单位：[1]Affiliated Drum Tower Hospital, Medical School of Nanjing University, Nanjing, China[2]Zhongshan Hospital, Fudan University, Shanghai, China[3]Nanjing First Hospital, Nanjing, China[4]Jingzhou Hospital Affiliated to Yangtze University, Jingzhou, China[5]The First People’s Hospital of Changde City, Changde, China[6]Jinan Central Hospital Affiliated to Shandong First Medical University, Jinan, China[7]The First Hospital of Shanxi Medical University, Taiyuan, China[8]Zhuzhou Central Hospital, Zhuzhou, China[9]The Second Hospital of Jilin University, Changchun, China[10]Chenzhou First People’s Hospital, Chenzhou, China[11]Taihe Hospital, Hubei University of Medicine, Shiyan, China[12]Tongji Hospital of Tongji University, Shanghai, China[13]The First Affiliated Hospital of Anhui Medical University, Hefei, China[14]The Second Affiliated Hospital of Nanjing Medical University, Nanjing, China[15]Wuxi People’s Hospital, Wuxi, China[16]Changsha Central Hospital, Changsha, China[17]The First Hospital of Jilin University, Changchun, China[18]Affiliated Hospital of Jiangsu University, Zhenjiang, China[19]West China Hospital, Sichuan University, Chengdu, China四川大学华西医院[20]The First Affiliated Hospital of Shandong First Medical University & Shandong Provincial Qianfoshan Hospital, Jinan, China[21]The Affiliated Hospital of Qingdao University, Qingdao, China[22]Siping Hospital of China Medical University, Siping, China[23]The Affiliated Hospital of Guizhou Medical University, Guiyang, China[24]The 960th Hospital of the PLA Joint Logistics Support Force, Jinan, China[25]Southern Medical University Nanfang Hospital, Guangzhou, China[26]The First Affiliated Hospital, and College of Clinical Medicine of Henan University of Science and Technology, Luoyang, China[27]PLA Rocket Force Characteristic Medical Center, Beijing, China[28]Sanya Central Hospital, Sanya, China[29]The Second Affiliated Hospital of Hainan Medical University, Haikou, China[30]Chongqing Red Cross Hospital, Chongqing, China[31]Chongqing University Three Gorges Central Hospital, Chongqing, China[32]Tianjin Medical University General Hospital, Tianjin, China[33]The Third Medical Center of PLA General Hospital, Beijing, China[34]Peking Union Medical College Hospital, Beijing, China[35]Tongji Hospital, Tongji Medical College of HUST, Wuhan, China华中科技大学同济医学院附属同济医院[36]The First Affiliated Hospital of Zhengzhou University, Zhengzhou, China[37]Jiangxi Pingxiang People’s Hospital, Pingxiang, China[38]The Second Hospital of Dalian Medical University, Dalian, China[39]The Third Affiliated Hospital, Sun Yat-sen University, Guangzhou, China中山大学附属第三医院[40]Xuzhou Central Hospital, Xuzhou, China[41]Shanghai Changzheng Hospital, Shanghai, China[42]Hua Medicine, Shanghai, China[43]China-Japan Friendship Hospital, Beijing, China
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-naive 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-naive patients with T2D and showed a good tolerability and safety profile. The SEED study is a phase 3 clinical trial demonstrating a beneficial effect on glycemic control of dorzagliatin, a glucokinase activator, in drug-naive patients with newly diagnosed type 2 diabetes.
基金：
Hua Medicine - Hua Medicine; National Major Scientific and Technological Special Project for Significant New Drug Development [2014ZX09101002004, 2018ZX09711002-012-001]; Shanghai Science and Technology Innovation Action Project [14431908300, 15XD1520500, 17DZ1910200, 19431905200]; Shanghai Pudong District Science and Technology Innovation Action Project [PKJ2014-S06]; Shanghai Municipal Commission of Economy and Informatization Innovation Action Project [XC-ZXSJ-01-2015-02, 18XI-18]
语种：
外文
WOS：
中科院(CAS)分区：
出版当年[2021]版：
大类|1 区医学
小类|1 区生化与分子生物学1 区细胞生物学1 区医学：研究与实验
最新[2025]版：
大类|1 区医学
小类|1 区生化与分子生物学1 区细胞生物学1 区医学：研究与实验
JCR分区：
出版当年[2020]版：
Q1MEDICINE, RESEARCH & EXPERIMENTALQ1CELL BIOLOGYQ1BIOCHEMISTRY & MOLECULAR BIOLOGY
最新[2023]版：
Q1BIOCHEMISTRY & MOLECULAR BIOLOGYQ1CELL BIOLOGYQ1MEDICINE, RESEARCH & EXPERIMENTAL
第一作者单位：[1]Affiliated Drum Tower Hospital, Medical School of Nanjing University, Nanjing, China
共同第一作者：
通讯作者：
推荐引用方式(GB/T 7714)：
Zhu Dalong,Li Xiaoying,Ma Jianhua,et al.Dorzagliatin in drug-naive patients with type 2 diabetes: a randomized, double-blind, placebo-controlled phase 3 trial[J].NATURE MEDICINE.2022,28(5):965-+.doi:10.1038/s41591-022-01802-6.
APA：
Zhu, Dalong,Li, Xiaoying,Ma, Jianhua,Zeng, Jiao'e,Gan, Shenglian...&Chen, Li.(2022).Dorzagliatin in drug-naive patients with type 2 diabetes: a randomized, double-blind, placebo-controlled phase 3 trial.NATURE MEDICINE,28,(5)
MLA：
Zhu, Dalong,et al."Dorzagliatin in drug-naive patients with type 2 diabetes: a randomized, double-blind, placebo-controlled phase 3 trial".NATURE MEDICINE 28..5(2022):965-+
医学