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The study is being conducted to evaluate the efficacy and safety of HRS9531 once weekly (QW) in subjects with type 2 diabetes mellitus not adequately controlled with metformin monotherapy or in combination with SGLT2 inhibitors compared to Semaglutide QW for 36 weeks and 52 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment group A | Experimental | HRS953-low dose |
|
| Treatment group B | Experimental | HRS9531-high dose |
|
| Treatment group C | Active Comparator | Semaglutide-1mg |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HRS9531 Injection | Drug | HRS9531 injected subcutaneously once weekly. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in HbA1c | Change from baseline in Glycosylated Haemoglobin after 36 weeks of treatment. | Week 0 to Week 36 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in body weight | Change from baseline in body weight after 36 weeks of treatment. | Week 0 to Week 36 |
| Proportion of Subjects with HbA1c≤6.5% | Proportion of subjects with HbA1c≤6.5% after 36 weeks of treatment. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zhu Xianyi Memorial Hospital,Tianjin Medical University | Tianjin | Tianjin Municipality | 300000 | China |
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| Semaglutide Injection | Drug | Semaglutide injected subcutaneously once weekly. |
|
| Week 0 to Week 36 |
| Proportion of Subjects with HbA1c<7% | Proportion of subjects with HbA1c<7% after 36 weeks of treatment. | Week 0 to Week 36 |
| Change in FPG (fasting plasma glucose) | Change from baseline in FPG after 36 weeks of treatment. | Week 0 to Week 36 |
| Change in FPG (fasting plasma glucose) | Change from baseline in FPG after 52 weeks of treatment. | Week 0 to Week 52 |
| 7-points SMPG profiles | Fluctuation of 7-point SMPG. Plasma glucose measured: before breakfast, 120 minutes after start of breakfast, before lunch, 120 minutes after start of lunch, before dinner,120 minutes after start of dinner, before bedtime. | Week 0 to Week 36 |
| Incidence and severity of adverse events | Severity (mild, moderate and severe) is assessed by investigator. | Week 0 to Week 52+4 weeks follow-up |
| 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 |
|---|---|
| C000591245 | semaglutide |
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