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The purpose of this study is to evaluate the glycemic control and safety of SHR-3167 and Insulin Degludec in type 2 diabetic participants treated with basal insulin with or without oral antidiabetic drugs.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SHR-3167 Group A | Experimental |
| |
| SHR-3167 Group B | Experimental |
| |
| Insulin Degludec Group | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SHR-3167 | Drug | SHR-3167 Injection. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change in glycosylated hemoglobin (HbA1c) from baseline. | 16 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of subjects with glycosylated hemoglobin (HbA1c) < 7.0% from baseline. | 16 weeks. | |
| Change in fasting plasma glucose (FPG) from baseline. | 16 weeks. | |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of Chongqing Medical University | Chongqing | Chongqing Municipality | 400000 | China | ||
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| Insulin Degludec |
| Drug |
Insulin Degludec Injection. |
|
| Change in self-measured (capillary) blood glucose (SMBG) from baseline. |
| 16 weeks. |
| Zhongshan Hospital Affiliated to Fudan University |
| Shanghai |
| Shanghai Municipality |
| 200032 |
| China |
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| 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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