NCT03059719

Clinical Trial for PB-119 in Subjects With Type 2 Diabetes Mellitus

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: PegBio Co., Ltd. · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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).

Detailed description

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.

Conditions

• Type II Diabetes Mellitus

Interventions

Type	Name	Description
BIOLOGICAL	Exenatide injection(Byetta)
BIOLOGICAL	PB-119 injection

Timeline

• Start date: 2015-04-08
• Primary completion: 2016-09-30
• Completion: 2016-10-27
• First posted: 2017-02-23
• Last updated: 2017-02-23

Locations

1 site across 1 country: China