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Trial record 1 of 1 for:    NCT00867594
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Effectiveness of Oral Insulin in Unstable Type 1 Diabetes Patients

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ClinicalTrials.gov Identifier: NCT00867594
Recruitment Status : Completed
First Posted : March 24, 2009
Last Update Posted : August 11, 2011
Sponsor:
Collaborator:
Oramed Pharmaceutical Inc.
Information provided by:
Hadassah Medical Organization

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

Condition or disease Intervention/treatment Phase
Brittle Type I Diabetes Mellitus Drug: ORMD 0801 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 12 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Single Blind, Open-Label Study to Assess the Safety, Pharmacokinetics and Pharmacodynamics of Oral Insulin Formulation in Type 1 Subjects
Study Start Date : July 2008
Actual Primary Completion Date : August 2008
Actual Study Completion Date : August 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1


Intervention Details:
  • Drug: ORMD 0801
    1 capsule ORMD 0801 3 times a day, before each meal


Primary Outcome Measures :
  1. 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 Measures :
  1. 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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00867594


Locations
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Israel
Hadassah University Hospital
Jerusalem, Israel, 91120
Sponsors and Collaborators
Hadassah Medical Organization
Oramed Pharmaceutical Inc.
Investigators
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Principal Investigator: Roy Eldor Hadassah
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Dr. Roy Eldor, Hadassah Medical Organization, Jerusalem
ClinicalTrials.gov Identifier: NCT00867594    
Other Study ID Numbers: 0566-08-HMO-CTIL
First Posted: March 24, 2009    Key Record Dates
Last Update Posted: August 11, 2011
Last Verified: March 2008
Additional relevant MeSH terms:
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Diabetes Mellitus, Type 1
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases