Ignite Creation Date:
2025-12-25 @ 3:04 AM
Ignite Modification Date:
2026-01-01 @ 1:52 AM
Study NCT ID:
NCT00424333
Status:
COMPLETED
Last Update Posted:
2007-02-13
First Post:
2007-01-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Six Month Clinical Trial Assessing Efficacy and Safety of Inhaled Insulin in Type 1 Diabetes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003922', 'term': 'Diabetes Mellitus, Type 1'}], 'ancestors': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'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': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'count': 320}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '1999-05'}, 'statusVerifiedDate': '2007-02', 'completionDateStruct': {'date': '2000-10'}, 'lastUpdateSubmitDate': '2007-02-09', 'studyFirstSubmitDate': '2007-01-17', 'studyFirstSubmitQcDate': '2007-01-17', 'lastUpdatePostDateStruct': {'date': '2007-02-13', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-01-19', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Primary outcome is 24 week change in baseline in HbA1c.'}], 'secondaryOutcomes': [{'measure': 'The secondary endpoints include the following efficacy assessments:'}, {'measure': 'Incidence of hypoglycemia'}, {'measure': 'Proportion of subjects with acceptable glycemic control (e.g., HbA1c<8%)'}, {'measure': 'Change from baseline in fasting lipid profile'}, {'measure': 'Change from baseline in fasting plasma glucose level'}, {'measure': 'Change from baseline in meal glucose response (2-hour postprandial increment in plasma glucose)'}, {'measure': 'Dose of insulin (total dose of injected sustained-duration insulin, and total dose of inhaled or injected Regular insulin during the study).'}, {'measure': 'Change from baseline in body weight'}, {'measure': 'Change from baseline in 24-hour home glucose profile (based on the area under the glucose profile curve calculated by the trapezoid rule with special weights assigned to the pre-breakfast and bedtime assessments).'}, {'measure': 'Patient satisfaction and preference.'}]}, 'conditionsModule': {'conditions': ['Diabetes Mellitus, Type 1']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=107&StudyName=Six+Month+Clinical+Trial+Assessing+Efficacy+and+Safety+of+Inhaled+Insulin+in+Type+1+Diabetes', 'label': 'To obtain contact information for a study center near you, click here.'}]}, 'descriptionModule': {'briefSummary': 'To determine in subjects with Type 1 Diabetes Mellitus:\n\n1. Whether glycemic control can be achieved at least as effectively with a) an intensive insulin regimen involving pre-meal inhaled insulin plus twice daily subcutaneous NPH insulin as with b) an intensive subcutaneous insulin regimen involving pre-meal regular insulin plus twice daily NPH, given as 4 injections per day. The treatment regimens differ only by the route of delivery of the short acting insulin.\n2. The toleration and safety of inhaled insulin therapy and its effects after 6months, if any, on measures of pulmonary function.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '12 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Type 1 Diabetes for more than 1 year\n* Stable insulin regimen of at least 2 injections per day\n\nExclusion Criteria:\n\n* Any smoking within the last 6 months. Smoking is not permitted at any time during this study.\n* Subjects on insulin pump during 2 months prior to screening.\n* Subjects with poorly-controlled asthma, clinically significant chronic obstructive pulmonary disease, or other significant respiratory disease.'}, 'identificationModule': {'nctId': 'NCT00424333', 'briefTitle': 'Six Month Clinical Trial Assessing Efficacy and Safety of Inhaled Insulin in Type 1 Diabetes', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pfizer'}, 'officialTitle': 'Efficacy and Safety of Inhaled Compared With Subcutaneous Human Insulin in an Intensive Insulin Regimen for Subjects With Type 1 Diabetes Mellitus: A Six-Month, Outpatient, Parallel Comparative Trial', 'orgStudyIdInfo': {'id': '217-107'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Inhaled human insulin', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Duarte', 'state': 'California', 'country': 'United States', 'facility': 'Pfizer Investigational 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