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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Biodel
ClinicalTrials.gov Identifier:
NCT01110746
First received: April 13, 2010
Last updated: February 4, 2013
Last verified: June 2010
  Purpose

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.


Condition Intervention Phase
Type 1 Diabetes Mellitus
Drug: Viaject 7
Drug: LISPRO
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Biodel:

Primary Outcome Measures:
  • 3 hour incremental area under the glucose curve after a standardized high glycemic index meal. [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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). [ Designated as safety issue: No ]

Enrollment: 20
Study Start Date: February 2010
Study Completion Date: June 2010
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Formulation A
Single Injection
Drug: Viaject 7
100IU/mL administered subcutaneously
Experimental: Formulation B
Single Injection
Drug: LISPRO
100IU/mL administered subcutaneously

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01110746

Locations
United States, Oregon
Oregon Health and Science University/Legacy Health System
Portland, Oregon, United States, 97232
Sponsors and Collaborators
Biodel
  More Information

No publications provided

Responsible Party: Biodel
ClinicalTrials.gov Identifier: NCT01110746     History of Changes
Other Study ID Numbers: VIAject -032J
Study First Received: April 13, 2010
Last Updated: February 4, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Insulin, Globin Zinc
Insulin
Insulin Lispro
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 22, 2014