Ignite Creation Date:
2025-12-24 @ 9:17 PM
Ignite Modification Date:
2025-12-29 @ 3:39 PM
Study NCT ID:
NCT01196104
Status:
TERMINATED
Last Update Posted:
2014-10-30
First Post:
2010-08-30
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Clinical Trial Evaluating the Efficacy and Safety of Technosphere® Inhalation Insulin (TI) Inhalation Powder Using the Gen2 Inhaler
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}], '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D061267', 'term': 'Insulin Aspart'}, {'id': 'D000069036', 'term': 'Insulin Glargine'}], 'ancestors': [{'id': 'D061266', 'term': 'Insulin, Short-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': 'D049528', 'term': 'Insulin, Long-Acting'}]}}, '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}, 'limitationsAndCaveats': {'description': '\\- Early termination of trial leading to small numbers of subjects analyzed.'}}, 'adverseEventsModule': {'timeFrame': 'From first dose to 30d post last dose', 'eventGroups': [{'id': 'EG000', 'title': 'Technosphere® Insulin Inhalation Powder (TI)', 'description': 'Insulin Glargine and Technosphere® Insulin Inhalation Powder\n\nTechnosphere® Insulin Inhalation Powder\n\nInsulin Glargine', 'otherNumAtRisk': 19, 'otherNumAffected': 13, 'seriousNumAtRisk': 19, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'Comparator', 'description': 'Insulin Glargine and Insulin Aspart\n\nInsulin Aspart: Usual Care\n\nInsulin Glargine', 'otherNumAtRisk': 18, 'otherNumAffected': 11, 'seriousNumAtRisk': 18, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Angina Pectoris', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Atrial Fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Ventricular extrasystoles', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Hypothyroidism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 0}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Mydriasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Vitreous haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Oedema Peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Upper Respiratory Tract Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Ear Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Onychomycosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Urinary Tract Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Pharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Blood Testosterone Decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA15.1'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Back Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Chest Wall Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Plantar Fasciitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Hypoaesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Renal Failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Sinus Congestion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Throat Irritation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Dry Throat', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Productive Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Respiratory Tract Congestion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Wheezing', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Cataract Operation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}], 'seriousEvents': [{'term': 'Angina unstable', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 7.1'}, {'term': 'Rib Fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 7.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in HbA1c (%) From Baseline to Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Technosphere Insulin + Insulin Glargine', 'description': 'Technosphere Insulin Inhalation Powder (administered prior to each meal) in combination with insulin glargine (once or twice daily); doses individualized for each patient'}, {'id': 'OG001', 'title': 'Insulin Aspart + Insulin Glargine', 'description': 'Insulin Aspart (prior to each meal) and Insulin Glargine (once or twice daily) ; doses individualized for each patient'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.2179', 'spread': '0.1468', 'groupId': 'OG000'}, {'value': '-1.2652', 'spread': '0.1571', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.8283', 'groupIds': ['OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.0473', 'ciLowerLimit': '-0.4901', 'ciUpperLimit': '0.3956', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.2158', 'groupDescription': 'ANCOVA model with terms of treatment as a fixed effect and baseline HbA1c as covariate', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'Study terminated early due to business reasons, results are not properly powered.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline to Week 16', 'description': 'Change from Baseline in glycated hemoglobin at Week 16', 'unitOfMeasure': 'Percentage of total hemoglobin', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population, participants with data available at Baseline and Week 16'}, {'type': 'SECONDARY', 'title': 'To Evaluate the Effect of Each Treatment on HbA1c', 'timeFrame': 'Change from baseline to 16 weeks', 'description': 'Not analyzed due to early termination of the trial.', 'reportingStatus': 'NOT_POSTED'}, {'type': 'SECONDARY', 'title': 'Comparison of Fasting Plasma Glucose (FPG) Levels at Randomization and Throughout the Study', 'timeFrame': 'Change from baseline to 16 weeks', 'description': 'Not analyzed due to early termination of the trial.', 'reportingStatus': 'NOT_POSTED'}, {'type': 'SECONDARY', 'title': 'Comparison of Post-prandial Glucose (PPG) Levels at Randomization and Throughout the Study', 'timeFrame': 'Change from baseline to 16 weeks', 'description': 'Not analyzed due to early termination of the trial.', 'reportingStatus': 'NOT_POSTED'}, {'type': 'SECONDARY', 'title': 'Glycomark and Fructosamine Levels Measured Throughout the Study', 'timeFrame': 'Change from baseline to 16 weeks', 'description': 'Not analyzed due to early termination of the trial.', 'reportingStatus': 'NOT_POSTED'}, {'type': 'SECONDARY', 'title': 'Seven-point Glucose at Randomization and Throughout the Study', 'timeFrame': 'Change from baseline to 16 weeks', 'description': 'Not analyzed due to early termination of the trial.', 'reportingStatus': 'NOT_POSTED'}, {'type': 'SECONDARY', 'title': 'Glycemic Excursions and Variability as Assessed Through Continuous Glucose Monitoring (CGM)', 'timeFrame': 'Change from baseline to 16 weeks', 'description': 'Not analyzed due to early termination of the trial.', 'reportingStatus': 'NOT_POSTED'}, {'type': 'SECONDARY', 'title': 'Changes in Body Weight at 16 Weeks', 'timeFrame': 'Change from baseline to 16 weeks', 'description': 'Not analyzed due to early termination of the trial.', 'reportingStatus': 'NOT_POSTED'}, {'type': 'SECONDARY', 'title': 'Treatment Satisfaction as Assessed by Subject Treatment and Health Outcomes Questionnaires', 'timeFrame': 'Change from baseline to 16 weeks', 'description': 'Not analyzed due to early termination of the trial.', 'reportingStatus': 'NOT_POSTED'}, {'type': 'SECONDARY', 'title': 'Total Number of Cough Episodes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Technosphere Insulin + Insulin Glargine', 'description': 'Technosphere Insulin Inhalation Powder (administered prior to each meal) in combination with insulin glargine (once or twice daily); doses individualized for each patient'}, {'id': 'OG001', 'title': 'Insulin Aspart + Insulin Glargine', 'description': 'Insulin Aspart (prior to each meal) and Insulin Glargine (once or twice daily) ; doses individualized for each patient'}], 'classes': [{'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline to Week 16', 'description': 'Total number of times patients coughed once, intermittently or continuously (inclusive)', 'unitOfMeasure': 'Cough episodes', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population'}, {'type': 'SECONDARY', 'title': 'Severe Hypoglycemic Event Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Technosphere Insulin + Insulin Glargine', 'description': 'Technosphere Insulin Inhalation Powder (administered prior to each meal) in combination with insulin glargine (once or twice daily); doses individualized for each patient'}, {'id': 'OG001', 'title': 'Insulin Aspart + Insulin Glargine', 'description': 'Insulin Aspart (prior to each meal) and Insulin Glargine (once or twice daily) ; doses individualized for each patient'}], 'classes': [{'categories': [{'measurements': [{'value': '0.01', 'groupId': 'OG000'}, {'value': '0.34', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline to Week 16', 'description': 'Severe hypoglycemic event rate, ie, total number of events divided by subject-months of observation\n\nSevere hypoglycemia is defined as a subject who requires the assistance of another individual (not merely requested) and either:\n\n* SMBG levels ≤ 36 mg/dL OR\n* There is a prompt response to the administration of carbohydrate, glucagon, or other resuscitative measures', 'unitOfMeasure': 'Events / subject-month', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population'}, {'type': 'SECONDARY', 'title': 'Mild or Moderate Hypoglycemic Event Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Technosphere® Insulin Inhalation Powder (TI)', 'description': 'Insulin Glargine and Technosphere® Insulin Inhalation Powder\n\nTechnosphere® Insulin Inhalation Powder\n\nInsulin Glargine'}, {'id': 'OG001', 'title': 'Comparator', 'description': 'Insulin Glargine and Insulin Aspart\n\nInsulin Aspart: Usual Care\n\nInsulin Glargine'}], 'classes': [{'categories': [{'measurements': [{'value': '4.47', 'groupId': 'OG000'}, {'value': '4.41', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline to Week 16', 'description': 'Mild or moderate hypoglycemic event rate, ie, total number of events divided by subject-months of observation\n\nNonsevere hypoglycemia is defined as a subject:\n\n* SMBG levels \\< 70 mg/dL AND/OR\n* Symptoms that are relieved by the self-administration of carbohydrates', 'unitOfMeasure': 'Events / subject-month', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population'}, {'type': 'SECONDARY', 'title': 'Number of Subjects Reporting Cough Episodes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Technosphere Insulin + Insulin Glargine', 'description': 'Technosphere Insulin Inhalation Powder (administered prior to each meal) in combination with insulin glargine (once or twice daily); doses individualized for each patient'}, {'id': 'OG001', 'title': 'Insulin Aspart + Insulin Glargine', 'description': 'Insulin Aspart (prior to each meal) and Insulin Glargine (once or twice daily) ; doses individualized for each patient'}], 'classes': [{'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline to Week 16', 'description': 'Number of Subjects Reporting Cough Episodes', 'unitOfMeasure': 'Number of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population'}, {'type': 'SECONDARY', 'title': 'Number of Subjects Reporting Intermittent Coughing Episodes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Technosphere Insulin + Insulin Glargine', 'description': 'Technosphere Insulin Inhalation Powder (administered prior to each meal) in combination with insulin glargine (once or twice daily); doses individualized for each patient'}, {'id': 'OG001', 'title': 'Insulin Aspart + Insulin Glargine', 'description': 'Insulin Aspart (prior to each meal) and Insulin Glargine (once or twice daily) ; doses individualized for each patient'}], 'classes': [{'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline to Week 16', 'description': 'Number of subjects reporting Intermittent Coughing Episodes', 'unitOfMeasure': 'Number of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population'}, {'type': 'SECONDARY', 'title': 'Number of Single Coughing Episodes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Technosphere Insulin + Insulin Glargine', 'description': 'Technosphere Insulin Inhalation Powder (administered prior to each meal) in combination with insulin glargine (once or twice daily); doses individualized for each patient'}, {'id': 'OG001', 'title': 'Insulin Aspart + Insulin Glargine', 'description': 'Insulin Aspart (prior to each meal) and Insulin Glargine (once or twice daily) ; doses individualized for each patient'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline to Week 16', 'description': 'Total number of times patients coughed only once', 'unitOfMeasure': 'Cough episodes', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population'}, {'type': 'SECONDARY', 'title': 'Number of Cough Episodes Occuring Within 10 Minutes of Drug Inhalation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Technosphere Insulin + Insulin Glargine', 'description': 'Technosphere Insulin Inhalation Powder (administered prior to each meal) in combination with insulin glargine (once or twice daily); doses individualized for each patient'}, {'id': 'OG001', 'title': 'Insulin Aspart + Insulin Glargine', 'description': 'Insulin Aspart (prior to each meal) and Insulin Glargine (once or twice daily) ; doses individualized for each patient'}], 'classes': [{'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline to Week 16', 'unitOfMeasure': 'Cough episodes', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population'}, {'type': 'SECONDARY', 'title': 'Baseline Forced Expiratory Volume in 1 Second (FEV1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Technosphere Insulin + Insulin Glargine', 'description': 'Technosphere Insulin Inhalation Powder (administered prior to each meal) in combination with insulin glargine (once or twice daily); doses individualized for each patient'}, {'id': 'OG001', 'title': 'Insulin Aspart + Insulin Glargine', 'description': 'Insulin Aspart (prior to each meal) and Insulin Glargine (once or twice daily) ; doses individualized for each patient'}], 'classes': [{'categories': [{'measurements': [{'value': '2.97', 'spread': '0.63', 'groupId': 'OG000'}, {'value': '2.83', 'spread': '0.75', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline', 'description': 'Baseline FEV1', 'unitOfMeasure': 'L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population'}, {'type': 'SECONDARY', 'title': 'Week 16 Forced Expiratory Volume in 1 Second', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Technosphere Insulin + Insulin Glargine', 'description': 'Technosphere Insulin Inhalation Powder (administered prior to each meal) in combination with insulin glargine (once or twice daily); doses individualized for each patient'}, {'id': 'OG001', 'title': 'Insulin Aspart + Insulin Glargine', 'description': 'Insulin Aspart (prior to each meal) and Insulin Glargine (once or twice daily) ; doses individualized for each patient'}], 'classes': [{'categories': [{'measurements': [{'value': '2.91', 'spread': '0.57', 'groupId': 'OG000'}, {'value': '2.66', 'spread': '0.70', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 16', 'description': 'Week 16 FEV1', 'unitOfMeasure': 'L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population, with data available at Week 16'}, {'type': 'SECONDARY', 'title': 'Week 16 Change From Baseline in Forced Expiratory Volume in 1 Second', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Technosphere Insulin + Insulin Glargine', 'description': 'Technosphere Insulin Inhalation Powder (administered prior to each meal) in combination with insulin glargine (once or twice daily); doses individualized for each patient'}, {'id': 'OG001', 'title': 'Insulin Aspart + Insulin Glargine', 'description': 'Insulin Aspart (prior to each meal) and Insulin Glargine (once or twice daily) ; doses individualized for each patient'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.14', 'spread': '0.32', 'groupId': 'OG000'}, {'value': '-0.07', 'spread': '0.27', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to Week 16', 'description': 'Week 16 Change from Baseline in FEV1', 'unitOfMeasure': 'L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population, with data available at Week 16'}, {'type': 'SECONDARY', 'title': 'Week 20 (Follow-up) Forced Expiratory Volume in 1 Second', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Technosphere Insulin + Insulin Glargine', 'description': 'Technosphere Insulin Inhalation Powder (administered prior to each meal) in combination with insulin glargine (once or twice daily); doses individualized for each patient'}, {'id': 'OG001', 'title': 'Insulin Aspart + Insulin Glargine', 'description': 'Insulin Aspart (prior to each meal) and Insulin Glargine (once or twice daily) ; doses individualized for each patient'}], 'classes': [{'categories': [{'measurements': [{'value': '3.07', 'spread': '0.55', 'groupId': 'OG000'}, {'value': '2.86', 'spread': '0.70', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 20 (Follow-up)', 'description': 'Week 20 (Follow-up) FEV1, 4 weeks after discontinuation of study treatment', 'unitOfMeasure': 'L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population, with data available at Week 20'}, {'type': 'SECONDARY', 'title': 'Week 20 (Follow-up) Change From Baseline in Forced Expiratory Volume in 1 Second', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Technosphere Insulin + Insulin Glargine', 'description': 'Technosphere Insulin Inhalation Powder (administered prior to each meal) in combination with insulin glargine (once or twice daily); doses individualized for each patient'}, {'id': 'OG001', 'title': 'Insulin Aspart + Insulin Glargine', 'description': 'Insulin Aspart (prior to each meal) and Insulin Glargine (once or twice daily) ; doses individualized for each patient'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.07', 'spread': '0.29', 'groupId': 'OG000'}, {'value': '-0.05', 'spread': '0.28', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to Week 20', 'description': 'Week 20 (Follow-up, 4 weeks after discontinuation of study treatment) Change from Baseline in FEV1', 'unitOfMeasure': 'L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population, with data available at Week 20'}, {'type': 'SECONDARY', 'title': 'Baseline Forced Vital Capacity (FVC)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Technosphere Insulin + Insulin Glargine', 'description': 'Technosphere Insulin Inhalation Powder (administered prior to each meal) in combination with insulin glargine (once or twice daily); doses individualized for each patient'}, {'id': 'OG001', 'title': 'Insulin Aspart + Insulin Glargine', 'description': 'Insulin Aspart (prior to each meal) and Insulin Glargine (once or twice daily) ; doses individualized for each patient'}], 'classes': [{'categories': [{'measurements': [{'value': '3.63', 'spread': '0.78', 'groupId': 'OG000'}, {'value': '3.48', 'spread': '1.02', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline', 'description': 'Baseline FVC', 'unitOfMeasure': 'L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population'}, {'type': 'SECONDARY', 'title': 'Week 16 Forced Vital Capacity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Technosphere Insulin + Insulin Glargine', 'description': 'Technosphere Insulin Inhalation Powder (administered prior to each meal) in combination with insulin glargine (once or twice daily); doses individualized for each patient'}, {'id': 'OG001', 'title': 'Insulin Aspart + Insulin Glargine', 'description': 'Insulin Aspart (prior to each meal) and Insulin Glargine (once or twice daily) ; doses individualized for each patient'}], 'classes': [{'categories': [{'measurements': [{'value': '3.61', 'spread': '0.72', 'groupId': 'OG000'}, {'value': '3.33', 'spread': '0.98', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 16', 'description': 'Week 16 FVC', 'unitOfMeasure': 'L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population, with data available at Week 16'}, {'type': 'SECONDARY', 'title': 'Week 16 Change From Baseline Forced Vital Capacity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Technosphere Insulin + Insulin Glargine', 'description': 'Technosphere Insulin Inhalation Powder (administered prior to each meal) in combination with insulin glargine (once or twice daily); doses individualized for each patient'}, {'id': 'OG001', 'title': 'Insulin Aspart + Insulin Glargine', 'description': 'Insulin Aspart (prior to each meal) and Insulin Glargine (once or twice daily) ; doses individualized for each patient'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.13', 'spread': '0.34', 'groupId': 'OG000'}, {'value': '-0.07', 'spread': '0.36', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to Week 16', 'description': 'Week 16 Change from Baseline FVC', 'unitOfMeasure': 'L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population, with data available at Week 16'}, {'type': 'SECONDARY', 'title': 'Week 20 (Follow-up) Forced Vital Capacity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Technosphere Insulin + Insulin Glargine', 'description': 'Technosphere Insulin Inhalation Powder (administered prior to each meal) in combination with insulin glargine (once or twice daily); doses individualized for each patient'}, {'id': 'OG001', 'title': 'Insulin Aspart + Insulin Glargine', 'description': 'Insulin Aspart (prior to each meal) and Insulin Glargine (once or twice daily) ; doses individualized for each patient'}], 'classes': [{'categories': [{'measurements': [{'value': '3.77', 'spread': '0.73', 'groupId': 'OG000'}, {'value': '3.57', 'spread': '0.96', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 20', 'description': 'Week 20 (Follow-up, 4 weeks after discontinuation of study treatment) FVC', 'unitOfMeasure': 'L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population, with data available at Week 20'}, {'type': 'SECONDARY', 'title': 'Week 20 (Follow-up) Change From Baseline in Forced Vital Capacity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Technosphere Insulin + Insulin Glargine', 'description': 'Technosphere Insulin Inhalation Powder (administered prior to each meal) in combination with insulin glargine (once or twice daily); doses individualized for each patient'}, {'id': 'OG001', 'title': 'Insulin Aspart + Insulin Glargine', 'description': 'Insulin Aspart (prior to each meal) and Insulin Glargine (once or twice daily) ; doses individualized for each patient'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.05', 'spread': '0.35', 'groupId': 'OG000'}, {'value': '-0.06', 'spread': '0.38', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to Week 20', 'description': 'Week 20 (Follow-up, 4 weeks after discontinuation of study treatment) Change from Baseline in FVC', 'unitOfMeasure': 'L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population, with data available at Week 20'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Technosphere Insulin + Insulin Glargine', 'description': 'Technosphere Insulin Inhalation Powder (administered prior to each meal) in combination with insulin glargine (once or twice daily); doses individualized for each patient'}, {'id': 'FG001', 'title': 'Insulin Aspart + Insulin Glargine', 'description': 'Insulin Aspart (prior to each meal) and Insulin Glargine (once or twice daily) ; doses individualized for each patient'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '19'}, {'groupId': 'FG001', 'numSubjects': '20'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '15'}, {'groupId': 'FG001', 'numSubjects': '15'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '5'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Various', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'The FIrst Patient First Visit (FPFV) was September 21, 2010, and Last Patient Last Visit (LPLV) was August 25, 2011. Trial conducted in US. The study was terminated before completion of full enrollment for business reasons. Subjects already enrolled were allowed to complete the study to assess the safety of the titration algorithms.', 'preAssignmentDetails': 'After a 1 week to 5 week run-in period, subjects were randomized to receive either TI Inhalation Powder in combination with insulin glargine, or insulin aspart in combination with insulin glargine.\n\n105 Screened/46 Eligible. 39 subjects were randomized; 59 screen failures and 7 were screened but not randomized.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '37', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Technosphere Insulin + Insulin Glargine', 'description': 'Technosphere Insulin Inhalation Powder (administered prior to each meal) in combination with insulin glargine (once or twice daily); doses individualized for each patient'}, {'id': 'BG001', 'title': 'Insulin Aspart + Insulin Glargine', 'description': 'Insulin Aspart (prior to each meal) and Insulin Glargine (once or twice daily) ; doses individualized for each patient'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '60.6', 'spread': '7.95', 'groupId': 'BG000', 'lowerLimit': '47', 'upperLimit': '72'}, {'value': '58.1', 'spread': '10.67', 'groupId': 'BG001', 'lowerLimit': '42', 'upperLimit': '78'}, {'value': '59.4', 'groupId': 'BG002', 'lowerLimit': '42', 'upperLimit': '78'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '37', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Duration of Diabetes', 'classes': [{'categories': [{'measurements': [{'value': '14.6', 'spread': '7.95', 'groupId': 'BG000', 'lowerLimit': '3.7', 'upperLimit': '35.9'}, {'value': '15.6', 'spread': '10.67', 'groupId': 'BG001', 'lowerLimit': '2.5', 'upperLimit': '43.1'}, {'value': '15.1', 'groupId': 'BG002', 'lowerLimit': '2.5', 'upperLimit': '43.1'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Body Weight', 'classes': [{'categories': [{'measurements': [{'value': '100.9', 'spread': '21.84', 'groupId': 'BG000', 'lowerLimit': '54.1', 'upperLimit': '141.9'}, {'value': '100.8', 'spread': '20.30', 'groupId': 'BG001', 'lowerLimit': '66.4', 'upperLimit': '138.6'}, {'value': '100.9', 'groupId': 'BG002', 'lowerLimit': '54.1', 'upperLimit': '141.9'}]}]}], 'paramType': 'MEAN', 'description': 'Body Weight (kg) at Randomization', 'unitOfMeasure': 'kg', 'dispersionType': 'FULL_RANGE'}, {'title': 'Body Mass Index', 'classes': [{'categories': [{'measurements': [{'value': '33.2', 'spread': '5.78', 'groupId': 'BG000', 'lowerLimit': '19.3', 'upperLimit': '42.9'}, {'value': '33.3', 'spread': '5.51', 'groupId': 'BG001', 'lowerLimit': '24.3', 'upperLimit': '44.1'}, {'value': '33.2', 'groupId': 'BG002', 'lowerLimit': '19.3', 'upperLimit': '44.1'}]}]}], 'paramType': 'MEAN', 'description': 'Body Mass Index (kg/m2) at Randomization', 'unitOfMeasure': 'kg/m2', 'dispersionType': 'FULL_RANGE'}, {'title': 'HbA1c', 'classes': [{'categories': [{'measurements': [{'value': '7.76', 'spread': '1.097', 'groupId': 'BG000', 'lowerLimit': '6.3', 'upperLimit': '10.2'}, {'value': '7.94', 'spread': '1.098', 'groupId': 'BG001', 'lowerLimit': '6.7', 'upperLimit': '10.3'}, {'value': '7.85', 'groupId': 'BG002', 'lowerLimit': '6.3', 'upperLimit': '10.3'}]}]}], 'paramType': 'MEAN', 'description': 'HbA1c (%) at randomization (NOTE: Aspart group only had 17 with HbA1c measurements at baseline)', 'unitOfMeasure': '%', 'dispersionType': 'FULL_RANGE'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 39}}, 'statusModule': {'whyStopped': 'For Business Reasons', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2010-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-10', 'dispFirstSubmitDate': '2012-05-09', 'completionDateStruct': {'date': '2012-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-10-21', 'studyFirstSubmitDate': '2010-08-30', 'dispFirstSubmitQcDate': '2012-05-09', 'resultsFirstSubmitDate': '2014-07-22', 'studyFirstSubmitQcDate': '2010-09-03', 'dispFirstPostDateStruct': {'date': '2012-05-14', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2014-10-30', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2014-10-20', 'studyFirstPostDateStruct': {'date': '2010-09-08', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-10-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in HbA1c (%) From Baseline to Week 16', 'timeFrame': 'Baseline to Week 16', 'description': 'Change from Baseline in glycated hemoglobin at Week 16'}], 'secondaryOutcomes': [{'measure': 'To Evaluate the Effect of Each Treatment on HbA1c', 'timeFrame': 'Change from baseline to 16 weeks', 'description': 'Not analyzed due to early termination of the trial.'}, {'measure': 'Comparison of Fasting Plasma Glucose (FPG) Levels at Randomization and Throughout the Study', 'timeFrame': 'Change from baseline to 16 weeks', 'description': 'Not analyzed due to early termination of the trial.'}, {'measure': 'Comparison of Post-prandial Glucose (PPG) Levels at Randomization and Throughout the Study', 'timeFrame': 'Change from baseline to 16 weeks', 'description': 'Not analyzed due to early termination of the trial.'}, {'measure': 'Glycomark and Fructosamine Levels Measured Throughout the Study', 'timeFrame': 'Change from baseline to 16 weeks', 'description': 'Not analyzed due to early termination of the trial.'}, {'measure': 'Seven-point Glucose at Randomization and Throughout the Study', 'timeFrame': 'Change from baseline to 16 weeks', 'description': 'Not analyzed due to early termination of the trial.'}, {'measure': 'Glycemic Excursions and Variability as Assessed Through Continuous Glucose Monitoring (CGM)', 'timeFrame': 'Change from baseline to 16 weeks', 'description': 'Not analyzed due to early termination of the trial.'}, {'measure': 'Changes in Body Weight at 16 Weeks', 'timeFrame': 'Change from baseline to 16 weeks', 'description': 'Not analyzed due to early termination of the trial.'}, {'measure': 'Treatment Satisfaction as Assessed by Subject Treatment and Health Outcomes Questionnaires', 'timeFrame': 'Change from baseline to 16 weeks', 'description': 'Not analyzed due to early termination of the trial.'}, {'measure': 'Total Number of Cough Episodes', 'timeFrame': 'Baseline to Week 16', 'description': 'Total number of times patients coughed once, intermittently or continuously (inclusive)'}, {'measure': 'Severe Hypoglycemic Event Rate', 'timeFrame': 'Baseline to Week 16', 'description': 'Severe hypoglycemic event rate, ie, total number of events divided by subject-months of observation\n\nSevere hypoglycemia is defined as a subject who requires the assistance of another individual (not merely requested) and either:\n\n* SMBG levels ≤ 36 mg/dL OR\n* There is a prompt response to the administration of carbohydrate, glucagon, or other resuscitative measures'}, {'measure': 'Mild or Moderate Hypoglycemic Event Rate', 'timeFrame': 'Baseline to Week 16', 'description': 'Mild or moderate hypoglycemic event rate, ie, total number of events divided by subject-months of observation\n\nNonsevere hypoglycemia is defined as a subject:\n\n* SMBG levels \\< 70 mg/dL AND/OR\n* Symptoms that are relieved by the self-administration of carbohydrates'}, {'measure': 'Number of Subjects Reporting Cough Episodes', 'timeFrame': 'Baseline to Week 16', 'description': 'Number of Subjects Reporting Cough Episodes'}, {'measure': 'Number of Subjects Reporting Intermittent Coughing Episodes', 'timeFrame': 'Baseline to Week 16', 'description': 'Number of subjects reporting Intermittent Coughing Episodes'}, {'measure': 'Number of Single Coughing Episodes', 'timeFrame': 'Baseline to Week 16', 'description': 'Total number of times patients coughed only once'}, {'measure': 'Number of Cough Episodes Occuring Within 10 Minutes of Drug Inhalation', 'timeFrame': 'Baseline to Week 16'}, {'measure': 'Baseline Forced Expiratory Volume in 1 Second (FEV1)', 'timeFrame': 'Baseline', 'description': 'Baseline FEV1'}, {'measure': 'Week 16 Forced Expiratory Volume in 1 Second', 'timeFrame': 'Week 16', 'description': 'Week 16 FEV1'}, {'measure': 'Week 16 Change From Baseline in Forced Expiratory Volume in 1 Second', 'timeFrame': 'Baseline to Week 16', 'description': 'Week 16 Change from Baseline in FEV1'}, {'measure': 'Week 20 (Follow-up) Forced Expiratory Volume in 1 Second', 'timeFrame': 'Week 20 (Follow-up)', 'description': 'Week 20 (Follow-up) FEV1, 4 weeks after discontinuation of study treatment'}, {'measure': 'Week 20 (Follow-up) Change From Baseline in Forced Expiratory Volume in 1 Second', 'timeFrame': 'Baseline to Week 20', 'description': 'Week 20 (Follow-up, 4 weeks after discontinuation of study treatment) Change from Baseline in FEV1'}, {'measure': 'Baseline Forced Vital Capacity (FVC)', 'timeFrame': 'Baseline', 'description': 'Baseline FVC'}, {'measure': 'Week 16 Forced Vital Capacity', 'timeFrame': 'Week 16', 'description': 'Week 16 FVC'}, {'measure': 'Week 16 Change From Baseline Forced Vital Capacity', 'timeFrame': 'Baseline to Week 16', 'description': 'Week 16 Change from Baseline FVC'}, {'measure': 'Week 20 (Follow-up) Forced Vital Capacity', 'timeFrame': 'Week 20', 'description': 'Week 20 (Follow-up, 4 weeks after discontinuation of study treatment) FVC'}, {'measure': 'Week 20 (Follow-up) Change From Baseline in Forced Vital Capacity', 'timeFrame': 'Baseline to Week 20', 'description': 'Week 20 (Follow-up, 4 weeks after discontinuation of study treatment) Change from Baseline in FVC'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Type 2 Diabetes']}, 'descriptionModule': {'briefSummary': 'This is an open-label, randomized, forced-titration clinical trial evaluating the efficacy and safety of Technosphere Insulin (TI) Inhalation Powder in combination with insulin glargine versus insulin aspart in combination with insulin glargine in subjects with type 2 diabetes.', 'detailedDescription': 'Phase 3 clinical trial is designed to examine the efficacy and safety of inhaled prandial TI Inhalation Powder in combination with basal insulin verses insulin aspart in combination with basal insulin in subjects with type 2 diabetes who are suboptimally controlled with their current insulin regimens.This trial will employ a variety of methods to intensively manage these subjects.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Men and women ≥ 18 and ≤ 80 years of age\n* Clinical diagnosis of type 2 diabetes mellitus for more than 12 months\n* Body mass index (BMI) ≤ 45 kg/m2\n* Glycated Hemoglobin (HbA1c) \\> 6.5% and ≤ 10.0%\n* Treatment with 1 to 3 Oral Antidiabetic Drugs (OADs) and basal insulin for a minimum of 3 months before screening. Doses of OADs must have been stable for 3 months before study entry\n* Nonsmokers (includes cigarettes, cigars, pipes, and chewing tobacco) for the preceding ≥ 6 months\n* Office spirometry at the investigator site\n\n * Forced expiratory volume in 1 second (FEV1) ≥ 65% Third National Health and Nutrition Examination Survey (NHANES III) predicted\n * Forced vital capacity (FVC) ≥ 65% NHANES III predicted\n * Forced expiratory volume in 1 second as a percentage of forced vital capacity (FEV1/FVC) ≥ lower limit of normal (LLN)\n\nExclusion criteria:\n\n* Current or prior treatment with prandial or PreMix (70/30) insulin\n* History of insulin pump use within 6 weeks of Visit 1\n* Treatment with Glucagon-like Peptide (GLP-1) analog drugs within the preceding 12 weeks of Visit 1\n* History of chronic obstructive pulmonary disease (COPD), asthma, or any other clinically important pulmonary disease (eg, pulmonary fibrosis)\n* Any clinically significant radiological findings on screening chest x-ray\n* Use of medications for asthma, COPD, or any other chronic respiratory conditions\n* Evidence of serious complications of diabetes (eg, symptomatic autonomic neuropathy)\n* Significant cardiovascular dysfunction or history within 3 months of Visit 1 (eg, congestive heart failure \\[New York Heart Association {NYHA} Class III or IV\\])\n* Serious arrhythmia, myocardial infarction, cardiac surgery, recurrent syncope, transient ischemic attacks, or any cerebrovascular accident\n* History of pulmonary embolism or deep venous thrombosis in the 12 months before Screening (Visit 1)'}, 'identificationModule': {'nctId': 'NCT01196104', 'briefTitle': 'Clinical Trial Evaluating the Efficacy and Safety of Technosphere® Inhalation Insulin (TI) Inhalation Powder Using the Gen2 Inhaler', 'organization': {'class': 'INDUSTRY', 'fullName': 'Mannkind Corporation'}, 'officialTitle': 'A Phase 3b, Multicenter, Open-label, Randomized, Forced-titration Clinical Trial Evaluating the Efficacy and Safety of Technosphere® Insulin Inhalation Powder, Using the Gen2 Inhaler, in Combination With Insulin Glargine Versus Insulin Aspart in Combination With Insulin Glargine in Subjects With Type 2 Diabetes Mellitus Over a 16-week Treatment Period', 'orgStudyIdInfo': {'id': 'MKC-TI-162'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Technosphere® Insulin Inhalation Powder (TI)', 'description': 'Insulin Glargine and Technosphere® Insulin Inhalation Powder', 'interventionNames': ['Drug: Technosphere® Insulin Inhalation Powder', 'Drug: Insulin Glargine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Comparator', 'description': 'Insulin Glargine and Insulin Aspart', 'interventionNames': ['Drug: Insulin Aspart', 'Drug: Insulin Glargine']}], 'interventions': [{'name': 'Technosphere® Insulin Inhalation Powder', 'type': 'DRUG', 'armGroupLabels': ['Technosphere® Insulin Inhalation Powder (TI)']}, {'name': 'Insulin Aspart', 'type': 'DRUG', 'description': 'Usual Care', 'armGroupLabels': ['Comparator']}, {'name': 'Insulin Glargine', 'type': 'DRUG', 'armGroupLabels': ['Comparator', 'Technosphere® Insulin Inhalation Powder (TI)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '36608', 'city': 'Mobile', 'state': 'Alabama', 'country': 'United States', 'facility': 'Coastal Clinical Research Inc', 'geoPoint': {'lat': 30.69436, 'lon': -88.04305}}, {'zip': '93720', 'city': 'Fresno', 'state': 'California', 'country': 'United States', 'facility': 'Valley Research', 'geoPoint': {'lat': 36.74773, 'lon': -119.77237}}, {'zip': '90806', 'city': 'Long Beach', 'state': 'California', 'country': 'United States', 'facility': 'Health Care Partners Medical Group', 'geoPoint': {'lat': 33.76696, 'lon': -118.18923}}, {'zip': '92780', 'city': 'Tustin', 'state': 'California', 'country': 'United States', 'facility': 'Diabetes Research Center', 'geoPoint': {'lat': 33.74585, 'lon': -117.82617}}, {'zip': '94598', 'city': 'Walnut Creek', 'state': 'California', 'country': 'United States', 'facility': 'Diablo Clinical Research', 'geoPoint': {'lat': 37.90631, 'lon': -122.06496}}, {'zip': '30308', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Laureate Clinical Research Group', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '30309', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Atlanta Diabetes Associates', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '30338', 'city': 'Dunwoody', 'state': 'Georgia', 'country': 'United States', 'facility': 'Alta Pharmaceutical Research Center', 'geoPoint': {'lat': 33.94621, 'lon': -84.33465}}, {'zip': '60612', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'John H Stoger Jr Hospital of Cook County', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '46360', 'city': 'Michigan City', 'state': 'Indiana', 'country': 'United States', 'facility': 'LaPorte County Institute for Clinical Research Inc.', 'geoPoint': {'lat': 41.70754, 'lon': -86.89503}}, {'zip': '55435', 'city': 'Edina', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Radiant Research Inc (Minneapolis)', 'geoPoint': {'lat': 44.88969, 'lon': -93.34995}}, {'zip': '63376', 'city': 'City of Saint Peters', 'state': 'Missouri', 'country': 'United States', 'facility': "Amin Radparvar's Private Practice", 'geoPoint': {'lat': 38.80033, 'lon': -90.62651}}, {'zip': '63110', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Washington University School of Medicine', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '59101', 'city': 'Billings', 'state': 'Montana', 'country': 'United States', 'facility': 'Billings Clinic Research Center', 'geoPoint': {'lat': 45.78329, 'lon': -108.50069}}, {'zip': '68131', 'city': 'Omaha', 'state': 'Nebraska', 'country': 'United States', 'facility': 'Creighton Diabetes Center', 'geoPoint': {'lat': 41.25626, 'lon': -95.94043}}, {'zip': '87131', 'city': 'Albuquerque', 'state': 'New Mexico', 'country': 'United States', 'facility': 'University of New Mexico HCS', 'geoPoint': {'lat': 35.08449, 'lon': -106.65114}}, {'zip': '11501', 'city': 'Mineola', 'state': 'New York', 'country': 'United States', 'facility': 'Winthrop University Hospital', 'geoPoint': {'lat': 40.74927, 'lon': -73.64068}}, {'zip': '11042', 'city': 'New Hyde Park', 'state': 'New York', 'country': 'United States', 'facility': 'North Shore Diabetes and Endocrine Associates', 'geoPoint': {'lat': 40.7351, 'lon': -73.68791}}, {'zip': '27834', 'city': 'Greenville', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Endocrine Research Physicians East PA', 'geoPoint': {'lat': 35.61266, 'lon': -77.36635}}, {'zip': '44060', 'city': 'Mentor', 'state': 'Ohio', 'country': 'United States', 'facility': 'Your Diabetes Endocrine Nutrition Group, Inc.', 'geoPoint': {'lat': 41.66616, 'lon': -81.33955}}, {'zip': '97232', 'city': 'Portland', 'state': 'Oregon', 'country': 'United States', 'facility': 'Legacy Clinical Research', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}, {'zip': '97239', 'city': 'Portland', 'state': 'Oregon', 'country': 'United States', 'facility': 'OHSU Diabetes Center Research Oregon Health & Science University', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}, {'zip': '38119', 'city': 'Memphis', 'state': 'Tennessee', 'country': 'United States', 'facility': 'The Endocrine Clinic', 'geoPoint': {'lat': 35.14953, 'lon': -90.04898}}, {'zip': '75230', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'Dallas Diabetes & Endocrine Center', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '75246', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'Baylor Endocrine Center', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '75390', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'University of Texas Southwestern Medical Center', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '78229', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'SAM Clinical Research Center', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': '84044', 'city': 'Magna', 'state': 'Utah', 'country': 'United States', 'facility': 'Exodus Healthcare Network', 'geoPoint': {'lat': 40.70911, 'lon': -112.10161}}, {'zip': '05403', 'city': 'South Burlington', 'state': 'Vermont', 'country': 'United States', 'facility': 'Diabetes Research Center -Fletcher Allen Health Care', 'geoPoint': {'lat': 44.46699, 'lon': -73.17096}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mannkind Corporation', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}