drugset / Trial / NCT02477865

Efficacy and Safety Study of PEX168 in Monotherapy Diabetes Mellitus Type 2 Patients

NCT02477865

Phase 3 Unknown 406 enrolled Jiangsu Hansoh Pharmaceutical Co., Ltd.
RandomizedParallel-groupTriple-blindTreatment

Summary

This is a phase III, multicenter, randomized, double-blind, placebo-controlled study planning to include approximately 387 T2DM patients who have received at least 8 weeks of treatment with diet control and exercise; have not received any glucose-lowering agents within the 8 weeks prior to screening; and have inadequately controlled blood glucose.The subjects would receive PEX168 or placebo monotherapy for 52weeks in total.

Timeline

Start
2014-03-23
Primary completion
2016-05-15
Completion
2017-02

Drugs

EvaluationDrugModalityDoseRoute
Subject PEGLOXENATIDE Peptide 100 ug Subcutaneous
Subject PEGLOXENATIDE Peptide 200 ug Subcutaneous