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To evaluate the similarity of the efficacy and safety of semaglutide injection (QLG2065) vs. Ozempic® in patients with type 2 diabetes mellitus (T2DM) with poor blood glucose control after metformin treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| QLG2065 | Experimental | Up to 1.0 mg semaglutide (QLG2065) Metformin ≥ 1500 mg/day (or maximum tolerated dose ≥ 1000 mg/day). |
|
| Ozempic | Active Comparator | Up to 1.0 mg semaglutide (Ozempic) Metformin ≥ 1500 mg/day (or maximum tolerated dose ≥ 1000 mg/day). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Semaglutide | Drug | Up to 1.0 mg semaglutide injected subcutaneously once-weekly for 32 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in HbA1c | Change from baseline (week 1) to week 33 in glycosylated haemoglobin (HbA1c) was evaluated | Week 33 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in HbA1c | Change from baseline (week 1) to week 21 in glycosylated haemoglobin (HbA1c) was evaluated | Week 21 |
| Percentage of Participants Who Achieved HbA1c <7.0% , HbA1c ≤6.5% | Percentage of participants who achieved HbA1c < 7.0%, HbA1c ≤6.5% is presented |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Chuanzheng Han | Contact | 0531-55821374 | chuanzheng2.han@qilu-pharma.com |
| Name | Affiliation | Role |
|---|---|---|
| Jiajun Zhao | Shandong Provincial Hospital | Principal Investigator |
| 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 |
|---|---|
| C000591245 | semaglutide |
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| Semaglutide Pen Injector [Ozempic] | Drug | Up to 1.0 mg semaglutide injected subcutaneously once-weekly for 32 weeks |
|
|
| Week 21, 33 |
| Change in Fasting Glucose | Change from baseline (week 1) to week 21, 33 in Fasting Glucose was evaluated | Week 21, 33 |
| Change in Body Weight | Change from baseline (week 1) to week 21, 33 in body weight was evaluated | Week 21, 33 |
| Percentage of Participants That Achieved Body Weight Loss ≥5% | Percentage of participants losing ≥5% of baseline body weight is presented | Week 21, 33 |
| D004700 | Endocrine System Diseases |