NCT01235039

A Study Evaluating the Bioequivalence of VIAject®7 Compared to VIAject®25 and Comparing the Pharmacokinetic and Pharmacodynamic Properties of VIAject®7 to Insulin Lispro in Subjects With Type 1 Diabetes Mellitus

A Single Center, Double Blind, Randomized Crossover Study Evaluating the Bioequivalence of VIAject®7 Compared to VIAject®25 and Comparing the Pharmacokinetic and Pharmacodynamic Properties of VIAject®7 to Insulin Lispro in Subjects With Type 1 Diabetes Mellitus

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 43 (actual)
• Sponsor: Biodel · Industry
• Sex: All
• Age: 19 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The primary objective of this study is to test for bioequivalence of VIAject®7 and VIAject®25 and to compare the pharmacokinetic/Pharmacodynamic/tolerability characteristics of VIAject®7 with those of VIAject®25 and insulin lispro.

Conditions

• Diabetes Mellitus

Interventions

Type	Name	Description
DRUG	VIAject®25	Two vial presentation for reconstitution and single dose of 12 IU subcutaneous injection and 25 IU/mL
DRUG	VIAject®7	One vial presentation and single dose of 12 U for subcutaneous injection and 100 IU/mL
DRUG	Insulin Lispro	One vial presentation and single dose of 12 IU for subcutaneous injection and 100 IU/mL

Timeline

• Start date: 2009-07-01
• Primary completion: 2009-09-01
• Completion: 2009-09-01
• First posted: 2010-11-05
• Last updated: 2015-07-29

Locations

1 site across 1 country: Germany