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

Phase 3

Completed

• Conditions: Type 1 Diabetes Mellitus
• Interventions: Drug: Viaject 7; Drug: LISPRO

• Registration Number: NCT01110746
• Lead Sponsor: Biodel

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-02
• Study First Submitted: 2010-04-13
• Study First Submitted QC: 2010-04-26
• Study First Posted: 2010-04-27
• Primary Completion: 2010-06
• Study Completion: 2010-06
• Status Verified: 2015-07
• Disposition First Submitted: 2015-07-30
• Disposition First Submitted QC: 2015-07-30
• Last Update Submitted: 2015-07-30
• Disposition First Posted: 2015-08-03
• Last Update Posted: 2015-08-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Formulation A	Viaject 7	Single Injection
Formulation B	LISPRO	Single Injection

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Oregon Health and Science University/Legacy Health System; 🇺🇸 Portland, Oregon, United States