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To evaluate the safety, tolerability and pharmacokinetic (PK)/pharmacodynamic (PD) characteristics of HSK7653 tablets in Type 2 Diabetes Mellitus Patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HSK7653 10 mg | Experimental |
| |
| HSK7653 25 mg | Experimental |
| |
| HSK7653 50 mg | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HSK7653 10 mg | Drug | Tablet, HSK7653 10 mg Q2W, 12 weeks |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | Assessment by adverse event monitoring, 12 lead ECGs, vital signs and laboratory measurements. | From baseline to up to 2 weeks after last dose for a total of approximately 14 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Peak plasma concentration (Cmax) of HSK7653 | Cmax of HSK7653 after first dose and multi-dose administration | Day 1 to Day 43 |
| Area under the plasma concentration versus time curve (AUC) of HSK7653 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking university people's hospital | Beijing | Beijing Municipality | 100044 | 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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| HSK7653 25 mg |
| Drug |
Tablet, HSK7653 25 mg Q2W, 12 weeks |
|
| HSK7653 50 mg | Drug | Tablet, HSK7653 50 mg Q2W, 12 weeks |
|
| Placebo | Drug | Tablet, 0 mg Q2W, 12 weeks |
|
AUC of HSK7653 after first dose and multi-dose administration
| Day 1 to Day 43 |
| Half-life (t1/2) of HSK7653 | T1/2 of HSK7653 after single-dose and multi-dose administration | Day 1 to Day 43 |
| Change from baseline in dipeptidyl peptidase-IV (DPP-4) inhibition rate | Change from baseline in dipeptidyl peptidase-IV (DPP-4) inhibition rate after single-dose and multi-dose administration of HSK7653 | Day 1 to Day 84 |
| Change from baseline in GLP-1 | Change from baseline in GLP-1 after single-dose and multi-dose administration of HSK7653 | Day 1 to Day 84 |
| Change from baseline of fasting plasma glucose | Change from baseline in fasting plasma glucose after multi-dose administration of HSK7653 | Day 1 to Day 84 |
| Change from baseline of HbA1c | Change from baseline in HbA1c after multi-dose administration of HSK7653 | Day 1 to Day 84 |
| D004700 | Endocrine System Diseases |