Ignite Creation Date:
2025-12-25 @ 1:45 AM
Ignite Modification Date:
2026-02-25 @ 4:38 PM
Study NCT ID:
NCT00867594
Status:
COMPLETED
Last Update Posted:
2011-08-11
First Post:
2009-03-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effectiveness of Oral Insulin in Unstable Type 1 Diabetes Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 12}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-03', 'completionDateStruct': {'date': '2008-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-08-10', 'studyFirstSubmitDate': '2009-03-22', 'studyFirstSubmitQcDate': '2009-03-23', 'lastUpdatePostDateStruct': {'date': '2011-08-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-03-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To determine the safety and tolerability of multi-doses of Oramed oral insulin in people with type 1 diabetes', 'timeFrame': '15 days'}], 'secondaryOutcomes': [{'measure': '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', 'timeFrame': '15 days'}]}, 'conditionsModule': {'conditions': ['Brittle Type I Diabetes Mellitus']}, 'referencesModule': {'references': [{'pmid': '23593142', 'type': 'DERIVED', '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.'}]}, 'descriptionModule': {'briefSummary': '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'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Type 1 diabetes mellitus\n* Male or female aged 18-50 years inclusive\n* Body weight between 50-100kg and BMI between 18 and 30 kg/m2\n* Diagnosed 6 or more months ago, unstable diabetes with frequent episodes of hypoglycemia\n* No other medical problems\n\nExclusion Criteria:\n\n* 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\n* Positive pregnancy test or lactation\n* Lack of family support\n* Unwilling or unable to follow the study protocol\n* Concurrent medical problems'}, 'identificationModule': {'nctId': 'NCT00867594', 'briefTitle': 'Effectiveness of Oral Insulin in Unstable Type 1 Diabetes Patients', 'organization': {'class': 'OTHER', 'fullName': 'Hadassah Medical Organization'}, 'officialTitle': 'A Single Blind, Open-Label Study to Assess the Safety, Pharmacokinetics and Pharmacodynamics of Oral Insulin Formulation in Type 1 Subjects', 'orgStudyIdInfo': {'id': '0566-08-HMO-CTIL'}}, 'armsInterventionsModule': {'interventions': [{'name': 'ORMD 0801', 'type': 'DRUG', 'description': '1 capsule ORMD 0801 3 times a day, before each meal'}]}, 'contactsLocationsModule': {'locations': [{'zip': '91120', 'city': 'Jerusalem', 'country': 'Israel', 'facility': 'Hadassah University Hospital', 'geoPoint': {'lat': 31.76904, 'lon': 35.21633}}], 'overallOfficials': [{'name': 'Roy Eldor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hadassah'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hadassah Medical Organization', 'class': 'OTHER'}, 'collaborators': [{'name': 'Oramed Pharmaceutical Inc.', 'class': 'INDUSTRY'}], 'responsibleParty': {'oldNameTitle': 'Dr. Roy Eldor', 'oldOrganization': 'Hadassah Medical Organization, Jerusalem'}}}}