Ignite Creation Date:
2025-12-25 @ 12:01 AM
Ignite Modification Date:
2026-02-23 @ 8:10 AM
Study NCT ID:
NCT02820558
Status:
UNKNOWN
Last Update Posted:
2020-05-21
First Post:
2016-05-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Neuropeptide Therapy of Recent Onset Type 1 Diabetes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003922', 'term': 'Diabetes Mellitus, Type 1'}], 'ancestors': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D013373', 'term': 'Substance P'}], 'ancestors': [{'id': 'D015320', 'term': 'Tachykinins'}, {'id': 'D007705', 'term': 'Kinins'}, {'id': 'D036341', 'term': 'Intercellular Signaling Peptides and Proteins'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D009479', 'term': 'Neuropeptides'}, {'id': 'D009842', 'term': 'Oligopeptides'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D009419', 'term': 'Nerve Tissue Proteins'}, {'id': 'D012898', 'term': 'Autacoids'}, {'id': 'D018836', 'term': 'Inflammation Mediators'}, {'id': 'D001685', 'term': 'Biological Factors'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 12}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2016-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-05', 'completionDateStruct': {'date': '2022-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-05-19', 'studyFirstSubmitDate': '2016-05-19', 'studyFirstSubmitQcDate': '2016-06-28', 'lastUpdatePostDateStruct': {'date': '2020-05-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-07-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2022-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'sP Longevity', 'timeFrame': '3 and 6 months', 'description': 'To determine an estimate of sP longevity in the entire cohort of patients, by monitoring HbA1c values, exogenous insulin requirement, daily recorded blood sugar levels and adverse event recording at 3 and 6 months post injection of sP. Multiple measurements per patient will be aggregated to arrive at one reported value for the aforementioned outcome measures.'}], 'primaryOutcomes': [{'measure': 'Stage A Safety: Side effects reported for entire cohort', 'timeFrame': 'Reported during the first 20-27 days following sP administration', 'description': 'To determine if there are unexpected adverse events with intra arterial delivery of sP into the celiac artery in individuals with Type 1 Diabetes, and evidence of residual beta cell function as reflected by a peak C---peptide levels of \\> 200 pmol/L. Multiple measurements per patient will be aggregated to arrive at one reported value: Number of participants with abnormal laboratory values, adverse events and/or peak C-peptide levels \\>200pmol/L that are related to treatment.'}], 'secondaryOutcomes': [{'measure': 'C-Peptide Levels (small cohort)', 'timeFrame': 'Day 20-27 post sP injection', 'description': 'To determine in an initial small cohort (n=12, toxicity and dose finding cohort) if one or more sP doses significantly increases the basal or stimulated c---Peptide levels at Day 20---27 post---injection using data from Mixed Meal Tolerance Test (MMTT).'}, {'measure': 'C-Peptide Levels (large cohort)', 'timeFrame': 'Day 20-27 post sP injection', 'description': 'To assess in a larger cohort (n=40, continued safety and efficacy) whether sP dose, determined from the dose finding cohort, significantly increases basal or stimulated C-- peptide levels at Day 20---27 post sP---injection using MMTT data.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Neuropeptide', 'Therapy', 'Onset'], 'conditions': ['Diabetes Mellitus, Type 1']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://guidelines.diabetes.ca/Browse/Chapter3', 'label': 'CDA 2013 guidelines'}]}, 'descriptionModule': {'briefSummary': 'This study evaluates the delivery of substance P via the celiac artery in the treatment of recent onset type 1 diabetes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '10 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Recent onset T1D (CDA 2013 guidelines: See link in links section\n* Age 10-18 years\n* Disease Duration 3-30 months\n* Fasting C-Peptide (measured at screening) greater than or equal to 33 pmol/L\n* Post honeymoon phase based on the following criteria: History of HbA1c values and insulin requirements from diagnosis indicating a honeymoon period followed by increased insulin requirements which at time of recruitment are \\> 0.50 units/Kg together with an HbA1c value \\> 7.2 %; Patients with diabetes duration \\> 3 months who never experienced a honeymoon period as reflected by consistent HbA1c values \\> 7.2 % from the time of diagnosis and at the time of recruitment are using an insulin dose \\> 0.50 units/Kg.\n* The presence of one or more of the TRPV1 alleles similar to those found in patients currently enrolled in the TRPV1-North American - European Study.\n* Stimulated C-Peptide (measured at mixed meal tolerance at Stage A and Stage B of sP trial) ≥ 200 pmol/L and less than or equal to 1500 pmol/L.\n\nExclusion Criteria:\n\n* Patients with known co-morbidities, including ACE-inhibitor treated hypertension as well as chromosomal abnormalities, involving one or more organ systems.\n* Type 2 Diabetes Mellitus\n* Patients with a known radiographic contrast allergy\n* Pregnancy.'}, 'identificationModule': {'nctId': 'NCT02820558', 'briefTitle': 'Neuropeptide Therapy of Recent Onset Type 1 Diabetes', 'organization': {'class': 'INDUSTRY', 'fullName': 'Vanilloid Genetics Inc.'}, 'officialTitle': 'A Phase I Study of Safety and Pharmacological Activity of Substance P (sP) in the Reversal of Recent-Onset Type 1 Diabetes (T1D)', 'orgStudyIdInfo': {'id': 'VanilloidGenetics-001-13'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Substance P - 1nmol/kg', 'description': 'Substance P 1nmol/kg intra-celiac artery, single treatment', 'interventionNames': ['Drug: Substance P']}, {'type': 'EXPERIMENTAL', 'label': 'Substance P - 5nmol/kg', 'description': 'Substance P 5nmol/kg intra-celiac artery, single treatment', 'interventionNames': ['Drug: Substance P']}, {'type': 'EXPERIMENTAL', 'label': 'Substance P - 15nmol/kg', 'description': 'Substance P 15nmol/kg intra-celiac artery, single treatment', 'interventionNames': ['Drug: Substance P']}, {'type': 'EXPERIMENTAL', 'label': 'Substance P - 45nmol/kg', 'description': 'Substance P 45nmol/kg intra-celiac artery, single treatment', 'interventionNames': ['Drug: Substance P']}], 'interventions': [{'name': 'Substance P', 'type': 'DRUG', 'armGroupLabels': ['Substance P - 15nmol/kg', 'Substance P - 1nmol/kg', 'Substance P - 45nmol/kg', 'Substance P - 5nmol/kg']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Toronto', 'state': 'Ontario', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Holly Tschirhart', 'role': 'CONTACT', 'email': 'holly.tschirhart@sickkids.ca', 'phone': '416-813-7654', 'phoneExt': '204517'}, {'name': 'Catherine Pastor', 'role': 'CONTACT', 'email': 'catherine.pastor@sickkids.ca', 'phone': '416-813-7654', 'phoneExt': '204396'}], 'facility': 'Hospital for Sick Children', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}], 'centralContacts': [{'name': 'Holly Tschirhart', 'role': 'CONTACT', 'email': 'holly.tschirhart@sickkids.ca', 'phone': '416-813-7654', 'phoneExt': '204517'}, {'name': 'Catherine Pastor', 'role': 'CONTACT', 'phone': '416-813-7654', 'phoneExt': '204396'}], 'overallOfficials': [{'name': 'Etienne Sochett, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospital for Sick Children, Toronto Ontario'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Vanilloid Genetics Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}