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The aim of this trial is to evaluate the efficacy and safety of HRS-7535 compared with dapagliflozin in subjects with type 2 diabetes mellitus with inadequate glycemic control using metformin.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment group A | Experimental | subjects will receive HRS-7535 tablet orally at dose 1. |
|
| Treatment group B | Experimental | subjects will receive HRS-7535 tablet orally at dose 2. |
|
| Treatment group C | Experimental | subjects will receive HRS-7535 tablet orally at dose 3. |
|
| Treatment group D | Active Comparator | subjects will receive dapagliflozin tablet orally. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HRS-7535 tablet | Drug | HRS-7535 tablet |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in HbA1c at 32 weeks of treatment | at 32 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Who Achieved HbA1c <7.0% at Week 32 | at 32 weeks | |
| Percentage of Participants Who Achieved HbA1c ≤6.5% at Week 32 | at 32 weeks | |
| Change from Baseline in Fasting Serum Glucose, from Baseline to Week 32 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Hospital | Beijing | Beijing Municipality | 100730 | China |
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HRS-7535 tablet compared with dapagliflozin tablet
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| dapagliflozin tablet | Drug | dapagliflozin tablet |
|
| at 32 weeks |
| Percentage Change from Baseline in Body Weight, from Baseline to Week 32 | at 32 weeks |
| Change from Baseline in Body Weight, from Baseline to Week 32 | at 32 weeks |
| Change from Baseline in Waist Circumference, from Baseline to Week 32 | at 32 weeks |
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| C529054 | dapagliflozin |
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