Ignite Creation Date:
2025-12-25 @ 2:02 AM
Ignite Modification Date:
2025-12-28 @ 12:03 AM
Study NCT ID:
NCT00872560
Status:
COMPLETED
Last Update Posted:
2018-08-07
First Post:
2009-03-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of 2 NovoFine® Needles on the Reflux of Insulin
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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '1998-01-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-08', 'completionDateStruct': {'date': '1998-07-27', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-08-03', 'studyFirstSubmitDate': '2009-03-30', 'studyFirstSubmitQcDate': '2009-03-30', 'lastUpdatePostDateStruct': {'date': '2018-08-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2009-03-31', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '1998-07-27', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Weighing of reflux of insulin', 'timeFrame': '6 seconds after injection'}], 'secondaryOutcomes': [{'measure': 'Pain perception', 'timeFrame': 'after 6 weeks of treatment'}, {'measure': 'Number and severity of bleedings', 'timeFrame': 'after 6 weeks of treatment'}, {'measure': 'Reactions at injection sites', 'timeFrame': 'after 6 weeks of treatment'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Diabetes', 'Diabetes Mellitus, Type 1', 'Delivery Systems']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://novonordisk-trials.com', 'label': 'Clinical Trials at Novo Nordisk'}]}, 'descriptionModule': {'briefSummary': 'This trial is conducted in Europe. This trial aims to ensure that there is no substantial clinically relevant difference between the two Novo Nordisk needles NovoFine® 6 x 0.30 mm and NovoFine® 8 x 0.30 mm on reflux of insulin back to the surface of cutis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '10 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Children/adolescents with type 1 diabetes mellitus\n* Usage of NovoPen® 1.5 for at least 3 months\n* Duration of insulin treatment more than 1 year\n* Normal weight according to Tanner scales\n* The means of the last 2 HbA1c measurements taken within the last 6 months must be less than 10.5%\n\nExclusion Criteria:\n\n* Pregnancy or desire to become pregnant\n* Clinical relevant peripheral neuropathy as judged by the investigators\n* Pronounced lipodystrophy in accordance with investigator's evaluation\n* Use of drugs that can influence the trial\n* Coagulation disorders (use of anti-coagulants)\n* Serious, chronic diseases, making it highly unlikely that the subject can complete the trial"}, 'identificationModule': {'nctId': 'NCT00872560', 'briefTitle': 'Comparison of 2 NovoFine® Needles on the Reflux of Insulin', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novo Nordisk A/S'}, 'officialTitle': 'Insulin Leakage and Pain Perception in IDDM Children or Adolescents, Where the Injections Are Performed With NovoFine™ 6 x 0.30 mm Needles and NovoFine® 8 x 0.30 mm Needles: An Open, Randomized, Two-period Cross-over, Multi-centre, Phase IIIb Trial at 4 Centres', 'orgStudyIdInfo': {'id': 'NEEDLEN/DCD/4/I'}}, 'armsInterventionsModule': {'interventions': [{'name': 'NovoFine® needle 6 mm', 'type': 'DEVICE', 'otherNames': ['NEEDLEN']}, {'name': 'NovoFine® needle 8 mm', 'type': 'DEVICE', 'otherNames': ['NEEDLEN']}]}, 'contactsLocationsModule': {'locations': [{'zip': '66100', 'city': 'Chieti', 'country': 'Italy', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 42.34827, 'lon': 14.16494}}], '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'}}}}