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This trial is conducted in Indonesia. The aim of the trial is to evaluate the efficacy and safety of BGM0504 versus semaglutide as add-on to metformin in patients with type 2 diabetes
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 5 mg BGM0504 | Experimental | 5 milligrams (mg) BGM0504 administered subcutaneously (SC) once a week. |
|
| 10 mg BGM0504 | Experimental | 10 mg BGM0504 administered SC once a week. |
|
| 1 mg Semaglutide | Active Comparator | 1 mg semaglutide administered SC once a week |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BGM0504 | Drug | Administered SC |
| |
| BGM0504 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Hemoglobin A1c (HbA1c) | Change from baseline in HbA1c after 24 weeks of treatment. | Week 0 to Week 24 |
| 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 |
| Change From Baseline in Body Weight | Change from baseline in body weight after 24 weeks 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 | |
|---|---|---|---|---|
| Tahapary | Contact | +62 821 1447 2567 | dicky.tahapary@ui.ac.id |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| RS Universitas Indonesia | Recruiting | Depok | West Java | Indonesia | ||
| RSUP Fatmawati |
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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 |
|---|---|
| C000591245 | semaglutide |
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| Drug |
Administered SC |
|
| Semaglutide | Drug | Administered SC |
|
| Week 0 to Week 24 |
| Percentage of Participants With HbA1c Target Value of <7% | Percentage of Participants With HbA1c Target Value of <7% after 24 weeks of treatment. | Week 0 to Week 24 |
| Percentage of Participants With HbA1c Target Value of <5.7% | Percentage of Participants With HbA1c Target Value of <5.7%after 24 weeks of treatment. | Week 0 to Week 24 |
| Change From Baseline in Fasting Serum Glucose | Change from baseline in FPG after 24 weeks of treatment. | Week 0 to Week 24 |
| Recruiting |
| Jakarta |
| Indonesia |
| RSUP Persahabatan | Recruiting | Jakarta | Indonesia |
| RSUPN Dr. Cipto Mangunkusumo | Recruiting | Jakarta | Indonesia |
| D004700 | Endocrine System Diseases |