globalchange  > 气候变化与战略
DOI: 10.1016/j.scib.2021.03.019
论文题名:
Efficacy and safety of chiglitazar, a novel peroxisome proliferator-activated receptor pan-agonist, in patients with type 2 diabetes: a randomized, double-blind, placebo-controlled, phase 3 trial (CMAP)
作者: Ji L.; Song W.; Fang H.; Li W.; Geng J.; Wang Y.; Guo L.; Cai H.; Yang T.; Li H.; Yang G.; Li Q.; Liu K.; Li S.; Liu Y.; Shi F.; Li X.; Gao X.; Tian H.; Ji Q.; Su Q.; Zhou Z.; Wang W.; Zhou Z.; Li X.; Xu Y.; Ning Z.; Cao H.; Pan D.; Yao H.; Lu X.; Jia W.
刊名: Science Bulletin
ISSN: 20959273
出版年: 2021
卷: 66, 期:15
起始页码: 1571
结束页码: 1580
语种: 英语
中文关键词: Carfloglitazar ; Chiglitazar ; Glycemic control ; Insulin resistance ; PPAR pan-agonist ; Type 2 diabetes
英文关键词: Cytology ; Patient treatment ; % reductions ; Adverse events ; Carfloglitazar ; Chiglitazar ; Confidential interval ; Glycemic control ; Insulin resistance ; Peroxisome proliferator-activated receptor ; Peroxisome proliferator-activated receptor pan-agonist ; Type-2 diabetes ; Insulin
英文摘要: Chiglitazar (Carfloglitazar) is a novel non-thiazolidinedione (TZD) structured peroxisome proliferator-activated receptor (PPAR) pan-agonist that has shown promising effects on glycemic control and lipid regulation in patients with type 2 diabetes in previous clinical studies. This randomized phase 3 trial aimed to compare the efficacy and safety of chiglitazar with placebo in patients with type 2 diabetes with insufficient glycemic control by strict diet and exercise alone. Eligible patients were randomly assigned to receive chiglitazar 32 mg (n = 167), chiglitazar 48 mg (n = 166), or placebo (n = 202) once daily. The primary endpoint was the change in glycosylated hemoglobin A1c (HbA1c) at week 24 with superiority of chiglitazar over placebo. The results showed that both chiglitazar 32 and 48 mg resulted in significant and clinically meaningful reductions in HbA1c, and placebo-adjusted estimated treatment differences at week 24 for chiglitazar 32 and 48 mg were −0.87% (95% confidential interval (CI): −1.10 to −0.65; P < 0.0001) and −1.05% (95% CI: −1.29 to −0.81; P < 0.0001), respectively. Secondary efficacy parameters including glycemic control, insulin sensitivity and triglyceride reduction were also significantly improved in the chiglitazar groups. The overall frequency of adverse events and study discontinuation attributable to adverse events were similar among the groups. Low incidences of mild edema and body weight gain were reported in the chiglitazar dose groups. The results from this phase 3 trial demonstrated that the PPAR pan-agonist chiglitazar possesses an overall good efficacy and safety profile in patients with type 2 diabetes inadequately controlled with lifestyle interventions, thereby providing adequate supporting evidence for using this PPAR pan-agonist as a treatment option for type 2 diabetes. © 2021 Science China Press
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资源类型: 期刊论文
标识符: http://119.78.100.158/handle/2HF3EXSE/170286
Appears in Collections:气候变化与战略

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作者单位: Peking University People's Hospital, Beijing, 100044, China; Chenzhou No.1 People's Hospital, Chenzhou, 423000, China; Tangshan Gongren Hospital, Tangshan, 063000, China; The Affiliated Hospital of Xuzhou Medical College, Xuzhou, 221006, China; Harrison International Peace Hospital, Hengshui, 053000, China; The Affiliate Hospital of Qingdao University, Qingdao, 266003, China; Chongqing Three Gorges Central Hospital, Chongqing, 404000, China; The Second Hospital of Jilin University, Changchun, 130041, China; Jiangsu Province Hospital, Nanjing, 210029, China; China Meitan General Hospital, Beijing, 100028, China; The Second Affiliate Hospital of Chongqing Medical University, Chongqing, 400010, China; The First Affiliate Hospital of Chongqing Medical University, Chongqing, 400016, China; The Third Hospital of Hebei Medical University, Shijiazhuang, 050051, China; Tianjin Medical University General Hospital, Tianjin, 300052, China; The 306th Hospital of PLA, Beijing, 100101, China; Baogang Hospital of Inner Mongolia, Baotou, 014010, China; Cangzhou's Central Hospital, Cangzhou, 031706, China; Zhongshan Hospital Fudan University, Shanghai, 200032, China; Huaxi Hopsital of Sichuan University, Chengdu, 610041, China; The First Affiliated Hospital of The 4th Military Medical University, Xi'an, 710000, China; Xin Hua Hospital Affiliated to Shanghai Jiaotong University School of Medicine, Shanghai, 200092, China; The Second Xiangya Hospital of Central South University, Changsha, 410008, China; Peking University Shougang Hospital, Beijing, 100144, China; The Central Hospital of Yangpu District of Shanghai, Shanghai, 200090, China; The First Affiliate Hospital of Xiamen University, Xiamen, 361003, China; Zhongnan Hospital of Wuhan University, Wuhan, 430071, China; Shenzhen Chipscreen Biosciences Co., Ltd., Shenzhen, 518057, China; Shanghai 6th People's Hospital, Shanghai, 200233, China

Recommended Citation:
Ji L.,Song W.,Fang H.,et al. Efficacy and safety of chiglitazar, a novel peroxisome proliferator-activated receptor pan-agonist, in patients with type 2 diabetes: a randomized, double-blind, placebo-controlled, phase 3 trial (CMAP)[J]. Science Bulletin,2021-01-01,66(15)
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