气候变化领域集成服务门户(CCPortal): Chiglitazar monotherapy with sitagliptin as an active comparator in patients with type 2 diabetes: a randomized, double-blind, phase 3 trial (CMAS)

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DOI	10.1016/j.scib.2021.02.027
	Chiglitazar monotherapy with sitagliptin as an active comparator in patients with type 2 diabetes: a randomized, double-blind, phase 3 trial (CMAS)
	Jia W.; Ma J.; Miao H.; Wang C.; Wang X.; Li Q.; Lu W.; Yang J.; Zhang L.; Yang J.; Wang G.; Zhang X.; Zhang M.; Sun L.; Yu X.; Du J.; Shi B.; Xiao C.; Zhu D.; Liu H.; Zhong L.; Xu C.; Xu Q.; Liang G.; Zhang Y.; Li G.; Gu M.; Liu J.; Yuan G.; Yan Z.; Yan D.; Ye S.; Zhang F.; Ning Z.; Cao H.; Pan D.; Yao H.; Lu X.; Ji L.
发表日期	2021
ISSN	20959273
起始页码	1581
结束页码	1590
卷号	66 期号:15
英文摘要	Chiglitazar (Carfloglitazar) is a novel 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 this randomized phase 3 trial, we compared the efficacy and safety of chiglitazar with sitagliptin in patients with type 2 diabetes who had insufficient glycemic control despite a strict diet and exercise regimen. Eligible patients were randomized (1:1:1) to receive chiglitazar 32 mg (n = 245), chiglitazar 48 mg (n = 246), or sitagliptin 100 mg (n = 248) once daily for 24 weeks. The primary endpoint was the change in glycosylated hemoglobin A1C (HbA1c) from baseline at week 24 with the non-inferiority of chiglitazar over sitagliptin. Both chiglitazar and sitagliptin significantly reduced HbA1c at week 24 with values of −1.40%, −1.47%, and −1.39% for chiglitazar 32 mg, chiglitazar 48 mg, and sitagliptin 100 mg, respectively. Chiglitazar 32 and 48 mg were both non-inferior to sitagliptin 100 mg, with mean differences of −0.04% (95% confidential interval (CI) −0.22 to 0.15) and −0.08% (95% CI −0.27 to 0.10), respectively. Compared with sitagliptin, greater reduction in fasting and 2-h postprandial plasma glucose and fasting insulin was observed with chiglitazar. Overall adverse event rates were similar between the groups. A small increase in mild edema in the chiglitazar 48 mg group and slight weight gain in both chiglitazar groups were reported. The overall results demonstrated that chiglitazar possesses 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	Chiglitazar Glycemic control Insulin resistance PPAR pan-agonist Type 2 diabetes
英文关键词	Comparators (optical); Cytology; Patient treatment; Chiglitazar; Confidential interval; Glycemic control; Insulin resistance; Mono-therapy; Non-inferiority; Peroxisome proliferator-activated receptor; Peroxisome proliferator-activated receptor pan-agonist; Sitagliptin; 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/207443
作者单位	Shanghai Jiaotong University Affiliated Sixth People's Hospital, Shanghai Diabetes Institute, Shanghai Key Laboratory of Diabetes Mellitus, Department of Endocrinology and Metabolism, Shanghai Clinical Center for Diabetes, Shanghai Key Clinical Center for Metabolic Disease, Shanghai, 200233, China; Nanjing First Hospital, Nanjing, 210029, China; The Second Hospital Affiliated to Nanjing Medical University, Nanjing, 210011, China; The First Hospital Affiliated to Anhui Medical University, Hefei, 230031, China; The First People's Hospital of Yueyang, Yueyang, 414000, China; PLA Rocket Force Characteristic Medical Center, Beijing, 100085, China; Huai'an First People's Hospital, Huai'an, 223300, China; The Central Hospital of Minhang District of Shanghai, Shanghai, 201100, China; The Second Hospital of Heibei Medical University, Shijiazhuang, 050000, China; Beijing Tongren Hospital Affiliated to Capital Medical University, Beijing, 100730, China; The First Hospital of Jilin University, Changchun, 130021, Chin...
推荐引用方式 GB/T 7714	Jia W.,Ma J.,Miao H.,et al. Chiglitazar monotherapy with sitagliptin as an active comparator in patients with type 2 diabetes: a randomized, double-blind, phase 3 trial (CMAS)[J],2021,66(15).
APA	Jia W..,Ma J..,Miao H..,Wang C..,Wang X..,...&Ji L..(2021).Chiglitazar monotherapy with sitagliptin as an active comparator in patients with type 2 diabetes: a randomized, double-blind, phase 3 trial (CMAS).Science Bulletin,66(15).
MLA	Jia W.,et al."Chiglitazar monotherapy with sitagliptin as an active comparator in patients with type 2 diabetes: a randomized, double-blind, phase 3 trial (CMAS)".Science Bulletin 66.15(2021).