drugset / Trial / NCT00875108

An Open Label, Multi-Center, Follow-on Study Examining the Long-Term Safety and Efficacy of Insulin VIAject™ in Subjects With Type 2 Diabetes Mellitus

NCT00875108

Phase 3 Completed 116 enrolled Biodel
NaSingle-groupOpen-labelTreatment

Summary

Follow-on study to the VIAject™-08J study to evaluate the long-term safety and efficacy of VIAject™ when used as prandial insulin in combination with Lantus® in subjects with type 2 diabetes mellitus. The VIAject™-08J study is the efficacy and safety study for insulin VIAject™ to demonstrate equivalent blood glucose control in patients with type 2 diabetes mellitus with VIAject™ insulin or regular human insulin as prandial insulin and to demonstrate an equivalent safety profile for VIAject™ in comparison to human insulin.

Timeline

Start
2007-07
Primary completion
2010-01
Completion
2010-01

Drugs

EvaluationDrugModalityDoseRoute
Subject VIAject™ Protein / enzyme biologic 25 unknown Subcutaneous