globalchange  > 气候变化与战略
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)
Author: 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.
Source Publication: Science Bulletin
ISSN: 20959273
Publishing Year: 2021
Volume: 66, Issue:15
pages begin: 1581
pages end: 1590
Language: 英语
keyword in Chinese: Chiglitazar ; Glycemic control ; Insulin resistance ; PPAR pan-agonist ; Type 2 diabetes
Keyword: 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
English Abstract: 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
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Document Type: 期刊论文
Appears in Collections:气候变化与战略

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Affiliation: 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, China; Tongji Hospital of Tongji University, Shanghai, 200092, China; The Qingpu Branch of Zhongshan Hospital Affiliate to Fudan University, Shanghai, 201700, China; Siping Central People's Hospital, Siping, 136000, China; Tongji Medical College of Huazhong University of Science and Technology, Wuhan, 430030, China; The First Affiliated Hospital of Dalian Medical University, Dalian, 116011, China; The First Affiliated Hospital of Xi'an Jiaotong University, Xi'an, 710061, China; The First Affiliated Hospital of Guangxi Medical University (The Western Hospital), Nanning, 530021, China; Gulou Hospital Affiliated to Nanjing Medical University, Nanjing, 210008, China; The First Affiliated Hospital of Guangxi Medical University (The Eastern Hospital), Nanning, 530021, China; Beijing Tiantan Hospital, Capital Medical University, Beijing, 100070, China; The General Hospital of the Chinese People's Armed Police Forces, Beijing, 100022, China; The Second Affiliated Hospital of Shantou University Medical College, Shantou, 515041, China; Zhongshan People's Hospital, Zhongshan, 528403, China; The Third Hospital Affiliated to Guangzhou Medical College, Guangzhou, 510150, China; Fuwai Hospital, Beijing, 100037, China; Shanghai First People's Hospital, Shanghai, 200080, China; Shanghai 5th People's Hospital, Shanghai, 200040, China; The Affiliated Hospital of Jiangsu University, Zhenjiang, 212001, China; The Affiliated Hospital of Inner Mongolia, Hohhot, 000306, China; Shenzhen Second People's Hospital, Shenzhen, 518035, China; Anhui Provincial Hospital, Hefei, 518035, China; Beijing University Shenzhen Hospital, Shenzhen, 518036, China; Shenzhen Chipscreen Biosciences, Ltd., Shenzhen, 518057, China; Peking University People's Hospital, Beijing, 100044, China

Recommended Citation:
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]. Science Bulletin,2021-01-01,66(15)
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