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SP2086 is a new dipeptidy1 peptidase(DPP)-4 inhibitors. This study aims to evaluate the efficacy and safety of SP2086 in combination therapy with Metformin in patients with Type 2 Diabetes Mellitus in Metformin monotherapy Who Have Inadequate Glycemic Control
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo/Metformin | Placebo Comparator |
| |
| SP2086 (50mg b.i.d)/Metformin | Experimental |
| |
| SP2086 (50mg q.d.)/Metformin | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo/Metformin | 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 |
|---|---|---|
| Percentage of Participants Achieving Less Than (<) 6.5% or <7% HbA1c Levels | week24, 52 | |
| Change From Baseline in fasting plasma glucose (FPG) at Week 24,52 | Change from baseline at Week 24,52 is defined as Week 24 ,52 FPG minus Week 0 FPG |
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Inclusion Criteria:
Exclusion Criteria:
1) Somatropin therapy within 6 months prior to randomization 2) History of drug or alcohol abuse within 6 months prior to randomization 3) Participate in clinical trials of any drugs or medical devices within 3 months prior to randomization 4) Receive corticosteroids long-term (more than 7 consecutive days) oral, non-gastrointestinal administration or intra-articular administration within 2 months prior to randomization 5) Weight control drugs administration or Surgeries resulting in weight instability within 2 months prior to randomization 6) In investigator's opinion, patients used any drugs that interfere with assessment of the investigational product, or produce vital organs toxicity 4. Patients with history of the following diseases or proof prior to randomization:
5. Patients with any laboratory parameters meet the following criteria prior to randomization:
6. At Screening patients not installed pacemaker with II or III degree atrioventricular block, long QT syndrome or QT corrected > 500 ms 7. Patients who received blood transfusions or blood donation≥ 400 mL or severe blood loss at least 400 mL within 8 weeks prior to randomization
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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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| ID | Term |
|---|---|
| D008687 | Metformin |
| ID | Term |
|---|---|
| D001645 | Biguanides |
| D006146 | Guanidines |
| D000578 | Amidines |
| D009930 | Organic Chemicals |
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| SP2086 50 mg b.i.d/Metformin | Drug |
|
|
| SP2086 50 mg q.d./Metformin | Drug |
|
|
| Weeks 0-24-52 |
| Change From Baseline in 2-hour Post-meal Glucose (2-hr PMG) at Week 24 | Change from baseline at Week 24 is defined as Week 24 2-hr PMG minus Week 0 2-hr PMG | Weeks 0-24 |
| Change From Baseline in HbA1c at Week 52 | A1C is measured as a percent. Thus, this change from baseline reflects the Week 52 HbA1c percent minus the Week 0 HbA1c percent | 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 |