Ignite Creation Date:
2025-12-26 @ 11:07 AM
Ignite Modification Date:
2025-12-29 @ 4:27 AM
Study NCT ID:
NCT01120912
Status:
COMPLETED
Last Update Posted:
2012-04-17
First Post:
2010-05-08
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety and Efficacy of Single Administration of Oshadi Oral Insulin in Type I Diabetes Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 8}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-02', 'completionDateStruct': {'date': '2011-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-04-16', 'studyFirstSubmitDate': '2010-05-08', 'studyFirstSubmitQcDate': '2010-05-10', 'lastUpdatePostDateStruct': {'date': '2012-04-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-05-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Adverse events occurrence', 'timeFrame': 'one month'}], 'secondaryOutcomes': [{'measure': 'Evaluate the glucose lowering effect of Oshadi Oral Insulin', 'timeFrame': '12 hours following administration'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['oral insulin'], 'conditions': ['Diabetes']}, 'descriptionModule': {'briefSummary': 'The study will be a non-randomized, open label, single dose, single blind, placebo control, single center, single arm study in Type I diabetes patients. The study will include single dose administration for the evaluation of single dose acute toxicity, pharmacokinetics and activity.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Stable type I diabetes mellitus.\n* Male/female 18 years old and up.\n* Glucose level is treated only by s.c basal/bolus insulin injection (not by insulin pump) at least 48 hours prior to study initiation.\n* Patients must understand and be willing to give written informed consent prior to any study procedures or evaluations and be willing to adhere to all study schedules and requirements.\n* Patients must be sterile or infertile or use an approved method of contraception from the time that the first dose of study medication is taken until three months following study completion or discontinuation.\n\nExclusion Criteria:\n\n* Any history of significant cardiac, renal, neurologic, metabolic, pulmonary, gastrointestinal, hematologic abnormality, chronic hepatic disease or any other disease which in the judgment of the investigator would interfere with the study or confound the results.\n* Patients with positive HIV serology or positive HBsAg at screening.\n* History or evidence of any active liver disease.\n* C-peptide \\> 3 mg/ml (fasting).\n* Hba1c\\<10.\n* eGFR\\>60.\n* Female patients who are breastfeeding or have a positive pregnancy test at screening or at any time during the study.\n* Inability to give written informed consent.\n* History of alcohol or drug abuse within 6 months of screening.\n* Patients who have a positive urine drug screen for substances of abuse (benzodiazepine, THC, opiates, amphetamines, cocaine) at the screening.\n* Mental disorders.\n* Patients with poor venous access.\n* Significant swallowing disorders.\n* Digestive disorders.\n* Small bowel surgery.\n* Mall absorption disorders.'}, 'identificationModule': {'nctId': 'NCT01120912', 'briefTitle': 'Safety and Efficacy of Single Administration of Oshadi Oral Insulin in Type I Diabetes Patients', 'organization': {'class': 'INDUSTRY', 'fullName': 'Oshadi Drug Administration'}, 'officialTitle': 'A Single Center, Non-randomized, Single Blind, Placebo Controlled, Single Dose Study of the Safety and Efficacy of Single Administration of Oshadi Oral Insulin in Type I Diabetes Patients - Phase 1 Study', 'orgStudyIdInfo': {'id': 'OS-INS-P1-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Oral insulin and placebo', 'interventionNames': ['Drug: Oshadi Oral Insulin']}], 'interventions': [{'name': 'Oshadi Oral Insulin', 'type': 'DRUG', 'description': 'Oral insulin single administration', 'armGroupLabels': ['Oral insulin and placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '70300', 'city': 'Zrifin', 'state': 'Beer-Yaakov', 'country': 'Israel', 'facility': 'Assaf Harofe Medical Center'}], 'overallOfficials': [{'name': 'Hanna Levy, Dr.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Oshadi Drug Administration'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Oshadi Drug Administration', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}