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The purpose of this study is to evaluate the efficacy and safety of 3 different doses of SHR3824 compared with placebo in patients with type 2 diabetes mellitus who are receiving treatment with metformin monotherapy (ie, treatment with a single drug) and have inadequate glycemic (blood sugar) control.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SHR3824 Placebo | Experimental | SHR3824 Placebo , once daily, 12 weeks, Metformin, Three times daily, 500mg, background drug. |
|
| SHR3824 5 mg | Experimental | SHR3824 5 mg , once daily, 12 weeks, Metformin, Three times daily, 500mg, background drug. |
|
| SHR3824 10 mg | Experimental | SHR3824 10 mg , once daily, 12 weeks, Metformin, Three times daily, 500mg, background drug. |
|
| SHR3824 20 mg | Experimental | SHR3824 20mg , once daily, 12 weeks, Metformin, Three times daily, 500mg, background drug. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SHR3824 | Drug |
| ||
| Placebo |
| 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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| 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 |
| D008687 | Metformin |
| ID | Term |
|---|---|
| D001645 | Biguanides |
| D006146 | Guanidines |
| D000578 | Amidines |
| D009930 | Organic Chemicals |
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| Drug |
|
| Metformin | Drug |
|
| D004700 | Endocrine System Diseases |