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The purpose of this study is to explore the differences in efficacy and safety of sitagliptin,vildagliptin and saxagliptin and to find which one is more better in treating type 2 diabetes mellitus.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sitagliptin | Experimental | Drug: sitagliptin sitagliptin 100mg tablet by mouth , once daily for 12 weeks |
|
| Vildagliptin | Experimental | Drug: vildagliptin saxagliptin 50mg tablet by mouth , twice daily for 12 weeks |
|
| Saxagliptin | Experimental | Drug: saxagliptin saxagliptin 5mg tablet by mouth , once daily for 12 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sitagliptin | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Hemoglobin A1c (A1C) Levels at Week 12 | Change from baseline reflects the Week 12 value minus the baseline value. A1C represents the percentage of glycosylated hemoglobin | Baseline and Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Fasting Plasma Glucose (FPG) at Week 12 | Baseline to Week 12 | |
| Change From Baseline in 2-hour Postprandial Glucose at Week 12 | Baseline and Week 12 | |
| Measure | Description | Time Frame |
|---|---|---|
| gene polymorphism study | We will choose 6 mutation types of CYP3A4 common in Chinese,and make blood medicinal concentration assay of participants with these gene types,and then analyse the association between different gene types and the change of glucose level or HbA1c or rate of adverse event. | baseline and week 12 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lin Liao, MD | Contact | 8615168888260 | liaolin@medmail.com.cn |
| Name | Affiliation | Role |
|---|---|---|
| Lin Liao, MD | Qianfoshan Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| YuCheng people's hospital | Recruiting | Dezhou | Shandong | 253000 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30822272 | Derived | Zhou XJ, Ding L, Liu JX, Su LQ, Dong JJ, Liao L. Efficacy and short-term side effects of sitagliptin, vildagliptin and saxagliptin in Chinese diabetes: a randomized clinical trial. Endocr Connect. 2019 Apr;8(4):318-325. doi: 10.1530/EC-18-0523. |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D000068900 | Sitagliptin Phosphate |
| D000077597 | Vildagliptin |
| C502994 | saxagliptin |
| ID | Term |
|---|---|
| D014230 | Triazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Vildagliptin | Drug |
|
|
|
| Saxagliptin | Drug |
|
|
|
| Change From Baseline in Fasting Insulin at Week 12 |
| Baseline to Week 12 |
| Change From Baseline in Fasting Glucagon at Week 12 | Baseline and Week 12 |
| Change From Baseline in 2-hour Postprandial Insulin at Week 12 | Baseline and Week 12 |
| Change From Baseline in 2-hour Postprandial Glucagon at Week 12 | Baseline and Week 12 |
| Change From Baseline in abdominal perimeter at Week 12 | Baseline and Week 12 |
| Change From Baseline in Body Weight at Week 12 | Baseline and Week 12 |
| Change From Baseline in Fasting Plasma Lipids at Week 12 | fasting plasma lipid parameters including total cholesterol(TC), triglyceride(TG) and Low density lipoprotein(LDL) | Baseline and Week 12 |
| The Proportion of Patients Achieving A1C < 7% and Achieving A1C<6.5% at Week12 | Baseline and Week 12 |
| The side effect of each drug. | Baseline to week 12 |
| change from baseline in content of NOS |
| baseline and week 12 |
| Hospital of SINOTRUK | Recruiting | Jinan | Shandong | 250010 | China |
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| Jinan central hospital | Recruiting | Jinan | Shandong | 250010 | China |
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| The jinan military region general hospital | Recruiting | Jinan | Shandong | 250010 | China |
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| Qianfoshan Hospital | Recruiting | Jinan | Shandong | 250012 | China |
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| People's Hospital of Qingdao Chengyang | Recruiting | Qingdao | Shandong | 266100 | China |
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| Zibo central hospital | Recruiting | Zibo | Shandong | 255000 | China |
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| Zibo eighth people's hospital | Recruiting | Zibo | Shandong | 255000 | China |
|
| D004700 | Endocrine System Diseases |
| D011719 |
| Pyrazines |
| D009570 | Nitriles |
| D009930 | Organic Chemicals |
| D011759 | Pyrrolidines |