Ignite Creation Date:
2025-12-24 @ 11:52 PM
Ignite Modification Date:
2025-12-25 @ 9:47 PM
Study NCT ID:
NCT01445951
Status:
COMPLETED
Last Update Posted:
2014-10-22
First Post:
2011-09-30
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Clinical Trial Evaluating Technosphere® Insulin Versus Insulin Aspart in Subjects With Type 1 Diabetes Mellitus Over a 24-week Treatment Period
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D061267', 'term': 'Insulin Aspart'}], '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'}]}}, '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': 'Baseline to Week 24', 'description': 'Adverse Events (AE) are summarized according to how subjects were treated, not randomized. One subject that was randomized to the Technosphere Insulin-MedTone + Basal Insulin arm was treated with Insulin aspart + Basal Insulin throughout the trial.', 'eventGroups': [{'id': 'EG000', 'title': 'Technosphere ® Insulin-Gen2 Group', 'description': 'Subject will receive Technosphere Insulin with Gen2 Inhaler and remain on the basal insulin they were taking prior to study entry\n\nTechnosphere ®Insulin with Gen2 Inhaler: Inhalation Powder and injectable insulin', 'otherNumAtRisk': 174, 'otherNumAffected': 81, 'seriousNumAtRisk': 174, 'seriousNumAffected': 5}, {'id': 'EG001', 'title': 'Technosphere® Insulin With MedTone C Inhaler', 'description': 'Subjects will receive TI with the MedToneC inhaler and remain on the basal insulin they were taking prior to study entry\n\nTechnosphere® Insulin with MedTone C Inhaler: Inhalation Powder and injectable insulin', 'otherNumAtRisk': 173, 'otherNumAffected': 74, 'seriousNumAtRisk': 173, 'seriousNumAffected': 9}, {'id': 'EG002', 'title': 'Aspart Group', 'description': 'Subjects will receive insulin aspart and remain on the basal insulin they were taking prior to study entry\n\nInsulin Aspart in combination with a basal insulin: Injectable insulin', 'otherNumAtRisk': 171, 'otherNumAffected': 50, 'seriousNumAtRisk': 171, 'seriousNumAffected': 7}], 'otherEvents': [{'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numAffected': 55}, {'groupId': 'EG001', 'numAtRisk': 173, 'numAffected': 39}, {'groupId': 'EG002', 'numAtRisk': 171, 'numAffected': 4}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Upper Respiratory Tract Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 173, 'numAffected': 16}, {'groupId': 'EG002', 'numAtRisk': 171, 'numAffected': 12}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 173, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 171, 'numAffected': 4}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 173, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 171, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 173, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 171, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 173, 'numAffected': 13}, {'groupId': 'EG002', 'numAtRisk': 171, 'numAffected': 12}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Throat Irritation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 173, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 171, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 173, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 171, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Oropharyngeal Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 173, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 171, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 173, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 171, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 173, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 171, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Urinary Tract Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 173, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 171, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 173, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 171, 'numAffected': 6}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Blood Creatine Phosphokinase Increase', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 173, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 171, 'numAffected': 4}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}], 'seriousEvents': [{'term': 'Chest Discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 173, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 171, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Drowning', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 173, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 171, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Cytomegalovirus Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 173, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 171, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Appendicitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 173, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 171, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Joint Dislocation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 173, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 171, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Hypoglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 173, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 171, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Spinal Osteoarthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 173, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 171, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Hypoglycaemic Unconsciousness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 173, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 171, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Hypoglycaemic Seizure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 173, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 171, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Mental Status Changes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 173, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 171, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Cervical Polyp', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 173, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 171, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Bronchial Hyperreactivity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 173, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 171, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}], 'frequencyThreshold': '2'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change From Baseline to Week 24 in HbA1c', 'denoms': [{'units': 'Participants', 'counts': [{'value': '174', 'groupId': 'OG000'}, {'value': '174', 'groupId': 'OG001'}, {'value': '170', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Technosphere Insulin-Gen2 + Basal Insulin', 'description': 'Technosphere Insulin delivered via the Gen2 Inhaler plus subcutaneous basal insulin, doses individualized for each patient'}, {'id': 'OG001', 'title': 'Technosphere Insulin-MedTone + Basal Insulin', 'description': 'Technosphere Insulin delivered via the MedTone C Inhaler plus subcutaneous basal insulin, doses individualized for each patient'}, {'id': 'OG002', 'title': 'Insulin Aspart + Basal Insulin', 'description': 'Subcutaneous insulin aspart plus subcutaneous basal insulin, doses individualized for each patient'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.21', 'spread': '0.062', 'groupId': 'OG000'}, {'value': '-0.29', 'spread': '0.061', 'groupId': 'OG001'}, {'value': '-0.40', 'spread': '0.060', 'groupId': 'OG002'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.19', 'ciLowerLimit': '0.02', 'ciUpperLimit': '0.36', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.086', 'groupDescription': 'MMRM (mixed model repeated measures) model with auto-regression (1): HbA1c = Baseline HbA1c + region + basal insulin stratum + visit + treatment + (visit\\*treatment)', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'Non-inferiority with 0.4 margin'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline to Week 24', 'description': 'Effect of treatment as measured by change from baseline in glycated hemoglobin (HbA1c). Primary treatment difference is TI-Gen2 vs. Insulin Aspart at Week 24', 'unitOfMeasure': 'Percent of hemoglobin', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set'}, {'type': 'SECONDARY', 'title': 'FEV1 Change From Baseline to Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '174', 'groupId': 'OG000'}, {'value': '173', 'groupId': 'OG001'}, {'value': '171', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Technosphere Insulin-Gen2 + Basal Insulin', 'description': 'Technosphere Insulin delivered via the Gen2 Inhaler plus subcutaneous basal insulin, doses individualized for each patient'}, {'id': 'OG001', 'title': 'Technosphere Insulin-MedTone + Basal Insulin', 'description': 'Technosphere Insulin delivered via the MedTone C Inhaler plus subcutaneous basal insulin, doses individualized for each patient'}, {'id': 'OG002', 'title': 'Insulin Aspart + Basal Insulin', 'description': 'Subcutaneous insulin aspart plus subcutaneous basal insulin, doses individualized for each patient'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.07', 'spread': '0.012', 'groupId': 'OG000'}, {'value': '-0.08', 'spread': '0.012', 'groupId': 'OG001'}, {'value': '-0.04', 'spread': '0.011', 'groupId': 'OG002'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.01', 'ciLowerLimit': '-0.02', 'ciUpperLimit': '0.04', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.016', 'estimateComment': 'Mixed Model Repeated Measure (MMRM): FEV1 = Baseline FEV1 + Age + Gender + Race + Baseline Height + Visit + Treatment + (Visit\\*Treatment)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline to Week 24', 'description': 'Forced Expiratory Volume in 1 second - change from baseline to week 24', 'unitOfMeasure': 'Liters', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population'}, {'type': 'SECONDARY', 'title': 'FPG Change From Baseline to Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '174', 'groupId': 'OG000'}, {'value': '174', 'groupId': 'OG001'}, {'value': '170', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Technosphere Insulin-Gen2 + Basal Insulin', 'description': 'Technosphere Insulin delivered via the Gen2 Inhaler plus subcutaneous basal insulin, doses individualized for each patient'}, {'id': 'OG001', 'title': 'Technosphere Insulin-MedTone + Basal Insulin', 'description': 'Technosphere Insulin delivered via the MedTone C Inhaler plus subcutaneous basal insulin, doses individualized for each patient'}, {'id': 'OG002', 'title': 'Insulin Aspart + Basal Insulin', 'description': 'Subcutaneous insulin aspart plus subcutaneous basal insulin, doses individualized for each patient'}], 'classes': [{'categories': [{'measurements': [{'value': '-25.27', 'spread': '7.62', 'groupId': 'OG000'}, {'value': '7.15', 'spread': '7.53', 'groupId': 'OG001'}, {'value': '10.15', 'spread': '7.40', 'groupId': 'OG002'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-35.42', 'ciLowerLimit': '-56.25', 'ciUpperLimit': '-14.59', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '10.622', 'estimateComment': 'MMRM: FPG = Baseline FPG + Region + Basal insulin stratum + Visit + Treatment + (Visit\\*Treatment)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline to Week 24', 'description': 'Comparison of mean change from Baseline to Week 24 visit in fasting plasma glucose (FPG) levels (central laboratory results)', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set'}, {'type': 'SECONDARY', 'title': 'Mean 7-point Glucose Baseline Values', 'denoms': [{'units': 'Participants', 'counts': [{'value': '174', 'groupId': 'OG000'}, {'value': '174', 'groupId': 'OG001'}, {'value': '170', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Technosphere Insulin-Gen2 + Basal Insulin', 'description': 'Technosphere Insulin delivered via the Gen2 Inhaler plus subcutaneous basal insulin, doses individualized for each patient'}, {'id': 'OG001', 'title': 'Technosphere Insulin-MedTone + Basal Insulin', 'description': 'Technosphere Insulin delivered via the MedTone C Inhaler plus subcutaneous basal insulin, doses individualized for each patient'}, {'id': 'OG002', 'title': 'Insulin Aspart + Basal Insulin', 'description': 'Subcutaneous insulin aspart plus subcutaneous basal insulin, doses individualized for each patient'}], 'classes': [{'title': 'Before breakfast', 'categories': [{'measurements': [{'value': '154.1', 'spread': '38.85', 'groupId': 'OG000'}, {'value': '151.8', 'spread': '40.32', 'groupId': 'OG001'}, {'value': '147.0', 'spread': '39.09', 'groupId': 'OG002'}]}]}, {'title': 'After breakfast', 'categories': [{'measurements': [{'value': '173.3', 'spread': '48.77', 'groupId': 'OG000'}, {'value': '173.5', 'spread': '48.36', 'groupId': 'OG001'}, {'value': '162.6', 'spread': '49.50', 'groupId': 'OG002'}]}]}, {'title': 'Before lunch', 'categories': [{'measurements': [{'value': '158.0', 'spread': '47.39', 'groupId': 'OG000'}, {'value': '156.6', 'spread': '42.91', 'groupId': 'OG001'}, {'value': '142.3', 'spread': '37.86', 'groupId': 'OG002'}]}]}, {'title': 'After lunch', 'categories': [{'measurements': [{'value': '169.5', 'spread': '52.25', 'groupId': 'OG000'}, {'value': '169.7', 'spread': '49.23', 'groupId': 'OG001'}, {'value': '157.6', 'spread': '48.08', 'groupId': 'OG002'}]}]}, {'title': 'Before dinner', 'categories': [{'measurements': [{'value': '169.9', 'spread': '47.12', 'groupId': 'OG000'}, {'value': '168.1', 'spread': '45.24', 'groupId': 'OG001'}, {'value': '154.0', 'spread': '46.53', 'groupId': 'OG002'}]}]}, {'title': 'After dinner', 'categories': [{'measurements': [{'value': '176.2', 'spread': '51.55', 'groupId': 'OG000'}, {'value': '177.0', 'spread': '53.17', 'groupId': 'OG001'}, {'value': '158.5', 'spread': '47.64', 'groupId': 'OG002'}]}]}, {'title': 'Bedtime', 'categories': [{'measurements': [{'value': '178.3', 'spread': '51.38', 'groupId': 'OG000'}, {'value': '175.1', 'spread': '43.99', 'groupId': 'OG001'}, {'value': '164.4', 'spread': '49.97', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline', 'description': 'Mean 7-point glucose at baseline', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set'}, {'type': 'SECONDARY', 'title': 'Mean 7-point Glucose Week 24 Values', 'denoms': [{'units': 'Participants', 'counts': [{'value': '174', 'groupId': 'OG000'}, {'value': '174', 'groupId': 'OG001'}, {'value': '170', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Technosphere Insulin-Gen2 + Basal Insulin', 'description': 'Technosphere Insulin delivered via the Gen2 Inhaler plus subcutaneous basal insulin, doses individualized for each patient'}, {'id': 'OG001', 'title': 'Technosphere Insulin-MedTone + Basal Insulin', 'description': 'Technosphere Insulin delivered via the MedTone C Inhaler plus subcutaneous basal insulin, doses individualized for each patient'}, {'id': 'OG002', 'title': 'Insulin Aspart + Basal Insulin', 'description': 'Subcutaneous insulin aspart plus subcutaneous basal insulin, doses individualized for each patient'}], 'classes': [{'title': 'Before breakfast', 'categories': [{'measurements': [{'value': '148.2', 'spread': '40.64', 'groupId': 'OG000'}, {'value': '147.9', 'spread': '43.17', 'groupId': 'OG001'}, {'value': '155.3', 'spread': '48.44', 'groupId': 'OG002'}]}]}, {'title': 'After breakfast', 'categories': [{'measurements': [{'value': '169.7', 'spread': '67.53', 'groupId': 'OG000'}, {'value': '164.1', 'spread': '60.97', 'groupId': 'OG001'}, {'value': '163.0', 'spread': '58.00', 'groupId': 'OG002'}]}]}, {'title': 'Before lunch', 'categories': [{'measurements': [{'value': '168.2', 'spread': '56.93', 'groupId': 'OG000'}, {'value': '165.9', 'spread': '59.95', 'groupId': 'OG001'}, {'value': '149.1', 'spread': '50.58', 'groupId': 'OG002'}]}]}, {'title': 'After lunch', 'categories': [{'measurements': [{'value': '173.7', 'spread': '57.09', 'groupId': 'OG000'}, {'value': '163.1', 'spread': '50.92', 'groupId': 'OG001'}, {'value': '158.2', 'spread': '50.04', 'groupId': 'OG002'}]}]}, {'title': 'Before dinner', 'categories': [{'measurements': [{'value': '177.8', 'spread': '59.96', 'groupId': 'OG000'}, {'value': '177.3', 'spread': '56.71', 'groupId': 'OG001'}, {'value': '156.8', 'spread': '48.30', 'groupId': 'OG002'}]}]}, {'title': 'After dinner', 'categories': [{'measurements': [{'value': '180.8', 'spread': '63.50', 'groupId': 'OG000'}, {'value': '168.2', 'spread': '60.77', 'groupId': 'OG001'}, {'value': '157.8', 'spread': '52.62', 'groupId': 'OG002'}]}]}, {'title': 'Bedtime', 'categories': [{'measurements': [{'value': '185.2', 'spread': '62.36', 'groupId': 'OG000'}, {'value': '185.6', 'spread': '54.96', 'groupId': 'OG001'}, {'value': '175.4', 'spread': '57.37', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 24', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set'}, {'type': 'SECONDARY', 'title': 'Change in Body Weight From Baseline to Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '132', 'groupId': 'OG000'}, {'value': '140', 'groupId': 'OG001'}, {'value': '153', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Technosphere Insulin-Gen2 + Basal Insulin', 'description': 'Technosphere Insulin delivered via the Gen2 Inhaler plus subcutaneous basal insulin, doses individualized for each patient'}, {'id': 'OG001', 'title': 'Technosphere Insulin-MedTone + Basal Insulin', 'description': 'Technosphere Insulin delivered via the MedTone C Inhaler plus subcutaneous basal insulin, doses individualized for each patient'}, {'id': 'OG002', 'title': 'Insulin Aspart + Basal Insulin', 'description': 'Subcutaneous insulin aspart plus subcutaneous basal insulin, doses individualized for each patient'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.39', 'spread': '0.438', 'groupId': 'OG000'}, {'value': '-0.19', 'spread': '0.428', 'groupId': 'OG001'}, {'value': '0.93', 'spread': '0.441', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.0102', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.32', 'ciLowerLimit': '-2.33', 'ciUpperLimit': '-0.31', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.512', 'estimateComment': 'ANCOVA: Weight change from baseline = Baseline weight + Change from baseline in HbA1c + Region + Basal insulin stratum + Treatment', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'ANCOVA: Weight change from baseline = Baseline weight + Change from baseline in HbA1c + Region + Basal insulin stratum + Treatment', 'testedNonInferiority': False}, {'pValue': '0.4955', 'groupIds': ['OG000'], 'groupDescription': 'Within treatment analysis of change from Baseline comparing if change was different from zero', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.6807', 'groupIds': ['OG001'], 'groupDescription': 'Within treatment analysis of change from Baseline comparing if change was different from zero', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.0079', 'groupIds': ['OG002'], 'groupDescription': 'Within treatment analysis of change from Baseline comparing if change was different from zero', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline to Week 24', 'description': 'Change in body weight from Baseline to Week 24', 'unitOfMeasure': 'kg', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set (subjects with data available at Baseline and at Week 24)'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Incidence of Total Hypoglycemia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '174', 'groupId': 'OG000'}, {'value': '173', 'groupId': 'OG001'}, {'value': '171', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Technosphere Insulin-Gen2 + Basal Insulin', 'description': 'Technosphere Insulin delivered via the Gen2 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{'type': 'OTHER_PRE_SPECIFIED', 'title': 'Incidence of Severe Hypoglycemia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '174', 'groupId': 'OG000'}, {'value': '173', 'groupId': 'OG001'}, {'value': '171', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Technosphere Insulin-Gen2 + Basal Insulin', 'description': 'Technosphere Insulin delivered via the Gen2 Inhaler plus subcutaneous basal insulin, doses individualized for each patient'}, {'id': 'OG001', 'title': 'Technosphere Insulin-MedTone + Basal Insulin', 'description': 'Technosphere Insulin delivered via the MedTone C Inhaler plus subcutaneous basal insulin, doses individualized for each patient'}, {'id': 'OG002', 'title': 'Insulin Aspart + Basal Insulin', 'description': 'Subcutaneous insulin aspart plus subcutaneous basal insulin, doses individualized for each patient'}], 'classes': [{'categories': [{'measurements': [{'value': '18.4', 'groupId': 'OG000'}, {'value': '21.4', 'groupId': 'OG001'}, {'value': '29.2', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.0156', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.5328', 'ciLowerLimit': '0.3198', 'ciUpperLimit': '0.8877', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Logistic model with affects for Region, Basal insulin stratum, and Treatment', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline to Week 24', 'description': 'Severe Hypoglycemia defined as: Requiring 3rd party assistance.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Total Hypoglycemia Event Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '174', 'groupId': 'OG000'}, {'value': '173', 'groupId': 'OG001'}, {'value': '171', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Technosphere Insulin-Gen2 + Basal Insulin', 'description': 'Technosphere Insulin delivered via the Gen2 Inhaler plus subcutaneous basal insulin, doses individualized for each patient'}, {'id': 'OG001', 'title': 'Technosphere Insulin-MedTone + Basal Insulin', 'description': 'Technosphere Insulin delivered via the MedTone C Inhaler plus subcutaneous basal insulin, doses individualized for each patient'}, {'id': 'OG002', 'title': 'Insulin Aspart + Basal Insulin', 'description': 'Subcutaneous insulin aspart plus subcutaneous basal insulin, doses individualized for each patient'}], 'classes': [{'categories': [{'measurements': [{'value': '9.80', 'groupId': 'OG000'}, {'value': '10.30', 'groupId': 'OG001'}, {'value': '13.97', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG002'], 'statisticalMethod': 'Negative Binomial Regression', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Model: Region + Basal Insulin Stratum + Treatment + Exposure Time', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline to Week 24', 'description': 'Number of Hypoglycemic Events/Total Subject Exposure Time (in months)', 'unitOfMeasure': 'Events/Subject-Month', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Severe Hypoglycemia Event Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '174', 'groupId': 'OG000'}, {'value': '173', 'groupId': 'OG001'}, {'value': '171', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Technosphere Insulin-Gen2 + Basal Insulin', 'description': 'Technosphere Insulin delivered via the Gen2 Inhaler plus subcutaneous basal insulin, doses individualized for each patient'}, {'id': 'OG001', 'title': 'Technosphere Insulin-MedTone + Basal Insulin', 'description': 'Technosphere Insulin delivered via the MedTone C Inhaler plus subcutaneous basal insulin, doses individualized for each patient'}, {'id': 'OG002', 'title': 'Insulin Aspart + Basal Insulin', 'description': 'Subcutaneous insulin aspart plus subcutaneous basal insulin, doses individualized for each patient'}], 'classes': [{'categories': [{'measurements': [{'value': '8.05', 'groupId': 'OG000'}, {'value': '9.99', 'groupId': 'OG001'}, {'value': '14.45', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.1022', 'groupIds': ['OG000', 'OG002'], 'statisticalMethod': 'Negative Binomial Regression', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Model: Region + Basal Insulin Stratum + Treatment + Exposure Time', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline to Week 24', 'description': 'Number of Severe Hypoglycemic Events/Total Subject Exposure Time (in months)', 'unitOfMeasure': 'Events/Subject-Month', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population'}, {'type': 'SECONDARY', 'title': 'Proportion of Responders Achieving HbA1c <= 7.0%', 'denoms': [{'units': 'Participants', 'counts': [{'value': '131', 'groupId': 'OG000'}, {'value': '138', 'groupId': 'OG001'}, {'value': '150', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Technosphere Insulin-Gen2 + Basal Insulin', 'description': 'Technosphere Insulin delivered via the Gen2 Inhaler plus subcutaneous basal insulin, doses individualized for each patient'}, {'id': 'OG001', 'title': 'Technosphere Insulin-MedTone + Basal Insulin', 'description': 'Technosphere Insulin delivered via the MedTone C Inhaler plus subcutaneous basal insulin, doses individualized for each patient'}, {'id': 'OG002', 'title': 'Insulin Aspart + Basal Insulin', 'description': 'Subcutaneous insulin aspart plus subcutaneous basal insulin, doses individualized for each patient'}], 'classes': [{'categories': [{'measurements': [{'value': '18.3', 'groupId': 'OG000'}, {'value': '21.7', 'groupId': 'OG001'}, {'value': '30.7', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.0158', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.449', 'ciLowerLimit': '0.23', 'ciUpperLimit': '0.86', 'estimateComment': 'Gen2 in the numerator, Aspart in the denominator', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Model: Treatment + Basal insulin stratum + Region + Baseline HbA1c', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Week 24', 'description': 'Efficacy as measured in proportion of subjects achieving HbA1c \\< or = to 7.0%', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Technosphere Insulin-Gen2 + Basal Insulin', 'description': 'Technosphere Insulin delivered via the Gen2 Inhaler plus subcutaneous basal insulin, doses individualized for each patient'}, {'id': 'FG001', 'title': 'Technosphere Insulin-MedTone + Basal Insulin', 'description': 'Technosphere Insulin delivered via the MedTone C Inhaler plus subcutaneous basal insulin, doses individualized for each patient'}, {'id': 'FG002', 'title': 'Insulin Aspart + Basal Insulin', 'description': 'Subcutaneous insulin aspart plus subcutaneous basal insulin, doses individualized for each patient'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '174'}, {'groupId': 'FG001', 'numSubjects': '174'}, {'groupId': 'FG002', 'numSubjects': '170'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '130'}, {'groupId': 'FG001', 'numSubjects': '138'}, {'groupId': 'FG002', 'numSubjects': '151'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '44'}, {'groupId': 'FG001', 'numSubjects': '36'}, {'groupId': 'FG002', 'numSubjects': '19'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '16'}, {'groupId': 'FG001', 'numSubjects': '9'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '2'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '21'}, {'groupId': 'FG001', 'numSubjects': '16'}, {'groupId': 'FG002', 'numSubjects': '8'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '4'}]}, {'type': 'Pregnancy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '4'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Non-compliance with study drug', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Non-compliance with protocol', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Sponsor decision - subject travel', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Cough', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'First Patient enrolled Sept 2011. Multi-national trial conducted in US, Russia, Ukraine and Brazil.', 'preAssignmentDetails': '3 week Screening Period prior to run-in (basal insulin optimization period). 1401 Screened / 621 Eligible of which 614 entered the run-in period. 538 met randomization criteria at end of run-in of which 518 were randomized.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '174', 'groupId': 'BG000'}, {'value': '174', 'groupId': 'BG001'}, {'value': '170', 'groupId': 'BG002'}, {'value': '518', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Technosphere Insulin-Gen2 + Basal Insulin', 'description': 'Technosphere Insulin delivered via the Gen2 Inhaler plus subcutaneous basal insulin, doses individualized for each patient'}, {'id': 'BG001', 'title': 'Technosphere Insulin-MedTone + Basal Insulin', 'description': 'Technosphere Insulin delivered via the MedTone C Inhaler plus subcutaneous basal insulin, doses individualized for each patient'}, {'id': 'BG002', 'title': 'Insulin Aspart + Basal Insulin', 'description': 'Subcutaneous insulin aspart plus subcutaneous basal insulin, doses individualized for each patient'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': '18-30 years', 'categories': [{'measurements': [{'value': '56', 'groupId': 'BG000'}, {'value': '48', 'groupId': 'BG001'}, {'value': '46', 'groupId': 'BG002'}, {'value': '150', 'groupId': 'BG003'}]}]}, {'title': '31-49 years', 'categories': [{'measurements': [{'value': '93', 'groupId': 'BG000'}, {'value': '84', 'groupId': 'BG001'}, {'value': '88', 'groupId': 'BG002'}, {'value': '265', 'groupId': 'BG003'}]}]}, {'title': '50-64 years', 'categories': [{'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '33', 'groupId': 'BG001'}, {'value': '28', 'groupId': 'BG002'}, {'value': '79', 'groupId': 'BG003'}]}]}, {'title': '>= 65 years', 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '24', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '97', 'groupId': 'BG000'}, {'value': '94', 'groupId': 'BG001'}, {'value': '96', 'groupId': 'BG002'}, {'value': '287', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '77', 'groupId': 'BG000'}, {'value': '80', 'groupId': 'BG001'}, {'value': '74', 'groupId': 'BG002'}, {'value': '231', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}, {'value': '57', 'groupId': 'BG003'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '157', 'groupId': 'BG000'}, {'value': '152', 'groupId': 'BG001'}, {'value': '152', 'groupId': 'BG002'}, {'value': '461', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], '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'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Asian', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}, {'title': 'Black or African American', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '16', 'groupId': 'BG003'}]}, {'title': 'White', 'measurements': [{'value': '164', 'groupId': 'BG000'}, {'value': '167', 'groupId': 'BG001'}, {'value': '166', 'groupId': 'BG002'}, {'value': '497', 'groupId': 'BG003'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '71', 'groupId': 'BG000'}, {'value': '69', 'groupId': 'BG001'}, {'value': '67', 'groupId': 'BG002'}, {'value': '207', 'groupId': 'BG003'}]}]}, {'title': 'Brazil', 'categories': [{'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}, {'value': '42', 'groupId': 'BG003'}]}]}, {'title': 'Ukraine', 'categories': [{'measurements': [{'value': '44', 'groupId': 'BG000'}, {'value': '38', 'groupId': 'BG001'}, {'value': '38', 'groupId': 'BG002'}, {'value': '120', 'groupId': 'BG003'}]}]}, {'title': 'Russian Federation', 'categories': [{'measurements': [{'value': '45', 'groupId': 'BG000'}, {'value': '52', 'groupId': 'BG001'}, {'value': '52', 'groupId': 'BG002'}, {'value': '149', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Duration of Diabetes', 'classes': [{'categories': [{'measurements': [{'value': '16.0', 'groupId': 'BG000', 'lowerLimit': '1.1', 'upperLimit': '57.3'}, {'value': '17.7', 'groupId': 'BG001', 'lowerLimit': '1.1', 'upperLimit': '49.5'}, {'value': '16.7', 'groupId': 'BG002', 'lowerLimit': '1.0', 'upperLimit': '42.2'}, {'value': '16.8', 'groupId': 'BG003', 'lowerLimit': '1.0', 'upperLimit': '57.3'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Weight', 'classes': [{'categories': [{'measurements': [{'value': '75.7', 'groupId': 'BG000', 'lowerLimit': '41.7', 'upperLimit': '129.4'}, {'value': '76.8', 'groupId': 'BG001', 'lowerLimit': '47.6', 'upperLimit': '124.0'}, {'value': '72.6', 'groupId': 'BG002', 'lowerLimit': '46.6', 'upperLimit': '120.2'}, {'value': '75.1', 'groupId': 'BG003', 'lowerLimit': '41.7', 'upperLimit': '129.4'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg', 'dispersionType': 'FULL_RANGE'}, {'title': 'BMI', 'classes': [{'categories': [{'measurements': [{'value': '26.0', 'groupId': 'BG000', 'lowerLimit': '16.6', 'upperLimit': '38.6'}, {'value': '26.2', 'groupId': 'BG001', 'lowerLimit': '18.1', 'upperLimit': '36.4'}, {'value': '25.4', 'groupId': 'BG002', 'lowerLimit': '17.4', 'upperLimit': '37.2'}, {'value': '25.9', 'groupId': 'BG003', 'lowerLimit': '16.6', 'upperLimit': '38.6'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'FULL_RANGE'}, {'title': 'Fasting Plasma Glucose', 'classes': [{'categories': [{'measurements': [{'value': '155.0', 'groupId': 'BG000', 'lowerLimit': '21.0', 'upperLimit': '403.0'}, {'value': '144.3', 'groupId': 'BG001', 'lowerLimit': '43.0', 'upperLimit': '358.0'}, {'value': '151.2', 'groupId': 'BG002', 'lowerLimit': '23.0', 'upperLimit': '375.0'}, {'value': '150.2', 'groupId': 'BG003', 'lowerLimit': '21.0', 'upperLimit': '403.0'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'FULL_RANGE'}, {'title': 'HbA1c', 'classes': [{'categories': [{'measurements': [{'value': '7.98', 'groupId': 'BG000', 'lowerLimit': '6.20', 'upperLimit': '10.60'}, {'value': '8.00', 'groupId': 'BG001', 'lowerLimit': '6.10', 'upperLimit': '10.20'}, {'value': '7.88', 'groupId': 'BG002', 'lowerLimit': '5.80', 'upperLimit': '10.10'}, {'value': '7.95', 'groupId': 'BG003', 'lowerLimit': '5.80', 'upperLimit': '10.60'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Percent of hemoglobin', 'dispersionType': 'FULL_RANGE'}], 'populationDescription': 'Full analysis set'}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 518}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-10', 'dispFirstSubmitDate': '2013-08-19', 'completionDateStruct': {'date': '2013-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-10-20', 'studyFirstSubmitDate': '2011-09-30', 'dispFirstSubmitQcDate': '2013-08-19', 'resultsFirstSubmitDate': '2014-07-22', 'studyFirstSubmitQcDate': '2011-10-03', 'dispFirstPostDateStruct': {'date': '2013-08-27', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2014-10-22', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2014-10-20', 'studyFirstPostDateStruct': {'date': '2011-10-04', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-10-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Incidence of Total Hypoglycemia', 'timeFrame': 'Baseline to Week 24', 'description': 'Hypoglycemia, defined as blood glucose \\<= 70 mg/dL or in absence of blood glucose, symptoms that are resolved by the administration of carbohydrates.'}, {'measure': 'Incidence of Severe Hypoglycemia', 'timeFrame': 'Baseline to Week 24', 'description': 'Severe Hypoglycemia defined as: Requiring 3rd party assistance.'}, {'measure': 'Total Hypoglycemia Event Rate', 'timeFrame': 'Baseline to Week 24', 'description': 'Number of Hypoglycemic Events/Total Subject Exposure Time (in months)'}, {'measure': 'Severe Hypoglycemia Event Rate', 'timeFrame': 'Baseline to Week 24', 'description': 'Number of Severe Hypoglycemic Events/Total Subject Exposure Time (in months)'}], 'primaryOutcomes': [{'measure': 'Change From Baseline to Week 24 in HbA1c', 'timeFrame': 'Baseline to Week 24', 'description': 'Effect of treatment as measured by change from baseline in glycated hemoglobin (HbA1c). Primary treatment difference is TI-Gen2 vs. Insulin Aspart at Week 24'}], 'secondaryOutcomes': [{'measure': 'FEV1 Change From Baseline to Week 24', 'timeFrame': 'Baseline to Week 24', 'description': 'Forced Expiratory Volume in 1 second - change from baseline to week 24'}, {'measure': 'FPG Change From Baseline to Week 24', 'timeFrame': 'Baseline to Week 24', 'description': 'Comparison of mean change from Baseline to Week 24 visit in fasting plasma glucose (FPG) levels (central laboratory results)'}, {'measure': 'Mean 7-point Glucose Baseline Values', 'timeFrame': 'Baseline', 'description': 'Mean 7-point glucose at baseline'}, {'measure': 'Mean 7-point Glucose Week 24 Values', 'timeFrame': 'Week 24'}, {'measure': 'Change in Body Weight From Baseline to Week 24', 'timeFrame': 'Baseline to Week 24', 'description': 'Change in body weight from Baseline to Week 24'}, {'measure': 'Proportion of Responders Achieving HbA1c <= 7.0%', 'timeFrame': 'Week 24', 'description': 'Efficacy as measured in proportion of subjects achieving HbA1c \\< or = to 7.0%'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Type 1 Diabetes Mellitus']}, 'referencesModule': {'references': [{'pmid': '31811662', 'type': 'DERIVED', 'citation': 'Seaquist ER, Blonde L, McGill JB, Heller SR, Kendall DM, Bumpass JB, Pompilio FM, Grant ML. Hypoglycaemia is reduced with use of inhaled Technosphere(R) Insulin relative to insulin aspart in type 1 diabetes mellitus. Diabet Med. 2020 May;37(5):752-759. doi: 10.1111/dme.14202. Epub 2019 Dec 19.'}, {'pmid': '26180109', 'type': 'DERIVED', 'citation': 'Bode BW, McGill JB, Lorber DL, Gross JL, Chang PC, Bregman DB; Affinity 1 Study Group. Inhaled Technosphere Insulin Compared With Injected Prandial Insulin in Type 1 Diabetes: A Randomized 24-Week Trial. Diabetes Care. 2015 Dec;38(12):2266-73. doi: 10.2337/dc15-0075. Epub 2015 Jul 15.'}]}, 'descriptionModule': {'briefSummary': 'Open-label, randomized, forced-titration clinical trial evaluating the efficacy and safety of TI Inhalation Power in combination with a basal insulin versus insulin aspart in combination with a basal insulin', 'detailedDescription': 'Phase 3 clinical trial designed to examine the efficacy and safety of inhaled prandial TI Inhalation Power in combination with basal insulin versus insulin aspart in combination with basal insulin in subjects with type 1 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'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Men and women = 18 years of age\n* Clinical diagnosis of type 1 diabetes mellitus for at least 12 months\n* Body mass index (BMI) = 38 kg/m2\n* Stable dose of basal/bolus insulin therapy for at least 3 months with an FPG consistently \\< 220 mg/dL:\n* HbA1c = 7.5% and = 10.0%\n* Fasting C-peptide = 0.30 pmol/mL\n* Subject willingness to not use CGM during the entire course of the trial\n* Nonsmoking (includes cigarettes, cigars, pipes, and chewing tobacco) for the preceding 6 months\n* Negative urine cotinine test, defined as = 100 ng/mL\n* Lung function tests: • Forced expiratory volume in 1 second (FEV1) = 70% Third National Health and Nutrition Examination Survey (NHANES III) predicted\n* Written informed consent\n\nExclusion Criteria:\n\n* Total daily insulin dose = 2 IU/kg/day. History of insulin pump use within 3 months of Screening or use of continuous glucose monitoring within 6 weeks of Screening\n* History of inhaled insulin use in the previous 6 months\n* Two or more unexplained severe hypoglycemic episodes within 3 months of Screening or an episode of severe hypoglycemia between Visit 1 and Visit 2. Unexplained refers to episodes of severe hypoglycemia that are not related to a dosing error, lack of or a change in meal size, or related to additional/unanticipated exercise\n* Any hospitalization or emergency room visit due to poor diabetic control within 6 months of Screening, or hospitalization or emergency room visit due to poor diabetic control between Visit 1 and Visit 2\n* Allergy or known hypersensitivity to insulin or to any of the drugs to be used in the study, or a history of hypersensitivity to TI Inhalation Powder or to drugs with a similar chemical structure\n* History of recent blood transfusions (within previous 3 months), hemoglobinopathies, or any other conditions that affect HbA1c measurements.\n* History of COPD, asthma, or any other clinically important pulmonary disease (eg, pulmonary fibrosis), or use of any medications for these conditions\n* Any clinically significant radiological findings on screening chest x-ray\n* Active respiratory infection within 30 days before Screening (subject may return after 30 days from resolution for rescreening)\n* Major organ system diseases, including: ? Seizure disorder; systemic autoimmune or collagen vascular disease requiring previous or current treatment with systemic corticosteroids, cytotoxic drugs, or penicillamine; cancer (other than excised cutaneous basal cell carcinoma) or any history of lung neoplasms\n* Current or previous chemotherapy or radiation therapy that may result in pulmonary toxicity; use of medications for weight loss (eg, sibutramine, orlistat) within 12 weeks of Screening; treatment with amiodarone within 12 weeks of Screening\n* Clinically significant abnormalities on screening laboratory evaluation or chest x-ray\n* Severe complications of diabetes, in the opinion of the PI, including symptomatic autonomic neuropathy; disabling peripheral neuropathy; active proliferative retinopathy; nephropathy with renal failure, renal transplant, or dialysis; nontraumatic amputations due to gangrene; or vascular claudication\n* Women who are pregnant, lactating, or planning to become pregnant during the clinical study period; women of childbearing potential (defined as premenopausal and not surgically sterilized or postmenopausal for fewer than 2 years) not practicing adequate birth control. Adequate birth control is defined as using oral, percutaneous, or transdermal contraceptives; condoms and diaphragms (double barrier) with a spermicide; or intrauterine devices. Postmenopausal for this study includes amenorrhea f\n* Current drug or alcohol abuse or a history of drug or alcohol abuse that, in the opinion of the PI, would make the subject an unsuitable candidate for participation in the study\n* Exposure to any investigational medications or devices within the previous 30 days before study entry\n* Unable to read or write, or unlikely to comprehend and follow the study protocol procedures; lack of compliance with medication or procedures that, in the PI's opinion, may affect the study data or subject safety and that precludes the subject from participation in the study; or any other concurrent medical or major psychiatric condition that, in the opinion of the PI, makes the subject unsuitable for the clinical study or could limit the validity of the informed consent or impair the subject'"}, 'identificationModule': {'nctId': 'NCT01445951', 'briefTitle': 'Clinical Trial Evaluating Technosphere® Insulin Versus Insulin Aspart in Subjects With Type 1 Diabetes Mellitus Over a 24-week Treatment Period', 'organization': {'class': 'INDUSTRY', 'fullName': 'Mannkind Corporation'}, 'officialTitle': 'A Phase 3, Multicenter, Open-label, Randomized, Forced-titration Clinical Trial Evaluating the Efficacy and Safety of Technosphere® Insulin Inhalation Powder in Combination With a Basal Insulin Versus Insulin Aspart in Combination With a Basal Insulin in Subjects With Type 1 Diabetes Mellitus Over a 24-week Treatment Period', 'orgStudyIdInfo': {'id': 'MKC-TI-171'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Technosphere® Insulin with MedTone C Inhaler', 'description': 'Subjects will receive TI with the MedToneC inhaler and remain on the basal insulin they were taking prior to study entry', 'interventionNames': ['Drug: Technosphere® Insulin with MedTone C Inhaler']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Aspart Group', 'description': 'Subjects will receive insulin aspart and remain on the basal insulin they were taking prior to study entry', 'interventionNames': ['Drug: Insulin Aspart in combination with a basal insulin']}, {'type': 'EXPERIMENTAL', 'label': 'Technosphere ® Insulin-Gen2 Group', 'description': 'Subject will receive Technosphere Insulin with Gen2 Inhaler and remain on the basal insulin they were taking prior to study entry', 'interventionNames': ['Drug: Technosphere ®Insulin with Gen2 Inhaler']}], 'interventions': [{'name': 'Technosphere® Insulin with MedTone C Inhaler', 'type': 'DRUG', 'description': 'Inhalation Powder and injectable insulin', 'armGroupLabels': ['Technosphere® Insulin with MedTone C Inhaler']}, {'name': 'Technosphere ®Insulin with Gen2 Inhaler', 'type': 'DRUG', 'description': 'Inhalation Powder and injectable insulin', 'armGroupLabels': ['Technosphere ® Insulin-Gen2 Group']}, {'name': 'Insulin Aspart in combination with a basal insulin', 'type': 'DRUG', 'description': 'Injectable insulin', 'armGroupLabels': ['Aspart Group']}]}, 'contactsLocationsModule': 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