Ignite Creation Date:
2025-12-24 @ 7:14 PM
Ignite Modification Date:
2025-12-30 @ 9:22 AM
Study NCT ID:
NCT01174303
Status:
COMPLETED
Last Update Posted:
2017-02-10
First Post:
2010-08-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Trial Investigating the Exposure of NN5401 in Young Adults and Elderly Subjects 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': 'C578220', 'term': 'insulin degludec, insulin aspart drug combination'}, {'id': 'C557564', 'term': 'insulin aspart, insulin aspart protamine drug combination 30:70'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 28}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-02', 'completionDateStruct': {'date': '2010-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-02-09', 'studyFirstSubmitDate': '2010-08-02', 'studyFirstSubmitQcDate': '2010-08-02', 'lastUpdatePostDateStruct': {'date': '2017-02-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2010-08-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Area under the Glucose Infusion Rate curve (only for NN5401)', 'timeFrame': 'from 0 to 24 hours after single-dose administration'}], 'secondaryOutcomes': [{'measure': 'Area under the glucose infusion rate curve (only for biphasic insulin aspart 30)', 'timeFrame': 'from 0 to 24 hours after single-dose administration'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Diabetes', 'Diabetes Mellitus, Type 1']}, 'referencesModule': {'references': [{'pmid': '26088815', 'type': 'RESULT', 'citation': 'Brunner M, Pieber T, Korsatko S, Kojzar H, Svendsen AL, Haahr H. The Distinct Prandial and Basal Pharmacodynamics of IDegAsp Observed in Younger Adults Are Preserved in Elderly Subjects with Type 1 Diabetes. Drugs Aging. 2015 Jul;32(7):583-90. doi: 10.1007/s40266-015-0272-y.'}], 'seeAlsoLinks': [{'url': 'http://novonordisk-trials.com', 'label': 'Clinical Trials at Novo Nordisk'}]}, 'descriptionModule': {'briefSummary': 'This trial is conducted in Europe. The aim of this trial is to investigate the exposure of NN5401 (insulin degludec/insulin aspart) in young adults and elderly subjects with type 1 diabetes mellitus.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or female aged 18-35 years (both inclusive) (young group) or at least 65 years (geriatric group)\n* Type 1 diabetes mellitus (as diagnosed clinically) for at least 12 months\n* Body mass index 18.0-28.0 kg/m\\^2 (both inclusive)\n* HbA1c (glycosylated haemoglobin A1c) maximum 10.0% by central laboratory analysis\n\nExclusion Criteria:\n\n* Subject who has donated any blood or plasma in the past month or more than 500 mL within 3 months prior to screening\n* Smoker (defined as a subject who is smoking more than 5 cigarettes or the equivalent per day)\n* Not able or willing to refrain from smoking and use of nicotine gum or transdermal nicotine patches during the inpatient period'}, 'identificationModule': {'nctId': 'NCT01174303', 'briefTitle': 'A Trial Investigating the Exposure of NN5401 in Young Adults and Elderly Subjects With Type 1 Diabetes', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novo Nordisk A/S'}, 'officialTitle': 'A Trial Investigating the Pharmacodynamic Properties of NN5401 in Young Adults and Geriatric Subjects With Type 1 Diabetes', 'orgStudyIdInfo': {'id': 'NN5401-1981'}, 'secondaryIdInfos': [{'id': 'U1111-1114-9373', 'type': 'OTHER', 'domain': 'WHO'}, {'id': '2009-017280-42', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'IDegAsp - BIAsp', 'interventionNames': ['Drug: insulin degludec/insulin aspart', 'Drug: biphasic insulin aspart 30']}, {'type': 'EXPERIMENTAL', 'label': 'BIAsp - IDegAsp', 'interventionNames': ['Drug: insulin degludec/insulin aspart', 'Drug: biphasic insulin aspart 30']}], 'interventions': [{'name': 'insulin degludec/insulin aspart', 'type': 'DRUG', 'description': 'Each subject will be randomly allocated to two single doses injected subcutaneously (under the skin) of insulin degludec/insulin aspart and biphasic insulin aspart 30 in random order.', 'armGroupLabels': ['BIAsp - IDegAsp', 'IDegAsp - BIAsp']}, {'name': 'biphasic insulin aspart 30', 'type': 'DRUG', 'description': 'Each subject will be randomly allocated to two single doses injected subcutaneously (under the skin) of insulin degludec/insulin aspart and biphasic insulin aspart 30 in random order.', 'armGroupLabels': ['BIAsp - IDegAsp', 'IDegAsp - BIAsp']}]}, 'contactsLocationsModule': {'locations': [{'zip': '8036', 'city': 'Graz', 'country': 'Austria', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 47.06733, 'lon': 15.44197}}], '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'}}}}