Ignite Creation Date:
2025-12-25 @ 4:54 AM
Ignite Modification Date:
2026-02-23 @ 1:09 AM
Study NCT ID:
NCT01865318
Status:
COMPLETED
Last Update Posted:
2015-10-22
First Post:
2013-05-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Investigation of Pharmacodynamic Characteristics of Explorative Formulation of Insulin Degludec in Male 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': 'C571886', 'term': 'insulin degludec'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 36}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-10', 'completionDateStruct': {'date': '2007-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-10-21', 'studyFirstSubmitDate': '2013-05-27', 'studyFirstSubmitQcDate': '2013-05-27', 'lastUpdatePostDateStruct': {'date': '2015-10-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-05-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Area under the glucose infusion rate curve', 'timeFrame': '0-24 hours after dosing'}], 'secondaryOutcomes': [{'measure': 'Maximum glucose infusion rate (GIRmax)', 'timeFrame': '0-24 hours after dosing'}, {'measure': 'Time to maximum glucose infusion rate (tGIRmax)', 'timeFrame': '0-24 hours after dosing'}, {'measure': 'Area under the serum insulin degludec curve', 'timeFrame': '0-96 hours after dosing'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Diabetes', 'Diabetes Mellitus, Type 1']}, 'referencesModule': {'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 pharmacodynamic (the effect of the investigated drug on the body) of insulin degludec (insulin 454), an explorative formulation, not similar to the proposed commercial formulation, under single-dose and steady-state conditions in male subjects with type 1 diabetes.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '69 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male and are considered to be generally healthy, except for the underlying diabetes mellitus, based on an assessment of medical history, physical examination and clinical laboratory data, as judged by the Investigator\n* Diagnosed with type 1 diabetes mellitus and treated with insulin for at least 12 months\n* Body Mass Index (BMI) between 18.0 and 27.0 kg/m\\^2 (both inclusive)\n* Glycosylated haemoglobin A1c (HbA1c) below or equal to 10.0 % based on central laboratory results\n\nExclusion Criteria:\n\n* History of significant multiple drug allergies or with a known or suspected allergy to the trial product or any medicine chemically related to the trial product, as judged by the Investigator\n* Participation in any other trials involving investigational products within 3 months preceding the start of dosing'}, 'identificationModule': {'nctId': 'NCT01865318', 'briefTitle': 'Investigation of Pharmacodynamic Characteristics of Explorative Formulation of Insulin Degludec in Male Subjects With Type 1 Diabetes', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novo Nordisk A/S'}, 'officialTitle': 'A Single Centre, Open-Label, Multiple Dose Trial Examining the Pharmacodynamic Characteristics of Insulin 454 Under Single-Dose and Steady-State Conditions in Male Subjects With Type 1 Diabetes', 'orgStudyIdInfo': {'id': 'NN5401-1740'}, 'secondaryIdInfos': [{'id': '2006-002212-97', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Part 1 (Once-daily dosing regimen, high concentration)', 'interventionNames': ['Drug: insulin degludec']}, {'type': 'EXPERIMENTAL', 'label': 'Part 2 (Twice-daily dosing regimen, high concentration)', 'interventionNames': ['Drug: insulin degludec']}, {'type': 'EXPERIMENTAL', 'label': 'Part 3 (Once-daily dosing regimen, low concentration)', 'interventionNames': ['Drug: insulin degludec']}], 'interventions': [{'name': 'insulin degludec', 'type': 'DRUG', 'description': 'Administered subcutaneously (s.c., under the skin)', 'armGroupLabels': ['Part 1 (Once-daily dosing regimen, high concentration)', 'Part 2 (Twice-daily dosing regimen, high concentration)', 'Part 3 (Once-daily dosing regimen, low concentration)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '41460', 'city': 'Neuss', 'country': 'Germany', 'geoPoint': {'lat': 51.19807, 'lon': 6.68504}}], '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'}}}}