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The purpose of this study is to evaluate the efficacy and safety of BGM0504 in Chinese patients with Type 2 Diabetes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 5 mg BGM0504 | Experimental |
| |
| 10 mg BGM0504 | Experimental |
| |
| 15 mg BGM0504 | Experimental |
| |
| 1 mg Semaglutide | Experimental |
| |
| Placebo | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BGM0504 Administered SC | Drug | 5 milligrams (mg) BGM0504 administered subcutaneously (SC) once a week. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Hemoglobin A1c (HbA1c) | Change from baseline in HbA1c after 12 weeks of treatment. | Week 0 to Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Body Weight | Change from baseline in body weight after 12 weeks of treatment. | Week 0 to Week 12 |
| Percentage of Participants With HbA1c Target Value of <7% | Percentage of Participants With HbA1c Target Value of <7% after 12 weeks of treatment. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Third Xiangya Hospital of Central South University | Changsha | Hunan | 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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| BGM0504 Administered SC | Drug | Experimental: 10 mg BGM0504 10 mg BGM0504 administered SC once a week. |
|
| BGM0504 Administered SC | Drug | Experimental: 15 mg BGM0504 15 mg BGM0504 administered SC once a week. |
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| Semaglutide Administered SC | Drug | Active Comparator: 1 mg Semaglutide 1 mg semaglutide administered SC once a week |
|
| Placebo Administered SC | Drug | Placebo Comparator: Placebo Placebo administered SC once a week. |
|
| Week 0 to Week 12 |
| Percentage of Participants With HbA1c Target Value of <6.5% | Percentage of Participants With HbA1c Target Value of <5.7% after 12 weeks of treatment. | Week 0 to Week 12 |
| Change From Baseline in Fasting Serum Glucose | Change from baseline in FPG after 12 weeks of treatment. | Week 0 to Week 12 |
| D004700 | Endocrine System Diseases |