To Evaluate the Effect on Post-prandial Glycemia Safety, and Tolerability of Viaject 7 vs. Lispro Insulin During Subcutaneous Insulin Pump Therapy
NCT ID: NCT01110746
Last Updated: 2015-08-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
20 participants
INTERVENTIONAL
2010-02-28
2010-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
DOUBLE
Study Groups
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Formulation A
Single Injection
Viaject 7
100IU/mL administered subcutaneously
Formulation B
Single Injection
LISPRO
100IU/mL administered subcutaneously
Interventions
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Viaject 7
100IU/mL administered subcutaneously
LISPRO
100IU/mL administered subcutaneously
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
75 Years
ALL
No
Sponsors
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Biodel
INDUSTRY
Responsible Party
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Locations
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Oregon Health and Science University/Legacy Health System
Portland, Oregon, United States
Countries
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Other Identifiers
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VIAject -032J
Identifier Type: -
Identifier Source: org_study_id
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