Ignite Creation Date:
2025-12-24 @ 10:30 PM
Ignite Modification Date:
2026-02-21 @ 10:09 AM
Study NCT ID:
NCT00571935
Status:
COMPLETED
Last Update Posted:
2016-12-21
First Post:
2007-12-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy and Safety of Insulin Aspart in MDI or CSII in Children Below 7 Years of Age With Type 1 Diabetes
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'}], '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': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 61}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2003-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-12', 'completionDateStruct': {'date': '2004-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-12-20', 'studyFirstSubmitDate': '2007-12-11', 'studyFirstSubmitQcDate': '2007-12-11', 'lastUpdatePostDateStruct': {'date': '2016-12-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-12-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2004-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'HbA1c', 'timeFrame': 'after 26 weeks of treatment'}], 'secondaryOutcomes': [{'measure': 'Overall glycaemic control'}, {'measure': 'Occurrence of adverse events'}, {'measure': 'Occurrence of serious adverse events'}, {'measure': 'Frequency of hypoglycaemia episodes'}, {'measure': 'Quality of Life (QoL)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Diabetes', 'Diabetes Mellitus, Type 1']}, 'referencesModule': {'references': [{'pmid': '20388052', 'type': 'RESULT', 'citation': 'Pankowska E, Nazim J, Szalecki M, Urban M. Equal metabolic control but superior caregiver treatment satisfaction with insulin aspart in preschool children. Diabetes Technol Ther. 2010 May;12(5):413-8. doi: 10.1089/dia.2009.0155.'}], 'seeAlsoLinks': [{'url': 'http://novonordisk-trials.com', 'label': 'Clinical Trials at Novo Nordisk'}]}, 'descriptionModule': {'briefSummary': 'This trial is conducted in Europe.\n\nThe aim of this trial is to investigate the efficacy of insulin aspart compared to soluble human insulin on blood glucose control in children below 7 years of age with type 1 diabetes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '7 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Type 1 diabetes for at least 1 year\n* HbA1c below 12.0%\n* Treatment with regular human insulin and insulin NPH for at least 1 month\n* Receive more than 2 injections daily\n\nExclusion Criteria:\n\n* Receipt of investigational product within 6 months prior to trial participation\n* Known or suspected allergy to investigational product\n* Receipt of of insulin aspart within 3 months prior to trial participation'}, 'identificationModule': {'nctId': 'NCT00571935', 'briefTitle': 'Efficacy and Safety of Insulin Aspart in MDI or CSII in Children Below 7 Years of Age With Type 1 Diabetes', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novo Nordisk A/S'}, 'officialTitle': 'Efficacy and Safety of Insulin Aspart in MDI or CSII in Children Below 7 Years of Age With Type 1 Diabetes Mellitus', 'orgStudyIdInfo': {'id': 'ANA-1507'}}, 'armsInterventionsModule': {'interventions': [{'name': 'insulin aspart', 'type': 'DRUG'}, {'name': 'soluble human insulin', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '15-274', 'city': 'Bialystok', 'country': 'Poland', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 53.13333, 'lon': 23.16433}}, {'zip': '44-100', 'city': 'Gliwice', 'country': 'Poland', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 50.29761, 'lon': 18.67658}}, {'zip': '25-734', 'city': 'Kielce', 'country': 'Poland', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 50.87033, 'lon': 20.62752}}, {'zip': '30-663', 'city': 'Krakow', 'country': 'Poland', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 50.06143, 'lon': 19.93658}}, {'zip': '01-184', 'city': 'Warsaw', 'country': 'Poland', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 52.22977, 'lon': 21.01178}}], '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'}}}}