18-OR: Efficacy and Safety of Chiglitazar vs. Sitagliptin in Patients with Type 2 Diabetes: A 24-Week, Randomized, Double-Blind, Noninferiority Phase 3 Trial (CMAS)

JIA, WEIPING; MA, JIANHUA; MIAO, HENG; WANG, CHANGJIANG; WANG, XIAOYUE; LI, QUANMIN; LU, WEIPING; YANG, JIALIN; ZHANG, LIHUI; YANG, JINKUI; WANG, GUIXIA; ZHANG, XIUZHENG; ZHANG, MIN; SUN, LI; YU, XUEFENG; DU, JIANLING; SHI, BINGYIN; XIAO, CHANGQING; ZHU, DALONG; LIU, HONG; ZHONG, LIYONG; XU, CHUN; XU, QI; LIANG, GANXIONG; ZHANG, YING; LI, GUANGWEI; GU, MINGYU; LIU, JUN; NING, ZHIQIANG; JI, LINONG

doi:10.2337/db19-18-OR

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OR: Clinical Therapeutics/New Technology—Other Therapeutic Agents| June 01 2019

18-OR: Efficacy and Safety of Chiglitazar vs. Sitagliptin in Patients with Type 2 Diabetes: A 24-Week, Randomized, Double-Blind, Noninferiority Phase 3 Trial (CMAS)

WEIPING JIA;

WEIPING JIA

Shanghai, China, Nanjing, China, Hefei, China, Yueyang, China, Beijing, China, Huai'an, China, Shijiazhuang, China, Changchun, China, Siping, China, Wuhan, China, Dalian, China, Xi'an, China, Nanning, China, Shantou, China, Zhongshan, China, Guangzhou, China, Shenzhen, China

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JIANHUA MA;

JIANHUA MA

Shanghai, China, Nanjing, China, Hefei, China, Yueyang, China, Beijing, China, Huai'an, China, Shijiazhuang, China, Changchun, China, Siping, China, Wuhan, China, Dalian, China, Xi'an, China, Nanning, China, Shantou, China, Zhongshan, China, Guangzhou, China, Shenzhen, China

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HENG MIAO;

HENG MIAO

Shanghai, China, Nanjing, China, Hefei, China, Yueyang, China, Beijing, China, Huai'an, China, Shijiazhuang, China, Changchun, China, Siping, China, Wuhan, China, Dalian, China, Xi'an, China, Nanning, China, Shantou, China, Zhongshan, China, Guangzhou, China, Shenzhen, China

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CHANGJIANG WANG;

CHANGJIANG WANG

Shanghai, China, Nanjing, China, Hefei, China, Yueyang, China, Beijing, China, Huai'an, China, Shijiazhuang, China, Changchun, China, Siping, China, Wuhan, China, Dalian, China, Xi'an, China, Nanning, China, Shantou, China, Zhongshan, China, Guangzhou, China, Shenzhen, China

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XIAOYUE WANG;

XIAOYUE WANG

Shanghai, China, Nanjing, China, Hefei, China, Yueyang, China, Beijing, China, Huai'an, China, Shijiazhuang, China, Changchun, China, Siping, China, Wuhan, China, Dalian, China, Xi'an, China, Nanning, China, Shantou, China, Zhongshan, China, Guangzhou, China, Shenzhen, China

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QUANMIN LI;

QUANMIN LI

Shanghai, China, Nanjing, China, Hefei, China, Yueyang, China, Beijing, China, Huai'an, China, Shijiazhuang, China, Changchun, China, Siping, China, Wuhan, China, Dalian, China, Xi'an, China, Nanning, China, Shantou, China, Zhongshan, China, Guangzhou, China, Shenzhen, China

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WEIPING LU;

WEIPING LU

Shanghai, China, Nanjing, China, Hefei, China, Yueyang, China, Beijing, China, Huai'an, China, Shijiazhuang, China, Changchun, China, Siping, China, Wuhan, China, Dalian, China, Xi'an, China, Nanning, China, Shantou, China, Zhongshan, China, Guangzhou, China, Shenzhen, China

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JIALIN YANG;

JIALIN YANG

Shanghai, China, Nanjing, China, Hefei, China, Yueyang, China, Beijing, China, Huai'an, China, Shijiazhuang, China, Changchun, China, Siping, China, Wuhan, China, Dalian, China, Xi'an, China, Nanning, China, Shantou, China, Zhongshan, China, Guangzhou, China, Shenzhen, China

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LIHUI ZHANG;

LIHUI ZHANG

Shanghai, China, Nanjing, China, Hefei, China, Yueyang, China, Beijing, China, Huai'an, China, Shijiazhuang, China, Changchun, China, Siping, China, Wuhan, China, Dalian, China, Xi'an, China, Nanning, China, Shantou, China, Zhongshan, China, Guangzhou, China, Shenzhen, China

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JINKUI YANG;

JINKUI YANG

Shanghai, China, Nanjing, China, Hefei, China, Yueyang, China, Beijing, China, Huai'an, China, Shijiazhuang, China, Changchun, China, Siping, China, Wuhan, China, Dalian, China, Xi'an, China, Nanning, China, Shantou, China, Zhongshan, China, Guangzhou, China, Shenzhen, China

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GUIXIA WANG;

GUIXIA WANG

Shanghai, China, Nanjing, China, Hefei, China, Yueyang, China, Beijing, China, Huai'an, China, Shijiazhuang, China, Changchun, China, Siping, China, Wuhan, China, Dalian, China, Xi'an, China, Nanning, China, Shantou, China, Zhongshan, China, Guangzhou, China, Shenzhen, China

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XIUZHENG ZHANG;

XIUZHENG ZHANG

Shanghai, China, Nanjing, China, Hefei, China, Yueyang, China, Beijing, China, Huai'an, China, Shijiazhuang, China, Changchun, China, Siping, China, Wuhan, China, Dalian, China, Xi'an, China, Nanning, China, Shantou, China, Zhongshan, China, Guangzhou, China, Shenzhen, China

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MIN ZHANG;

MIN ZHANG

Shanghai, China, Nanjing, China, Hefei, China, Yueyang, China, Beijing, China, Huai'an, China, Shijiazhuang, China, Changchun, China, Siping, China, Wuhan, China, Dalian, China, Xi'an, China, Nanning, China, Shantou, China, Zhongshan, China, Guangzhou, China, Shenzhen, China

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LI SUN;

LI SUN

Shanghai, China, Nanjing, China, Hefei, China, Yueyang, China, Beijing, China, Huai'an, China, Shijiazhuang, China, Changchun, China, Siping, China, Wuhan, China, Dalian, China, Xi'an, China, Nanning, China, Shantou, China, Zhongshan, China, Guangzhou, China, Shenzhen, China

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XUEFENG YU;

XUEFENG YU

Shanghai, China, Nanjing, China, Hefei, China, Yueyang, China, Beijing, China, Huai'an, China, Shijiazhuang, China, Changchun, China, Siping, China, Wuhan, China, Dalian, China, Xi'an, China, Nanning, China, Shantou, China, Zhongshan, China, Guangzhou, China, Shenzhen, China

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JIANLING DU;

JIANLING DU

Shanghai, China, Nanjing, China, Hefei, China, Yueyang, China, Beijing, China, Huai'an, China, Shijiazhuang, China, Changchun, China, Siping, China, Wuhan, China, Dalian, China, Xi'an, China, Nanning, China, Shantou, China, Zhongshan, China, Guangzhou, China, Shenzhen, China

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BINGYIN SHI;

BINGYIN SHI

Shanghai, China, Nanjing, China, Hefei, China, Yueyang, China, Beijing, China, Huai'an, China, Shijiazhuang, China, Changchun, China, Siping, China, Wuhan, China, Dalian, China, Xi'an, China, Nanning, China, Shantou, China, Zhongshan, China, Guangzhou, China, Shenzhen, China

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CHANGQING XIAO;

CHANGQING XIAO

Shanghai, China, Nanjing, China, Hefei, China, Yueyang, China, Beijing, China, Huai'an, China, Shijiazhuang, China, Changchun, China, Siping, China, Wuhan, China, Dalian, China, Xi'an, China, Nanning, China, Shantou, China, Zhongshan, China, Guangzhou, China, Shenzhen, China

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DALONG ZHU;

DALONG ZHU

Shanghai, China, Nanjing, China, Hefei, China, Yueyang, China, Beijing, China, Huai'an, China, Shijiazhuang, China, Changchun, China, Siping, China, Wuhan, China, Dalian, China, Xi'an, China, Nanning, China, Shantou, China, Zhongshan, China, Guangzhou, China, Shenzhen, China

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HONG LIU;

HONG LIU

Shanghai, China, Nanjing, China, Hefei, China, Yueyang, China, Beijing, China, Huai'an, China, Shijiazhuang, China, Changchun, China, Siping, China, Wuhan, China, Dalian, China, Xi'an, China, Nanning, China, Shantou, China, Zhongshan, China, Guangzhou, China, Shenzhen, China

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LIYONG ZHONG;

LIYONG ZHONG

Shanghai, China, Nanjing, China, Hefei, China, Yueyang, China, Beijing, China, Huai'an, China, Shijiazhuang, China, Changchun, China, Siping, China, Wuhan, China, Dalian, China, Xi'an, China, Nanning, China, Shantou, China, Zhongshan, China, Guangzhou, China, Shenzhen, China

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CHUN XU;

CHUN XU

Shanghai, China, Nanjing, China, Hefei, China, Yueyang, China, Beijing, China, Huai'an, China, Shijiazhuang, China, Changchun, China, Siping, China, Wuhan, China, Dalian, China, Xi'an, China, Nanning, China, Shantou, China, Zhongshan, China, Guangzhou, China, Shenzhen, China

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QI XU;

QI XU

Shanghai, China, Nanjing, China, Hefei, China, Yueyang, China, Beijing, China, Huai'an, China, Shijiazhuang, China, Changchun, China, Siping, China, Wuhan, China, Dalian, China, Xi'an, China, Nanning, China, Shantou, China, Zhongshan, China, Guangzhou, China, Shenzhen, China

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GANXIONG LIANG;

GANXIONG LIANG

Shanghai, China, Nanjing, China, Hefei, China, Yueyang, China, Beijing, China, Huai'an, China, Shijiazhuang, China, Changchun, China, Siping, China, Wuhan, China, Dalian, China, Xi'an, China, Nanning, China, Shantou, China, Zhongshan, China, Guangzhou, China, Shenzhen, China

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YING ZHANG;

YING ZHANG

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GUANGWEI LI;

GUANGWEI LI

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MINGYU GU;

MINGYU GU

Shanghai, China, Nanjing, China, Hefei, China, Yueyang, China, Beijing, China, Huai'an, China, Shijiazhuang, China, Changchun, China, Siping, China, Wuhan, China, Dalian, China, Xi'an, China, Nanning, China, Shantou, China, Zhongshan, China, Guangzhou, China, Shenzhen, China

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JUN LIU;

JUN LIU

Shanghai, China, Nanjing, China, Hefei, China, Yueyang, China, Beijing, China, Huai'an, China, Shijiazhuang, China, Changchun, China, Siping, China, Wuhan, China, Dalian, China, Xi'an, China, Nanning, China, Shantou, China, Zhongshan, China, Guangzhou, China, Shenzhen, China

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ZHIQIANG NING;

ZHIQIANG NING

Shanghai, China, Nanjing, China, Hefei, China, Yueyang, China, Beijing, China, Huai'an, China, Shijiazhuang, China, Changchun, China, Siping, China, Wuhan, China, Dalian, China, Xi'an, China, Nanning, China, Shantou, China, Zhongshan, China, Guangzhou, China, Shenzhen, China

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LINONG JI

Shanghai, China, Nanjing, China, Hefei, China, Yueyang, China, Beijing, China, Huai'an, China, Shijiazhuang, China, Changchun, China, Siping, China, Wuhan, China, Dalian, China, Xi'an, China, Nanning, China, Shantou, China, Zhongshan, China, Guangzhou, China, Shenzhen, China

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Diabetes 2019;68(Supplement_1):18-OR

https://doi.org/10.2337/db19-18-OR

Chiglitazar, a novel PPARα/γ/δ pan-agonist, showed favorable effects on glycemic control and lipid modulation with well tolerated safety profile in phase 2 trials. This trial aimed to compare the efficacy and safety of chiglitazar with DPP-4 inhibitor sitagliptin in patients with type 2 diabetes inadequately controlled with diet and exercise (ClinicalTrials.gov NCT02173457). Patients were randomly assigned to receive chiglitazar 32 mg or 48 mg, or sitagliptin 100 mg once daily. The primary endpoint was change in HbA1c from baseline at week 24, with a non-inferiority of each chiglitazar dose versus sitagliptin. Analysis was done in all randomized patients who received at least one dose of study drug (n=739). Chiglitazar showed comparable HbA1c lowering effect compared with sitagliptin at 24 weeks (LS mean difference -0.04% [95% CI -0.22 to 0.15] and -0.08% [95% CI -0.27 to 0.10] for 32 mg and 48 mg, respectively), along with different trends in secondary endpoints. Overall adverse events were comparable across study groups. The incidences of weight gain and edema were generally low but relatively higher in chiglitazar 48 mg.

In conclusion, chiglitazar showed non-inferior effect compared with sitagliptin on HbA1c reduction with well tolerated safety profile.

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Disclosure

W. Jia: None. J. Ma: None. H. Miao: None. C. Wang: None. X. Wang: None. Q. Li: None. W. Lu: None. J. Yang: None. L. Zhang: None. J. Yang: None. G. Wang: None. X. Zhang: None. M. Zhang: None. L. Sun: None. X. Yu: None. J. Du: None. B. Shi: None. C. Xiao: None. D. Zhu: None. H. Liu: None. L. Zhong: None. C. Xu: None. Q. Xu: None. G. Liang: None. Y. Zhang: None. G. Li: None. M. Gu: None. J. Liu: None. Z. Ning: None. 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.

Funding

Ministry of Science and Technology of the People´s Republic of China (2013ZX09401301)

2019

Readers may use this article as long as the work is properly cited, the use is educational and not for profit, and the work is not altered. More information is available at http://www.diabetesjournals.org/content/license.

18-OR: Efficacy and Safety of Chiglitazar vs. Sitagliptin in Patients with Type 2 Diabetes: A 24-Week, Randomized, Double-Blind, Noninferiority Phase 3 Trial (CMAS)

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18-OR: Efficacy and Safety of Chiglitazar vs. Sitagliptin in Patients with Type 2 Diabetes: A 24-Week, Randomized, Double-Blind, Noninferiority Phase 3 Trial (CMAS)

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