"Fotagliptin monotherapy with alogliptin as an active comparator in patients with uncontrolled type 2 diabetes mellitus: a randomized, multicenter, double-blind, placebo-controlled, phase 3 trial"

作者全名："Xu, Mingtong; Sun, Kan; Xu, Wenjie; Wang, Chuan; Yan, Dewen; Li, Shu; Cong, Li; Pi, Yinzhen; Song, Weihong; Sun, Qingyuan; Xiao, Rijun; Peng, Weixia; Wang, Jianping; Peng, Hui; Zhang, Yawei; Duan, Peng; Zhang, Meiying; Liu, Jianying; Huang, Qingmei; Li, Xuefeng; Bao, Yan; Zeng, Tianshu; Wang, Kun; Qin, Li; Wu, Chaoming; Deng, Chunying; Huang, Chenghu; Yan, Shuang; Zhang, Wei; Li, Meizi; Sun, Li; Wang, Yanjun; Li, Hongmei; Wang, Guang; Pang, Shuguang; Zheng, Xianling; Wang, Haifang; Wang, Fujun; Su, Xiuhai; Ma, Yujin; Zhang, Wei; Li, Ziling; Xie, Zuoling; Xu, Ning; Ni, Lin; Zhang, Li; Deng, Xiangqun; Pan, Tianrong; Dong, Qijuan; Wu, Xiaohong; Shen, Xingping; Zhang, Xin; Zou, Qijing; Jiang, Chengxia; Xi, Jue; Ma, Jianhua; Sun, Jingchao; Yan, Li"

作者地址："[Xu, Mingtong; Sun, Kan; Wang, Chuan; Yan, Li] Sun Yat Sen Univ, Sun Yat Sen Mem Hosp, Guangzhou, Peoples R China; [Xu, Wenjie; Sun, Jingchao] Shenzhen Salubris Pharmaceut Co Ltd, Shenzhen, Peoples R China; [Yan, Dewen] Shenzhen Second Peoples Hosp, Shenzhen, Peoples R China; [Li, Shu] HuiZhou Municipal Cent Hosp, Huizhou, Peoples R China; [Cong, Li] Sun Yat Sen Univ, Affiliated Hosp 5, Zhuhai, Peoples R China; [Pi, Yinzhen] First Hosp Changsha, Changsha, Peoples R China; [Song, Weihong] Chenzhou First Peoples Hosp, Chenzhou, Peoples R China; [Sun, Qingyuan] Yueyang Cent Hosp, Yueyang, Peoples R China; [Xiao, Rijun] Xiangtan Univ, Xiangtan, Peoples R China; [Peng, Weixia] Yiyang Cent Hosp, Yiyang, Peoples R China; [Wang, Jianping] Univ South China, Dept Anesthesiol, Affiliated Hosp 2, Hengyang, Peoples R China; [Peng, Hui] Yichun Univ, Dept Pediat, Affiliated Yichun Peoples Hosp, Yichun, Jiangxi, Peoples R China; [Zhang, Yawei] Pingxiang Peoples Hosp, Pingxiang, Jiangxi, Peoples R China; [Duan, Peng] Peoples Hosp Nanchang, Hosp Nanchang 3, Nanchang, Peoples R China; [Zhang, Meiying] Nanchang Univ, Affiliated Hosp 2, Nanchang, Peoples R China; [Liu, Jianying] Nanchang Univ, Dept Gastroenterol, Affiliated Hosp 1, Nanchang, Peoples R China; [Huang, Qingmei] Xinyu Peoples Hosp, Xinyu, Peoples R China; [Li, Xuefeng] Affilited Hosp Hubei Univ Med, Taihe Hosp, Shiyan, Peoples R China; [Bao, Yan] Wuhan Univ, Renmin Hosp, Wuhan, Peoples R China; [Zeng, Tianshu] Huazhong Univ Sci & Technol, Union Hosp, Tongji Med Coll, Wuhan, Peoples R China; [Wang, Kun] Nanjing Med Univ, Nanjing Jiangning Hosp, Affiliated Jiangning Hosp, Nanjing, Peoples R China; [Qin, Li] Shanghai Jiaotong Univ SJTU, Sch Med, Dept Cardiol, Xinhua Hosp, Shanghai, Peoples R China; [Wu, Chaoming] WMU, Sch Med 2, Affiliated Hosp 2, Wenzhou, Peoples R China; [Deng, Chunying] Zigong Fourth Peoples Hosp, Zigong, Peoples R China; [Huang, Chenghu] Chongqing Med Univ, Bishan Hosp Chongqing, Chongqing, Peoples R China; [Yan, Shuang] Harbin Med Univ, Dept Ophthalmol, Affiliated Hosp 4, Harbin, Peoples R China; [Zhang, Wei] First Hosp Qiqihar, Qiqihar, Peoples R China; [Li, Meizi] Yanbian Univ, Affiliated Hosp, Yanbian 133000, Peoples R China; [Sun, Li] Siping Cent Peoples Hosp, Siping, Peoples R China; [Wang, Yanjun] Jilin Univ, Hosp 2, Changchun, Peoples R China; [Li, Hongmei] Emergency Gen Hosp, Beijing, Peoples R China; [Wang, Guang] Capital Med Univ, Beijing Chao Yang Hosp, Beijing, Peoples R China; [Pang, Shuguang] Shandong First Med Univ, Jinan Cent Hosp, Cent Hosp, Jinan, Peoples R China; [Zheng, Xianling] HanDan Cent Hosp, Handan, Peoples R China; [Wang, Haifang] Handan First Hosp, Handan, Peoples R China; [Wang, Fujun] Shijiazhuang Tiedao Univ, Shijiazhuang, Peoples R China; [Su, Xiuhai] Cangzhou Hosp Integrated TCM WM, Cangzhou, Peoples R China; [Ma, Yujin] Henan Univ Sci & Technol, Affiliated Hosp 1, Coll Clin Med, Luoyang, Peoples R China; [Zhang, Wei] Puyang Oilfield Gen Hosp, Puyang, Peoples R China; [Li, Ziling] Inner Mongolia Med Univ, Hohhot, Peoples R China; [Xie, Zuoling] Southeast Univ, Zhongda Hosp, Nanjing, Peoples R China; [Xu, Ning] First Peoples Hosp Lianyungang, Lianyungang 222000, Peoples R China; [Ni, Lin] First Peoples Hosp Huzhou, Huzhou Teachers Coll, Affiliated Hosp 1, Huzhou, Peoples R China; [Zhang, Li] Third Peoples Hosp Hainan Prov, Sanya, Peoples R China; [Deng, Xiangqun] Wuhan Third Hosp, Wuhan, Hubei, Peoples R China; [Pan, Tianrong] Second Hosp Anhui Med Univ, Hefei, Peoples R China; [Dong, Qijuan] Henan Univ Chinese Med, Peoples Hosp, Zhengzhou, Henan, Peoples R China; [Wu, Xiaohong] Hangzhou Med Coll, Zhejiang Prov Peoples Hosp, Hangzhou, Peoples R China; [Shen, Xingping] Xiamen Univ, Zhongshan Hosp, Xiamen, Peoples R China; [Zhang, Xin] Genertec Liaoyou Gem Flowe Hosp, Panjin, Peoples R China; [Zou, Qijing] Cent Hosp Yongzhou, Yongzhou, Peoples R China; [Jiang, Chengxia] First Peoples Hosp Zunyi, Zunyi, Peoples R China; [Xi, Jue] Xuzhou Med Univ, Affiliated Hosp, Xuzhou, Peoples R China; [Ma, Jianhua] Nanjing First Hosp, Nanjing, Peoples R China"

通信作者："Yan, L (通讯作者)，Sun Yat Sen Univ, Sun Yat Sen Mem Hosp, Guangzhou, Peoples R China."

来源：BMC MEDICINE

ESI学科分类：CLINICAL MEDICINE

WOS号：WOS:001081502700001

JCR分区：Q1

影响因子：9.3

年份：2023

卷号：21

期号：1

开始页：　

结束页：　

文献类型：Article

关键词：Dipeptidyl peptidase-4 inhibitors; Fotagliptin; Type 2 diabetes mellitus; HbA1c

摘要："Background Dipeptidyl peptidase-4 inhibitors (DPP-4i) have become firmly established in treatment algorithms and national guidelines for improving glycemic control in type 2 diabetes mellitus (T2DM).To report the findings from a multicenter, randomized, double-blind, placebo-controlled phase 3 clinical trial, which was designed to assess the efficacy and safety of a novel DPP-4 inhibitor fotagliptin in treatmentnaive patients with T2DM.Methods Patients with T2DM were randomized to receive fotagliptin (n = 230), alogliptin (n = 113) or placebo (n = 115) at a 2:1:1 ratio for 24 weeks of double-blind treatment period, followed by an open-label treatment period, making up a total of 52 weeks. The primary efficacy endpoint was to determine the superiority of fotagliptin over placebo in the change of HbA1c from baseline to Week 24. All serious or significant adverse events were recorded.Results After 24 weeks, mean decreases in HbA1c from baseline were -0.70% for fotagliptin, -0.72% for alogliptin and -0.26% for placebo. Estimated mean treatment differences in HbA1c were -0.44% (95% confidence interval [CI]: -0.62% to -0.27%) for fotagliptin versus placebo, and -0.46% (95% CI: -0.67% to -0.26%) for alogliptin versus placebo, and 0.02% (95%CI: -0.16% to 0.19%; upper limit of 95%CI < margin of 0.4%) for fotagliptin versus alogliptin. So fotagliptin was non-inferior to alogliptin. Compared with subjects with placebo (15.5%), significantly more patients with fotagliptin (37.0%) and alogliptin (35.5%) achieved HbA1c < 7.0% after 24 weeks of treatment. During the whole 52 weeks of treatment, the overall incidence of hypoglycemia was low for both of the fotagliptin and alogliptin groups (1.0% each). No drug-related serious adverse events were observed in any treatment group.Conclusions In summary, the study demonstrated improvement in glycemic control and a favorable safety profile for fotagliptin in treatment-naive patients with T2DM.Trial registrationClinicalTrail.gov NCT05782192."

基金机构：We are indebted to the participants in the present study for their outstanding support and to our colleagues for their valuable assistance. Medical writing and editorial support were provided by Xiangnan Zhou (Clinical Operation Director at Shenzhen Salubr

基金资助正文："We are indebted to the participants in the present study for their outstanding support and to our colleagues for their valuable assistance. Medical writing and editorial support were provided by Xiangnan Zhou (Clinical Operation Director at Shenzhen Salubris Pharmaceuticals), Chongyang Deng (Medical Manager at Shenzhen Salubris Pharmaceuticals) and Yue Yang (Statistician at Shenzhen Salubris Pharmaceuticals)."