drugset / Trial / NCT00542724

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 1 Diabetes Mellitus

NCT00542724

Phase 3 Completed 462 enrolled Biodel
RandomizedParallel-groupOpen-labelTreatment

Summary

The purpose of this study is to demonstrate equivalent blood glucose control in patients with type 1 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
2006-09
Primary completion
2008-07
Completion

Drugs

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