Ignite Creation Date:
2025-12-25 @ 1:15 AM
Ignite Modification Date:
2025-12-25 @ 11:24 PM
Study NCT ID:
NCT00948493
Status:
NO_LONGER_AVAILABLE
Last Update Posted:
2013-03-20
First Post:
2009-07-27
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Treatment Use of Generex Oral-lyn™ in Patients With Diabetes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['United States']}, 'conditionBrowseModule': {'meshes': [{'id': 'D003922', 'term': 'Diabetes Mellitus, Type 1'}, {'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}], 'ancestors': [{'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'EXPANDED_ACCESS'}, 'statusModule': {'overallStatus': 'NO_LONGER_AVAILABLE', 'statusVerifiedDate': '2013-03', 'lastUpdateSubmitDate': '2013-03-18', 'studyFirstSubmitDate': '2009-07-27', 'studyFirstSubmitQcDate': '2009-07-28', 'lastUpdatePostDateStruct': {'date': '2013-03-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-07-29', 'type': 'ESTIMATED'}}, 'conditionsModule': {'keywords': ['diabetes', 'insulin therapy'], 'conditions': ['Type 1 Diabetes Mellitus', 'Type 2 Diabetes Mellitus']}, 'descriptionModule': {'briefSummary': 'The objective of this Treatment IND protocol is to provide Generex Oral-lyn™ to patients with serious or life-threatening Type 1 or Type 2 diabetes mellitus, with no satisfactory alternative therapy available for treatment of diabetes, and who are not eligible to participate in the ongoing pivotal clinical trial (Protocol GEN-084-OL). This protocol is intended as a substitute for the Single Patient IND mechanism to obtain Generex Oral-lyn™.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'eligibilityCriteria': 'Study is closed'}, 'identificationModule': {'nctId': 'NCT00948493', 'briefTitle': 'Treatment Use of Generex Oral-lyn™ in Patients With Diabetes', 'organization': {'class': 'INDUSTRY', 'fullName': 'Generex Biotechnology Corp.'}, 'officialTitle': 'An Open-Label Treatment Investigational New Drug (IND) for the Use of Generex Oral-lyn™ in Patients With Type 1 or Type 2 Diabetes Mellitus', 'orgStudyIdInfo': {'id': 'GEN-100-OL'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Buccal insulin spray', 'type': 'DRUG', 'otherNames': ['Generex Oral-lynTM (oral, buccal insulin spray)'], 'description': 'Oral insulin spray absorbed in buccal mucosa'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Generex Biotechnology Corp.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}