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The purpose of this study is to obtain information on PK/PD, efficacy and safety of SHR3824 over 12 weeks in Chinese patients with Type 2 Diabetes. This will be done by comparing the effect of SHR3824 to placebo when given in oral doses.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SHR3824 Placebo | Experimental | once daily, 12 weeks |
|
| SHR3824 5 mg | Experimental | once daily, 12 weeks |
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| SHR3824 10 mg | Experimental | once daily, 12 weeks |
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| SHR3824 20 mg | Experimental | once daily, 12 weeks |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SHR3824 | Drug | Once daily, 12 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Adjusted Mean Change in HbA1c Levels | Baseline to Week 12 | |
| The number of volunteers with adverse events as a measure of safety and tolerability | Baseline to Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Adjusted Mean Change in Fasting Plasma Glucose | Baseline to Week 12 | |
| Proportion of Participants Achieving Glycemic Response Defined as HbA1c <7% | Baseline to Week 12 |
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Inclusion Criteria:
Exclusion Criteria:
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| 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 |
|---|---|
| C000611095 | henagliflozin |
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| Placebo | Drug | Once daily, 12 weeks |
|
| D004700 | Endocrine System Diseases |