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To assess the effectiveness of HSK7653 tablets following the substitution of daily DPP-4 inhibitor (DPP-4i) over a 24-week treatment period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HSK7653 | Experimental | HSK7653 10mg Q2W |
|
| Daily DPP-4 inhibitor | Active Comparator | Daily DPP-4 inhibitor |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HSK7653 10 mg | Drug | HSK7653 10 mg Q2W |
| |
| Daily DPP-4 inhibitor |
| Measure | Description | Time Frame |
|---|---|---|
| Time in range | The change in time in range (TIR) of continuous glucose monitoring (CGM) relative to the baseline after 24 weeks of treatment. | 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| HbA1c | Change from baseline in HbA1c after 24 weeks | 24 weeks |
| Fasting glucose | Change from baseline in fasting glucose after 24 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chu Hsien-I Memorial Hospital, Tianjin Medical University | Tianjin | 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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| Drug |
Daily DPP-4 inhibitor |
|
| 24 weeks |
| Mean glucose | Change from baseline in mean glucose after 24 weeks | 24 weeks |
| Treatment-emergent adverse events. | The incidence of treatment-emergent adverse events. | 24 weeks |
| D004700 | Endocrine System Diseases |