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The aim of this trial is to evaluate the efficacy and safety of HRS-7535 compared with placebo in subjects with type 2 diabetes mellitus with inadequate glycemic control with diet and exercise
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment group A: subjects will receive HRS-7535 tablet orally at dose 1 | Experimental |
| |
| Treatment group B: subjects will receive HRS-7535 tablet orally at dose 2 | Experimental |
| |
| Treatment group C: subjects will receive HRS-7535 tablet orally at dose 3 | Experimental |
| |
| Treatment group D: subjects will receive HRS-7535 placebo tablet orally. | Placebo Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HRS-7535 tablet | Drug | HRS-7535 tablet; low dose |
|
| 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 |
|---|---|---|---|---|---|---|
| Peking Union Medical College Hospital | Beijing | Beijing Municipality | 100730 | China |
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| HRS-7535 tablet | Drug | HRS-7535 tablet; middle dose |
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| HRS-7535 tablet | Drug | HRS-7535 tablet; high dose |
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| HRS-7535 placebo tablet | Drug | HRS-7535 placebo 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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