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SP2086 is a new dipeptidy1 peptidase(DPP)-4 inhibitors. This study aims to evaluate the efficacy and safety of SP2086 as monotherapy in patients with Type 2 Diabetes Mellitus in Metformin monotherapy Who Have Inadequate Glycemic Control treated with diet and exercise for 3 months
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator |
| |
| SP2086 50 mg b.i.d | Experimental |
| |
| SP2086 100 mg q.d. | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in HbA1c (Hemoglobin A1C) at Week24 | A1C is measured as a percent. Thus, this change from baseline reflects the Week 24 A1C percent minus the Week 0 A1C percent | baseline, week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in fasting plasma glucose (FPG) at Week 24 | Change from baseline at Week 24 is defined as Week 24 FPG minus Week 0 FPG | Weeks 0-24 |
| Change From Baseline in 2-hour Post-meal Glucose (2-hr PMG) at Week 24 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Changyu Pan, M.D. | Contact | 86 10 66887329 | panchy301@aliyun.com | |
| Huaqiong Shen, P.H.D | Contact | 86 21 68868570 | 827 | shenhuaqiong@hrs.com.cn |
| Name | Affiliation | Role |
|---|---|---|
| Changyu Pan, M.D. | Chinese PLA General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chinese PLA General Hospital | Recruiting | 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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| SP2086 50 mg b.i.d. | Drug |
|
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| SP2086 100 mg q.d. | Drug |
|
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Change from baseline at Week 24 is defined as Week 24 2-hr PMG minus Week 0 2-hr PMG
| Weeks 0-24 |
| Percentage of Participants Achieving Less Than (<) 6.5% or <7% HbA1c Levels | week24 |
| Change From Baseline in A1C at Week 52 | A1C is measured as a percent. Thus, this change from baseline reflects the Week 52 A1C percent minus the Week 0 A1C percent | week 52 |
| Change From Baseline in FPG at Week 52 | Change from baseline at Week 52 is defined as Week 104 FPG minus Week 0 FPG | week 52 |
| Change From Baseline in lipid at Week 4、8、12、24、38、52 | Week 4、8、12、24、38、52 |
| Change From Baseline in Body Weight at Week 4,8,12、24、38、52 | Week 4、8、12、24、38、52 |
| D004700 | Endocrine System Diseases |