Ignite Creation Date:
2025-12-25 @ 4:24 AM
Ignite Modification Date:
2025-12-26 @ 3:27 AM
Study NCT ID:
NCT01446120
Status:
UNKNOWN
Last Update Posted:
2011-10-05
First Post:
2011-09-15
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Insulin Loaded Orally Dissolved Films (Insulin-ODF)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D007336', 'term': 'Insulin, Isophane'}], 'ancestors': [{'id': 'D049528', 'term': 'Insulin, Long-Acting'}, {'id': 'D061385', 'term': 'Insulins'}, {'id': 'D010187', 'term': 'Pancreatic Hormones'}, {'id': 'D036361', 'term': 'Peptide Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 7}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-10', 'lastUpdateSubmitDate': '2011-10-04', 'studyFirstSubmitDate': '2011-09-15', 'studyFirstSubmitQcDate': '2011-10-04', 'lastUpdatePostDateStruct': {'date': '2011-10-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-10-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Blood Insulin', 'description': 'To assess the Cmax , Tmax and AUC (Area Under the Curve) of blood insulin level during six hours of the trial.'}], 'secondaryOutcomes': [{'measure': 'glucose and C-peptide levels', 'description': 'Evaluating the glucose and C-peptide levels during six hours of the trial.'}, {'measure': 'hypoglycemia and irritation.', 'description': 'All the examinations will be done in the presence of a physician along with a medical assistant. Hypoglycemia and irritation are the main adverse event that we anticipate in this study. In any such event the proper reporting and treatment will be administrated, while these subjects will be followed up for a further 1 month'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['this is phase one study. The study population are healthy volunteers.'], 'conditions': ['Healthy Volunteers']}, 'descriptionModule': {'briefSummary': 'This study is assessing the pharmacokinetics efficacy and of Insulin loaded Orally Dissolved Films (insulin-ODF) treatment. The Insulin-ODF is attached to the inner tissue of the chick (buccal) , Releasing the insulin to the circulation, while the film is dissolved..\n\nPrimary endpoint:\n\n1. The Cmax (Maximum Concentration of insulin in mg).\n2. Tmax (the time to Cmax in minutes)\n3. AUC (Area Under the Curve) of blood insulin levels during six hours of the trial.\n\nSecondary endpoints:\n\n1. The glucose and C-peptide levels during six hours of the trial. (mg)\n2. The safety of the treatment in a descriptive manner by recording all adverse events in the study population.\n\nMethods\n\nSeven healthy volunteers will be randomly assigned to one of the following groups:\n\nA. Insulin-ODF following treatment group; Or B. commercial NPH Insulin treatment.\n\nThe study is designed a crossover, in which each group is treated 3-7 days of washout.\n\nThe volunteer subjects will arrive to the clinic after eight hours fasting. Each subject will be examined by a physician, evaluating the elegibilities to the trial (i.e. inclusion and exclusion criteria).\n\nAn I.V catheter will be administrated assessing the Glucose, Insulin and C-peptide levels, ten minutes and five minutes before injecting the NPH Insulin or the Insulin-ODF.\n\nBlood Insulin and glucose levels will be evaluated at baseline, and after the following time points: 15,30,60,90,120,150,180,210,240,270,300,330,360 minutes. C-peptide levels will be evaluated at baseline and after the following time points: 60,120,240, 360 minutes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Signed Informed Consent.\n2. 18.5\\<BMI\\<30\n\nExclusion Criteria:\n\n1. Smokers.\n2. Known mouth cavity, gums or gastrointestinal disease.'}, 'identificationModule': {'nctId': 'NCT01446120', 'briefTitle': 'Insulin Loaded Orally Dissolved Films (Insulin-ODF)', 'organization': {'class': 'OTHER', 'fullName': 'Hadassah Medical Organization'}, 'orgStudyIdInfo': {'id': 'OFRI01-CTIL-HMO'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Insulin loaded Orally Dissolved Films (insulin-ODF)', 'interventionNames': ['Drug: Insulin loaded Orally Dissolved Films (insulin-ODF']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Human Insulin Specific RIA Kit <5uCi', 'interventionNames': ['Drug: NPH-Insulin Injection']}], 'interventions': [{'name': 'NPH-Insulin Injection', 'type': 'DRUG', 'armGroupLabels': ['Human Insulin Specific RIA Kit <5uCi']}, {'name': 'Insulin loaded Orally Dissolved Films (insulin-ODF', 'type': 'DRUG', 'armGroupLabels': ['Insulin loaded Orally Dissolved Films (insulin-ODF)']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hadassah Medical Organization', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}