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The study is being conducted to evaluate the efficacy and safety of HS-20094 once weekly (QW) in subjects with type 2 diabetes mellitus not adequately controlled with metformin monotherapy or in combination with SGLT2 inhibitors compared to Dulaglutide QW for 44 weeks and 52 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment Group A | Experimental | HS-20094-low dose |
|
| Treatment Group B | Experimental | HS-20094-high dose |
|
| Treatment Group C | Active Comparator | Dulaglutide -1.5mg |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HS-20094 Injection | Drug | HS-20094 injected subcutaneously once weekly |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in HbA1c | Change from baseline in HbA1c after 44 weeks of treatment | Week 0 to Week 44 |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of subjects with HbA1c<7.0% and ≤6.5% | Proportion of subjects with HbA1c<7.0% and ≤6.5% after 44 weeks of treatment | Week 0 to Week 44 |
| Change in FPG | Change from baseline in FPG after 44 weeks of treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shandong Provincial Hospital | Jinan | Shandong | 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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| ID | Term |
|---|---|
| C555680 | dulaglutide |
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| Dulaglutide Injection | Drug | Dulaglutide injected subcutaneously once weekly |
|
| Week 0 to Week 44 |
| Change in body weight | Change from baseline in Change in body weight after 44 weeks of treatment | Week 0 to Week 44 |
| Proportion of subjects with weight loss ≥5% and ≥10% | Proportion of subjects with weight loss ≥5% and ≥10% after 44 weeks of treatment | Week 0 to Week 44. |
| Change in HbA1c | Change from baseline in HbA1c after 52 weeks of treatment | Week 0 to Week 52 |
| Proportion of subjects with HbA1c<7.0% and ≤6.5% | Proportion of subjects with HbA1c<7.0% and ≤6.5% after 52 weeks of treatment | Week 0 to Week 52 |
| Change in FPG | Change from baseline in FPG after 52 weeks of treatment | Week 0 to Week 52 |
| Change in body weight | Change from baseline in Change in body weight after 52 weeks of treatment | Week 0 to Week 52 |
| Proportion of subjects with weight loss ≥5% and ≥10% | Proportion of subjects with weight loss ≥5% and ≥10% after 52 weeks of treatment | Week 0 to Week 52 |
| Incidence and severity of adverse events | Severity (mild, moderate and severe) is assessed by investigator | Week 0 to Week 52+4 weeks follow-up |
| Tianjin Medical University General Hospital (Zhu Xianyi Memorial Hospital) | Tianjin | Tianjn | China |
|
| D004700 | Endocrine System Diseases |