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The purpose of the trial is to evaluate the effect of Chiglitazar added to metformin to type 2 diabetes Inadequately controlled with metformin Monotherapy.
This clinical trial is a multi-center, randomized, double-blind, placebo parallel control design, and uses superiority test to determine whether the experimental group is superior to the control group in terms of main efficacy endpoints.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Chiglitazar sodium 32mg QD+metformin | Experimental | Chiglitazar 32mg qd+metformin |
|
| Chiglitazar sodium 48 mg QD+metformin | Experimental | Chiglitazar 48 mg qd+metformin |
|
| placebo+metformin | Placebo Comparator | placebo+metformin |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Chiglitazar 32mg | Drug | Administrated once daily |
|
| Measure | Description | Time Frame |
|---|---|---|
| percentage of HbA1c change from baseline | central lab test | 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in blood fasting plasma glucose level from baseline | central lab test | 12 and 24 weeks |
| Changes of HOMA-the IR value from baseline | model calculated |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Linong Ji, Prof. | Peking University People's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hefei Second People's Hospital | Hefei | Anhui | China | |||
| The First Affiliated Hospital of Anhui Medical University |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36654286 | Result | Ji L, Song W, Fang H, Li W, Geng J, Wang Y, Guo L, Cai H, Yang T, Li H, Yang G, Li Q, Liu K, Li S, Liu Y, Shi F, Li X, Gao X, Tian H, Ji Q, Su Q, Zhou Z, Wang W, Zhou Z, Li X, Xu Y, Ning Z, Cao H, Pan D, Yao H, Lu X, Jia W. Efficacy and safety of chiglitazar, a novel peroxisome proliferator-activated receptor pan-agonist, in patients with type 2 diabetes: a randomized, double-blind, placebo-controlled, phase 3 trial (CMAP). Sci Bull (Beijing). 2021 Aug 15;66(15):1571-1580. doi: 10.1016/j.scib.2021.03.019. Epub 2021 Mar 23. | |
| 36654287 |
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| Chiglitazar 48mg | Drug | Administrated once daily |
|
|
| Placebo | Drug | Placebo of Chiglitazar |
|
|
| Metformin Hydrochloride | Drug | most tolerable dose |
|
|
| 12 and 24 weeks |
| Changes of blood lipids level from baseline | includeing TC, LDL-C, HDL-C, VLDL-C, non-HDL-C, TG, FFA, ApoA1, ApoB | 12 and 24 weeks |
| percentage of AEs | safety | 28 weeks |
| number of participants with lab abnormality | number or rate of founds in lab tests | 24 weeks |
| Hefei |
| Anhui |
| China |
| The Second Affiliated Hospital of Anhui Medical University | Hefei | Anhui | China |
| Yijishan Hospital of Wannan Medical College | Wuhu | Anhui | China |
| Beijing Chaoyang Hospital, Capital Medical University | Beijing | Beijing Municipality | China |
| Beijing Friendship Hospital, Capital Medical University | Beijing | Beijing Municipality | China |
| Beijing Luhe Hospital, Capital Medical University | Beijing | Beijing Municipality | China |
| Beijing Tongren Hospital, Capital Medical University | Beijing | Beijing Municipality | China |
| Beijing Tsinghua Chang Gung Memorial Hospital | Beijing | Beijing Municipality | China |
| Beijing University First Hospital | Beijing | Beijing Municipality | China |
| Chinese People's Liberation Army Rocket Army Characteristic Medical Center | Beijing | Beijing Municipality | China |
| Peking University People's Hospital | Beijing | Beijing Municipality | China |
| Xuanwu Hospital, Capital Medical University | Beijing | Beijing Municipality | China |
| The Second Affiliated Hospital of Chongqing Medical University | Chongqing | Chongqing Municipality | China |
| Three Gorges Hospital Affiliated to Chongqing University | Wanzhou | Chongqing Municipality | China |
| Shenzhen People's Hospital | Shenzhen | Guangdong | China |
| Union Shenzhen Hospital of Huazhong University of Science and Technology | Shenzhen | Guangdong | China |
| Harrison International Peace Hospital | Hengshui | Hebei | China |
| The Second Hospital of Hebei Medical University | Shijiazhuang | Hebei | China |
| The Third Hospital of Hebei Medical University | Shijiazhuang | Hebei | China |
| Huaihe Hospital of Henan University | Kaifeng | Henan | China |
| The First Affiliated Hospital of Henan University of Science and Technology | Luoyang | Henan | China |
| The Third People's Hospital of Luoyang City | Luoyang | Henan | China |
| Xinxiang Central Hospital | Xinxiang | Henan | China |
| The First People's Hospital of Chenzhou City | Chenzhou | Hunan | China |
| Yueyang Second People's Hospital | Yueyang | Hunan | China |
| Zhuzhou Central Hospital | Zhuzhou | Hunan | China |
| Inner Mongolia Baotou Steel Hospital | Baotou | Inner Mongolia | China |
| The First People's Hospital of Huai'an | Huaian | Jiangsu | China |
| Jiangsu Provincial People's Hospital | Nanjing | Jiangsu | China |
| Nanjing First Hospital | Nanjing | Jiangsu | China |
| The Second Affiliated Hospital of Nanjing Medical University | Nanjing | Jiangsu | China |
| Yifu Hospital Affiliated to Nanjing Medical University | Nanjing | Jiangsu | China |
| Affiliated Hospital of Xuzhou Medical University | Xuzhou | Jiangsu | China |
| The First Hospital of Jilin University | Harbin | Jilin | China |
| The Fourth Affiliated Hospital of Harbin Medical University | Harbin | Jilin | China |
| The Second Hospital of Jilin University | Harbin | Jilin | China |
| Panjin Liaoyou Baoshihua Hospital | Panjin | Liaoning | China |
| Jinan Central Hospital | Jinan | Shandong | China |
| Qilu Hospital of Shandong University | Jinan | Shandong | China |
| Affiliated Hospital of Jining Medical College, Shandong Province | Jining | Shandong | China |
| Qingdao University Hospital | Qingdao | Shandong | China |
| Gongli Hospital, Pudong New Area, Shanghai | Shanghai | Shanghai Municipality | China |
| Shanghai Minhang District Central Hospital | Shanghai | Shanghai Municipality | China |
| Shanghai Pudong Hospital | Shanghai | Shanghai Municipality | China |
| Shanghai Seventh People's Hospital | Shanghai | Shanghai Municipality | China |
| Xinhua Hospital Affiliated to Shanghai Jiaotong University School of Medicine | Shanghai | Shanghai Municipality | China |
| Central Hospital of Yuncheng City, Shanxi Province | Yuncheng | Shanxi | China |
| Tangshan Workers' Hospital | Tangshan | Tianjin Municipality | China |
| Huzhou Central Hospital | Huzhou | Zhejiang | China |
| Result |
| 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. Chiglitazar monotherapy with sitagliptin as an active comparator in patients with type 2 diabetes: a randomized, double-blind, phase 3 trial (CMAS). Sci Bull (Beijing). 2021 Aug 15;66(15):1581-1590. doi: 10.1016/j.scib.2021.02.027. Epub 2021 Feb 16. |
| 40842343 | Derived | Gao L, Ji L, Yan X, Cheng Z, Zhang X, Sun W, Ma J, Song W, Liu Y, Lin X, Pang W, Cao H, Chen B, Li Z, Lu X; RECAM Study Group. Efficacy and safety of chiglitazar add-on to metformin in type 2 diabetes mellitus (RECAM study). Diabetes Obes Metab. 2025 Nov;27(11):6243-6253. doi: 10.1111/dom.70009. Epub 2025 Aug 22. |
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| C515629 | chiglitazar |
| D008687 | Metformin |
| ID | Term |
|---|---|
| D001645 | Biguanides |
| D006146 | Guanidines |
| D000578 | Amidines |
| D009930 | Organic Chemicals |
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