Ignite Creation Date:
2025-12-25 @ 5:07 AM
Ignite Modification Date:
2025-12-26 @ 4:11 AM
Study NCT ID:
NCT01135927
Status:
COMPLETED
Last Update Posted:
2017-01-20
First Post:
2010-05-31
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Trial Investigating the Effect of NN1250 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': 'C571886', 'term': 'insulin degludec'}, {'id': 'D000069057', 'term': 'Insulin Detemir'}], 'ancestors': [{'id': 'D049528', 'term': 'Insulin, Long-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': 22}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-01', 'completionDateStruct': {'date': '2010-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-01-19', 'studyFirstSubmitDate': '2010-05-31', 'studyFirstSubmitQcDate': '2010-05-31', 'lastUpdatePostDateStruct': {'date': '2017-01-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-06-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Area under the NN1250 GIR (glucose infusion rate) curve', 'timeFrame': 'During one dosing interval at steady state'}], 'secondaryOutcomes': [{'measure': 'Area under the serum insulin detemir concentration-time curve', 'timeFrame': 'During one dosing interval at steady state'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Diabetes', 'Diabetes Mellitus, Type 1']}, 'referencesModule': {'references': [{'pmid': '27042281', 'type': 'RESULT', 'citation': 'Ikushima I, Kaku K, Hirao K, Bardtrum L, Haahr H. Pharmacokinetic and pharmacodynamic properties of insulin degludec in Japanese patients with type 1 diabetes mellitus reflect similarities with Caucasian patients. J Diabetes Investig. 2016 Mar;7(2):270-5. doi: 10.1111/jdi.12399. Epub 2015 Aug 27.'}], 'seeAlsoLinks': [{'url': 'http://novonordisk-trials.com', 'label': 'Clinical Trials at Novo Nordisk'}]}, 'descriptionModule': {'briefSummary': 'This trial is conducted in Japan. The aim of this clinical trial is to investigate the effect of NN1250 (insulin degludec) in Japanese subjects with type 1 diabetes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Type 1 diabetes mellitus (as diagnosed clinically) for at least 12 months\n* Treated with multiple daily insulin injections or continuous subcutaneous insulin infusion (CSII) for at least 12 months\n* Current daily basal insulin requirement above or equal to 0.3 (I)U/kg/day\n* Glycosylated haemoglobin A1c (HbA1c) below or equal to 10.0% (one retest within a week is permitted with the result of the last test being conclusive)\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* Surgery or trauma with significant blood loss (more than 500 mL) within the last 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 (only clamp period)'}, 'identificationModule': {'nctId': 'NCT01135927', 'briefTitle': 'A Trial Investigating the Effect of NN1250 in Japanese Subjects With Type 1 Diabetes', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novo Nordisk A/S'}, 'officialTitle': 'A Trial Investigating the Pharmacodynamic Properties of NN1250 in Japanese Subjects With Type 1 Diabetes', 'orgStudyIdInfo': {'id': 'NN1250-1996'}, 'secondaryIdInfos': [{'id': 'U1111-1113-6722', 'type': 'OTHER', 'domain': 'WHO'}, {'id': 'JapicCTI-101158', 'type': 'OTHER', 'domain': 'JAPIC'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'A', 'interventionNames': ['Drug: insulin degludec']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'B', 'interventionNames': ['Drug: insulin detemir']}], 'interventions': [{'name': 'insulin degludec', 'type': 'DRUG', 'description': 'NN1250 (insulin degludec) injected s.c. (under the skin) once daily for 6 days', 'armGroupLabels': ['A']}, {'name': 'insulin detemir', 'type': 'DRUG', 'description': 'Insulin detemir injected s.c. (under the skin) once daily for 6 days', 'armGroupLabels': ['B']}]}, 'contactsLocationsModule': {'locations': [{'zip': '130-0004', 'city': 'Tokyo', 'country': 'Japan', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 35.6895, 'lon': 139.69171}}], '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'}}}}