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This study is to evaluate the efficacy and safety of QLG1091 vs Rybelsus as add-on to Metformin in Subjects With Type 2 Diabetes. The primary objective is to demonstrate equivalence of QLG1091 and Rybelsus. This study is a randomized, open-label, active-controlled, parallel-group, multi-center Study. The total duration of the study will be approximately 33 weeks including screening and follow-up.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| QLG1091 | Experimental |
| |
| Rybelsus | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| QLG1091 | Drug | Oral administration once-daily. |
| |
| Rybelsus |
| Measure | Description | Time Frame |
|---|---|---|
| Change in HbA1c | Change from baseline in HbA1c was evaluated at Week 26 | Week 26 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Fangyi Wang, Bachelor | Contact | +86-18266419923 | fangyi.wang@qilu-pharma.com |
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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 |
Oral administration once-daily |
|
| D004700 | Endocrine System Diseases |