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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

NCT01235039 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 43

Last updated 2015-07-29

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Biodel

    lead INDUSTRY

Principal Investigators

  • Tim Heise, M.D · Profil Institut für Stoffwechselforschung GmbH

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
19 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-07-31
Primary Completion
2009-09-30
Completion
2009-09-30

Countries

  • Germany

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01235039 on ClinicalTrials.gov