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Clinical Trial Details

Trial ID: L4496
Source ID: NCT02121717
Associated Drug: Chiglitazar
Title: Study of Chiglitazar Compare With Placebo in Type 2 Diabetes Patients
Acronym: CMAP
Status: COMPLETED
Study Results: NO
Results:
Conditions: Type 2 Diabetes
Interventions: DRUG: Chiglitazar|DRUG: Placebo
Outcome Measures: Primary: Change in HbA1c from baseline after 24 weeks of treatment, The change of HbA1c at week 24 from baseline, 24 weeks | Secondary: Change in HbA1c from baseline for patients with a baseline HbA1c >=8.5%, The change of HbA1c at week 24 from baseline for patients with a HbA1c \>=8.5% at baseline, 24 weeks|Change in HbA1c from baseline in patients with a baseline HbA1c < 8.5%, The change of HbA1c at week 24 from baseline for patients with a HbA1c \< 8.5% at baseline, 24 weeks|Change in HbA1c from baseline, The change of HbA1c at week 12 from baseline, 12 weeks|Change in HbA1c from baseline, The change of HbA1c at week 52 from baseline, 52 weeks|Percentage of patients that attained target HbA1c <7.0%, Percentage of patients whose HbA1c at week 24 are \< 7.0%, 24 weeks|Percentage of patients whose HbA1c lowered by at least 0.5%, Percentage of patients whose change of HbA1c at week 24 from baseline are \>= 0.5%, 24 weeks|Change in fasting plasma glucose from baseline, The change of fasting plasma glucose at week 12 and 24 from baseline, 12,24 and 52 weeks|Change in 2-h postprandial glucose (2hPPG) from baseline, The change of 2-h postprandial glucose (2hPPG) at week 12, 24 and 52 from baseline, 12, 24 and 52 weeks|Change in total cholesterol (TC) from baseline, The change of total cholesterol (TC) at week 12, 24 and 52 from baseline, 12, 24 and 52 weeks|Change in triglyceride from baseline, The change of triglyceride at week 12, 24 and 52 from baseline, 12,24 and 52 weeks|Change in high density lipoprotein cholesterol (HDL-C)from baseline, The change of high density lipoprotein cholesterol (HDL-C) at week week 12, 24 and 52 from baseline, 12, 24 and 52 weeks|Change in low density proprotein cholesterol (LDL-C) from baseline, The change of low density lipoprotein cholesterol (LDL-C) at week 12, 24 and 52 from baseline, 12, 24 and 52 weeks|Change in free fatty acid (FFA) from baseline, The change of free fatty acid (FFA) at week 12, 24 and 52 from baseline, 12, 24 and 52 weeks|Change in fasting plasma insulin from baseline, The change of fasting plasma insulin at week 12, 24 and 52 from baseline, 12, 24 and 52 weeks|Insulin sensitivity assessed by the homeostatic model assessment (HOMA) at 12,24 and 52 weeks, compared with that of baseline, The change of insulin sensitivity at week 12, 24 and 52 from baseline, 12, 24 and 52 weeks|Change in blood pressure from baseline, The change of blood pressure at week 24 from baseline, 24 weeks|Percentage of patients who use rescue therapy, The percentage of patients who use rescue therapy during the 52 weeks of treatment, 52 weeks
Sponsor/Collaborators: Sponsor: Chipscreen Biosciences, Ltd.
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE3
Enrollment: 535
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2014-06
Completion Date: 2017-11
Results First Posted:
Last Update Posted: 2019-10-25
Locations: Peking University Shougang Hospital, Beijing, Beijing, 100000, China|China Meitan General Hospital, Beijing, Beijing, 100028, China|Peking University People's Hospital, Beijing, Beijing, 100044, China|The 306th Hospital of PLA, Beijing, Beijing, 100101, China|The First Affiliated Hospital of Chongqing Medical University, Chongqing, Chongqing, 400016, China|The Second Affiliated Hospital of Chongqing Medical University, Chongqing, Chongqing, 400016, China|Chongqing Three Gorges Central Hospital, Chongqing, Chongqing, 404000, China|Cangzhou's Central Hospital, Cangzhou, Hebei, 061110, China|Harrison International Peace Hospital, Hengshui, Hebei, 053000, China|The Third Hospital of Hebei Medical University, Shijiazhuang, Hebei, 050051, China|Tangshan Gongren Hospital, Tangshan, Hebei, 063000, China|The First Affiliated Hospital of Ha'erbin Medical University, Ha'erbin, Heilongjiang, 150081, China|Zhongnan Hospital of Wuhan University, Wuhan, Hubei, 430071, China|The Second Xiangya Hospital of Central South University, Changsha, Hunan, 410001, China|Chenzhou First People's Hospital, Chenzhou, Hunan, 423000, China|Baogang Hospital of Inner Mongilia, Baotou, Inner Mongolia, 014010, China|The people's Hospital of Jiangsu Province, Nanjing, Jiangsu, 210029, China|The Affiliated Hospital of Xuzhou Medical College, Xuzhou, Jiangsu, 221000, China|The Second Hospital of Jilin University, Changchun, Jilin, 130041, China|The Affiliated Hospital of Qingdao Medical University, Qingdao, Shandong, 266071, China|Zhongshan Hospital Fudan University, Shanghai, Shanghai, 200032, China|Xin Hua Hospital Affiliated to Shanghai Jiaotong University School of Medicine, Shanghai, Shanghai, 200092, China|The Central Hospital of Yangpu District of Shanghai, Shanghai, Shanghai, 200433, China|The First Affiliated Hospital of The 4th Military Medical University, Xi'an, Shanxi, 710032, China|Huaxi Hopsital of Sichuan University, Chengdu, Sichuan, 610041, China|The General Hospital of Tianjin Medical University, Tianjin, Tianjin, 300052, China
URL: https://clinicaltrials.gov/show/NCT02121717