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2 weeks screening period, 3 weeks run-in period, 16 weeks double-blind treatment period, to evaluate the Safety and Efficacy of HRS-7535 in Subjects with Type 2 Diabetes who have Inadequate Glycemic Control on Metformin and SGLT2i.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A | Experimental | Subjects will receive escalated dose of HRS-7535 administered orally |
|
| Group B | Experimental | Subjects will receive dose of HRS-7535 administered orally |
|
| Group C | Placebo Comparator | Subjects will receive Placebo administered orally |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HRS-7535 | Drug | HRS-7535 |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Change in HbA1c from baseline at Week 16 | Week 16 |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of subjects achieving HbA1c target of <7.0% at 16 weeks | 16 weeks | |
| Proportion of subjects achieving HbA1c target of ≤6.5% at 16 weeks | 16 weeks | |
| The change in fasting blood glucose from baseline to 16 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Sun Yat-sen Memorial Hospital of Sun Yat-sen University | Guangdong | Guangzhou | 51020 | 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 |
Placebo |
|
| 16 weeks |
| The change in in body weight from baseline to 16 weeks | 16 weeks |
| The change in 7-point SMBG profile from baseline to 16 weeks | 16 weeks |
| D004700 | Endocrine System Diseases |