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This is a randomized, opened, positive drug-controlled (Exenatide, Byetta), sequential parallel group, multiple dose study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of twelve once-weekly subcutaneous doses of PB-119 to subjects with type 2 diabetes mellitus (T2DM).
There are two study phases according to different doses of investigational drug Phase 1:1 investigational group and 1 control group, i.e.; investigational drug PB-119 injection 25µg group and control drug exenatide group.
Phase 1: Plan to have 1 or 2 investigational group according to the study result from phase 1, i.e., investigational drug PB-119 injection 50 µg group and control drug exenatide group.
Subject Number:18 subjects will be randomized to each group, with equal number of females and males. 12 subjects will be in PB-119 group, 6 subjects will be in exenatide group.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PB-119 injection | Experimental | PB119 injection 25ug or 50ug once each week, for three months |
|
| Exenatide Injection (Byetta) | Active Comparator | Byetta 5ug or 10ug twice each day, for three months |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Exenatide injection(Byetta) | Biological |
| ||
| PB-119 injection |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of treatment-emergent AE (safety and tolerability) | N of participants with abnormal lab values and AE relevant to the treatment | the change form base line lab values at 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| PB-119 blood concentration | N of PB-119 blood concentration | hour0, hour12, hour24, hour48, hour72, hour96, hour120, hour144, hour168, hour336, hour504, hour672, hour1344, hour1848, hour1872, hour1896, hour1920, hour2016, hour2112, hour2184 and hour2580 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yuan Lv | No.1 Hospital of Peking University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| No.1 Hospital of Peking University | Beijing | Beijing Municipality | 100191 | 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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| Biological |
|
| D004700 | Endocrine System Diseases |