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Clinical Trial Details

Trial ID: L3046
Source ID: NCT04807348
Associated Drug: Chiglitazar 32mg
Title: Chiglitazar Added to Metformin for Type 2 Diabetes
Acronym:
Status: COMPLETED
Study Results: NO
Results:
Conditions: Type 2 Diabetes
Interventions: DRUG: Chiglitazar 32mg|DRUG: Chiglitazar 48mg|DRUG: Placebo|DRUG: Metformin Hydrochloride
Outcome Measures: Primary: percentage of HbA1c change from baseline, central lab test, 24 weeks | Secondary: 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, 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
Sponsor/Collaborators: Sponsor: Chipscreen Biosciences, Ltd.
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE3
Enrollment: 533
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2021-07-06
Completion Date: 2023-02-10
Results First Posted:
Last Update Posted: 2024-07-15
Locations: Hefei Second People's Hospital, Hefei, Anhui, China|The First Affiliated Hospital of Anhui Medical University, 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, China|Beijing Friendship Hospital, Capital Medical University, Beijing, Beijing, China|Beijing Luhe Hospital, Capital Medical University, Beijing, Beijing, China|Beijing Tongren Hospital, Capital Medical University, Beijing, Beijing, China|Beijing Tsinghua Chang Gung Memorial Hospital, Beijing, Beijing, China|Beijing University First Hospital, Beijing, Beijing, China|Chinese People's Liberation Army Rocket Army Characteristic Medical Center, Beijing, Beijing, China|Peking University People's Hospital, Beijing, Beijing, China|Xuanwu Hospital, Capital Medical University, Beijing, Beijing, China|The Second Affiliated Hospital of Chongqing Medical University, Chongqing, Chongqing, China|Three Gorges Hospital Affiliated to Chongqing University, Wanzhou, Chongqing, 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, Shijia Zhuang, Hebei, China|The Third Hospital of Hebei Medical University, Shijia Zhuang, 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, China|Shanghai Minhang District Central Hospital, Shanghai, Shanghai, China|Shanghai Pudong Hospital, Shanghai, Shanghai, China|Shanghai Seventh People's Hospital, Shanghai, Shanghai, China|Xinhua Hospital Affiliated to Shanghai Jiaotong University School of Medicine, Shanghai, Shanghai, China|Central Hospital of Yuncheng City, Shanxi Province, Yuncheng, Shanxi, China|Tangshan Workers' Hospital, Tangshan, Tianjin, China|Huzhou Central Hospital, Huzhou, Zhejiang, China
URL: https://clinicaltrials.gov/show/NCT04807348