Back to resultsEffectiveness of Oral Insulin in Unstable Type 1 Diabetes Patients
Primary Purpose
Brittle Type I Diabetes Mellitus
Status
Completed
Phase
Phase 2
Locations
Israel
Study Type
Interventional
Intervention
ORMD 0801
Sponsored by
About this trial
This is an interventional treatment trial for Brittle Type I Diabetes Mellitus
Eligibility Criteria
Inclusion Criteria:
- 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 Criteria:
- 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
Sites / Locations
- Hadassah University Hospital
Outcomes
Primary Outcome Measures
To determine the safety and tolerability of multi-doses of Oramed oral insulin in people with type 1 diabetes
Secondary Outcome Measures
To determine if oral insulin is likely to improve glycemic stability assessed by the reduction of the frequency and severity of hypoglycemic episodes in people with unstable type 1 diabetes
Full Information
NCT ID
NCT00867594
First Posted
March 22, 2009
Last Updated
August 10, 2011
Sponsor
Hadassah Medical Organization
Collaborators
Oramed Pharmaceutical Inc.
1. Study Identification
Unique Protocol Identification Number
NCT00867594
Brief Title
Effectiveness of Oral Insulin in Unstable Type 1 Diabetes Patients
Official Title
A Single Blind, Open-Label Study to Assess the Safety, Pharmacokinetics and Pharmacodynamics of Oral Insulin Formulation in Type 1 Subjects
Study Type
Interventional
2. Study Status
Record Verification Date
March 2008
Overall Recruitment Status
Completed
Study Start Date
July 2008 (undefined)
Primary Completion Date
August 2008 (Actual)
Study Completion Date
August 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Hadassah Medical Organization
Collaborators
Oramed Pharmaceutical Inc.
4. Oversight
5. Study Description
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 diabetes. Restoring hepatic glycogen stores is critical for the normalization of counter-regulation to hypoglycemia in these patients. Oral insulin can provide a means to increase portal insulin levels, shift the ratio of insulin/glucagon in favor of glycogenesis while sparing the patient the risk of hypoglycemia due to peripheral hyperinsulinemia
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Brittle Type I Diabetes Mellitus
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
12 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
ORMD 0801
Intervention Description
1 capsule ORMD 0801 3 times a day, before each meal
Primary Outcome Measure Information:
Title
To determine the safety and tolerability of multi-doses of Oramed oral insulin in people with type 1 diabetes
Time Frame
15 days
Secondary Outcome Measure Information:
Title
To determine if oral insulin is likely to improve glycemic stability assessed by the reduction of the frequency and severity of hypoglycemic episodes in people with unstable type 1 diabetes
Time Frame
15 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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 Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Roy Eldor
Organizational Affiliation
Hadassah
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hadassah University Hospital
City
Jerusalem
ZIP/Postal Code
91120
Country
Israel
12. IPD Sharing Statement
Citations:
PubMed Identifier
23593142
Citation
Eldor R, Arbit E, Corcos A, Kidron M. Glucose-reducing effect of the ORMD-0801 oral insulin preparation in patients with uncontrolled type 1 diabetes: a pilot study. PLoS One. 2013 Apr 9;8(4):e59524. doi: 10.1371/journal.pone.0059524. Print 2013.
Results Reference
derived
Learn more about this trial
Effectiveness of Oral Insulin in Unstable Type 1 Diabetes Patients
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