Status:
COMPLETED
Effectiveness of Oral Insulin in Unstable Type 1 Diabetes Patients
Lead Sponsor:
Hadassah Medical Organization
Collaborating Sponsors:
Oramed Pharmaceutical Inc.
Conditions:
Brittle Type I Diabetes Mellitus
Eligibility:
All Genders
18-50 years
Phase:
PHASE2
Brief Summary
The intent of the proposed study is to assess the potential of oral insulin to mitigate diabetic instability and reduce the frequency and severity of hypoglycemic episodes in patients with type 1 diab...
Eligibility Criteria
Inclusion
- Type 1 diabetes mellitus
- Male or female aged 18-50 years inclusive
- Body weight between 50-100kg and BMI between 18 and 30 kg/m2
- Diagnosed 6 or more months ago, unstable diabetes with frequent episodes of hypoglycemia
- No other medical problems
Exclusion
- History or presence of clinical significant gastrointestinal pathology or symptoms, liver or kidney disease or any condition that might interfere with the absorption, distribution, metabolism or excretion of the drug
- Positive pregnancy test or lactation
- Lack of family support
- Unwilling or unable to follow the study protocol
- Concurrent medical problems
Key Trial Info
Start Date :
July 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2008
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT00867594
Start Date
July 1 2008
End Date
August 1 2008
Last Update
August 11 2011
Active Locations (1)
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1
Hadassah University Hospital
Jerusalem, Israel, 91120