Ignite Creation Date:
2025-12-25 @ 4:56 AM
Ignite Modification Date:
2025-12-26 @ 3:56 AM
Study NCT ID:
NCT00419718
Status:
COMPLETED
Last Update Posted:
2017-01-24
First Post:
2007-01-08
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effect of Exercise on the Absorption of Inhaled Human Insulin 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'}]}}, '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': '2005-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-01', 'completionDateStruct': {'date': '2005-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-01-23', 'studyFirstSubmitDate': '2007-01-08', 'studyFirstSubmitQcDate': '2007-01-08', 'lastUpdatePostDateStruct': {'date': '2017-01-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-01-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2005-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Area under the plasma insulin profile in the interval', 'timeFrame': 'From 30-150 min after trial product administration'}], 'secondaryOutcomes': [{'measure': 'Area under the plasma insulin profile in the interval from 120-240 min after trial product administration'}, {'measure': 'Area under the plasma insulin profile in the interval from 240-360 min after trial product administration'}, {'measure': 'Area under the plasma insulin profile in the interval 0-600 min after trial product administration'}, {'measure': 'Maximum plasma insulin concentration'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Diabetes', 'Diabetes Mellitus, Type 1']}, 'referencesModule': {'references': [{'pmid': '17620446', 'type': 'RESULT', 'citation': 'Petersen AH, Kohler G, Korsatko S, Wutte A, Wonisch M, Jeppesen OK, Sparre T, Clauson P, Laursen T, Wollmer P, Pieber TR. The effect of exercise on the absorption of inhaled human insulin via the AERx insulin diabetes management system in people with type 1 diabetes. Diabetes Care. 2007 Oct;30(10):2571-6. doi: 10.2337/dc06-2589. Epub 2007 Jul 9.'}], 'seeAlsoLinks': [{'url': 'http://novonordisk-trials.com', 'label': 'Clinical Trials at Novo Nordisk'}]}, 'descriptionModule': {'briefSummary': 'The trial is conducted in Europe. This clinical pharmacology trial investigates the effect of exercise on the pharmacokinetics and pharmacodynamics of inhaled insulin in subjects with type 1 diabetes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Type 1 diabetes more than or equal to 12 months\n* Baseline HbA1c less than or equal to 11%\n* Body mass index (BMI) less than or equal to 29 kg/m2\n* Normal lung volumes\n* Treatment with intensified insulin therapy for at least 3 months\n\nExclusion Criteria:\n\n* Any present or history of pulmonary disease\n* Any findings from the cardiopulmonary exercise test compromising safety of moderate exercise\n* Impaired hepatic or renal function\n* Cardiac problems\n* Uncontrolled hypertension\n* Current proliferative retinopathy or maculopathy\n* Treatment with drugs, which may interfere with insulin action, glucose metabolism or recovery from hypoglycaemia (judged by investigator)\n* Current smoking or smoking within the last 6 months\n* Blood donation (more than 500 mL) within the last nine weeks'}, 'identificationModule': {'nctId': 'NCT00419718', 'briefTitle': 'Effect of Exercise on the Absorption of Inhaled Human Insulin in Subjects With Type 1 Diabetes', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novo Nordisk A/S'}, 'officialTitle': 'Effect of Exercise on the Pharmacokinetics and Pharmacodynamics of Inhaled Human Insulin in Subjects With Type 1 Diabetes', 'orgStudyIdInfo': {'id': 'NN1998-1562'}}, 'armsInterventionsModule': {'interventions': [{'name': 'inhaled human insulin', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '8036', 'city': 'Graz', 'country': 'Austria', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 47.06733, 'lon': 15.44197}}], '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'}}}}