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SP2086 is a new dipeptidyl peptidase(DPP)-4 inhibitor. This study aims to evaluate the efficacy and safety of SP2086 in combination therapy with Metformin in patients with Type 2 Diabetes in Metformin monotherapy Who have Inadequate Glycemic Control
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo/Metformin | Placebo Comparator |
| |
| SP2086 (50mg q.d)/Metformin | Experimental |
| |
| SP2086 (100mg q.d.)/Metformin | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo /Metformin | Drug | Patients are administered oral tablets of placebo once daily and metformin 500 mg t.i.d for 2 weeks at run-in period.After randomized,patients will be administered the drugs too |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in HbA1c (Hemoglobin A1C) at Week 12 | 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:
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 | 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 |
|---|---|
| D008687 | Metformin |
| ID | Term |
|---|---|
| D001645 | Biguanides |
| D006146 | Guanidines |
| D000578 | Amidines |
| D009930 | Organic Chemicals |
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| SP2086(50 mg q.d.)/Metformin | Drug | patients are administered oral placebo once daily and metformin 500 mg t.i.d for 2 weeks at the run-in period .After randomized ,patients will be administered SP2086 50 mg q.d. and 500 mg t.i.d for 12 weeks |
|
| SP2086 (100 mg q.d.)/Metformin | Drug | patients are administered oral placebo once daily and metformin 500 mg t.i.d for 2 weeks at the run-in period .After randomized ,patients will be administered SP2086 100 mg q.d. and 500 mg t.i.d for 12 weeks |
|
| Post-meal total and incremental glucose,insulin and C-peptide area under the curve at week 12 |
| baseline, week 12 |
| Change from baseline in Homeostasis model assessment-beta(HOMA-β) at week12 | baseline, week 12 |
| Change From Baseline in lipid at Week 12 | baseline, week12 |
| Change From Baseline in Body Weight at Week 4,8,12 | baseline, Week 4, 8,12 |
| D004700 | Endocrine System Diseases |