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The purpose of this study is to evaluate the efficacy and safety of Chiglitazar, compare with placebo.
The efficacy and safety will be compared between Chiglitazar and placebo after treatment of 24 weeks. The long term efficacy and safety of Chiglitazar will be evaluated after 52 weeks treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 | Experimental | Patients administrate Chiglitazar 32mg once daily for 52 weeks |
|
| Arm 2 | Experimental | Patients administrate Chiglitazar 48mg once daily for 52 weeks |
|
| Arm 3 | Placebo Comparator | Patients administrate placebo for 24 weeks.From week 25 to 52, patients are randomly switched to Arm 1 and Arm 2, and receive the treatment accordingly. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Chiglitazar | Drug | Take orally |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in HbA1c from baseline after 24 weeks of treatment | The change of HbA1c at week 24 from baseline | 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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% |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Linong Ji, Dr. | Peking University People's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking University Shougang Hospital | Beijing | Beijing Municipality | 100000 | China | ||
| China Meitan General Hospital |
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| Placebo | Drug | Take orally |
|
|
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 |
| Beijing |
| Beijing Municipality |
| 100028 |
| China |
| Peking University People's Hospital | Beijing | Beijing Municipality | 100044 | China |
| The 306th Hospital of PLA | Beijing | Beijing Municipality | 100101 | China |
| The First Affiliated Hospital of Chongqing Medical University | Chongqing | Chongqing Municipality | 400016 | China |
| The Second Affiliated Hospital of Chongqing Medical University | Chongqing | Chongqing Municipality | 400016 | China |
| Chongqing Three Gorges Central Hospital | Chongqing | Chongqing Municipality | 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 | Harbin | 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 Municipality | 200032 | China |
| Xin Hua Hospital Affiliated to Shanghai Jiaotong University School of Medicine | Shanghai | Shanghai Municipality | 200092 | China |
| The Central Hospital of Yangpu District of Shanghai | Shanghai | Shanghai Municipality | 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 Municipality | 300052 | China |
| 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 |
| C016056 | phospholamban |
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