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

Biodel0 sites462 target enrollmentSeptember 2006

ConditionsType 1 Diabetes Mellitus

InterventionsVIAject™Regular Human Insulin

DrugsVIAject™Regular Human Insulin

Overview

Phase: Phase 3
Intervention: VIAject™
Conditions: Type 1 Diabetes Mellitus
Sponsor: Biodel
Enrollment: 462
Primary Endpoint: Change in HbA1c
Status: Completed
Last Updated: 10 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

September 2006

End Date

July 2008

Last Updated

10 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Biodel

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Male or female patients with type 1 diabetes must present with the following:
•Established diagnosis of type 1 diabetes for more than 1 year.
•HbA1c values of not more than 10.5%.
•Three months on a stable insulin regimen that meets the current standard of care and that includes at least two daily insulin injections.
•Age: 18 to 70 years.
•Body Mass Index: 18 - 38 Kg/m2.

Exclusion Criteria

•Patients presenting with any of the following will not be included in the study:
•Type 2 diabetes mellitus as determined by the investigator.
•History of frequent severe hypoglycemia within the prior six months.
•C-peptide \> 1.0 ng/ml unless there is a documented history of ketoacidosis or a documented history of a positive anti GAD test.
•History of known hypersensitivity to any of the components in the study medication.
•History of severe or multiple allergies.
•Treatment with investigational diabetes drug in the last 3 months or treatment with any other investigational drug in the last 30 days before study entry.
•Current short-term treatment with systemic oral, injected, or inhaled corticosteroids. (inhaled corticosteroids may be allowed when the treatment is long-term).
•Progressive disease likely to prove fatal.
•History of malignancy within the past 5 years except for basal cell epithelioma.

Arms & Interventions

A

VIAject™

Intervention: VIAject™

B

Regular Human Insulin

Intervention: Regular Human Insulin

Outcomes

Primary Outcomes

Change in HbA1c

Time Frame: 6 months

To evaluate the mean changes in hemoglobin A1c (HbA1c) from baseline to the end of the study in subjects with type 1 diabetes after treatment for 6 months with Viaject in comparison to the mean changes in HbA1c from baseline to end of study in subjects treated with regular human insulin (RHI).