drugset / Trial / NCT03059719

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

NCT03059719

Phase 1 Completed 36 enrolled PegBio Co., Ltd.
RandomizedParallel-groupSingle-blindTreatment

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).

Timeline

Start
2015-04-08
Primary completion
2016-09-30
Completion
2016-10-27

Drugs

EvaluationDrugModalityDoseRoute
Comparator Exenatide Peptide 5 ug
Comparator Exenatide Peptide 10 ug
Subject PB-119 Peptide 25 ug Subcutaneous
Subject PB-119 Peptide 50 ug Subcutaneous