Ignite Creation Date:
2025-12-26 @ 11:09 AM
Ignite Modification Date:
2026-01-13 @ 9:51 AM
Study NCT ID:
NCT01934712
Status:
COMPLETED
Last Update Posted:
2018-12-11
First Post:
2013-08-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Trial Investigating the Pharmacokinetic Properties of FIAsp in Japanese 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': 'D061267', 'term': 'Insulin Aspart'}], 'ancestors': [{'id': 'D061266', 'term': 'Insulin, Short-Acting'}, {'id': 'D061385', 'term': 'Insulins'}, {'id': 'D010187', 'term': 'Pancreatic Hormones'}, {'id': 'D036361', 'term': 'Peptide Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-08-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-12', 'completionDateStruct': {'date': '2014-01-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-12-07', 'studyFirstSubmitDate': '2013-08-30', 'studyFirstSubmitQcDate': '2013-08-30', 'lastUpdatePostDateStruct': {'date': '2018-12-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-09-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-01-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Area under the serum insulin aspart concentration-time curve', 'timeFrame': 'From 0-1 hour'}], 'secondaryOutcomes': [{'measure': 'Area under the serum insulin aspart concentration-time curve', 'timeFrame': 'From 0-12 hours'}, {'measure': 'Area under the glucose infusion rate (GIR) curve', 'timeFrame': 'From 0-1 hour'}, {'measure': 'Area under the glucose infusion rate (GIR) curve', 'timeFrame': 'From 0-12 hours'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Diabetes', 'Diabetes Mellitus, Type 1']}, 'referencesModule': {'references': [{'pmid': '28556616', 'type': 'BACKGROUND', 'citation': 'Shiramoto M, Nishida T, Hansen AK, Haahr H. Fast-acting insulin aspart in Japanese patients with type 1 diabetes: Faster onset, higher early exposure and greater early glucose-lowering effect relative to insulin aspart. J Diabetes Investig. 2018 Mar;9(2):303-310. doi: 10.1111/jdi.12697. Epub 2017 Jul 7.'}, {'pmid': '30402720', 'type': 'RESULT', 'citation': 'Haahr H, Pieber TR, Mathieu C, Gondolf T, Shiramoto M, Erichsen L, Heise T. Clinical Pharmacology of Fast-Acting Insulin Aspart Versus Insulin Aspart Measured as Free or Total Insulin Aspart and the Relation to Anti-Insulin Aspart Antibody Levels in Subjects with Type 1 Diabetes Mellitus. Clin Pharmacokinet. 2019 May;58(5):639-649. doi: 10.1007/s40262-018-0718-6.'}], 'seeAlsoLinks': [{'url': 'http://novonordisk-trials.com', 'label': 'Clinical Trials at Novo Nordisk'}]}, 'descriptionModule': {'briefSummary': 'This trial is conducted in Japan. The aim of the trial is to evaluate the pharmacokinetic (the exposure of the trial drug in the body) and pharmacodynamic (the effect of the trial drug on the body) properties of FIAsp (faster-acting insulin aspart) and the currently marketed insulin aspart (NovoRapid®) in Japanese subjects with type 1 diabetes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '64 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Type 1 diabetes mellitus (as diagnosed clinically) for 12 months or longer\n* Body mass index (BMI) 18.5-28.0 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': 'NCT01934712', 'briefTitle': 'A Trial Investigating the Pharmacokinetic Properties of FIAsp in Japanese Subjects With Type 1 Diabetes', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novo Nordisk A/S'}, 'officialTitle': 'A Trial Investigating the Pharmacokinetic Properties of FIAsp in Japanese Subjects With Type 1 Diabetes', 'orgStudyIdInfo': {'id': 'NN1218-3918'}, 'secondaryIdInfos': [{'id': 'U1111-1121-2896', 'type': 'OTHER', 'domain': 'WHO'}, {'id': 'JapicCTI-132253', 'type': 'REGISTRY', 'domain': 'JAPIC'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'FIAsp', 'description': 'Each subject will be randomly allocated to one of the two treatment sequences consisting of 2 dosing visits', 'interventionNames': ['Drug: Faster-acting insulin aspart', 'Drug: insulin aspart']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'NovoRapid®', 'description': 'Each subject will be randomly allocated to one of the two treatment sequences consisting of 2 dosing visits', 'interventionNames': ['Drug: Faster-acting insulin aspart', 'Drug: insulin aspart']}], 'interventions': [{'name': 'Faster-acting insulin aspart', 'type': 'DRUG', 'description': 'Single dose injected subcutaneously (s.c, under the skin)', 'armGroupLabels': ['FIAsp', 'NovoRapid®']}, {'name': 'insulin aspart', 'type': 'DRUG', 'description': 'Single dose injected subcutaneously (s.c, under the skin)', 'armGroupLabels': ['FIAsp', 'NovoRapid®']}]}, 'contactsLocationsModule': {'locations': [{'zip': '812-0025', 'city': 'Fukuoka', 'country': 'Japan', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 33.6, 'lon': 130.41667}}], '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'}}}}