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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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收录情况： ◇ SCIE ◇ 统计源期刊 ◇ CSCD-C ◇ EI ◇ 卓越：领军期刊

作者：

机构： [a]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 [b]Nanjing First Hospital, Nanjing 210029, China [c]The Second Hospital Affiliated to Nanjing Medical University, Nanjing 210011, China [d]The First Hospital Affiliated to Anhui Medical University, Hefei 230031, China [e]The First People’s Hospital of Yueyang, Yueyang 414000, China [f]PLA Rocket Force Characteristic Medical Center, Beijing 100085, China [g]Huai’an First People’s Hospital, Huai’an 223300, China [h]The Central Hospital of Minhang District of Shanghai, Shanghai 201100, China [i]The Second Hospital of Heibei Medical University, Shijiazhuang 050000, China [j]Beijing Tongren Hospital Affiliated to Capital Medical University, Beijing 100730, China [k]The First Hospital of Jilin University, Changchun 130021, China [l]Tongji Hospital of Tongji University, Shanghai 200092, China [m]The Qingpu Branch of Zhongshan Hospital Affiliate to Fudan University, Shanghai 201700, China [n]Siping Central People’s Hospital, Siping 136000, China [o]Tongji Medical College of Huazhong University of Science &Technology, Wuhan 430030, China [p]The First Affiliated Hospital of Dalian Medical University, Dalian 116011, China [q]The First Affiliated Hospital of Xi’an Jiaotong University, Xi’an 710061, China [r]The First Affiliated Hospital of Guangxi Medical University (The Western Hospital), Nanning 530021, China [s]Gulou Hospital Affiliated to Nanjing Medical University, Nanjing 210008, China [t]The First Affiliated Hospital of Guangxi Medical University (The Eastern Hospital), Nanning 530021, China [u]Beijing Tiantan Hospital, Capital Medical University, Beijing 100070, China [v]The General Hospital of the Chinese People’s Armed Police Forces, Beijing 100022, China [w]The Second Affiliated Hospital of Shantou University Medical College, Shantou 515041, China [x]Zhongshan People’s Hospital, Zhongshan 528403, China [y]The Third Hospital Affiliated to Guangzhou Medical College, Guangzhou 510150, China [z]Fuwai Hospital, Beijing 100037, China [aa]Shanghai First People’s Hospital, Shanghai 200080, China [ab]Shanghai 5th People’s Hospital, Shanghai 200040, China [ac]The Affiliated Hospital of Jiangsu University, Zhenjiang 212001, China [ad]The Affiliated Hospital of Inner Mongolia, Hohhot 000306, China [ae]Shenzhen Second People’s Hospital, Shenzhen 518035, China [af]Anhui Provincial Hospital, Hefei 518035, China [ag]Beijing University Shenzhen Hospital, Shenzhen 518036, China [ah]Shenzhen Chipscreen Biosciences, Ltd., Shenzhen 518057, China [ai]Peking University People’s Hospital, Beijing 100044, China

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关键词： Chiglitazar Glycemic control Insulin resistance PPAR pan-agonist Type 2 diabetes

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 HbA1c from baseline at week 24 with the non-inferiority of chiglitazar over sitagliptin. Both chiglitazar and sitagliptin significantly reduced glycated hemoglobin A1c (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 mg 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

基金：

基金编号： 2008ZX09101-002 2013ZX09401301 2011A080501010 2010-1746

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出版当年[2020]版：

大类 | 1 区

综合性期刊

小类 | 1 区综合性期刊

最新[2025]版：

大类 | 1 区

综合性期刊

小类 | 1 区综合性期刊

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出版当年[2019]版：

Q1 MULTIDISCIPLINARY SCIENCES

最新[2023]版：

Q1 MULTIDISCIPLINARY SCIENCES

影响因子： 18.8 最新[2023版] 15.9 最新五年平均 9.511 出版当年[2019版] 6.079 出版当年五年平均 6.277 出版前一年[2018版] 11.78 出版后一年[2020版]

第一作者：

第一作者机构： [a]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

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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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