NCT00542724

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
462

participants targeted

Target at P50-P75 for phase_3

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2006

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

October 5, 2007

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 11, 2007

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2008

Completed
Last Updated

August 3, 2015

Status Verified

July 1, 2015

Enrollment Period

1.8 years

First QC Date

October 5, 2007

Last Update Submit

July 30, 2015

Conditions

Type 1 Diabetes Mellitus

Keywords

InsulinDiabetes Mellitus type IJuvenile diabetes

Outcome Measures

Primary Outcomes (1)

  • Change in HbA1c

    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).

    6 months

Study Arms (2)

A

EXPERIMENTAL

VIAject™

Drug: VIAject™

B

ACTIVE COMPARATOR

Regular Human Insulin

Drug: Regular Human Insulin

Interventions

VIAject™DRUG

Dosage as individually required

A
Regular Human InsulinDRUG

Dosage as individually required

B

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.
  • Known significant hepatic disease or serum AST or ALT values ≥ 3 X upper limit of normal or bilirubin levels ≥ 1.5 X upper limit of normal.
  • Severe complications of diabetes mellitus including a history or finding of Stage III or IV diabetic retinopathy, proteinuria \> 2+ by urine dipstick, serum creatinine of \>1.8 mg/dl for males or \>1.5 mg/dl for females, history of renal transplant, severe peripheral vascular disease which has resulted in an amputation, chronic foot ulcers claudication or absent pedal pulses.
  • Known history of autonomic neuropathy.
  • History of moderate to severe ketoacidosis within the 3 months preceding screening for the study.
  • Current drug or alcohol abuse, or a history which in the opinion of the Investigator will impair patient safety or protocol compliance.
  • +9 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Links

MeSH Terms

Conditions

Diabetes Mellitus, Type 1Insulin Resistance

Interventions

Insulin

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System DiseasesHyperinsulinism

Intervention Hierarchy (Ancestors)

ProinsulinInsulinsPancreatic HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptidesAmino Acids, Peptides, and Proteins

Study Officials

  • David C Klonoff, M.D., F.A.C.P.

    Diabetes Research Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 5, 2007

First Posted

October 11, 2007

Study Start

September 1, 2006

Primary Completion

July 1, 2008

Last Updated

August 3, 2015

Record last verified: 2015-07