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SHR117887 is a new dipeptidyl peptidase(DPP)-4 inhibitor. This study aims to evaluate the efficacy and safety of SHR117887 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 | patients are administered oral tablets of placebo once daily and 500mg TID for 4 weeks at the run-in period. After randomized ,patients administer the drugs too. |
|
| SHR117887 (50mg q.d)/Metformin | Experimental | patients are administered oral placebo once daily and metformin 500mg TID for 4 weeks at the run-in period.After randomised,patients adminitered SHR117887 50mg QD and metformin 500mg TID for 12 weeks. |
|
| SHR117887 (100mg q.d)/Metformin | Experimental | patients are administered oral placebo once daily and metformin 500mg TID for 4 weeks at the run-in period.After randomised,patients adminitered SHR117887 100mg QD and metformin 500mg TID for 12 weeks. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug |
| ||
| SHR117887 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in HbA1c (Hemoglobin A1C) at Week 12 | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Achieving Less Than (<) 6.5% or <7% HbA1c Levels | 12 weeks | |
| Change From Baseline in Fasting Plasma Glucose,insulin and C-peptide at Week 12 | 12 weeks | |
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Inclusion Criteria:
Exclusion Criteria:
-
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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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| Post-meal total and incremental glucose,insulin and C-peptide area under the curve at week 12 |
| 12 weeks |
| Change From Baseline in Body Weight at Week 12 | 12 weeks |
| D004700 | Endocrine System Diseases |