Ignite Creation Date:
2025-12-24 @ 5:18 PM
Ignite Modification Date:
2025-12-27 @ 3:11 AM
Study NCT ID:
NCT01542450
Status:
COMPLETED
Last Update Posted:
2017-01-27
First Post:
2012-02-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pharmacokinetics of Insulin Detemir in 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': 'D000069057', 'term': 'Insulin Detemir'}, {'id': 'D007336', 'term': 'Insulin, Isophane'}], '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': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 23}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2002-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-01', 'completionDateStruct': {'date': '2003-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-01-26', 'studyFirstSubmitDate': '2012-02-24', 'studyFirstSubmitQcDate': '2012-02-24', 'lastUpdatePostDateStruct': {'date': '2017-01-27', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-03-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2003-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The ratio of area under the glucose infusion rate curve (AUCGIR) 0-5 hours to AUCGIR 0-24 hours'}], 'secondaryOutcomes': [{'measure': 'AUCGIR, area under the glucose infusion rate value curve'}, {'measure': 'GIRmax, the maximum GIR value'}, {'measure': 'tmax GIR, time to maximum GIR value'}, {'measure': 'Cmax, maximum concentration'}, {'measure': 'Area under the curve'}, {'measure': 'tmax, time to maximum concentration'}, {'measure': 'MRT, mean residence time'}, {'measure': 't½, terminal half-life'}, {'measure': 'Adverse events'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Diabetes', 'Diabetes Mellitus, Type 1']}, 'referencesModule': {'references': [{'type': 'RESULT', 'citation': 'Irie S, Matsumura Y, Hirano K. Pharmacokinetics and Pharmacodynamics of Single Dose Insulin Detemir, Long-acting soluble insulin analogue compared to NPH insulin in Patients with type 1 Diabetes Mellitus. Journal of Clinical Ther. and Med. 2007; 5 (23): 349-356'}], 'seeAlsoLinks': [{'url': 'http://novonordisk-trials.com', 'label': 'Clinical Trials at Novo Nordisk'}]}, 'descriptionModule': {'briefSummary': 'This trial is conducted in Japan. The aim for this trial is to investigate the pharmacodynamics and pharmacokinetics of insulin detemir and insulin NPH in Japanese subjects with type 1 diabetes mellitus.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Type 1 diabetes mellitus\n* HbA1c (glycosylated haemoglobin) maximum 9.0%\n* Duration of diabetes at least 1 year\n* Body Mass Index (BMI) maximum 25.0 kg/m\\^2\n\nExclusion Criteria:\n\n* Recurrent severe hypoglycaemia\n* Proliferative retinopathy or maculopathy requiring acute treatment as judged by the Investigator\n* Impaired hepatic function\n* Impaired renal function\n* Cardiac problems\n* Uncontrolled treated / untreated hypertension\n* Hepatitis B surface antigen, Hepatitis C antibodies or HIV (human immunodeficiency virus) antibodies, positive\n* Known or suspected allergy against the trial products or related products including the components\n* Previous history of serious allergy or anaphylactic reaction\n* Any disease or condition which the Investigator feel would interfere with the trial participation or evaluation of the results\n* Severe late-phase diabetic complications including nephropathy\n* Blood donation of more than 400 mL (inclusive) in total within the last 12 weeks or more than 200 mL (inclusive) in total within the last 3 weeks\n* Known or suspected alcohol and illicit substance abuse or dependence\n* Pregnancy, breast-feeding (within a year after labour) or the intention to become pregnant\n* The receipt of any investigational drug within the last 12 weeks prior to this trial\n* Current or anticipated treatment with systemic corticosteroids'}, 'identificationModule': {'nctId': 'NCT01542450', 'briefTitle': 'Pharmacokinetics of Insulin Detemir in Subjects With Type 1 Diabetes', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novo Nordisk A/S'}, 'officialTitle': 'A Randomised, Open-labelled, Single-centre, Two-period Crossover Trial Investigating the Pharmacodynamics and Pharmacokinetics of Single s.c. Doses of NN304 (Insulin Detemir) and NPH Human Insulin in Japanese Subjects With Type 1 Diabetes Mellitus', 'orgStudyIdInfo': {'id': 'NN304-1475'}, 'secondaryIdInfos': [{'id': 'JapicCTI-R070015', 'type': 'REGISTRY', 'domain': 'JAPIC'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment period 1', 'interventionNames': ['Drug: insulin detemir', 'Drug: insulin NPH']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Treatment period 2', 'interventionNames': ['Drug: insulin detemir', 'Drug: insulin NPH']}], 'interventions': [{'name': 'insulin detemir', 'type': 'DRUG', 'description': 'Single dose of 0.3 U/kg administered subcutaneously (s.c. under the skin) in each treatment period separated by a washout period of 4-28 days', 'armGroupLabels': ['Treatment period 1', 'Treatment period 2']}, {'name': 'insulin NPH', 'type': 'DRUG', 'description': 'Single dose of 0.3 U/kg administered subcutaneously (s.c. under the skin) in each treatment period separated by a washout period of 4-28 days', 'armGroupLabels': ['Treatment period 1', 'Treatment period 2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1000005', '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'}}}}