Clinical Trial for PB-119 in Subjects With Type 2 Diabetes Mellitus
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|ClinicalTrials.gov Identifier: NCT03059719|
Recruitment Status : Completed
First Posted : February 23, 2017
Last Update Posted : February 23, 2017
|Condition or disease||Intervention/treatment||Phase|
|Type II Diabetes Mellitus||Biological: Exenatide injection(Byetta) Biological: PB-119 injection||Phase 1|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||36 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||A Randomized, Open, Comparative to the Positive-Controlled, Parallel Group, Multiple Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of PB-119 to Subjects Newly Diagnosed as Type 2 Diabetes Mellitus|
|Actual Study Start Date :||April 8, 2015|
|Actual Primary Completion Date :||September 30, 2016|
|Actual Study Completion Date :||October 27, 2016|
Experimental: PB-119 injection
PB119 injection 25ug or 50ug once each week, for three months
Biological: PB-119 injection
Active Comparator: Exenatide Injection (Byetta)
Byetta 5ug or 10ug twice each day, for three months
Biological: Exenatide injection(Byetta)
- Incidence of treatment-emergent AE (safety and tolerability) [ Time Frame: the change form base line lab values at 3 months ]N of participants with abnormal lab values and AE relevant to the treatment
- PB-119 blood concentration [ Time Frame: hour0, hour12, hour24, hour48, hour72, hour96, hour120, hour144, hour168, hour336, hour504, hour672, hour1344, hour1848, hour1872, hour1896, hour1920, hour2016, hour2112, hour2184 and hour2580 ]N of PB-119 blood concentration
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03059719
|No.1 Hospital of Peking University|
|Beijing, Beijing, China, 100191|
|Principal Investigator:||Yuan Lv||No.1 Hospital of Peking University|