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

PHASE1/PHASE2CompletedINTERVENTIONAL
Enrollment

43

Participants

Timeline

Start Date

July 31, 2009

Primary Completion Date

September 30, 2009

Study Completion Date

September 30, 2009

Conditions
Diabetes Mellitus
Interventions
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

Trial Locations (1)

41460

Profil Institut für Stoffwechselforschung GmbH, Neuss

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Biodel

INDUSTRY

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 | Biotech Hunter | Biotech Hunter