A Study in Type 1 Diabetic Patients With Repeated Doses of E1 in Combination With G1
Type 1 Diabetes
About this trial
This is an interventional treatment trial for Type 1 Diabetes focused on measuring Type 1 diabetes
Eligibility Criteria
Inclusion Criteria: Clinical diagnosis Type 1 diabetes requiring treatment with insulin for a minimum of 1 year On a stable insulin regimen for at least 60 days prior to screening Currently self monitoring blood glucose levels at least 3 times per day No episodes of severe hypoglycemia for 60 days prior to screening Body mass index within the range 19-30 kg/m2 Patient cannot live alone during the treatment phase and up to 1 month in follow-up Exclusion Criteria: Known of suspected history of significant liver, or other GI disease History of significant cardiovascular disease including stroke, peripheral vascular disease or any related symptoms History of peptic ulcer disease and/or GI bleeding/perforation History of cancer History or presence of proliferative retinopathy, severe non-proliferative retinopathy, macular edema or presence of untreated diabetic eye disease History of treated peripheral or autonomic neuropathy Serum creatine superior or equal to 2.0 mg/dL History of hypoglycemia unawareness Non-healed diabetic ulcer
Sites / Locations
- Pinnacle Research Group
- Diablo Clinical Research
- Diabetes - Endocrinology Center of West New York
- Highgate Specialty Center
- Diabetes and Glandular Disease Research Associates