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This study is conducted in China. The aim of this trial is to assess the tolerability to HS-20004 with titration administration in type 2 diabetic patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental | Experimental | Weekly-dose titration from 0.04mg/day HS-20004 to the maximum tolerable dose or of the ultimate 0.18mg/day |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HS-20004 | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Treatment Emergent Adverse Events(TEAEs) | through study completion, an maximum of 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Nausea and vomiting during titration | through study completion, an maximum of 8 weeks | |
| Mean Change From Baseline in Body Weight at different dose steps | through study completion, an maximum of 8 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Zhiguang - Zhou | Contact | 0731-85292097 | zhouzg@hotmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Second Xiangya Hospital of Central South University | Recruiting | Changsha | Hunan | 410011 | 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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| Change in plasma concentration of HS-20004 from baseline at different dose steps | through study completion, an maximum of 8 weeks |
| Change in plasma concentration of glucose from baseline at different dose steps | through study completion, an maximum of 8 weeks |
| Change in plasma concentration of insulin from baseline at different dose steps | through study completion, an maximum of 8 weeks |
| Change in plasma concentration of glucagon from baseline at different dose steps | through study completion, an maximum of 8 weeks |
| The minimum dose of HS-20004 that could keep plasma glucose under 6.1 mmol/L in Type 2 Diabetic Patients | through study completion, an maximum of 8 weeks |
| D004700 | Endocrine System Diseases |