机构：[1]China-Japan Friendship Hospital, Beijing, China[2]Affiliated Drum Tower Hospital, Medical School of Nanjing University, Nanjing, China[3]The First People’sHospital of Changde City, Changde, China[4]Jinan Central Hospital Affiliated to Shandong First Medical University, Jinan, China[5]Cangzhou People’sHospital, Cangzhou, China[6]Peking Union Medical College Hospital, Beijing, China[7]The First Affiliated Hospital, and College of Clinical Medicine of HenanUniversity of Science and Technology, Luoyang, China[8]The Affiliated Hospital of Qingdao University, Qingdao, China[9]Qingdao Central Hospital, Qingdao,China[10]Chenzhou First People’s Hospital, Chenzhou, China[11]The Second Affiliated Hospital of Nanjing Medical University, Nanjing, China[12]TongjiHospital of Tongji University, Shanghai, China[13]The First Affiliated Hospital of Kunming Medical University, Kunming, China昆明医科大学附属第一医院[14]The First Bethune Hospitalof Jilin University, Changchun, China[15]Huzhou Central Hospital, Huzhou, China[16]The Affiliated Hospital of Jiangsu University, Zhenjiang, China[17]NanjingFirst Hospital, Nanjing, China[18]The Affiliated Hospital of Xuzhou Medical University, Xuzhou, China[19]Inner Mongolia Baogang Hospital, Baotou, China[20]The First People’s Hospital of Yue Yang, Yueyang, China[21]Jingzhou Hospital Affiliated to Yangtze University, Jingzhou, China[22]Jiangxi Pingxiang People’sHospital, Pingxiang, China[23]Jiangxi Provincial People’s Hospital, Nanchang, China[24]The First People’s Hospital of Shunde, Foshan, China[25]ChongqingGeneral Hospital, Chongqing, China[26]Qinghai University Affiliated Hospital, Xining, China[27]Luoyang Central Hospital, Luoyang, China[28]General Hospitalof Ningxia Medical University, Yinchuan, China[29]The General Hospital of Xuzhou City Mining Group, Xuzhou, China[30]Shanghai Pudong New AreaPeople’s Hospital, Shanghai, China[31]Beijing Friendship Hospital Pinggu Campus, Capital Medical University, Beijing, China首都医科大学附属北京友谊医院[32]Xinhua Hospital Affiliated toShanghai Jiao Tong University School of Medicine, Shanghai, China[33]Baotou Central Hospital, Baotou, China[34]West China Hospital of Sichuan University,Chengdu, China四川大学华西医院[35]The 960th Hospital of the PLA Joint Logistics Support Force, Jinan, China[36]Yiyang Central Hospital, Yiyang, China[37]Yangpu Hospital,Tongji University, Shanghai, China[38]The First Affiliated Hospital of Anhui Medical University, Hefei, China[39]Taihe Hospital, Hubei University of Medicine,Shiyan, China[40]The First Hospital of China Medical University, Shenyang, China[41]Southern Medical University Nanfang Hospital, Guangzhou, China[42]The Central Hospital of Wuhan, Wuhan, China[43]The Affiliated Hospital of Guizhou Medical University, Guiyang, China[44]Anhui Provincial Hospital,Hefei, China[45]The First Affiliated Hospital of Bengbu Medical College, Bengbu, China[46]Huadong Hospital Affiliated to Fudan University, Shanghai, China[47]Jiangsu Province Hospital, Nanjing, China江苏省人民医院[48]Jining No.1 People’s Hospital, Jining, China[49]Tianjin People’s Hospital, Tianjin, China[50]The First Hospitalof Qiqihar, Qiqihar, China[51]Jilin Central General Hospital, Jilin, China[52]Third People’s Hospital of Yunnan Province, Kunming, China[53]Peking UniversityFirst Hospital, Beijing, China[54]Ningbo First Hospital, Ningbo, China[55]The Affiliated Huai’an No.1 People’s Hospital of Nanjing Medical University, Huai’an,China[56]Shanghai Tenth People’s Hospital, Shanghai, China[57]Emergency General Hospital, Beijing, China[58]The First Affiliated Hospital of Hainan MedicalUniversity, Haikou, China[59]Peking University Shougang Hospital, Beijing, China[60]Qinghai Provincial People’s Hospital, Xining, China[61]Hainan GeneralHospital, Haikou, China[62]Liuzhou People’s Hospital, Liuzhou, China[63]Yijishan Hospital, The First Affiliated Hospital of Wannan Medical University, Wuhu,China[64]The Second People’s Hospital of Huai’an, Huai’an, China[65]Jiangsu Taizhou People’s Hospital, Taizhou, China[66]Zhejiang Hospital, Hangzhou,China[67]Aerospace Center Hospital, Beijing, China[68]Yanbian University Hospital, Yanji, China[69]The Third Affiliated Hospital of Southern MedicalUniversity, Guangzhou, China[70]Beijing Luhe Hospital Affiliated to Capital Medical University, Beijing, China[71]Shanghai East Hospital, Tongji University,Shanghai, China[72]Hua Medicine (Shanghai) Ltd., Shanghai, China[73]Zhongshan Hospital, Fudan University, Shanghai, China
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 (1,500 mg per day) 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 (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).
基金：
National Major
Scientific and Technological Special Project for Significant New Drugs Development
(2014ZX09101002004 and 2018ZX09711002–012–001), the Shanghai Science and
Technology Innovation Action Project (14431908300, 15XD1520500, 17DZ1910200
and 19431905200), the Shanghai Pudong District Science and Technology Innovation
Action Project (PKJ2014-S06) and the Shanghai Municipal Commission of Economy and
Informatization Innovation Action Project (XC-ZXSJ-01–2015–02 and 18XI-18).
语种：
外文
被引次数：
WOS：
PubmedID：
中科院(CAS)分区：
出版当年[2023]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[2023]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[2022]版：
Q1BIOCHEMISTRY & MOLECULAR BIOLOGYQ1CELL BIOLOGYQ1MEDICINE, RESEARCH & EXPERIMENTAL
最新[2023]版：
Q1BIOCHEMISTRY & MOLECULAR BIOLOGYQ1CELL BIOLOGYQ1MEDICINE, RESEARCH & EXPERIMENTAL
第一作者机构：[1]China-Japan Friendship Hospital, Beijing, China
通讯作者：
推荐引用方式(GB/T 7714)：
Wenying Yang,Dalong Zhu,Shenglian Gan,et al.Dorzagliatin add-on therapy to metformin in patients with type 2 diabetes: a randomized, double-blind, placebo-controlled phase 3 trial[J].NATURE MEDICINE.2022,28(5):974-+.doi:10.1038/s41591-022-01803-5.
APA：
Wenying Yang,Dalong Zhu,Shenglian Gan,Xiaolin Dong,Junping Su...&Li Chen.(2022).Dorzagliatin add-on therapy to metformin in patients with type 2 diabetes: a randomized, double-blind, placebo-controlled phase 3 trial.NATURE MEDICINE,28,(5)
MLA：
Wenying Yang,et al."Dorzagliatin add-on therapy to metformin in patients with type 2 diabetes: a randomized, double-blind, placebo-controlled phase 3 trial".NATURE MEDICINE 28..5(2022):974-+
医学