Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to evaluate the safety and glycemic control of SHR-3167 fixed-dose titration and individualized-dose titration in adults with Type 2 Diabetes inadequately controlled with oral antihyperglycemic agents.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SHR-3167 fixed-dose titration group | Experimental |
| |
| SHR-3167 individualized-dose titration group | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SHR-3167 Injection | Drug | SHR-3167 injection. |
|
| Measure | Description | Time Frame |
|---|---|---|
| The percentage of participants who experienced at least one hypoglycemic event. | From the baseline to 20-weeks treatment. |
| Measure | Description | Time Frame |
|---|---|---|
| The event rate of hypoglycemic events. | From the baseline to 20-weeks treatment. | |
| Change in glycosylated hemoglobin (HbA1c) from baseline. | From the baseline to 20-weeks treatment. | |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking University Shenzhen Hospital | Shenzhen | Guangdong | 518000 | China | ||
| Nanjing Drum Tower Hospital |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The study is a Phase II clinical trial to evaluate the safety and efficacy of SHR-3167 fixed-dose titration and individualized-dose titration in adults with Type 2 Diabetes inadequately controlled with oral antihyperglycemic agents.
Not provided
Not provided
Not provided
Not provided
| SHR-3167 Injection Placebo | Drug | SHR-3167 injection placebo. |
|
| Change in fasting plasma glucose (FPG) from baseline. |
| From the baseline to 20-weeks treatment. |
| The relative change in HbA1c after 20-weeks treatment compared to the baseline level. | From the baseline to 20-weeks treatment. |
| Nanjing |
| Jiangsu |
| 210003 |
| 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 |
Not provided
Not provided