NCT00875459

An Open Label, Multi-Center, Follow-on Study Examining the Long-Term Safety and Efficacy of Insulin VIAject™ in Subjects With Type 1 Diabetes Mellitus

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 233 (actual)
• Sponsor: Biodel · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

Follow-on study to the VIAject™ 06J study to evaluate the long-term safety and efficacy of VIAject™ when used as prandial insulin in combination with Lantus® in subjects with type 1 diabetes mellitus. The VIAject™ 06J study is the efficacy and safety study for insulin VIAject™ to demonstrate equivalent blood glucose control in patients with type 1 diabetes mellitus with insulin and regular human insulin as prandial insulin and to demonstrate an equivalent safety profile for VIAject™ in comparison to human insulin

Conditions

• Diabetes Mellitus

Interventions

Type	Name	Description
DRUG	VIAject™	Subcutaneous injection 25 IU/mL

Timeline

• Start date: 2007-04-01
• Primary completion: 2010-02-01
• Completion: 2010-02-01
• First posted: 2009-04-03
• Last updated: 2015-07-29