RT Journal Article
SR Electronic
T1 17-OR: Efficacy and Safety of Chiglitazar, a Novel PPARα/γ/d Pan-Agonist, in Patients with Type 2 Diabetes: A Randomized, Double-Blind, Placebo-Controlled Phase 3 Superiority Trial (CMAP)
JF Diabetes
JO Diabetes
FD American Diabetes Association
SP 17-OR
DO 10.2337/db19-17-OR
VO 68
IS Supplement 1
A1 JI, LINONG
A1 SONG, WEIHONG
A1 FANG, HUI
A1 LI, WEI
A1 GENG, JIANLIN
A1 XU, YAN CHENG
A1 WANG, YANGANG
A1 GUO, LIAN
A1 CAI, HANQING
A1 YANG, TAO
A1 LI, HONG-MEI
A1 YANG, GANGYI
A1 LI, QIFU
A1 LIU, KUANZHI
A1 LI, SHUYING
A1 LIU, YANJUN
A1 SHI, FUYAN
A1 LI, XIN SHENG
A1 GAO, XIN
A1 JI, QIUHE
A1 TIAN, HAOMING
A1 SU, QING
A1 ZHOU, ZHIGUANG
A1 WANG, WENBO
A1 ZHOU, ZUNHAI
A1 LI, XUEJUN
A1 XU, YAN CHENG
A1 NING, ZHIQIANG
A1 LU, XIANPING
A1 JIA, WEIPING
YR 2019
UL http://diabetes.diabetesjournals.org/content/68/Supplement_1/17-OR.abstract
AB Chiglitazar showed favorable effect on glycemic control and lipid modulation with well tolerated safety profile in phase 2 trials. This trial aimed to further compare the efficacy and safety of chiglitazar with placebo in patients with type 2 diabetes inadequately controlled with lifestyle interventions (ClinicalTrials.gov NCT02121717). Patients were randomly assigned to receive chiglitazar 32 mg or 48 mg, or placebo once daily. After 24-week treatment, patients in placebo group were randomly assigned to receive chiglitazar 32 mg or 48 mg, while others remained on the planned treatment till to 52 weeks. The primary endpoint was change in HbA1c at week 24 with superiority of each chiglitazar dose versus placebo. Analysis was done in all randomized patients who received at least one dose of study drug (n= 535). Chiglitazar was superior to placebo in HbA1c reduction at 24 weeks (LS mean difference -0.87% [95% CI -1.10 to -0.65] and -1.05% [95% CI -1.29 to -0.81] for 32 mg and 48 mg, respectively) and achieved sustainable effect till to 52 weeks. Overall adverse events were comparable across groups. The incidences of weight gain, edema, and hypoglycemia were relatively higher in chiglitazar groups. Chiglitazar showed superior and sustainable HbA1c lowering effect with well tolerated safety profile in patients with type 2 diabetes.Disclosure L. Ji: Advisory Panel; Self; AstraZeneca. Consultant; Self; AstraZeneca, Bayer AG, Boehringer Ingelheim International GmbH, Bristol-Myers Squibb Company, Eli Lilly and Company, Merck KGaA, Merck Sharp & Dohme Corp., Novartis AG, Novo Nordisk A/S, Roche Pharma, Sanofi, Takeda Pharmaceutical Company Limited. Research Support; Self; AstraZeneca, Bristol-Myers Squibb Company, Eli Lilly and Company, Merck Sharp & Dohme Corp., Novartis AG, Roche Pharma, Sanofi. W. Song: None. H. Fang: None. W. Li: None. J. Geng: None. Y. Xu: None. Y. Wang: None. L. Guo: None. H. Cai: None. T. Yang: None. H. Li: None. G. Yang: None. Q. Li: None. K. Liu: None. S. Li: None. Y. Liu: None. F. Shi: None. X. Li: None. X. Gao: None. Q. Ji: None. H. Tian: None. Q. Su: None. Z. Zhou: None. W. Wang: None. Z. Zhou: None. X. Li: None. Y. Xu: None. Z. Ning: None. X. Lu: None. W. Jia: None.Funding Ministry of Science and Technology of the People´s Republic of China (2013ZX09401301)