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| Name | Class |
|---|---|
| BrightGene New Bio-Medical Technology(Wuxi) Co.Ltd. | INDUSTRY |
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This trial is conducted in China. The aim of the trial is to evaluate the efficacy and safety of BGM0504 versus semaglutide as add-on to metformin and/or sulfonylureas in patients with type 2 diabetes
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental: 5 mg BGM0504 5 milligrams (mg) BGM0504 administered subcutaneously (SC) once a week. | Experimental | Drug: BGM0504 Administered SC |
|
| Experimental: 10 mg BGM0504 10 mg BGM0504 administered SC once a week. | Experimental | Drug: BGM0504 Administered SC |
|
| Active Comparator: 1 mg Semaglutide 1 mg semaglutide administered SC once a week | Active Comparator | Drug: Semaglutide Administered SC |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Drug: 5 mg BGM0504 Administered SC | Drug | Experimental: 5 mg BGM0504 5 milligrams (mg) BGM0504 administered subcutaneously (SC) once a week. |
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| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Hemoglobin A1c (HbA1c) | Change from baseline in HbA1c after 32 weeks of treatment. | Week 0 to Week 32 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Body Weight | Change from baseline in body weight after 52 weeks of treatment. | Week 0 to Week 52 |
| Change From Baseline in Hemoglobin A1c (HbA1c) | Change from baseline in HbA1c after 52weeks of treatment. |
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Inclusion Criteria:
â– Have been diagnosed with type 2 diabetes mellitus (T2DM);
Exclusion Criteria:
â– Previous diagnosis of type 1 diabetes, special type diabetes;
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Linong Ji,MD, chief physician, Peking University People's Hospital | Contact | +86 13910978815 | jiln@bjmu.edu.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking University People's Hospital | Recruiting | Beijing | Beijing Municipality | 100044 | 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 |
|---|---|
| D004364 | Pharmaceutical Preparations |
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| Drug:10 mg BGM0504 Administered SC | Drug | Experimental: 10 mg BGM0504 10 mg BGM0504 administered SC once a week. |
|
| Drug: Semaglutide Administered SC | Drug | Active Comparator: 1 mg Semaglutide 1 mg semaglutide administered SC once a week |
|
| Week 0 to Week 52 |
| Percentage of Participants With HbA1c Target Value of <7% | Percentage of Participants With HbA1c Target Value of <7% after 52weeks of treatment. | Week 0 to Week 52 |
| Percentage of Participants With HbA1c Target Value of <5.7% | Percentage of Participants With HbA1c Target Value of <5.7%after 52weeks of treatment. | Week 0 to Week 52 |
| Change From Baseline in Fasting Serum Glucose | Change from baseline in FPG after 52 weeks of treatment. | Week 0 to Week 52 |
| D004700 | Endocrine System Diseases |