Ignite Creation Date:
2025-12-24 @ 5:37 PM
Ignite Modification Date:
2025-12-27 @ 2:20 AM
Study NCT ID:
NCT00966368
Status:
COMPLETED
Last Update Posted:
2015-09-28
First Post:
2009-08-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of Two NN1250 Formulations in Healthy Volunteers
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': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 27}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-09', 'completionDateStruct': {'date': '2009-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-09-24', 'studyFirstSubmitDate': '2009-08-25', 'studyFirstSubmitQcDate': '2009-08-25', 'lastUpdatePostDateStruct': {'date': '2015-09-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-08-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Area under the Insulin Degludec concentration-time curve from 0 to 120 hours after single dose', 'timeFrame': 'From 0 to 120 hours after dosing'}, {'measure': 'Maximum observed Insulin Degludec concentration after single dose', 'timeFrame': 'From 0 to 120 hours after dosing'}], 'secondaryOutcomes': [{'measure': 'Time to maximum observed Insulin Degludec concentration after single dose', 'timeFrame': 'From 0 to 120 hours after dosing'}, {'measure': 'Area under the Insulin Degludec concentration-time curve from 0 to 24 hours after single dose', 'timeFrame': 'From 0-24 hours after dosing'}, {'measure': 'Terminal half-life for Insulin Degludec', 'timeFrame': 'From 0 to 120 hours after dosing'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Diabetes', 'Healthy']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://novonordisk-trials.com', 'label': 'Clinical Trials at Novo Nordisk'}]}, 'descriptionModule': {'briefSummary': 'This trial was conducted in North America. The aim of this clinical trial was to investigate if two formulations of NN1250 (insulin degludec) have the same level of drug exposure to the body.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Considered generally healthy upon completion of medical history, physical examination, vital signs and ECG (electrocardiogram), as judged by the Investigator\n* Body mass index 18.0-27.0 kg/m\\^2 (both inclusive)\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': 'NCT00966368', 'briefTitle': 'Comparison of Two NN1250 Formulations in Healthy Volunteers', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novo Nordisk A/S'}, 'officialTitle': 'A Trial to Test for Bioequivalence Between Two NN1250 Formulations in Healthy Subjects', 'orgStudyIdInfo': {'id': 'NN1250-1988'}, 'secondaryIdInfos': [{'id': 'U1111-1122-2992', 'type': 'OTHER', 'domain': 'WHO'}, {'id': '2011-002949-35', 'type': 'EUDRACT_NUMBER'}, {'id': 'P/44/2010', 'type': 'OTHER', 'domain': 'EMA (PDCO)'}, {'id': 'P/96/2011', 'type': 'OTHER', 'domain': 'EMA (PDCO)'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'IDeg E', 'interventionNames': ['Drug: insulin degludec']}, {'type': 'EXPERIMENTAL', 'label': 'IDeg M', 'interventionNames': ['Drug: insulin degludec']}], 'interventions': [{'name': 'insulin degludec', 'type': 'DRUG', 'description': 'Single dose of NN1250, formulation 1, 0.4U/kg body weight injected subcutaneously (under the skin)', 'armGroupLabels': ['IDeg E']}, {'name': 'insulin degludec', 'type': 'DRUG', 'description': 'Single dose of NN1250, formulation 2, 0.4U/kg body weight injected subcutaneously (under the skin)', 'armGroupLabels': ['IDeg M']}]}, 'contactsLocationsModule': {'locations': [{'zip': '91911-1350', 'city': 'Chula Vista', 'state': 'California', 'country': 'United States', 'facility': 'Novo Nordisk Clinical Trial Call Center', 'geoPoint': {'lat': 32.64005, 'lon': -117.0842}}], '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'}}}}