search
Back to results

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

Primary Purpose

Type 1 Diabetes Mellitus

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Viaject 7
LISPRO
Sponsored by
Biodel
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type 1 Diabetes Mellitus

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Oregon Health and Science University/Legacy Health System

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Formulation A

Formulation B

Arm Description

Single Injection

Single Injection

Outcomes

Primary Outcome Measures

3 hour incremental area under the glucose curve after a standardized high glycemic index meal.

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).

Full Information

First Posted
April 13, 2010
Last Updated
July 30, 2015
Sponsor
Biodel
search

1. Study Identification

Unique Protocol Identification Number
NCT01110746
Brief Title
To Evaluate the Effect on Post-prandial Glycemia Safety, and Tolerability of Viaject 7 vs. Lispro Insulin During Subcutaneous Insulin Pump Therapy
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2015
Overall Recruitment Status
Completed
Study Start Date
February 2010 (undefined)
Primary Completion Date
June 2010 (Actual)
Study Completion Date
June 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Biodel

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 1 Diabetes Mellitus

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Formulation A
Arm Type
Experimental
Arm Description
Single Injection
Arm Title
Formulation B
Arm Type
Experimental
Arm Description
Single Injection
Intervention Type
Drug
Intervention Name(s)
Viaject 7
Intervention Description
100IU/mL administered subcutaneously
Intervention Type
Drug
Intervention Name(s)
LISPRO
Intervention Description
100IU/mL administered subcutaneously
Primary Outcome Measure Information:
Title
3 hour incremental area under the glucose curve after a standardized high glycemic index meal.
Time Frame
3 hours
Secondary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Males or females diagnosed with type 1 diabetes mellitus for at least 6 months Current usage of subcutaneous insulin pump treatment with one of the following pumps: Medtronic Paradigm® Animas® OmniPod® ACCU-CHEK Spirit® Age 18-75 years HbA1c of 6.0 - 9.0% at screening visit. Willingness to attend 9 clinic visits. Exclusion Criteria: Pregnancy or Lactation Renal insufficiency (serum creatinine of 2.0 mg/dL or greater). Anemia Congestive heart failure. Visual impairment preventing reading of glucose meter values or the ability to use an insulin pump or continuous glucose monitoring device. Active coronary artery disease or heart procedure within the past 4 months. Active foot ulceration. Severe peripheral arterial disease. Stroke within the past 6 months. Active alcohol abuse, substance abuse, or severe mental illness. Active cancer, except basal cell or squamous cell skin cancers. Major surgical operation within 30 days prior to screening. Seizure disorder (epilepsy). Any concurrent illness, other than diabetes, that is not controlled by a stable therapeutic regimen. Currently use of corticosteroids. History of major non-compliance. Use of an investigational drug within 30 days prior to screening. Bleeding disorder, treatment with warfarin, or low platelet count. Any insulin allergy Current complaints of major infusion site problems with commercially- available insulin preparations, such as frequent occurrence of infections, marked swelling or marked erythema. History of gastroparesis.
Facility Information:
Facility Name
Oregon Health and Science University/Legacy Health System
City
Portland
State/Province
Oregon
ZIP/Postal Code
97232
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs