Ignite Creation Date:
2025-12-24 @ 11:51 AM
Ignite Modification Date:
2025-12-26 @ 8:09 AM
Study NCT ID:
NCT00873561
Status:
COMPLETED
Last Update Posted:
2009-04-01
First Post:
2009-03-27
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Evaluate NBI-6024 in Adult and Adolescent Patients With New Onset of Type 1 Diabetes Mellitus
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003922', 'term': 'Diabetes Mellitus, Type 1'}, {'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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C460599', 'term': 'NBI6024'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 188}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2001-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-03', 'completionDateStruct': {'date': '2006-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-03-30', 'studyFirstSubmitDate': '2009-03-27', 'studyFirstSubmitQcDate': '2009-03-30', 'lastUpdatePostDateStruct': {'date': '2009-04-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-04-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2006-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To assess the effect of repeated administrations of NBI-6024 on endogenous insulin production as measured by C-peptide levels in adult and adolescent patients with new onset type 1 diabetes mellitus', 'timeFrame': 'monthly assessments, up to 24 months (end of study)'}], 'secondaryOutcomes': [{'measure': 'To examine the effects of repeated administrations of NBI-6024 on insulin usage, glycemic control, and immune function (immunodynamics and pharmacodynamics) To examine the safety and tolerability of repeated administrations of NBI-6024', 'timeFrame': 'monthly assessments, up to 24 months (end of study)'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['diabetes', 'type 1', 'adult', 'adolescent', 'new onset'], 'conditions': ['Type 1 Diabetes Mellitus']}, 'referencesModule': {'references': [{'pmid': '19690081', 'type': 'DERIVED', 'citation': 'Walter M, Philotheou A, Bonnici F, Ziegler AG, Jimenez R; NBI-6024 Study Group. No effect of the altered peptide ligand NBI-6024 on beta-cell residual function and insulin needs in new-onset type 1 diabetes. Diabetes Care. 2009 Nov;32(11):2036-40. doi: 10.2337/dc09-0449. Epub 2009 Aug 18.'}]}, 'descriptionModule': {'briefSummary': 'This was a study designed to evaluate the efficacy of multiple doses of an investigational drug, NBI-6024, in adult (18 to 35 years of age) and adolescent (10 to 17 years of age) patients with new onset type 1 diabetes mellitus, on endogenous insulin production.\n\nA total of 188 patients were enrolled in the study. The study was divided into three periods: screening, treatment (comprising an induction phase and maintenance phase), and follow-up.\n\nNBI-6024 was generally well tolerated and exhibits a benign safety profile, as there were no significant safety issues with NBI-6024 treatment. In summary, NBI-6024 did not demonstrate statistically significant efficacy compared with placebo.', 'detailedDescription': 'This was a Phase II, multicenter (international), randomized, double-blind, placebo-controlled, parallel, dose-ranging study to evaluate the efficacy of multiple doses of an altered peptide ligand, NBI-6024, in adult (18 to 35 years of age) and adolescent (10 to 17 years of age) patients with new onset type 1 diabetes mellitus.\n\nStudy drug was administered subcutaneously a total of 26 times over a 24-month period. The first three doses were administered every 2 weeks (induction phase); all subsequent dosing occurred monthly (maintenance phase). Patients returned to the study center to receive study drug and have efficacy and safety assessments collected. The primary efficacy endpoint was the 2-hour peak C-peptide at Month 24. Other secondary analyses included AUC C-peptide, prescribed insulin usage, AUC blood glucose, HbA1c, hypoglycemic events, and hyperglycemic events.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '35 Years', 'minimumAge': '10 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or female between the age of 12 and 35 years, inclusive (changed to between the age of 10 and 35 years, inclusive, under Amendment 2)\n* If female of childbearing potential, patient must use an acceptable method of birth control prior to and for 30 days post study\n* Adult (greater than or equal to 18 years) female patients who were not of childbearing potential must be 2 years postmenopausal, or have had a hysterectomy or tubal ligation\n* Were newly diagnosed with type 1 diabetes mellitus\n* Presence of one or more of the following:\n\n * Anti-ICA512 antibodies\n * Anti-GAD antibodies\n * Anti-insulin antibodies, provided that the patient was not on insulin therapy for greater than 1 week\n* Body mass index (BMI) \\< 28 kg/m2\n* Stimulated serum C-peptide peak level between 0.4 pmol/mL and 3.0 pmol/mL, inclusive, at the time of screening\n* Laboratory and 12-lead electrocardiogram (ECG) results within normal ranges or, if abnormal, considered by the investigator as non clinically significant for the safety and well being of the patient or for the purposes of the study\n\nExclusion Criteria:\n\n* Use of an excluded medication/therapy including any of the following:\n\n * Steroids\n * Oral hypoglycemic agents\n * Chemotherapy and radiation\n * Immunosupressants\n * Nicotinamide \\>100 mg per day\n * Any drugs containing sibutramine\n* Female patients with a positive pregnancy test or who are lactating\n* Adult patients with body weight \\<45 kg; adolescent patients with body weight \\<30 kg; 10- and 11-year-old patients with body weight \\<25 kg\n* History of cancer or have existing or actively managed cancer\n* History of severe or anaphylactic allergic reactions\n* Patients suffering from active skin infections that would prevent subcutaneous injection\n* Positive test for HIV antigens, hepatitis B surface antigen, or hepatitis C antibodies\n* History of alcohol or substance abuse'}, 'identificationModule': {'nctId': 'NCT00873561', 'briefTitle': 'A Study to Evaluate NBI-6024 in Adult and Adolescent Patients With New Onset of Type 1 Diabetes Mellitus', 'organization': {'class': 'INDUSTRY', 'fullName': 'Neurocrine Biosciences'}, 'officialTitle': 'A Randomized, Double-Blind, Placebo-Controlled, Multicenter, Parallel, Dose-Ranging Study to Evaluate The Efficacy, Safety, Tolerability, and Pharmacodynamics of NBI-6024 In Adult and Adolescent Patients With New Onset Type 1 Diabetes Mellitus', 'orgStudyIdInfo': {'id': 'NBI 6024-0101'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '1 Experimental', 'description': 'NBI-6024 0.1 mg', 'interventionNames': ['Drug: NBI-6024']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2 Experimental', 'description': 'NBI-6024 0.5 mg', 'interventionNames': ['Drug: NBI-6024']}, {'type': 'ACTIVE_COMPARATOR', 'label': '3 Experimental', 'description': 'NBI-6024 1 mg', 'interventionNames': ['Drug: NBI-6024']}, {'type': 'NO_INTERVENTION', 'label': '4 placebo', 'description': 'Placebo injection'}], 'interventions': [{'name': 'NBI-6024', 'type': 'DRUG', 'description': '0.1, 0.5 or 1 mg NBI-6024 First 3 doses every 2 weeks. Remaining doses given monthly. Total duration of dosing 24 months. Placebo controlled.', 'armGroupLabels': ['1 Experimental', '2 Experimental', '3 Experimental']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Ottawa', 'state': 'Ontario', 'country': 'Canada', 'facility': "Children's Hospital of Eastern Ontario", 'geoPoint': {'lat': 45.41117, 'lon': -75.69812}}, {'city': 'Sherbrooke', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Center Hospitalier Universitaire de Sherbrooke', 'geoPoint': {'lat': 45.40008, 'lon': -71.89908}}, {'city': 'Laval', 'country': 'Canada', 'facility': 'Centre de recherche clinique de Laval', 'geoPoint': {'lat': 45.56995, 'lon': -73.692}}, {'city': 'Olomouc', 'country': 'Czechia', 'facility': 'University Hospital and School of Medicine', 'geoPoint': {'lat': 49.59552, 'lon': 17.25175}}, {'city': 'Prague', 'country': 'Czechia', 'facility': 'Faculty Hospital Motol', 'geoPoint': {'lat': 50.08804, 'lon': 14.42076}}, {'city': 'Helsinki', 'country': 'Finland', 'facility': 'Helsinki University Hospital', 'geoPoint': {'lat': 60.16952, 'lon': 24.93545}}, {'city': 'Lyon', 'country': 'France', 'facility': 'Hôpital Debrousse', 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}, {'city': 'Paris', 'country': 'France', 'facility': 'Hôpital St Vincent de Paul', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'city': 'Hanover', 'country': 'Germany', 'facility': 'Diabetes Center for Children and Adolescents', 'geoPoint': {'lat': 52.37052, 'lon': 9.73322}}, {'city': 'München', 'country': 'Germany', 'facility': 'Institut für Diabetesforschung', 'geoPoint': {'lat': 51.60698, 'lon': 13.31243}}, {'city': 'Cape Town', 'country': 'South Africa', 'facility': 'New Groote Schuur Hospital', 'geoPoint': {'lat': -33.92584, 'lon': 18.42322}}, {'city': 'Durban', 'country': 'South Africa', 'facility': 'Parklands Medical Center', 'geoPoint': {'lat': -29.8579, 'lon': 31.0292}}, {'city': 'Johannesburg', 'country': 'South Africa', 'facility': 'Center for Diabetes and Endocrinology', 'geoPoint': {'lat': -26.20227, 'lon': 28.04363}}, {'city': 'Johannesburg', 'country': 'South Africa', 'facility': 'Donald Gordon Medical Center', 'geoPoint': {'lat': -26.20227, 'lon': 28.04363}}, {'city': 'KwaZulu Natal', 'country': 'South Africa', 'facility': 'Medigate Medical Center'}, {'city': 'Somerset West', 'country': 'South Africa', 'facility': 'Helderberg Diabetic Clinic and Practice', 'geoPoint': {'lat': -34.08401, 'lon': 18.82113}}, {'city': 'Barcelona', 'country': 'Spain', 'facility': 'Hospital Clinic de Barcelona', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'city': 'Cruces-Baracado', 'country': 'Spain', 'facility': 'Hospital de Cruces'}, {'city': 'Málaga', 'country': 'Spain', 'facility': 'Hospital Materno-Infantil', 'geoPoint': {'lat': 36.72016, 'lon': -4.42034}}, {'city': 'Seville', 'country': 'Spain', 'facility': 'University Hospital Virgen del Rocío', 'geoPoint': {'lat': 37.38283, 'lon': -5.97317}}, {'city': 'Dundee', 'country': 'United Kingdom', 'facility': 'Maternal and Child Health Services 2', 'geoPoint': {'lat': 56.46913, 'lon': -2.97489}}], 'overallOfficials': [{'name': 'Areti Philotheou, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'New Groote Schuur Hospital, Capetown, South Africa'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Neurocrine Biosciences', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': "Chris O'Brien, Chief Medical Office and VP of Clinical Development", 'oldOrganization': 'Neurocrine Biosciences Inc'}}}}