To Evaluate the Effect on Post-prandial Glycemia Safety, and Tolerability of Viaject 7 vs. Lispro Insulin During Subcutaneous Insulin Pump Therapy

July 30, 2015 updated by: Biodel

A Double-blind Study of the Effect on Post-prandial Glycemia Safety, and Tolerability of Viaject 7 vs. Lispro Insulin During Subcutaneous Insulin Pump Therapy

The purpose of this study is to evaluate the Effect on Post-prandial Glycemia Safety, and Tolerability of Viaject 7 vs. Lispro Insulin during SC Insulin Pump Therapy.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Oregon
      • Portland, Oregon, United States, 97232
        • Oregon Health and Science University/Legacy Health System

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Males or females diagnosed with type 1 diabetes mellitus for at least 6 months

  2. Current usage of subcutaneous insulin pump treatment with one of the following pumps:

    • Medtronic Paradigm®
    • Animas®
    • OmniPod®
    • ACCU-CHEK Spirit®
  3. Age 18-75 years
  4. HbA1c of 6.0 - 9.0% at screening visit.
  5. Willingness to attend 9 clinic visits.

Exclusion Criteria:

  1. Pregnancy or Lactation
  2. Renal insufficiency (serum creatinine of 2.0 mg/dL or greater).
  3. Anemia
  4. Congestive heart failure.
  5. Visual impairment preventing reading of glucose meter values or the ability to use an insulin pump or continuous glucose monitoring device.
  6. Active coronary artery disease or heart procedure within the past 4 months.
  7. Active foot ulceration.
  8. Severe peripheral arterial disease.
  9. Stroke within the past 6 months.
  10. Active alcohol abuse, substance abuse, or severe mental illness.
  11. Active cancer, except basal cell or squamous cell skin cancers.
  12. Major surgical operation within 30 days prior to screening.
  13. Seizure disorder (epilepsy).
  14. Any concurrent illness, other than diabetes, that is not controlled by a stable therapeutic regimen.
  15. Currently use of corticosteroids.
  16. History of major non-compliance.
  17. Use of an investigational drug within 30 days prior to screening.
  18. Bleeding disorder, treatment with warfarin, or low platelet count.
  19. Any insulin allergy
  20. Current complaints of major infusion site problems with commercially- available insulin preparations, such as frequent occurrence of infections, marked swelling or marked erythema.
  21. History of gastroparesis.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Formulation A
Single Injection
Drug: Viaject 7
100IU/mL administered subcutaneously
Experimental: Formulation B
Single Injection
Drug: LISPRO
100IU/mL administered subcutaneously

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
3 hour incremental area under the glucose curve after a standardized high glycemic index meal.
Time Frame: 3 hours
3 hours

Secondary Outcome Measures

Outcome Measure
Time Frame
Draize scores at insulin infusion site at 24 hour and 72 hour follow-up visits, frequency of discomfort with insulin infusion, and severity of discomfort with insulin infusion (ratings of mild, moderate, or severe).
Time Frame: 72 hours
72 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Biodel

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2010

Primary Completion (Actual)

June 1, 2010

Study Completion (Actual)

June 1, 2010

Study Registration Dates

First Submitted

April 13, 2010

First Submitted That Met QC Criteria

April 26, 2010

First Posted (Estimate)

April 27, 2010

Study Record Updates

Last Update Posted (Estimate)

August 3, 2015

Last Update Submitted That Met QC Criteria

July 30, 2015

Last Verified

July 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VIAject -032J

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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