Ignite Creation Date:
2025-12-24 @ 11:57 PM
Ignite Modification Date:
2026-02-20 @ 6:41 PM
Study NCT ID:
NCT02089451
Status:
COMPLETED
Last Update Posted:
2017-02-17
First Post:
2014-01-30
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Trial Comparing the Pharmacokinetic Properties of Faster-acting Insulin Aspart (FIAsp) After Different Injection Regions and Routes of Administration in Healthy Subjects
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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 21}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-03-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-02', 'completionDateStruct': {'date': '2014-06-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-02-16', 'studyFirstSubmitDate': '2014-01-30', 'studyFirstSubmitQcDate': '2014-03-14', 'lastUpdatePostDateStruct': {'date': '2017-02-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-03-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-06-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Area under the serum insulin aspart concentration-time curve (only for subcutaneous administration)', 'timeFrame': 'From 0 to 12 hours'}], 'secondaryOutcomes': [{'measure': 'Area under the serum insulin aspart concentration-time curve (only for intramuscular administration)', 'timeFrame': 'From 0 to 12 hours'}, {'measure': 'Maximum observed serum insulin aspart concentration (only for subcutaneous and intramuscular administration)', 'timeFrame': 'From 0 to 12 hours'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Diabetes', 'Healthy']}, 'referencesModule': {'references': [{'pmid': '28185141', 'type': 'RESULT', 'citation': 'Hovelmann U, Heise T, Nosek L, Sassenfeld B, Thomsen KMD, Haahr H. Pharmacokinetic Properties of Fast-Acting Insulin Aspart Administered in Different Subcutaneous Injection Regions. Clin Drug Investig. 2017 May;37(5):503-509. doi: 10.1007/s40261-017-0499-y.'}], 'seeAlsoLinks': [{'url': 'http://novonordisk-trials.com', 'label': 'Clinical Trials at Novo Nordisk'}]}, 'descriptionModule': {'briefSummary': 'This trial is conducted in Europe. The aim of the trial is to compare the pharmacokinetic properties (the exposure of the trial drug in the body) of faster-acting insulin aspart (FIAsp) after different injection regions and routes of administration in healthy subjects.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '64 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or female, aged 18-64 years both inclusive at the time of signing informed consent\n* Considered generally healthy upon completion of medical history, physical examination,analysis of laboratory safety variables, vital signs and ECG (electrocardiogram), as judged by the investigator\n* Body mass index 20.0-28.0 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 at least one cigarette, cigar or pipe daily)\n* Not able or willing to refrain from smoking and use of nicotine substitute products during the inpatient period'}, 'identificationModule': {'nctId': 'NCT02089451', 'briefTitle': 'A Trial Comparing the Pharmacokinetic Properties of Faster-acting Insulin Aspart (FIAsp) After Different Injection Regions and Routes of Administration in Healthy Subjects', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novo Nordisk A/S'}, 'officialTitle': 'A Trial Comparing the Pharmacokinetic Properties of FIAsp After Different Injection Regions and Routes of Administration in Healthy Subjects', 'orgStudyIdInfo': {'id': 'NN1218-3949'}, 'secondaryIdInfos': [{'id': '2011-002590-32', 'type': 'EUDRACT_NUMBER'}, {'id': 'U1111-1121-8351', 'type': 'OTHER', 'domain': 'WHO'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'FIAsp', 'description': 'Each subject will be randomised to a treatment sequence consisting of 5 treatment periods', 'interventionNames': ['Drug: Faster-acting insulin aspart']}], 'interventions': [{'name': 'Faster-acting insulin aspart', 'type': 'DRUG', 'description': 'Drug: insulin aspart (faster acting insulin aspart) Subjects will receive five single dose level of faster acting insulin aspart. Three single dose s.c under the skin (abdomen, deltoid/upper arm, thigh), one single dose i.m. (intramuscularly, into the muscle) and one single dose i.v. (intravenously, into the vein)', 'armGroupLabels': ['FIAsp']}]}, 'contactsLocationsModule': {'locations': [{'zip': '41460', 'city': 'Neuss', 'country': 'Germany', 'facility': 'Novo Nordisk Investigational Site', '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'}}}}