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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 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 462

Last updated 2015-08-03

No results posted yet for this study

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.

Conditions

  • Type 1 Diabetes Mellitus

Interventions

DRUG

VIAject™

Dosage as individually required

DRUG

Regular Human Insulin

Dosage as individually required

Sponsors & Collaborators

  • Biodel

    lead INDUSTRY

Principal Investigators

  • David C Klonoff, M.D., F.A.C.P. · Diabetes Research Institute

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-09-30
Primary Completion
2008-07-31

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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 NCT00542724 on ClinicalTrials.gov