drugset / Trial / NCT02477969

Efficacy and Safety Study of PEX168 in Combination Therapy Diabetes Mellitus Type 2 Patients With Metformin

NCT02477969

Phase 3 Unknown 587 enrolled Jiangsu Hansoh Pharmaceutical Co., Ltd.
RandomizedParallel-groupTriple-blindTreatment

Summary

This is a multicenter, randomized, double-blind, placebo-controlled, phase III clinical study that will enroll approximately 564 T2DM patients who before screening have inadequately controlled blood glucose (7.0%≤HbA1c≤10.5% at randomization)despite at least 8 weeks of metformin monotherapy at stable doses(≥1500 mg/day).

Timeline

Start
2014-02-27
Primary completion
2016-06-22
Completion
2017-06

Drugs

EvaluationDrugModalityDoseRoute
Subject PEGLOXENATIDE Peptide 100 ug Subcutaneous
Subject PEGLOXENATIDE Peptide 200 ug Subcutaneous
Background Metformin Small molecule 0.5 mg Oral