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

Study Overview
=================
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.

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

Conditions
-----------------
Type 1 Diabetes Mellitus

Intervention / Treatment
-----------------
* Drug: Viaject 7
* Drug: LISPRO


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Males or females diagnosed with type 1 diabetes mellitus for at least 6 months Current usage of subcutaneous insulin pump treatment with one of the following pumps: Medtronic Paradigm® Animas® OmniPod® ACCU-CHEK Spirit® Age 18-75 years HbA1c of 6.0 - 9.0% at screening visit. Willingness to attend 9 clinic visits. Exclusion Criteria: Pregnancy or Lactation Renal insufficiency (serum creatinine of 2.0 mg/dL or greater). Anemia Congestive heart failure. Visual impairment preventing reading of glucose meter values or the ability to use an insulin pump or continuous glucose monitoring device. Active coronary artery disease or heart procedure within the past 4 months. Active foot ulceration. Severe peripheral arterial disease. Stroke within the past 6 months. Active alcohol abuse, substance abuse, or severe mental illness. Active cancer, except basal cell or squamous cell skin cancers. Major surgical operation within 30 days prior to screening. Seizure disorder (epilepsy). Any concurrent illness, other than diabetes, that is not controlled by a stable therapeutic regimen. Currently use of corticosteroids. History of major non-compliance. Use of an investigational drug within 30 days prior to screening. Bleeding disorder, treatment with warfarin, or low platelet count. Any insulin allergy Current complaints of major infusion site problems with commercially- available insulin preparations, such as frequent occurrence of infections, marked swelling or marked erythema. History of gastroparesis.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Formulation A<br>Single Injection | Drug: Viaject 7<br>* 100IU/mL administered subcutaneously<br>|
| Experimental: Formulation B<br>Single Injection | Drug: LISPRO<br>* 100IU/mL administered subcutaneously<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 3 hour incremental area under the glucose curve after a standardized high glycemic index meal. |  | 3 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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 |