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

Biodel

Status and phase: Completed; Phase 3

Conditions: Type 1 Diabetes Mellitus

Treatments: Drug: LISPRO; Drug: Viaject 7

Study type: Interventional

Funder types: Industry

Identifiers

NCT01110746

VIAject -032J

Details and patient eligibility

About

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.

Enrollment: 20 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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20 participants in 2 patient groups

Formulation A

Experimental group

Description:

Single Injection

Treatment:

Drug: Viaject 7

Formulation B

Experimental group

Description:

Single Injection

Treatment:

Drug: LISPRO