drugset / Trial / NCT00542633

An Open Label, Multi-Center, Randomized, Parallel Group Study Comparing the Efficacy and Safety of Insulin VIAject™ and Regular Human Insulin in Patients With Type 2 Diabetes Mellitus

NCT00542633

Phase 3 Completed 472 enrolled Biodel
RandomizedParallel-groupOpen-labelTreatment

Summary

The purpose of this study is to demonstrate equivalent blood glucose control in patients with type 2 diabetes mellitus with insulin VIAject™ and regular human insulin as prandial insulin and to demonstrate an equivalent safety profile for VIAject™ in comparison to regular human insulin.

Timeline

Start
2006-12
Primary completion
2008-08
Completion

Drugs

EvaluationDrugModalityDoseRoute
Comparator Insulin Protein / enzyme biologic
Subject VIAject™ Protein / enzyme biologic