confidence interval) was -1.07% (-1.19%, -0.95%) in the dorzagliatin group and -0.50% (-0.68%, -0.32%) in the placebo group (estimated treatment difference, -0.57%; 95% confidence interval: -0.79%, -0.36%; P < 0.001). The incidence of adverse events was similar between the two groups. There were no severe hypoglycemia events or drug-related serious adverse events in the dorzagliatin group. In summary, dorzagliatin improved glycemic control in drug-naïve patients with T2D and showed a good tolerability and safety profile.
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Diabetes Mellitus Tipo 2 Tipo de estudio: Clinical_trials Límite: Humans Idioma: En Revista: Nat Med Asunto de la revista: BIOLOGIA MOLECULAR / MEDICINA Año: 2022 Tipo del documento: Article País de afiliación: China Pais de publicación: Estados Unidos
Texto completo
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Diabetes Mellitus Tipo 2 Tipo de estudio: Clinical_trials Límite: Humans Idioma: En Revista: Nat Med Asunto de la revista: BIOLOGIA MOLECULAR / MEDICINA Año: 2022 Tipo del documento: Article País de afiliación: China Pais de publicación: Estados Unidos