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

Type 1 Diabetes Mellitus Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01110746
• Other study ID #: VIAject -032J
• Status: Completed
• Phase: Phase 3
• First received: April 13, 2010
• Last updated: July 30, 2015
• Start date: February 2010
• Est. completion date: June 2010

Study information

• Verified date: July 2015
• Source: Biodel
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: June 2010
• Est. primary completion date: June 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 1
• Type 1 Diabetes Mellitus

Intervention

Drug:
• Viaject 7
100IU/mL administered subcutaneously
• LISPRO
100IU/mL administered subcutaneously

Locations

Country	Name	City	State
United States	Oregon Health and Science University/Legacy Health System	Portland	Oregon

Sponsors (1)

Lead Sponsor	Collaborator
Biodel

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	3 hour incremental area under the glucose curve after a standardized high glycemic index meal.		3 hours	No
Secondary	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).		72 hours	No