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The purpose of this study is to evaluate the efficacy and safety of Chiglitazar, compare with Sitagliptin.
The efficacy and safety will be compared between Chiglitazar and Sitagliptin after treatment of 24 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 | Experimental | Patients administrate Chiglitazar 32mg once daily for 24 weeks |
|
| Arm 2 | Experimental | Patients administrate Chiglitazar 48mg once daily for 24 weeks |
|
| Arm 3 | Active Comparator | Patients administrate Sitagliptin 100mg once daily for 24 weeks |
|
| 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 for patients with a baseline HbA1c <8.5% |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Weiping Jia, Dr. | Shanghai 6th People's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Anhui Provincial Hospital | Hefei | Anhui | 230001 | China | ||
| The First Hospital Affiliated to Anhui Medical University |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38162801 | Derived | Wang Y, Zhou Y, Zhou X, Su X, Xu X, Li H, Ma J. Effect of Chiglitazar and Sitagliptin on Bone Mineral Density and Body Composition in Untreated Patients with Type 2 Diabetes. Diabetes Metab Syndr Obes. 2023 Dec 27;16:4205-4214. doi: 10.2147/DMSO.S439479. eCollection 2023. | |
| 35547000 | Derived | Zhou Y, Wang H, Wang Y, Xu X, Li F, Zhou J, Shan T, Huang R, Cai T, Liu X, Su X, Li H, Ma J. Comparative Evaluation of Chiglitazar and Sitagliptin on the Levels of Retinol-Binding Protein 4 and Its Correlation With Insulin Resistance in Patients With Type 2 Diabetes. Front Endocrinol (Lausanne). 2022 Apr 25;13:801271. doi: 10.3389/fendo.2022.801271. eCollection 2022. |
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| Sitagliptin | 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 |
| 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 24d 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 and 24 weeks |
| Change in 2-h postprandial glucose (2hPPG) from baseline | The change of 2-h postprandial glucose (2hPPG) at week 12 and 24 from baseline | 12 and 24 weeks |
| Change in total cholesterol (TC) from baseline | The change of total cholesterol (TC) at week 12 and 24 from baseline | 12 and 24 weeks |
| Change in triglyceride from baseline | The change of triglyceride at week 12 and 24 from baseline | 12 and 24 weeks |
| Change in high density lipoprotein cholesterol (HDL-C) from baseline | The change of high density lipoprotein cholesterol (HDL-C) at week 12 and 24 from baseline | 12 and 24 weeks |
| Change in low density proprotein cholesterol (LDL-C) from baseline | The change of low density lipoprotein cholesterol (LDL-C) at week 12 and 24 from baseline | 12 and 24 weeks |
| Change in free fatty acid (FFA) from baseline | The change of free fatty acid (FFA) at week 12 and 24 from baseline | 12 and 24 weeks |
| Change in fasting plasma insulin from baseline | The change of fasting plasma insulin at week 12 and 24 from baseline | 12 and 24 weeks |
| Insulin sensitivity assessed by the homeostatic model assessment (HOMA) at 12 and 24 weeks, compared with that of baseline | The change of insulin sensitivity at week 12 and 24 from baseline | 12 and 24 weeks |
| Change in blood pressure from baseline | The change of blood pressure at week 24 from baseline | 24 weeks |
| Percentage of patients who discontinue the trial due to hyperglycemia | The percentage of patients who discontinue the trial due to hyperglycemia during the 24 weeks of treatment | 24 weeks |
| Hefei |
| Anhui |
| 230022 |
| China |
| Fuwai Hospital | Beijing | Beijing Municipality | 100037 | China |
| The General Hospital of the Chinese People's Armed Police Forces | Beijing | Beijing Municipality | 100039 | China |
| Beijing Tiantan Hospital | Beijing | Beijing Municipality | 100050 | China |
| The Second Artillery General Hospital of Chinese People's Liberation Army | Beijing | Beijing Municipality | 100068 | China |
| Beijing Tongren Hospital Affiliated to Capital Medical Universtiy | Beijing | Beijing Municipality | 100730 | China |
| The Third Hospital Affiliated to Guangzhou Medical College | Guangzhou | Guangdong | 510360 | China |
| The Second Affiliated Hospital of Shantou University Medical College | Shantou | Guangdong | 512021 | China |
| Shenzhen Second People's Hospital | Shenzhen | Guangdong | 518000 | China |
| Beijing University Shenzhen Hospital | Shenzhen | Guangdong | 518036 | China |
| Zhongshan People's Hospital | Zhongshan | Guangdong | 528403 | China |
| The First Affiliated Hospital of Guangxi Medical University (The Eastern Hospital) | Nanning | Guangxi | 530021 | China |
| The First Affiliated Hospital of Guangxi Medical University (The Western Hospital) | Nanning | Guangxi | 530021 | China |
| The Second Hospital of Heibei Medical University | Shijiazhuang | Hebei | 050000 | China |
| Tongji Hospital Affiliated to Tongji Medical College of HUST | Wuhan | Hubei | 430030 | China |
| The First Hospital Affiliated to Nanhua University | Hengyang | Hunan | 421001 | China |
| The First People's Hospital of Yueyang | Yueyang | Hunan | 414000 | China |
| The Affiliated Hospital of Inner Mongolia | Hohhot | Inner Mongolia | 010050 | China |
| Huai'an First People's Hospital | Huai'an | Jiangsu | 223300 | China |
| Gulou Hospital Affiliated to Nanjing Medical University | Nanjing | Jiangsu | 210008 | China |
| The Second Hospital Affiliated to Nanjing Medical University | Nanjing | Jiangsu | 210009 | China |
| Nanjing First Hospital | Nanjing | Jiangsu | 210029 | China |
| The Affiliated Hospital of Jiangsu University | Zhenjiang | Jiangsu | 212013 | China |
| The First Hospital of Jilin University | Changchun | Jilin | 100031 | China |
| Siping Central People's Hospital | Siping | Jilin | 136000 | China |
| The First Affiliated Hospital of Dalian Medical University | Dalian | Liaoning | 116044 | China |
| The First Hospital of China Medical University | Shenyang | Liaoning | 110001 | China |
| The First Affiliated Hospital of Xi'an Jiaotong University | Xi'an | Shan'xi | 710061 | China |
| Shanghai Changzheng Hospital | Shanghai | Shanghai Municipality | 200003 | China |
| The Qingpu Branch of Zhongshan Hospital Affiliate to Fudan University | Shanghai | Shanghai Municipality | 200043 | China |
| Tongji Hospital Affiliated to Tongji University | Shanghai | Shanghai Municipality | 200065 | China |
| Shanghai First People's Hospital | Shanghai | Shanghai Municipality | 200080 | China |
| Shanghai 6th People's Hospital | Shanghai | Shanghai Municipality | 200235 | China |
| Shanghai 5th People's Hospital | Shanghai | Shanghai Municipality | 200240 | China |
| The Central Hospital of Minhang District of Shanghai | Shanghai | Shanghai Municipality | 201199 | China |
| Sichuan Provincial People's Hospital | Chengdu | Sichuan | 610072 | China |
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| C515629 | chiglitazar |
| D000068900 | Sitagliptin Phosphate |
| D012856 | 4-Acetamido-4'-isothiocyanatostilbene-2,2'-disulfonic Acid |
| ID | Term |
|---|---|
| D014230 | Triazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D011719 | Pyrazines |
| D013267 | Stilbenes |
| D001597 | Benzylidene Compounds |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D017879 | Isothiocyanates |
| D017953 | Isocyanates |
| D013457 | Sulfur Compounds |
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