Ignite Creation Date:
2025-12-25 @ 3:01 AM
Ignite Modification Date:
2026-01-22 @ 4:47 AM
Study NCT ID:
NCT01459133
Status:
WITHDRAWN
Last Update Posted:
2015-03-17
First Post:
2011-10-21
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Single Site, Single Subject, Treatment IND With Mannkind Corporation's Technosphere Inhalation System
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': "Unable to register Treatment IND with the US Food And Drug Administration's new process of establishing TLS encryption for email correspondence.", 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2013-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-03', 'completionDateStruct': {'date': '2014-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2015-03-10', 'studyFirstSubmitDate': '2011-10-21', 'studyFirstSubmitQcDate': '2011-10-24', 'lastUpdatePostDateStruct': {'date': '2015-03-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-10-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Efficacy of Inhaled Insulin versus Subcutaneous Insulin in a patient who receives inadequate response from subcutaneous alone.', 'timeFrame': '12-months', 'description': 'Evaluate fasting plasma glucose and hemoglobin a1c'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['investigational', 'inhaled insulin product'], 'conditions': ['Diabetes']}, 'descriptionModule': {'briefSummary': 'The purpose of this program is to allow patients with diabetes and with specific medical needs which require them to use this investigational inhaled insulin product in order to adequately manage their diabetes. Treatment use of this investigational product is only anticipated when exceptional need is identified by a treating physician on a per patient case by case review.', 'detailedDescription': 'This program is for patients who have been diagnosed with diabetes mellitus and has established a need for treatment with this investigational product documented by a health care professional. The treating doctor, or a member of his/her staff, will discuss the specific requirements for participation with the subject.\n\nINVESTIGATIONAL PRODUCT DESCRIPTION:\n\nTechnosphere® Insulin Inhalation System includes Technosphere® Insulin Inhalation Powder and inhaler. The Inhalation Powder comes in 10 unit and 20 unit cartridges.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nDocumented diagnosis with diabetes mellitus and have established a need for treatment with the investigational product.\n\nLocal Ethics Committee approval has been documented, as needed. Patient has signed the Informed Consent Form for participation. Patient has successfully completed training on the Technosphere Insulin Inhalation System.\n\nExclusion Criteria:\n\nAllergy to Insulin. Smoking in the previous 6-months. History of asthma or COPD or any other significant pulmonary disease, or exposure to pulmonary toxins.\n\nClinical significant abnormality in screening laboratory tests. Positive pregnancy test or the intention to become pregnant. Women of childbearing age without appropriate method of contraception.'}, 'identificationModule': {'nctId': 'NCT01459133', 'briefTitle': "Single Site, Single Subject, Treatment IND With Mannkind Corporation's Technosphere Inhalation System", 'organization': {'class': 'OTHER', 'fullName': 'South Orange County Endocrinology'}, 'officialTitle': "Single Site, Single Subject, Treatment IND With Mannkind Corporation's Technosphere", 'orgStudyIdInfo': {'id': 'IND110021'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Technosphere® Insulin Inhalation System', 'description': 'Single Site, Single Subject use of Technosphere® Insulin Inhalation System', 'interventionNames': ['Drug: Technosphere® Insulin Inhalation System']}], 'interventions': [{'name': 'Technosphere® Insulin Inhalation System', 'type': 'DRUG', 'description': 'Single Site, Single Subject use of Technosphere® Insulin Inhalation System', 'armGroupLabels': ['Technosphere® Insulin Inhalation System']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92653', 'city': 'Laguna Hills', 'state': 'California', 'country': 'United States', 'facility': 'South Orange County Endocrinology', 'geoPoint': {'lat': 33.61252, 'lon': -117.71283}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'South Orange County Endocrinology', 'class': 'OTHER'}, 'collaborators': [{'name': 'Mannkind Corporation', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}