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This trial is conducted in China. The aim of the trial is to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of mutiple-dose GZR4 in subjects with type 2 diabetes
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GZR4 | Experimental | s.c., once weekly |
|
| Insulin Degludec | Active Comparator | s.c., once daily |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GZR4 | Drug | Administered once weekly subcutaneously (s.c., under the skin) for 6 weeks |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of TEAE | Baseline to Week 6 |
| Measure | Description | Time Frame |
|---|---|---|
| AUC0-inf | Week 6 | |
| AUC0-last | Week 6 | |
| AUC0-168h |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Gan & Lee Pharmaceuticals Co., Ltd | Beijing | Beijing Municipality | 100000 | China |
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| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| C571886 | insulin degludec |
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| Insulin Degludec |
| Drug |
Administered once daily subcutaneously (s.c., under the skin) for 6 weeks |
|
| Week 1, Week 6 |
| Tmax,GZR4 | Week 1, Week 6 |
| ADA of GZR4 | Baseline to Week 10 |