Ignite Creation Date:
2025-12-24 @ 3:16 PM
Ignite Modification Date:
2026-02-20 @ 10:09 PM
Study NCT ID:
NCT00730392
Status:
COMPLETED
Last Update Posted:
2023-04-28
First Post:
2008-08-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Etanercept in New 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': 'D000068800', 'term': 'Etanercept'}], 'ancestors': [{'id': 'D007141', 'term': 'Immunoglobulin Fc Fragments'}, {'id': 'D007128', 'term': 'Immunoglobulin Fragments'}, {'id': 'D010446', 'term': 'Peptide Fragments'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D007127', 'term': 'Immunoglobulin Constant Regions'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D007162', 'term': 'Immunoproteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}, {'id': 'D018124', 'term': 'Receptors, Tumor Necrosis Factor'}, {'id': 'D018121', 'term': 'Receptors, Cytokine'}, {'id': 'D011971', 'term': 'Receptors, Immunologic'}, {'id': 'D011956', 'term': 'Receptors, Cell Surface'}, {'id': 'D008565', 'term': 'Membrane Proteins'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 18}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2002-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-04', 'completionDateStruct': {'date': '2008-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-04-26', 'studyFirstSubmitDate': '2008-08-05', 'studyFirstSubmitQcDate': '2008-08-05', 'lastUpdatePostDateStruct': {'date': '2023-04-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2008-08-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The primary end points of this study are percent change from baseline for HbA1c and C-peptide area under the curve (AUC).', 'timeFrame': 'At baseline and at the end of the 24-week blind treatment'}], 'secondaryOutcomes': [{'measure': 'Secondary end points are insulin dose and number of insulin injection discontinued, if any', 'timeFrame': 'At baseline and at end of the 24-week treatment period'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Type 1 diabetes, Etanercept, honeymoon period'], 'conditions': ['Type 1 Diabetes']}, 'referencesModule': {'references': [{'pmid': '19366957', 'type': 'DERIVED', 'citation': 'Mastrandrea L, Yu J, Behrens T, Buchlis J, Albini C, Fourtner S, Quattrin T. Etanercept treatment in children with new-onset type 1 diabetes: pilot randomized, placebo-controlled, double-blind study. Diabetes Care. 2009 Jul;32(7):1244-9. doi: 10.2337/dc09-0054. Epub 2009 Apr 14.'}]}, 'descriptionModule': {'briefSummary': 'The investigators hypothesized that the administration of Etanercept to children newly diagnosed with T1DM may be able to interdict the progression of T1DM. The aim of this study is to evaluate the feasibility and safety of Etanercept administration to pediatric patients recently diagnosed with type 1 DM.', 'detailedDescription': 'This is a double-blind randomized 24-week placebo-controlled feasibility and safety study. Subjects received study drug for a 24- week period, followed by 4 and 12-week wash out periods.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '3 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Males and females subjects with T1DM aged 3-18 years\n* Positive GAD 65 and/or islet cell antibody\n* HbA1c at diagnosis above 6%\n* Insulin regimen with 3 injection of insulin daily (as described below)\n* White blood count between 3,000-10,000 and platelets \\> 100,000\n* Normal ALT and AST, creatinine \\< 1.8 mg/dl\n* T1DM duration equal or less than 4 weeks\n\nExclusion Criteria:\n\n* Infection requiring IV antibiotics at diagnosis or within past 14 days from study entry\n* BMI over 85th percentile for age and gender\n* Unstable household\n* Unable to provide compliance with study drug, insulin and study visits,\n* Evidence of psychiatric disease in the potential study subject and/or primary care taker\n* And chronic diseases, including additional autoimmune disorders with the exception of euthyroid autoimmune thyroiditis'}, 'identificationModule': {'nctId': 'NCT00730392', 'briefTitle': 'Etanercept in New Onset Type 1 Diabetes', 'organization': {'class': 'OTHER', 'fullName': 'State University of New York at Buffalo'}, 'officialTitle': '"ENBREL® (Etanercept) Administration to Patients Newly Diagnosed With Type 1 Diabetes Mellitus: Feasibility-Safety Study" ("Study")', 'orgStudyIdInfo': {'id': '20020197'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1 drug, 2 placebo', 'description': '1. Etanercept\n2. Placebo', 'interventionNames': ['Drug: Etanercept', 'Drug: Placebo']}], 'interventions': [{'name': 'Etanercept', 'type': 'DRUG', 'description': 'The study drug was provided in lyophilized 10 mg vials to be reconstituted with 1 ml of diluent/vial and was administered at a dose of 0.4 mg/Kg up to maximum dose of 25 mg/dose SC twice weekly', 'armGroupLabels': ['1 drug, 2 placebo']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'administered at 0.4 mg/Kg/dose SC up to 25 mg max twice weekly', 'armGroupLabels': ['1 drug, 2 placebo']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Teresa Quattrin, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'School of Medicine and Biochemical Sciences-SUNYAB'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'State University of New York at Buffalo', 'class': 'OTHER'}, 'collaborators': [{'name': 'Amgen', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Teresa Quattrin', 'investigatorAffiliation': 'State University of New York at Buffalo'}}}}