Ignite Creation Date:
2025-12-24 @ 6:33 PM
Ignite Modification Date:
2026-01-02 @ 4:33 AM
Study NCT ID:
NCT00322257
Status:
TERMINATED
Last Update Posted:
2018-09-05
First Post:
2006-05-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety and Efficacy of Inhaled Insulin in 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': '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': 596}}, 'statusModule': {'whyStopped': 'See termination reason in detailed description', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2006-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-09', 'dispFirstSubmitDate': '2018-09-03', 'completionDateStruct': {'date': '2008-04-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-09-03', 'studyFirstSubmitDate': '2006-05-03', 'dispFirstSubmitQcDate': '2018-09-03', 'studyFirstSubmitQcDate': '2006-05-04', 'dispFirstPostDateStruct': {'date': '2018-09-05', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2018-09-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2006-05-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-04-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'HbA1c', 'timeFrame': 'After 52 weeks'}], 'secondaryOutcomes': [{'measure': 'Body weight', 'timeFrame': 'after 52 weeks'}, {'measure': 'Antibodies', 'timeFrame': 'after 52 weeks'}, {'measure': 'Hypoglycemia', 'timeFrame': 'For the duration of the trial'}, {'measure': 'Insulin doses', 'timeFrame': 'For the duration of the trial'}, {'measure': 'Pulmonary Function', 'timeFrame': 'For the duration of the trial'}, {'measure': 'Fasting plasma glucose', 'timeFrame': 'after 52 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Diabetes', 'Diabetes Mellitus, Type 1']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://novonordisk-trials.com', 'label': 'Clinical Trials at Novo Nordisk'}]}, 'descriptionModule': {'briefSummary': 'This trial is conducted in the United States of America (USA) and Canada. The aim of this research is to compare the efficacy (reduction in HbA1c and blood glucose) and pulmonary safety (pulmonary function, chest x-rays) of mealtime inhaled insulin with subcutaneous insulin aspart both in combination with insulin determir in Type 1 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'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Type 1 diabetes\n* HbA1c less than or equal to 11%\n* Body mass index (BMI) less than or equal to 40.0 kg/m2\n\nExclusion Criteria:\n\n* Total daily insulin dosage more than 100 IU or U/day.\n* Current smoking or smoking within the last 6 months\n* Impaired hepatic or renal function\n* Cardiac problems\n* Uncontrolled hypertension\n* Current proliferative retinopathy or maculopathy requiring acute treatment'}, 'identificationModule': {'nctId': 'NCT00322257', 'briefTitle': 'Safety and Efficacy of Inhaled Insulin in Type 1 Diabetes', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novo Nordisk A/S'}, 'officialTitle': 'Inhaled Mealtime Insulin With the AERx® iDMS Versus Subcutaneous Injected Insulin Aspart Both in Combination With Insulin Detemir in Type 1 Diabetes: A 104 Week, Open-Label, Multicenter, Randomised, Parallel Trial (Followed by a Twelve-Week Re-Randomised Extension) To Investigate Safety and Efficacy', 'orgStudyIdInfo': {'id': 'NN1998-2076'}}, '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']}], 'interventions': [{'name': 'inhaled human insulin', 'type': 'DRUG', 'description': 'Treat-to-target dose titration scheme, inhalation.', 'armGroupLabels': ['A']}, {'name': 'insulin detemir', 'type': 'DRUG', 'otherNames': ['Levemir, NN304'], 'description': 'Injection s.c., 50% of daily dose', 'armGroupLabels': ['A', 'B']}, {'name': 'insulin aspart', 'type': 'DRUG', 'description': 'Treat-to-target dose titration scheme, injection s.c.', 'armGroupLabels': ['B']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35294', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '35406', 'city': 'Tuscaloosa', 'state': 'Alabama', 'country': 'United States', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 33.20984, 'lon': -87.56917}}, {'zip': '94520', 'city': 'Concord', 'state': 'California', 'country': 'United States', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 37.97798, 'lon': -122.03107}}, {'zip': '91436', 'city': 'Encino', 'state': 'California', 'country': 'United States', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 34.15917, 'lon': -118.50119}}, {'zip': '92025', 'city': 'Escondido', 'state': 'California', 'country': 'United States', 'facility': 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