Status:
COMPLETED
A Study in Type 1 Diabetic Patients With Repeated Doses of E1 in Combination With G1
Lead Sponsor:
OPKO Health, Inc.
Conditions:
Type 1 Diabetes
Eligibility:
All Genders
18-40 years
Phase:
PHASE1
Brief Summary
The purpose of the study is to determine whether E1 and G1 are safe and effective in the treatment of type 1 diabetes. Type 1 diabetes is an autoimmune disease, in which the immune system attacks pan...
Detailed Description
In this study, 20 type 1 diabetic patients requiring insulin therapy will be randomized. Fifteen (15) patients will be randomized to receive active study medication and 5 patients will be randomized t...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2005
Trial Type :
INTERVENTIONAL
End Date :
December 1 2006
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00239148
Start Date
June 1 2005
End Date
December 1 2006
Last Update
October 18 2019
Active Locations (5)
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1
Pinnacle Research Group
Anniston, Alabama, United States, 36207
2
Diablo Clinical Research
Walnut Creek, California, United States, 94598
3
Diabetes - Endocrinology Center of West New York
Buffalo, New York, United States, 14209
4
Highgate Specialty Center
Durham, North Carolina, United States, 27713