Ignite Creation Date:
2025-12-24 @ 9:13 PM
Ignite Modification Date:
2025-12-25 @ 7:03 PM
Study NCT ID:
NCT00331604
Status:
TERMINATED
Last Update Posted:
2017-03-01
First Post:
2006-05-24
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Safety and Efficacy of Inhaled Insulin in Type 2 Diabetes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}], '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069057', 'term': 'Insulin Detemir'}, {'id': 'D061267', 'term': 'Insulin Aspart'}], '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'}, {'id': 'D061266', 'term': 'Insulin, Short-Acting'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 618}}, 'statusModule': {'whyStopped': 'See termination reason in detailed description', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2006-08-31', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-02', 'completionDateStruct': {'date': '2008-05-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-02-28', 'studyFirstSubmitDate': '2006-05-24', 'studyFirstSubmitQcDate': '2006-05-29', 'lastUpdatePostDateStruct': {'date': '2017-03-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2006-05-31', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-05-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Treatment difference in HbA1c', 'timeFrame': 'After 52 weeks'}], 'secondaryOutcomes': [{'measure': 'Adverse events', 'timeFrame': 'For the duration of the trial'}, {'measure': 'Blood glucose', 'timeFrame': 'After 52, 104 and 116 weeks of treatment'}, {'measure': 'Body weight', 'timeFrame': 'During treatment'}, {'measure': 'Lung function', 'timeFrame': 'After 52, 104 and 116 weeks of treatment'}, {'measure': 'Hypoglycaemia', 'timeFrame': 'From 12 weeks of treatment'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Diabetes', 'Diabetes Mellitus, Type 2']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://novonordisk-trials.com', 'label': 'Clinical Trials at Novo Nordisk'}]}, 'descriptionModule': {'briefSummary': 'This trial is conducted in Asia, Europe and South America. The aim of this research is to compare the efficacy (reduction in HbA1c and blood glucose) and pulmonary safety (pulmonary function tests, chest x-rays) of mealtime inhaled insulin with subcutaneous insulin aspart both in combination with insulin detemir in Type 2 Diabetes.', 'detailedDescription': 'The decision to discontinue the development of AERx® is not due to any safety concerns. An analysis concluded that fast-acting inhaled insulin in the form it is known today, is unlikely to offer significant clinical or convenience benefits over injections of modern insulin with pen devices.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Type 2 diabetes\n* Currently treated with insulin\n* Body mass index of (BMI) less than or equal to 40.0 kg/m2\n* HbA1c less than or equal to 11.0%\n\nExclusion Criteria:\n\n* Total daily insulin dosage less than or equal to 100 IU or U/day\n* Current smoking or smoking within the last 6 months\n* Cardiac problems\n* Uncontrolled hypertension\n* Current proliferative retinopathy or maculopathy'}, 'identificationModule': {'nctId': 'NCT00331604', 'briefTitle': 'Safety and Efficacy of Inhaled Insulin in Type 2 Diabetes', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novo Nordisk A/S'}, 'officialTitle': 'Inhaled Pre-prandial Human Insulin With the AERx® iDMS Versus s.c. Insulin Aspart in Type 2 Diabetes: A 104 Week, Open-label, Multicenter, Randomised, Trial Followed by a 12 Week Re-randomised Extension to Investigate Safety and Efficacy', 'orgStudyIdInfo': {'id': 'NN1998-2161'}, 'secondaryIdInfos': [{'id': '2005-005378-58', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'A', 'interventionNames': ['Drug: inhaled human insulin', 'Drug: insulin detemir']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'B', 'interventionNames': ['Drug: insulin detemir', 'Drug: insulin aspart']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'C', 'interventionNames': ['Drug: insulin detemir', 'Drug: insulin aspart']}], 'interventions': [{'name': 'inhaled human insulin', 'type': 'DRUG', 'description': 'Treat-to-target dose titration scheme, inhalation.', 'armGroupLabels': ['A']}, {'name': 'insulin detemir', 'type': 'DRUG', 'otherNames': ['NN304', 'Levemir'], 'description': 'Injection s.c., 50% of daily dose.', 'armGroupLabels': ['A', 'B', 'C']}, {'name': 'insulin aspart', 'type': 'DRUG', 'description': 'Treat-to-target dose titration scheme, injection s.c.', 'armGroupLabels': ['B', 'C']}, {'name': 'insulin aspart', 'type': 'DRUG', 'description': 'Treat-to-target dose titration scheme, injection s.c. After 2 years.', 'armGroupLabels': ['C']}]}, 'contactsLocationsModule': {'locations': [{'zip': '13083-900', 'city': 'Campinas', 'country': 'Brazil', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': -22.90556, 'lon': -47.06083}}, {'zip': '01244-030', 'city': 'Higienópolis', 'country': 'Brazil', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': -30.01647, 'lon': -51.18399}}, {'zip': '90035-170', 'city': 'Porto Alegre', 'country': 'Brazil', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': -30.03283, 'lon': -51.23019}}, {'zip': '04022-001', 'city': 'São Paulo', 'country': 'Brazil', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}, {'zip': '8000', 'city': 'Århus C', 'country': 'Denmark', 'facility': 'Novo Nordisk Investigational Site'}, {'zip': '3400', 'city': 'Hillerød', 'country': 'Denmark', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 55.92791, 'lon': 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