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TQ-F3083 capsule is a new type inhibitor of DPP-IV, which is currently a very effective target for the treatment of type 2 diabetes mellitus at clinical. In addition, it can promote insulin secretion with low potential toxicity, and half-life is shorter than Linagliptin.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Low dose group | Experimental | Subjects in the low dose group administrated one TQ-F3083 capsule 10mg, one TQ-F3083 blank analog capsule and one Linagliptin blank analog tablet orally, once daily for 12 weeks. |
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| High dose group | Experimental | Subjects in the high dose group administrated twoTQ-F3083 capsules 20mg and one Linagliptin blank analog tablet orally, once daily for 12 weeks. |
|
| Positive drug control group | Active Comparator | Subjects in the positive drug control group administrated two TQ-F3083 blank analog capsules and one Linagliptin tablet orally, once daily for 12 weeks. |
|
| Placebo group | Placebo Comparator | Subjects in the placebo group administrated two TQ-F3083 blank analog capsules and one Linagliptin blank analog tablet orally, once daily for 12 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TQ-F3083 capsule 10 mg | Drug | Subjects in the low dose group administrated TQ-F3083 capsule 10mg, once daily for 12 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Glycosylated hemoglobin (HbA1c) | Changes in HbA1c compared with baseline after 12 weeks of treatment | up to approximately 15 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Fasting plasma glucose (FPG) | Changes in FPG compared with baseline after 12 weeks of treatment | up to approximately 15 weeks |
| 2 hours-postprandial blood sugar (2h-PPG) | Changes in 2h-PPG compared with baseline after 12 weeks of treatment |
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Inclusion Criteria:
1.Understood and signed an informed consent form; 2.18 and 70 years old; 3.Body mass index (BMI) of 19 to 37.5 kg/m2; 4.Type 2 diabetes mellitus confirmed at least 6 weeks before screen by WHO (1999) diabetes mellitus diagnostic criteria; 5.Has inadequate glycemic control on diet/exercise therapy and irregular use hypoglycemic agents before screening, HbA1c ≥7.0% and ≤10.0% ; Has regular hypoglycemic agents with stable dose within 6 weeks before screening, HbA1c ≥7.0% and ≤9 %; 6.PFG ≤ 13.3 mmol / L; 7. Adequate laboratory inspection standards.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Nanwei Tong, Doctor | Contact | 18980601196 | tongnw@scu.edu.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Second Affiliated Hospital of Chongqing Medical Uversity | Not yet recruiting | Chongqing | Chongqing Municipality | 400010 | China |
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| TQ-F3083 capsule 20 mg | Drug | Subjects in the high dose group administrated TQ-F3083 capsule 20 mg, once daily for 12 weeks. |
|
| TQ-F3083 blank analog capsule | Drug | Subjects administrated one TQ-F3083 blank analog capsule orally, once daily for 12 weeks. |
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| TQ-F3083 blank analog capsule | Drug | Subjects administrated two TQ-F3083 blank analog capsules orally, once daily for 12 weeks. |
|
| Linagliptin blank analog tablet | Drug | Subjects administrated one Linagliptin blank analog tablet orally, once daily for 12 weeks. |
|
| Linagliptin tablet | Drug | Subjects in the positive drug control group administrated one Linagliptin tablet orally, once daily for 12 weeks. |
|
| up to approximately 15 weeks |
| Weight | Changes in weight compared with baseline after 4, 8, 12 weeks of treatment | up to approximately 7, 11, 15 weeks |
| HbA1c | The proportion of patients with HbA1c less than 7% after 12 weeks of treatment | up to approximately 15 weeks |
| HbA1c | The proportion of patients with HbA1c reduced at least 0.5% after 12 weeks of treatment | up to approximately 15 weeks |
| DPP-4 activity ( dipeptidyl peptidase-4) | changes in DPP-4 activity compared with baseline after 4, 8, 12 weeks of treatment | baseline up to 4, 8, 12 weeks |
| GLP-1 (glucagon-like peptide-1) | changes in DPP-4 activity GLP-1 concentrations compared with baseline after 4, 8, 12 weeks of treatment | baseline up to 4, 8, 12 weeks |
| Chongqing General Hospital, UCAS | Not yet recruiting | Chongqing | Chongqing Municipality | 400013 | China |
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| The Third Affiliated Hospital of Sun Yat-Sen University | Not yet recruiting | Guangzhou | Guangdong | 510630 | China |
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| The First Affiliated Hospital of Guangxi Medical University | Not yet recruiting | Nanning | Guangxi | 530021 | China |
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| Xiangya Hospital Central South University | Not yet recruiting | Changsha | Hunan | 410008 | China |
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| Yuncheng Central Hospital | Not yet recruiting | Jinan | Shandong | 250000 | China |
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| Jincheng Geberal Hospital | Not yet recruiting | Jincheng | Shanxi | 048000 | China |
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| West China Hospital of Sichuan University | Recruiting | Chengdu | Sichuan | 610041 | China |
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| The First People's Hospital of Yunnan Province | Not yet recruiting | Kunming | Yunnan | 650032 | 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 |
|---|---|
| D000069476 | Linagliptin |
| ID | Term |
|---|---|
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D011799 | Quinazolines |
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