气候变化领域集成服务门户(CCPortal): 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)

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DOI	10.1016/j.scib.2021.03.019
	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)
	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.
发表日期	2021
ISSN	20959273
起始页码	1571
结束页码	1580
卷号	66 期号:15
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
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
语种	英语
来源期刊	Science Bulletin
文献类型	期刊论文
条目标识符	http://gcip.llas.ac.cn/handle/2XKMVOVA/207442
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 M...
推荐引用方式 GB/T 7714	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],2021,66(15).
APA	Ji L..,Song W..,Fang H..,Li W..,Geng J..,...&Jia W..(2021).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).Science Bulletin,66(15).
MLA	Ji L.,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)".Science Bulletin 66.15(2021).