Ignite Creation Date:
2025-12-24 @ 10:51 PM
Ignite Modification Date:
2025-12-25 @ 8:20 PM
Study NCT ID:
NCT01487369
Status:
COMPLETED
Last Update Posted:
2016-03-04
First Post:
2011-11-29
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Special Survey of Production of Insulin Aspart Specific Antibody
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D003922', 'term': 'Diabetes Mellitus, Type 1'}, {'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}], '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': 'D061267', 'term': 'Insulin Aspart'}], 'ancestors': [{'id': 'D061266', 'term': 'Insulin, Short-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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 204}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2002-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-03', 'completionDateStruct': {'date': '2009-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-03-03', 'studyFirstSubmitDate': '2011-11-29', 'studyFirstSubmitQcDate': '2011-12-05', 'lastUpdatePostDateStruct': {'date': '2016-03-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-12-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Antibody titre findings'}], 'secondaryOutcomes': [{'measure': 'Hypoglycemic events'}, {'measure': 'Adverse events'}, {'measure': 'HbA1c (glycosylated haemoglobin)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Diabetes', 'Diabetes Mellitus, Type 1', 'Diabetes Mellitus, Type 2']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://novonordisk-trials.com', 'label': 'Clinical Trials at Novo Nordisk'}]}, 'descriptionModule': {'briefSummary': 'This study is conducted in Japan. The aim of this study is to collect data of production of insulin aspart specific antibody under normal clinical practice conditions.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with diabetes requiring insulin therapy and who had a treatment history of NovoRapid® (insulin aspart)', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with diabetes requiring insulin therapy\n\nExclusion Criteria:\n\n* Patients who had a treatment history of NovoRapid® (insulin aspart)'}, 'identificationModule': {'nctId': 'NCT01487369', 'briefTitle': 'Special Survey of Production of Insulin Aspart Specific Antibody', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novo Nordisk A/S'}, 'officialTitle': 'Special Survey of Production of Insulin Aspart (IAsp) Specific Antibody', 'orgStudyIdInfo': {'id': 'ANA-1946'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Insulin Aspart', 'interventionNames': ['Drug: insulin aspart']}], 'interventions': [{'name': 'insulin aspart', 'type': 'DRUG', 'description': 'Injected subcutaneously (s.c., under the skin). Prescribed by physician as a result of normal clinical practice.', 'armGroupLabels': ['Insulin Aspart']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1000005', 'city': 'Tokyo', 'country': 'Japan', 'geoPoint': {'lat': 35.6895, 'lon': 139.69171}}], 'overallOfficials': [{'name': 'Global Clinical Registry (GCR, 1452)', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Novo Nordisk A/S'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Novo Nordisk A/S', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}