Ignite Creation Date:
2025-12-24 @ 6:47 PM
Ignite Modification Date:
2026-02-23 @ 12:22 PM
Study NCT ID:
NCT00662857
Status:
COMPLETED
Last Update Posted:
2014-10-16
First Post:
2008-04-16
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study Designed to Compare 2 Dose Strengths of TI Inhalation Powder in Adults With Type 1 Diabetes Mellitus and to Compare One of Those Formulations (30Units) With an Injection of Insulin Lispro
Sponsor:
Organization:
Raw JSON
{'hasResults': True, '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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'aboss@mannkindcorp.com', 'phone': '201-983-5000', 'title': 'Chief Medical Officer', 'organization': 'MannKind Corporation'}, 'certainAgreement': {'otherDetails': 'MannKind has right to 1st joint multicenter publication. After 1st publication PI may publish data only if PI submits proposed publication to MNKD for review 60 days prior to publication date. MNKD may remove any confidential information. If a multicenter publication is not submitted 12 months after conclusion, abandonment, or termination of the Study at all sites, or if MNKD confirms there will be no multicenter Study publication, PI may publish the Study results subject to MNKD rights herein.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'From time of first dose to 30d after last dose; Serious adverse event (SAE) = until resolution', 'eventGroups': [{'id': 'EG000', 'title': 'Techosphere Insulin - A (2 x 15 U)', 'description': '30 U of Technosphere Insulin (TI) administered as 2 x 15 U cartridges as a single-dose during a glucose clamp procedure', 'otherNumAtRisk': 27, 'otherNumAffected': 9, 'seriousNumAtRisk': 27, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Techosphere Insulin - B (1 x 30 U)', 'description': '30 U of Technosphere Insulin (TI) administered as 1 x 30 U cartridges as a single-dose during a glucose clamp procedure', 'otherNumAtRisk': 29, 'otherNumAffected': 14, 'seriousNumAtRisk': 29, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': '10 U Subcutaneous (sc) Insulin Lispro', 'description': '10 U of insulin lispro administered subcutaneously during a glucose clamp procedure', 'otherNumAtRisk': 26, 'otherNumAffected': 5, 'seriousNumAtRisk': 26, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 7.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 7.1'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 7.1'}, {'term': 'Hypoglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 7.1'}, {'term': 'Hepatic enzyme increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 7.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Bioequivalence of Two 15 U Cartridges (TI Inhalation Powder A) and One 30 U Cartridge (TI Inhalation Powder B) Based on Baseline Corrected Insulin AUC0-360', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Techosphere Insulin - A (2 x 15 U)', 'description': '30 U of Technosphere Insulin (TI) administered as 2 x 15 U cartridges as a single-dose during a glucose clamp procedure'}, {'id': 'OG001', 'title': 'Techosphere Insulin - B (1 x 30 U)', 'description': '30 U of Technosphere Insulin (TI) administered as 1 x 30 U cartridges as a single-dose during a glucose clamp procedure'}], 'classes': [{'categories': [{'measurements': [{'value': '3337.2', 'spread': '1.096', 'groupId': 'OG000'}, {'value': '3396.6', 'spread': '1.096', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio of Geometric Means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.982', 'ciLowerLimit': '0.846', 'ciUpperLimit': '1.141', 'estimateComment': 'Geometric Mean Ratio of serum insulin from a single 30 U cartridge to 2 x 15 U cartridges of TI.\n\nBased on pair-wise comparisons from analysis of covariance fitting the model: natural log of parameter = cohort, treatment, visit, subject (cohort).', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '0 to 360 minutes post-dose', 'description': 'Dose-normalized baseline-corrected area under the serum insulin vs. time curve', 'unitOfMeasure': '(micro U)*min/mL', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Per Protocol Population - All subjects who completed the crossover portion of the trial (through Visit 3), had serum insulin concentration data for both TI Inhalation Powder A and TI Inhalation Powder B and were deemed to be protocol compliant (no major protocol violations during the clinical trial).'}, {'type': 'PRIMARY', 'title': 'Bioequivalence of Two 15 U Cartridges (TI Inhalation Powder A) and One 30 U Cartridge (TI Inhalation Powder B) Based on Baseline Corrected Insulin Cmax.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Techosphere Insulin - A (2 x 15 U)', 'description': '30 U of Technosphere Insulin (TI) administered as 2 x 15 U cartridges as a single-dose during a glucose clamp procedure'}, {'id': 'OG001', 'title': 'Techosphere Insulin - B (1 x 30 U)', 'description': '30 U of Technosphere Insulin (TI) administered as 1 x 30 U cartridges as a single-dose during a glucose clamp procedure'}], 'classes': [{'categories': [{'measurements': [{'value': '65.72', 'spread': '1.098', 'groupId': 'OG000', 'lowerLimit': '0.823', 'upperLimit': '1.099'}, {'value': '69.08', 'spread': '1.098', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio of Geometric Means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.951', 'ciLowerLimit': '0.823', 'ciUpperLimit': '1.099', 'estimateComment': 'Geometric Mean Ratio of serum insulin from a single 30 U cartridge to 2 x 15 U cartridges of TI.\n\nBased on pair-wise comparisons from analysis of covariance fitting the model: natural log of parameter = cohort, treatment, visit, subject (cohort).', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '0 to 360 minutes post-dose', 'description': 'Maximum observed baseline-corrected serum insulin concentration', 'unitOfMeasure': '(micro U)/mL', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Per Protocol Population - All subjects who completed the crossover portion of the trial (through Visit 3), had serum insulin concentration data for both TI Inhalation Powder A and TI Inhalation Powder B and were deemed to be protocol compliant (no major protocol violations during the clinical trial).'}, {'type': 'PRIMARY', 'title': 'Bioequivalence of Two 15 U Cartridges (TI Inhalation Powder A) and One 30 U Cartridge (TI Inhalation Powder B) Based on Baseline Corrected Insulin Tmax', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Techosphere Insulin - A (2 x 15 U)', 'description': '30 U of Technosphere Insulin (TI) administered as 2 x 15 U cartridges as a single-dose during a glucose clamp procedure'}, {'id': 'OG001', 'title': 'Techosphere Insulin - B (1 x 30 U)', 'description': '30 U of Technosphere Insulin (TI) administered as 1 x 30 U cartridges as a single-dose during a glucose clamp procedure'}], 'classes': [{'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000', 'lowerLimit': '5', 'upperLimit': '24'}, {'value': '10', 'groupId': 'OG001', 'lowerLimit': '5', 'upperLimit': '20'}]}]}], 'analyses': [{'pValue': '0.3531', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Median Difference (Final Values)', 'paramValue': '0', 'statisticalMethod': 'Signed Rank Test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEDIAN', 'timeFrame': '0 to 360 minutes post-dose', 'unitOfMeasure': 'min', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Per Protocol Population - All subjects who completed the crossover portion of the trial (through Visit 3), had serum insulin concentration data for both TI Inhalation Powder A and TI Inhalation Powder B and were deemed to be protocol compliant (no major protocol violations during the clinical trial).'}, {'type': 'PRIMARY', 'title': 'Relative Bioavailability of 30 U of TI (TI Inhalation Powder B) Versus 10 U of sc Insulin Lispro', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Techosphere Insulin - B (1 x 30 U)', 'description': '30 U of Technosphere Insulin (TI) administered as 1 x 30 U cartridges as a single-dose during a glucose clamp procedure'}, {'id': 'OG001', 'title': '10 U Subcutaneous (sc) Insulin Lispro', 'description': '10 U of insulin lispro administered subcutaneously during a glucose clamp procedure'}], 'classes': [{'categories': [{'measurements': [{'value': '3406.8', 'spread': '1.095', 'groupId': 'OG000'}, {'value': '7404.0', 'spread': '1.102', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio of Geometric Means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.460', 'ciLowerLimit': '0.366', 'ciUpperLimit': '0.578', 'estimateComment': 'Geometric Mean Ratio of serum insulin from a single 30 U cartridge of TI to 10 U sc insulin lispro.\n\nBased on pair-wise comparisons from analysis of covariance fitting the model: natural log of parameter = cohort, treatment, visit, subject (cohort).', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '0 to 360 minutes post-dose', 'description': 'Dose-normalized baseline-corrected area under the serum insulin vs. time curve (time 0 to 360 minutes post-dose)', 'unitOfMeasure': '(micro U)*min/mL', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Rapid-acting insulin Analogue (RAA) Population\n\nAll subjects who had serum insulin concentration data for both TI Inhalation Powder B and insulin lispro and were deemed to be protocol compliant (no major protocol violations during the clinical trial).'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'TI - A (2x15 U)/TI - B (1x30 U)/10 U sc Insulin Lispro', 'description': 'Treatment sequence: 30 U of Technosphere Insulin (TI) administered as 2 x 15 U cartridges as a single-dose, followed by 30 U of Technosphere Insulin (TI) administered as 1 x 30 U cartridges as a single-dose, and then 10 U of insulin lispro administered subcutaneously (sc) during a glucose clamp procedure'}, {'id': 'FG001', 'title': 'TI - B (1x30 U)/TI - A (2x15 U)/10 U sc Insulin Lispro', 'description': 'Treatment sequence: 30 U of Technosphere Insulin (TI) administered as 1 x 30 U cartridges as a single-dose, followed by 30 U of Technosphere Insulin (TI) administered as 2 x 15 U cartridges as a single-dose, and then 10 U of insulin lispro administered subcutaneously (sc) during a glucose clamp procedure'}], 'periods': [{'title': 'TI Dosing Period 1 (1 Day)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '13'}, {'groupId': 'FG001', 'numSubjects': '16'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '13'}, {'groupId': 'FG001', 'numSubjects': '16'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}, {'title': 'Washout 1 (3 - 14 Days)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '13'}, {'groupId': 'FG001', 'numSubjects': '16'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '13'}, {'groupId': 'FG001', 'numSubjects': '14'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}]}], 'dropWithdraws': [{'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}, {'title': 'TI Dosing Period 2 (1 Day)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '13'}, {'groupId': 'FG001', 'numSubjects': '14'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '13'}, {'groupId': 'FG001', 'numSubjects': '14'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}, {'title': 'Washout 2 (3 - 14 Days)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '13'}, {'groupId': 'FG001', 'numSubjects': '14'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '14'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Cannot Use Clamp Data', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}, {'title': 'Lispro Dosing Period (1 Day)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '14'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '14'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'This was a single site with first subject screened 24 Apr 2008', 'preAssignmentDetails': 'Subjects assigned at Visit 2 to either: 2 15 U cartridges (TI Inhalation Powder A) or 1 30 U cartridge (TI Inhalation Powder B). At Visit 3 each subject was crossed over to the other treatment group. At Visit 4 subjects received a single sc injection of 10 IU of insulin lispro to 1 of 3 possible injection sites: arm, leg, or abdomen.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Safety Population', 'description': 'Any subject that received at least one treatment with TI inhalation powder'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '37.4', 'spread': '12.71', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '10', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '19', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Body mass index (BMI)', 'classes': [{'categories': [{'measurements': [{'value': '26.61', 'spread': '2.772', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m squared', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 29}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-10', 'dispFirstSubmitDate': '2009-06-09', 'completionDateStruct': {'date': '2008-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-10-09', 'studyFirstSubmitDate': '2008-04-16', 'dispFirstSubmitQcDate': '2014-10-09', 'resultsFirstSubmitDate': '2014-07-22', 'studyFirstSubmitQcDate': '2008-04-16', 'dispFirstPostDateStruct': {'date': '2014-10-16', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2014-10-16', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2014-10-09', 'studyFirstPostDateStruct': {'date': '2008-04-21', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-10-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Bioequivalence of Two 15 U Cartridges (TI Inhalation Powder A) and One 30 U Cartridge (TI Inhalation Powder B) Based on Baseline Corrected Insulin AUC0-360', 'timeFrame': '0 to 360 minutes post-dose', 'description': 'Dose-normalized baseline-corrected area under the serum insulin vs. time curve'}, {'measure': 'Bioequivalence of Two 15 U Cartridges (TI Inhalation Powder A) and One 30 U Cartridge (TI Inhalation Powder B) Based on Baseline Corrected Insulin Cmax.', 'timeFrame': '0 to 360 minutes post-dose', 'description': 'Maximum observed baseline-corrected serum insulin concentration'}, {'measure': 'Bioequivalence of Two 15 U Cartridges (TI Inhalation Powder A) and One 30 U Cartridge (TI Inhalation Powder B) Based on Baseline Corrected Insulin Tmax', 'timeFrame': '0 to 360 minutes post-dose'}, {'measure': 'Relative Bioavailability of 30 U of TI (TI Inhalation Powder B) Versus 10 U of sc Insulin Lispro', 'timeFrame': '0 to 360 minutes post-dose', 'description': 'Dose-normalized baseline-corrected area under the serum insulin vs. time curve (time 0 to 360 minutes post-dose)'}]}, 'conditionsModule': {'keywords': ['Diabetic adult male, diabetic adult female'], 'conditions': ['Diabetes Mellitus: Type 1']}, 'descriptionModule': {'briefSummary': '28 subjects to be enrolled for a screening period, 3 dosing visits \\& a follow-up visit. Visits 2 and 3 dosing of TI Inhalation Powder, cross over between two 15 U cartridges and one 30 U cartridge. Visit 4 dosing will be a sc injection of 10 IU of RAA (rapid-acting insulin analogue).', 'detailedDescription': '28 eligible subjects were planned to be enrolled to determine bioequivalence and safety parameters of two 15 U TI Inhalation Powder cartridges versus one 30 U TI Inhalation Powder cartridge, according to a randomized, 2-way crossover design. Additionally, bioavailability of one 30 U TI Inhalation Powder cartridge to a single subcutaneous injection of 10 IU of RAA will be compared.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nMales and Females \\> 18 and \\< 60 years of age Clinical diagnosis of type 1 diabetes mellitus with stable anti-diabetic regimen for at least 90 days prior to Screening BMI of \\< 30 kg/m2 Non-smokers (never smoked or former smokers (\\> 6 months since cessation) Pulmonary Function Testing (FEV1 \\> 70%, FEV1/FVC \\> 70%, TLC \\> 80% DLco \\[unc\\] \\> 70% of Predicted Written Informed consent\n\nExclusion Criteria:\n\nTwo or more severe hypoglycemic episodes within 6 months of Screening/Visit 1 Severe complications of diabetes Previous exposure to any inhaled insulin product other than TI inhalation Powder or similar formulation Inability to perform PFT maneuvers meeting recommended American Thoracic Society (ATS) standards of acceptability and repeatability criteria Respiratory tract infection within 8 weeks prior to Screening/Visit 1 History of chronic obstructive pulmonary disease (COPD), clinically proven asthma, and/or any other clinically important pulmonary disease (eg. Obstructive sleep apnea), confirmed by pulmonary function testing, and/or radiologic findings Major organ system diseases including seizures, heart failure, uncontrolled hypertension, cancer within the past 5 years, liver disease, anemia or autoimmune disorder Clinically significant abnormalities on screening laboratory evaluation Female subjects who are pregnant, lactating, or planning to become pregnant during the clinical trial period or not practicing adequate birth control Unable and/or unlikely to comprehend how to use the investigational device in this study or to follow study instructions'}, 'identificationModule': {'nctId': 'NCT00662857', 'briefTitle': 'A Study Designed to Compare 2 Dose Strengths of TI Inhalation Powder in Adults With Type 1 Diabetes Mellitus and to Compare One of Those Formulations (30Units) With an Injection of Insulin Lispro', 'organization': {'class': 'INDUSTRY', 'fullName': 'Mannkind Corporation'}, 'officialTitle': 'A Phase 2, Open-Label, Randomized, 2-Way Crossover, Clinical Trial to Compare the Pharmacokinetics of 2 Formulations of "Intended Commercial Product" Technosphere® Insulin Inhalation Powder and to Determine the Bioavailability of a 30 Unit Cartridge of "Intended Commercial Product" Technosphere® Insulin Inhalation Powder Versus a 10 Unit Subcutaneous Injection of Insulin Lispro in Subjects With Type 1 Diabetes Mellitus', 'orgStudyIdInfo': {'id': 'MKC-TI-116'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1: TI Inhalation Powder A', 'description': 'Technosphere® Insulin Inhalation Powder, two 15 U cartridges', 'interventionNames': ['Drug: Technosphere® Insulin Inhalation Powder']}, {'type': 'EXPERIMENTAL', 'label': '2: TI Inhalation Powder B', 'description': 'Technosphere® Insulin Inhalation Powder, one 30 U cartridge', 'interventionNames': ['Drug: Technosphere Insulin® Inhalation Powder']}, {'type': 'EXPERIMENTAL', 'label': '3: RAA Population', 'description': 'Rapid Acting Analogue subjects received 10 IU sc Insulin Lispro', 'interventionNames': ['Drug: RAA Population']}], 'interventions': [{'name': 'Technosphere® Insulin Inhalation Powder', 'type': 'DRUG', 'description': 'TI Inhalation Powder, two 15 U cartridges', 'armGroupLabels': ['1: TI Inhalation Powder A']}, {'name': 'Technosphere Insulin® Inhalation Powder', 'type': 'DRUG', 'description': 'TI Inhalation Powder, one 30 U cartridge', 'armGroupLabels': ['2: TI Inhalation Powder B']}, {'name': 'RAA Population', 'type': 'DRUG', 'description': 'RAA Population: All subjects received a single 10 IU sc injection of insulin lispro.', 'armGroupLabels': ['3: RAA Population']}]}, 'contactsLocationsModule': {'locations': [{'zip': '91911', 'city': 'Chula Vista', 'state': 'California', 'country': 'United States', 'facility': 'Profil Institute for Clinical Research Inc.', 'geoPoint': {'lat': 32.64005, 'lon': -117.0842}}, {'zip': '78229', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'Diabetes & Glandular Disease Research Assoc PA', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mannkind Corporation', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}