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| Name | Class |
|---|---|
| Tigermed Consulting Co., Ltd | INDUSTRY |
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This is a multicenter, randomized, double-blind, placebo-controlled, parallel dose cohort, multiple dose study to evaluate the efficacy, safety, and tolerability of different doses of PB-119 in drug-naïve subjects with T2DM.
Subjects will be assessed for eligibility over a 2-week screening period prior to a 2-week run-in period and a 12-week double-blind treatment period,4-week follow up period. The eligible patients will be randomized to 1 of 3 dose cohorts (A, B, or C). Each patient will subsequently be randomized within the designated cohort to active drug or placebo at a 3:1 active drug:placebo ratio.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PB-119 75ug | Experimental | PB-119 injection 75ug subcutaneously injected once-weekly for 12 weeks |
|
| PB-119 150ug | Experimental | PB-119 injection 150ug subcutaneously injected once-weekly for 12 weeks |
|
| PB-119 200ug | Experimental | PB-119 injection 200ug subcutaneously injected once-weekly for 12 weeks |
|
| placebo | Placebo Comparator | placebo injection subcutaneously injected once-weekly for 12 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PB-119 75ug | Drug | 60 eligible patients will be included in this group |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change of glycosylated hemoglobin(HbA1c) | Change of HbA1c from baseline value to end of treatment | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of patients achieving HbA1c <7% | Percentage of patients achieving HbA1c <7% at Week 12 | 12 weeks |
| Percentage of patients achieving HbA1c ≤6.5% | Percentage of patients achieving HbA1c ≤6.5% at Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Body mass index(BMI) | Changes of BMI from baseline value at Weeks 2, 4, 8, and 12. | 2, 4, 8, and 12 weeks |
| Waist and hip circumferences and waist-to-hip ratio | Change of waist and hip circumferences and waist-to-hip ratio from baseline value at end of treatment(waist and hip circumferences will be used to calculate waist-to-hip ratio |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Linong Ji, MD,PhD | Peking University People's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking University People's Hospital | Beijing | 100000 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33687487 | Derived | Ji L, Du Y, Xu M, Zhou X, Mo Z, Ma J, Li J, Li Y, Lin J, Wang Y, Yang J, Song W, Jin H, Pang S, Liu H, Li P, Liu J, Yao M, Li W, Jiang X, Shen F, Geng H, Zhou H, Ran J, Lei M, Du Y, Ye S, Guan Q, Lv W, Tan H, Chen T, Yang J, Qin G, Li S, Chen L. Efficacy and safety of PEGylated exenatide injection (PB-119) in treatment-naive type 2 diabetes mellitus patients: a Phase II randomised, double-blind, parallel, placebo-controlled study. Diabetologia. 2021 May;64(5):1066-1078. doi: 10.1007/s00125-021-05392-9. Epub 2021 Mar 9. | |
| 30957581 |
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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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| PB-119 150ug |
| Drug |
60 eligible patients will be included in this group |
|
| PB-119 200ug | Drug | 60 eligible patients will be included in this group |
|
| placebo | Drug | 60 eligible patients will be included in this group |
|
| 12 weeks |
| HbA1c | Changes of HbA1c from baseline value at Weeks 2, 4, and 8 | 2, 4, and 8 weeks |
| Fasting plasma glucose(FPG) | Changes of fasting plasma glucose(FPG) from baseline value at Weeks 2, 4, 8, and 12. | 2, 4, 8, and 12 weeks |
| 2-hour postprandial glucose(2-h PPG) | Changes of 2-hour postprandial glucose(2-h PPG) from baseline value at Weeks 4, 8, and 12. | 4, 8, and 12 weeks |
| Insulin | Changes of insulin from baseline value at Weeks 4, 8, and 12 | 4, 8, and 12 weeks |
| C-peptide | Changes of C-peptide from baseline value at Weeks 4, 8, and 12 | 4, 8, and 12 weeks |
| Self-monitoring of blood glucose (SMBG) | Changes of mean profile and mean increments from baseline value of the 7-point SMBG | 4, 8, and 12 weeks |
| 12 weeks |
| Blood pressure(both systolic and diastolic) | Changes of blood pressure from baseline value at Weeks 2, 4, 8, and 12. | 2, 4, 8, and 12 weeks |
| Blood lipid | Changes of blood lipid from baseline value at Weeks 2, 4, 8, and 12 | 2, 4, 8, and 12 weeks |
| Derived |
| Park EJ, Choi J, Lee KC, Na DH. Emerging PEGylated non-biologic drugs. Expert Opin Emerg Drugs. 2019 Jun;24(2):107-119. doi: 10.1080/14728214.2019.1604684. Epub 2019 Apr 19. |
| D004700 | Endocrine System Diseases |