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Evaluate the efficacy of GZR33 Injection and Insulin Degludec Injection (Tresiba®) in Patients with Type 2 Diabetes Mellitus Inadequately Controlled with Oral Antidiabetic Drugs.
This study will be conducted to evaluate the efficacy of once-daily GZR33 Injection and once-daily Insulin Degludec Injection (Tresiba®) in Patients with Type 2 Diabetes Mellitus Inadequately Controlled with Oral Antidiabetic Drugs.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GZR33 Injection | Experimental |
| |
| Insulin Degludec Injection (Tresiba®) | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GZR33 Injection | Drug | GZR33 Injection Administered SC, once-daily |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Hemoglobin A1c (HbA1c) from baseline after 26 weeks of treatment. | Baseline , 26 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in fasting plasma glucose (FPG) from baseline after 26 weeks of treatment | Baseline , 26 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Safety Endpoints | Number of adverse events (AEs) and serious adverse events (SAEs), and number and percent | Baseline , 27 weeks |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yuchi Liu | Contact | 010-8059-5000 | yuchi.liu@ganlee.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Gan & Lee Pharmaceuticals | Recruiting | Beijing | 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 |
|---|---|
| C571886 | insulin degludec |
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| Insulin Degludec Injection (Tresiba®) |
| Drug |
Administered SC, once-daily |
|
| D004700 | Endocrine System Diseases |