Chiglitazar monotherapy with sitagliptin as an active comparator in patients with type 2 diabetes:a randomized,double-blind,phase 3 trial(CMAS)

• 作者: Weiping Jia Jianhua Ma Heng Miao Changjiang Wang Xiaoyue Wang Quanmin Li Weiping Lu Jialin Yang Lihui Zhang Jinkui Yang Guixia Wang Xiuzhen Zhang Min Zhang Li Sun Xuefeng Yu Jianling Du Bingyin Shi Changqing Xiao Dalong Zhu Hong Liu Liyong Zhong Chun Xu Qi Xu Ganxiong Liang Ying Zhang Guangwei Li Mingyu Gu Jun Liu Guoyue Yuan Zhaoli Yan Dewen Yan Shandong Ye Fan Zhang Zhiqiang Ning Haixiang Cao Desi Pan He Yao Xianping Lu Linong Ji
• 来源期刊: 科学通报（英文版）
• 年，卷（期）: 2021,（15）
• 所属期刊栏目: Medical Sciences
• 页码范围: 1581-1590
• 页数: 10页
• 语种: 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 reg-imen.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 ade-quate supporting evidence for using this PPAR pan-agonist as a treatment option for type 2 diabetes.