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SP2086 is a new dipeptidy1 peptidase(DPP)-4 inhibitors. This study aims to explore the effective dose range of SP2086 in Patients with type 2 diabetes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator |
| |
| 50 mg SP2086 | Experimental |
| |
| 100 mg SP2086 | Experimental |
| |
| 200 mg SP2086 | Experimental |
| |
| 100 mg Sitagliptin | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug | Tablets(n=4),once daily for 84 days |
| |
| 50 mg SP2086 |
| Measure | Description | Time Frame |
|---|---|---|
| the change from baseline in HbA1c at 12 week | baseline, week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Achieving Less Than (<) 6.5% or <7% HbA1c Levels | week 12 | |
| Change From Baseline in Fasting Plasma Glucose at Week 4, 8 and 12 | Baseline, Week 4, 8, 12 | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Changyu Pan, M.D. | Chinese PLA General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chinese PLA General Hospital | Beijing | China |
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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 |
| ID | Term |
|---|---|
| D014230 | Triazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Drug |
Tablets(n=1),50mg strength+tablets(n=3) 0 mg once daily for 84 days |
|
| 100 mg SP2086 | Drug | Tablets(n=1),100 mg strength+tablets(n=3) once 0 mg daily for 84 days |
|
| 200 mg SP2086 | Drug | Tablets(n=2),100 mg strength+tablets(n=2) 0mg once daily for 84 days |
|
| 100 mg Sitagliptin | Drug | Tablets(n=1),100 mg strength+tablets(n=3),0 mg strength once daily for 84 days |
|
| Post-meal total and incremental glucose,insulin and C-peptide area under the curve at week 4 ,12 |
| baseline, week 4 ,12 |
| Change from baseline in Homeostasis model assessment-beta(HOMA-β) at week 4,week12 | baseline, week 4,12week |
| Change From Baseline in lipid at Week 4, 8 and 12 | baseline, week 4, 8, 12 |
| Change From Baseline in Body Weight at Week 4,8,12 | baseline, Week 4, 8,12 |
| D004700 | Endocrine System Diseases |
| D011719 |
| Pyrazines |