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This study evaluates the beta cell function, pharmacodynamics, pharmacokinetics, safety and tolerability after 4 weeks treatment of 75mgBID or 75mgQD of HMS5552.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HMS5552 dose 1 | Experimental | HMS5552 75mg.Oral administration,twice per day. |
|
| HMS5552 dose 2 | Experimental | HMS5552 75mg.Oral administration,once per day. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HMS5552 | Drug |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| beta cell function | will be assessed by change of beta cell function index | 4 weeks |
| HbA1 | 4 weeks | |
| 24-hour glucose change | 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| The study drug concentration in blood samples to be collected after drug administration | 4 weeks | |
| Composite measure of adverse events monitoring, physical examinations,12 lead ECGs, vital sign,and safety laboratory measurement | 4 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The 1st Betuhune Hospital of Jilin University | Changchun | 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 |
|---|---|
| C000629807 | Dorzagliatin |
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| D004700 | Endocrine System Diseases |