Ignite Creation Date:
2025-12-24 @ 6:37 PM
Ignite Modification Date:
2026-01-02 @ 2:59 AM
Study NCT ID:
NCT01006057
Status:
COMPLETED
Last Update Posted:
2017-01-20
First Post:
2009-10-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Trial Investigating the NN1250 Concentration-time Curve in Subjects With Various Degrees of Renal Impairment and in Subjects With Normal Renal Function
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}], '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C571886', 'term': 'insulin degludec'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 32}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-01', 'completionDateStruct': {'date': '2010-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-01-19', 'studyFirstSubmitDate': '2009-10-30', 'studyFirstSubmitQcDate': '2009-10-30', 'lastUpdatePostDateStruct': {'date': '2017-01-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-11-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Area under the insulin degludec concentration-time curve', 'timeFrame': 'from 0 to 120 hours after trial product administration'}], 'secondaryOutcomes': [{'measure': 'Maximum observed insulin degludec concentration', 'timeFrame': 'from 0 to 120 hours after trial product administration'}, {'measure': 'Renal clearance of insulin degludec after single-dose', 'timeFrame': 'from 0 to 24 hours after trial product administration'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Diabetes', 'Healthy']}, 'referencesModule': {'references': [{'pmid': '24163264', 'type': 'RESULT', 'citation': 'Kiss I, Arold G, Roepstorff C, Bottcher SG, Klim S, Haahr H. Insulin degludec: pharmacokinetics in patients with renal impairment. Clin Pharmacokinet. 2014 Feb;53(2):175-83. doi: 10.1007/s40262-013-0113-2.'}], 'seeAlsoLinks': [{'url': 'http://novonordisk-trials.com', 'label': 'Clinical Trials at Novo Nordisk'}]}, 'descriptionModule': {'briefSummary': 'This trial was conducted in Europe. The aim of this clinical trial was to evaluate if the NN1250 (insulin degludec/insulin 454) concentration-time curve is altered to such an extent that the dose should be adjusted in subjects with impaired renal function compared to the dose for subjects with normal renal function.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subject with normal renal function or renal impairment (mild, moderate, severe or end stage renal disease (ESRD) requiring haemodialysis)\n* Body mass index maximum 40.0 kg/m\\^2\n\nExclusion Criteria:\n\n* Subject with any disease or condition which the Investigator feels would interfere with the trial except for conditions associated with renal impairment in the group of subjects with compromised renal function. Diabetes mellitus can be accepted in the group of patients with renal impairment, but not in subjects with normal renal function\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* Significant history of alcoholism or drug/chemical abuse\n* Not able or willing to refrain from smoking during the inpatient period'}, 'identificationModule': {'nctId': 'NCT01006057', 'briefTitle': 'A Trial Investigating the NN1250 Concentration-time Curve in Subjects With Various Degrees of Renal Impairment and in Subjects With Normal Renal Function', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novo Nordisk A/S'}, 'officialTitle': 'A Trial Investigating the Pharmacokinetic and Safety of NN1250 in Subjects With Various Degrees of Renal Impairment and in Subjects With Normal Renal Function', 'orgStudyIdInfo': {'id': 'NN1250-1990'}, 'secondaryIdInfos': [{'id': '2009-009466-14', 'type': 'EUDRACT_NUMBER'}, {'id': 'U1111-1111-0810', 'type': 'OTHER', 'domain': 'WHO'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'ESRD', 'interventionNames': ['Drug: insulin degludec']}, {'type': 'EXPERIMENTAL', 'label': 'Mild', 'interventionNames': ['Drug: insulin degludec']}, {'type': 'EXPERIMENTAL', 'label': 'Moderate', 'interventionNames': ['Drug: insulin degludec']}, {'type': 'EXPERIMENTAL', 'label': 'Normal', 'interventionNames': ['Drug: insulin degludec']}, {'type': 'EXPERIMENTAL', 'label': 'Severe', 'interventionNames': ['Drug: insulin degludec']}], 'interventions': [{'name': 'insulin degludec', 'type': 'DRUG', 'description': 'Single dose of 0.4 U/kg body weight injected s.c. (under the skin) in subjects with end stage renal disease', 'armGroupLabels': ['ESRD']}, {'name': 'insulin degludec', 'type': 'DRUG', 'description': 'Single dose of 0.4 U/kg body weight injected s.c. (under the skin) in subjects with mild renal impairment', 'armGroupLabels': ['Mild']}, {'name': 'insulin degludec', 'type': 'DRUG', 'description': 'Single dose of 0.4 U/kg body weight injected s.c. (under the skin) in subjects with moderate renal impairment', 'armGroupLabels': ['Moderate']}, {'name': 'insulin degludec', 'type': 'DRUG', 'description': 'Single dose of 0.4 U/kg body weight injected s.c. (under the skin) in healthy volunteers', 'armGroupLabels': ['Normal']}, {'name': 'insulin degludec', 'type': 'DRUG', 'description': 'Single dose of 0.4 U/kg body weight injected s.c. (under the skin) in subjects with severe renal impairment', 'armGroupLabels': ['Severe']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1115', 'city': 'Budapest', 'country': 'Hungary', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 47.49835, 'lon': 19.04045}}], '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'}}}}