Effectiveness of Oral Insulin in Unstable Type 1 Diabetes Patients

This study is not yet open for participant recruitment.

Verified by Hadassah Medical Organization, March 2009

First Received: March 22, 2009 Last Updated: March 23, 2009 History of Changes

Sponsors and Collaborators:	Hadassah Medical Organization Oramed Pharmaceutical Inc.
Information provided by:	Hadassah Medical Organization
ClinicalTrials.gov Identifier:	NCT00867594

Purpose

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

Condition	Intervention	Phase
Unstable Type 1 Diabetes	Drug: ORMD 0801	Phase II

MedlinePlus related topics: Diabetes Diabetes Type 1

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study

Further study details as provided by Hadassah Medical Organization:

Primary Outcome Measures:

To determine the safety and tolerability of multi-doses of Oramed oral insulin in people with type 1 diabetes [ Time Frame: 15 days ] [ Designated as safety issue: Yes ]

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 [ Time Frame: 15 days ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	12
Study Start Date:	May 2009
Estimated Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

Intervention Details:

1 capsule ORMD 0801 3 times a day, before each meal

Eligibility

Ages Eligible for Study:	18 Years to 50 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00867594

Contacts

Contact: Roy Eldor, MD

00 972 2 6776927

eldorroy@yahoo.com

Locations

Israel
Hadassah University Hospital
Jerusalem, Israel, 91120

Sponsors and Collaborators

Hadassah Medical Organization

Oramed Pharmaceutical Inc.

More Information

No publications provided

Responsible Party:	Hadassah Medical Organization, Jerusalem ( Dr. Roy Eldor )
Study ID Numbers:	0566-08-HMO
Study First Received:	March 22, 2009
Last Updated:	March 23, 2009
ClinicalTrials.gov Identifier:	NCT00867594 History of Changes
Health Authority:	Israel: Israeli Health Ministry

Study placed in the following topic categories:

Autoimmune Diseases
Metabolic Diseases
Diabetes Mellitus, Type 1
Diabetes Mellitus
Endocrine System Diseases

Diabetes Mellitus Type 1
Endocrinopathy
Glucose Metabolism Disorders
Metabolic Disorder
Insulin

Additional relevant MeSH terms:

Autoimmune Diseases
Metabolic Diseases
Immune System Diseases
Diabetes Mellitus, Type 1

Diabetes Mellitus
Endocrine System Diseases
Glucose Metabolism Disorders

ClinicalTrials.gov processed this record on May 07, 2009