Type 1 Diabetes Mellitus
Conditions
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.
Interventions
DRUGViaject 7
100IU/mL administered subcutaneously
DRUGLISPRO
100IU/mL administered subcutaneously
Sponsors
Biodel
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 3 hour incremental area under the glucose curve after a standardized high glycemic index meal. | 3 hours |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
Countries
United States
Outcome results
None listed