Ignite Creation Date:
2025-12-24 @ 2:44 PM
Ignite Modification Date:
2025-12-25 @ 7:26 PM
Study NCT ID:
NCT00139659
Status:
COMPLETED
Last Update Posted:
2010-06-02
First Post:
2005-08-29
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A One Year Clinical Trial Assessing the Usefulness and Safety of Inhaled Insulin in Diabetics With Asthma
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001249', 'term': 'Asthma'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}], 'ancestors': [{'id': 'D001982', 'term': 'Bronchial Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012130', 'term': 'Respiratory Hypersensitivity'}, {'id': 'D006969', 'term': 'Hypersensitivity, Immediate'}, {'id': 'D006967', 'term': 'Hypersensitivity'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrials.govCallCenter@pfizer.com', 'phone': '1-800-718-1021', 'title': 'Pfizer ClinicalTrials.gov Call Center', 'organization': 'Pfizer, Inc.'}, 'certainAgreement': {'otherDetails': 'Pfizer has the right to review disclosures, requesting a delay of \\< 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), \\< 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'Data for some secondary endpoints were not tabulated or analyzed for this study and some concomitant medication data were not accurately recorded and tabulated due to lack of resources resulting from scaling down of Exubera® development.'}}, 'adverseEventsModule': {'description': 'Adverse events for this study are reported using MedDRA in these Basic Results, but are reported using COSTART in the Clinical Study Report and PhRMA Web Synopsis for consistency with earlier studies. Consequently, subtle differences may be observed.', 'eventGroups': [{'id': 'EG000', 'title': 'Inhaled Insulin', 'description': 'Inhaled insulin (Exubera®) with dose adjusted according to premeal blood glucose plus basal insulin.', 'otherNumAtRisk': 146, 'otherNumAffected': 140, 'seriousNumAtRisk': 146, 'seriousNumAffected': 21}, {'id': 'EG001', 'title': 'Subcutaneous Insulin', 'description': 'Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.', 'otherNumAtRisk': 141, 'otherNumAffected': 136, 'seriousNumAtRisk': 141, 'seriousNumAffected': 13}], 'otherEvents': [{'term': 'Conjunctivitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 146, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 141, 'numAffected': 9}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 146, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 141, 'numAffected': 8}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 146, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 141, 'numAffected': 6}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 146, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 141, 'numAffected': 8}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 146, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 141, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 146, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 141, 'numAffected': 7}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 146, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 141, 'numAffected': 7}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 146, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 141, 'numAffected': 14}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Seasonal allergy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 146, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 141, 'numAffected': 7}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 146, 'numAffected': 24}, {'groupId': 'EG001', 'numAtRisk': 141, 'numAffected': 18}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 146, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 141, 'numAffected': 7}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Gastroenteritis viral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 146, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 141, 'numAffected': 7}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 146, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 141, 'numAffected': 25}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 146, 'numAffected': 29}, {'groupId': 'EG001', 'numAtRisk': 141, 'numAffected': 26}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 146, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 141, 'numAffected': 21}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 146, 'numAffected': 44}, {'groupId': 'EG001', 'numAtRisk': 141, 'numAffected': 39}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 146, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 141, 'numAffected': 20}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Hypoglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 146, 'numAffected': 109}, {'groupId': 'EG001', 'numAtRisk': 141, 'numAffected': 120}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 146, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 141, 'numAffected': 13}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 146, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 141, 'numAffected': 12}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 146, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 141, 'numAffected': 15}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Tendonitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 146, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 141, 'numAffected': 8}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 146, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 141, 'numAffected': 10}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 146, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 141, 'numAffected': 14}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Neuropathy peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 146, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 141, 'numAffected': 7}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Tremor', 'stats': [{'groupId': 'EG000', 'numAtRisk': 146, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 141, 'numAffected': 17}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 146, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 141, 'numAffected': 6}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Asthma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 146, 'numAffected': 53}, {'groupId': 'EG001', 'numAtRisk': 141, 'numAffected': 63}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 146, 'numAffected': 29}, {'groupId': 'EG001', 'numAtRisk': 141, 'numAffected': 11}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 146, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 141, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Oropharyngeal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 146, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 141, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Hyperhidrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 146, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 141, 'numAffected': 13}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}], 'seriousEvents': [{'term': 'Haemorrhagic anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 146, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 141, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Acute coronary syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 146, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 141, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Angina pectoris', 'stats': [{'groupId': 'EG000', 'numAtRisk': 146, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 141, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Angina unstable', 'stats': [{'groupId': 'EG000', 'numAtRisk': 146, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 141, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Arteriosclerosis coronary artery', 'stats': [{'groupId': 'EG000', 'numAtRisk': 146, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 141, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 146, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 141, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Atrial flutter', 'stats': [{'groupId': 'EG000', 'numAtRisk': 146, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 141, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Atrioventricular block', 'stats': [{'groupId': 'EG000', 'numAtRisk': 146, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 141, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 146, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 141, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Hiatus hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 146, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 141, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Small intestinal obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 146, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 141, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Upper gastrointestinal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 146, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 141, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 146, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 141, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Hepatitis alcoholic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 146, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 141, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Abdominal wall abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 146, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 141, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Erysipelas', 'stats': [{'groupId': 'EG000', 'numAtRisk': 146, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 141, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 146, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 141, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 146, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 141, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Viral infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 146, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 141, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Diabetic ketoacidosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 146, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 141, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Hyperglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 146, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 141, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Hypoglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 146, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 141, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Ketoacidosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 146, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 141, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Intervertebral disc degeneration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 146, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 141, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Intervertebral disc protrusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 146, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 141, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Lumbar spinal stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 146, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 141, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Colon adenoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 146, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 141, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Lymphoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 146, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 141, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Cerebrovascular accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 146, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 141, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Abortion spontaneous', 'stats': [{'groupId': 'EG000', 'numAtRisk': 146, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 141, 'numAffected': 0}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Alcohol abuse', 'stats': [{'groupId': 'EG000', 'numAtRisk': 146, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 141, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Asthma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 146, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 141, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 146, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 141, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Pleural effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 146, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 141, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Annualized Rate of Change for Forced Expiratory Volume in 1 Second (FEV1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '117', 'groupId': 'OG000'}, {'value': '127', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Inhaled Insulin', 'description': 'Inhaled insulin (Exubera®) with dose adjusted according to premeal blood glucose plus basal insulin.'}, {'id': 'OG001', 'title': 'Subcutaneous Insulin', 'description': 'Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.070', 'spread': '0.020', 'groupId': 'OG000'}, {'value': '-0.035', 'spread': '0.019', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '90', 'paramValue': '-0.034', 'ciLowerLimit': '-0.080', 'ciUpperLimit': '0.011', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.028', 'estimateComment': 'Primary analysis model includes terms of Treatment, Time, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on day of randomization.', 'groupDescription': 'Treatment group difference (Exubera minus subcutaneous insulin): annualized rate of change over time. Longitudinal data analysis methods with random effects were used to model the pulmonary function test (PFT) measurements. Random effects included the intercept and slope with respect to time (visit); all remaining effects were fixed. The estimated rate of change over time for each treatment group was derived from this model.', 'statisticalMethod': 'longitudinal data analysis model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Confidence interval of least squares (LS) mean difference (INH - SC) between annual rates of change for the two treatment groups.', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Weeks -3, -2, -1, 1, 2, 3, 4, 6, 12, 18, 26, 39, and 52', 'description': 'Annualized rates of change (slope throughout time from baseline to end of study\\[visit\\]) for forced expiratory volume in 1 second (FEV1) (liters per year \\[L/yr\\]) measured 30 minutes following the administration of albuterol.', 'unitOfMeasure': 'L/yr', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Primary analysis set (PAS): all subjects who were randomized, had no significant protocol violations, had baseline (BL) post-albuterol pulmonary function test (PFT) measurement, had at least 2 post-BL, post-albuterol PFT measurements with 1 measurement at least 6 months post-BL, and received study drug for at least 50% (154 days) of study duration.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Pre-Bronchodilator Forced Expiratory Volume in One Second (FEV1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '141', 'groupId': 'OG000'}, {'value': '139', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Inhaled Insulin', 'description': 'Inhaled insulin (Exubera®) with dose adjusted according to premeal blood glucose plus basal insulin.'}, {'id': 'OG001', 'title': 'Subcutaneous Insulin', 'description': 'Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.'}], 'classes': [{'title': 'Baseline (141, 139)', 'categories': [{'measurements': [{'value': '2.435', 'spread': '0.748', 'groupId': 'OG000'}, {'value': '2.412', 'spread': '0.727', 'groupId': 'OG001'}]}]}, {'title': 'Week 1 (123, 125)', 'categories': [{'measurements': [{'value': '-0.057', 'spread': '0.142', 'groupId': 'OG000'}, {'value': '-0.035', 'spread': '0.131', 'groupId': 'OG001'}]}]}, {'title': 'Week 2 (n=127, 117)', 'categories': [{'measurements': [{'value': '-0.065', 'spread': '0.159', 'groupId': 'OG000'}, {'value': '-0.034', 'spread': '0.150', 'groupId': 'OG001'}]}]}, {'title': 'Week 3 (n=130, 121)', 'categories': [{'measurements': [{'value': '-0.067', 'spread': '0.185', 'groupId': 'OG000'}, {'value': '-0.044', 'spread': '0.171', 'groupId': 'OG001'}]}]}, {'title': 'Week 4 (n=123, 130)', 'categories': [{'measurements': [{'value': '-0.076', 'spread': '0.185', 'groupId': 'OG000'}, {'value': '-0.037', 'spread': '0.181', 'groupId': 'OG001'}]}]}, {'title': 'Week 6 (n=130, 135)', 'categories': [{'measurements': [{'value': '-0.059', 'spread': '0.211', 'groupId': 'OG000'}, {'value': '-0.034', 'spread': '0.170', 'groupId': 'OG001'}]}]}, {'title': 'Week 12 (n=125, 130)', 'categories': [{'measurements': [{'value': '-0.067', 'spread': '0.237', 'groupId': 'OG000'}, {'value': '-0.032', 'spread': '0.193', 'groupId': 'OG001'}]}]}, {'title': 'Week 18 (n=125, 125)', 'categories': [{'measurements': [{'value': '-0.063', 'spread': '0.218', 'groupId': 'OG000'}, {'value': '-0.042', 'spread': '0.183', 'groupId': 'OG001'}]}]}, {'title': 'Week 26 (n=120, 129)', 'categories': [{'measurements': [{'value': '-0.058', 'spread': '0.190', 'groupId': 'OG000'}, {'value': '-0.043', 'spread': '0.195', 'groupId': 'OG001'}]}]}, {'title': 'Week 39 (n=108, 124)', 'categories': [{'measurements': [{'value': '-0.076', 'spread': '0.195', 'groupId': 'OG000'}, {'value': '-0.044', 'spread': '0.186', 'groupId': 'OG001'}]}]}, {'title': 'Week 52 (n=106, 112)', 'categories': [{'measurements': [{'value': '-0.136', 'spread': '0.259', 'groupId': 'OG000'}, {'value': '-0.056', 'spread': '0.230', 'groupId': 'OG001'}]}]}, {'title': 'Week 52 LOCF (n=141, 139)', 'categories': [{'measurements': [{'value': '-0.119', 'spread': '0.259', 'groupId': 'OG000'}, {'value': '-0.058', 'spread': '0.222', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '90', 'paramValue': '-0.025', 'ciLowerLimit': '-0.065', 'ciUpperLimit': '0.015', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.024', 'groupDescription': 'Week 1; Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Week, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '90', 'paramValue': '-0.034', 'ciLowerLimit': '-0.073', 'ciUpperLimit': '0.006', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.024', 'groupDescription': 'Week 2; Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Week, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '90', 'paramValue': '-0.024', 'ciLowerLimit': '-0.063', 'ciUpperLimit': '0.016', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.024', 'groupDescription': 'Week 3; Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Week, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '90', 'paramValue': '-0.035', 'ciLowerLimit': '-0.075', 'ciUpperLimit': '0.004', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.024', 'groupDescription': 'Week 4; Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Week, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '90', 'paramValue': '-0.027', 'ciLowerLimit': '-0.067', 'ciUpperLimit': '0.012', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.024', 'groupDescription': 'Week 6; Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Week, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '90', 'paramValue': '-0.033', 'ciLowerLimit': '-0.073', 'ciUpperLimit': '0.008', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.025', 'groupDescription': 'Week 12; Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Week, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '90', 'paramValue': '-0.018', 'ciLowerLimit': '-0.059', 'ciUpperLimit': '0.023', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.025', 'groupDescription': 'Week 18; Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Week, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '90', 'paramValue': '-0.010', 'ciLowerLimit': '-0.052', 'ciUpperLimit': '0.031', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.025', 'groupDescription': 'Week 26; Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Week, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '90', 'paramValue': '-0.025', 'ciLowerLimit': '-0.068', 'ciUpperLimit': '0.017', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.026', 'groupDescription': 'Week 39; Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Week, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '90', 'paramValue': '-0.073', 'ciLowerLimit': '-0.117', 'ciUpperLimit': '-0.029', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.027', 'groupDescription': 'Week 52; Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Week, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '90', 'paramValue': '-0.061', 'ciLowerLimit': '-0.108', 'ciUpperLimit': '-0.015', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.028', 'groupDescription': 'Week 52 (LOCF); Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Week, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Week 1, Week 2, Week 3, Week 4, Week 6, Week 12, Week 18, Week 26, Week 39, Week 52, Week 52 Last Observation Carried Forward (LOCF)', 'description': 'Change from Baseline in Pre-Bronchodilator Forced Expiratory Volume in One Second (FEV1) at each visit. FEV1 was measured in liters (L) before the administration of albuterol. Change from baseline: mean FEV1 (L) at observation minus mean baseline value.', 'unitOfMeasure': 'liters', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set (FAS); LOCF: last observation carried forward.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Pre-Bronchodilator Carbon Monoxide Diffusing Capacity (DLco)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '141', 'groupId': 'OG000'}, {'value': '139', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Inhaled Insulin', 'description': 'Inhaled insulin (Exubera®) with dose adjusted according to premeal blood glucose plus basal insulin.'}, {'id': 'OG001', 'title': 'Subcutaneous Insulin', 'description': 'Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.'}], 'classes': [{'title': 'Baseline (n=141, 139)', 'categories': [{'measurements': [{'value': '23.034', 'spread': '5.921', 'groupId': 'OG000'}, {'value': '22.911', 'spread': '6.059', 'groupId': 'OG001'}]}]}, {'title': 'Week 1 (n=123, 125)', 'categories': [{'measurements': [{'value': '-0.749', 'spread': '1.467', 'groupId': 'OG000'}, {'value': '-0.452', 'spread': '1.220', 'groupId': 'OG001'}]}]}, {'title': 'Week 2 (n=126, 114)', 'categories': [{'measurements': [{'value': '-0.835', 'spread': '1.353', 'groupId': 'OG000'}, {'value': '-0.456', 'spread': '1.485', 'groupId': 'OG001'}]}]}, {'title': 'Week 3 (n=128, 119)', 'categories': [{'measurements': [{'value': '-0.855', 'spread': '1.407', 'groupId': 'OG000'}, {'value': '-0.556', 'spread': '1.452', 'groupId': 'OG001'}]}]}, {'title': 'Week 4 (n=122, 127)', 'categories': [{'measurements': [{'value': '-1.120', 'spread': '1.609', 'groupId': 'OG000'}, {'value': '-0.648', 'spread': '1.500', 'groupId': 'OG001'}]}]}, {'title': 'Week 6 (n=129, 135)', 'categories': [{'measurements': [{'value': '-1.169', 'spread': '1.583', 'groupId': 'OG000'}, {'value': '-0.669', 'spread': '1.441', 'groupId': 'OG001'}]}]}, {'title': 'Week 12 (n=124, 128)', 'categories': [{'measurements': [{'value': '-1.018', 'spread': '1.842', 'groupId': 'OG000'}, {'value': '-0.725', 'spread': '1.788', 'groupId': 'OG001'}]}]}, {'title': 'Week 18 (n=123, 125)', 'categories': [{'measurements': [{'value': '-0.906', 'spread': '1.756', 'groupId': 'OG000'}, {'value': '-0.646', 'spread': '1.748', 'groupId': 'OG001'}]}]}, {'title': 'Week 26 (n=117, 127)', 'categories': [{'measurements': [{'value': '-0.945', 'spread': '1.683', 'groupId': 'OG000'}, {'value': '-0.561', 'spread': '1.982', 'groupId': 'OG001'}]}]}, {'title': 'Week 39 (n=106, 125)', 'categories': [{'measurements': [{'value': '-0.821', 'spread': '1.742', 'groupId': 'OG000'}, {'value': '-0.550', 'spread': '1.805', 'groupId': 'OG001'}]}]}, {'title': 'Week 52 (n=105, 111)', 'categories': [{'measurements': [{'value': '-1.699', 'spread': '2.157', 'groupId': 'OG000'}, {'value': '-0.911', 'spread': '2.239', 'groupId': 'OG001'}]}]}, {'title': 'Week 52 LOCF (n=141, 139)', 'categories': [{'measurements': [{'value': '-1.557', 'spread': '2.109', 'groupId': 'OG000'}, {'value': '-0.785', 'spread': '2.141', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '90', 'paramValue': '-0.327', 'ciLowerLimit': '-0.679', 'ciUpperLimit': '0.026', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.214', 'groupDescription': 'Week 1; Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Week, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '90', 'paramValue': '-0.378', 'ciLowerLimit': '-0.729', 'ciUpperLimit': '-0.027', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.213', 'groupDescription': 'Week 2; Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Week, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '90', 'paramValue': '-0.346', 'ciLowerLimit': '-0.696', 'ciUpperLimit': '0.004', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.213', 'groupDescription': 'Week 3; Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Week, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '90', 'paramValue': '-0.496', 'ciLowerLimit': '-0.847', 'ciUpperLimit': '-0.145', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.213', 'groupDescription': 'Week 4; Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Week, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '90', 'paramValue': '-0.610', 'ciLowerLimit': '-0.960', 'ciUpperLimit': '-0.260', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.213', 'groupDescription': 'Week 6; Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Week, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '90', 'paramValue': '-0.360', 'ciLowerLimit': '-0.721', 'ciUpperLimit': '0.001', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.219', 'groupDescription': 'Week 12; Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Week, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '90', 'paramValue': '-0.291', 'ciLowerLimit': '-0.655', 'ciUpperLimit': '0.073', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.221', 'groupDescription': 'Week 18; Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Week, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '90', 'paramValue': '-0.420', 'ciLowerLimit': '-0.788', 'ciUpperLimit': '-0.052', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.224', 'groupDescription': 'Week 26; Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Week, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '90', 'paramValue': '-0.337', 'ciLowerLimit': '-0.717', 'ciUpperLimit': '0.042', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.231', 'groupDescription': 'Week 39; Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Week, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '90', 'paramValue': '-0.789', 'ciLowerLimit': '-1.181', 'ciUpperLimit': '-0.397', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.238', 'groupDescription': 'Week 52; Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Week, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '90', 'paramValue': '-0.786', 'ciLowerLimit': '-1.178', 'ciUpperLimit': '-0.393', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.238', 'groupDescription': 'Week 52 (LOCF); Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Week, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 1, Week 2, Week 3, Week 4, Week 6, Week 12, Week 18, Week 26, Week 39, Week 52, Week 52 Last Observation carried Forward (LOCF)', 'description': 'Change From Baseline in Pre-Bronchodilator Carbon Monoxide Diffusing Capacity (DLco) measured in milliters/minutes/millimeters of mercury (mL/min/mmHg): change = DLco at observation minus DLco at Baseline.', 'unitOfMeasure': 'ml/min/mmHg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set (FAS); LOCF: last observation carried forward.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Pre-Insulin Forced Expiratory Volume in One Second (FEV1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '130', 'groupId': 'OG000'}, {'value': '133', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Inhaled Insulin', 'description': 'Inhaled insulin (Exubera®) with dose adjusted according to premeal blood glucose plus basal insulin.'}, {'id': 'OG001', 'title': 'Subcutaneous Insulin', 'description': 'Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.'}], 'classes': [{'title': 'Baseline (n=130, 133)', 'categories': [{'measurements': [{'value': '2.449', 'spread': '0.775', 'groupId': 'OG000'}, {'value': '2.403', 'spread': '0.727', 'groupId': 'OG001'}]}]}, {'title': 'Week 9 (n=111, 108)', 'categories': [{'measurements': [{'value': '-0.038', 'spread': '0.235', 'groupId': 'OG000'}, {'value': '-0.028', 'spread': '0.163', 'groupId': 'OG001'}]}]}, {'title': 'Week 51 (n=103, 119)', 'categories': [{'measurements': [{'value': '-0.078', 'spread': '0.227', 'groupId': 'OG000'}, {'value': '-0.017', 'spread': '0.245', 'groupId': 'OG001'}]}]}, {'title': 'Week 51 LOCF (n=130, 133)', 'categories': [{'measurements': [{'value': '-0.068', 'spread': '0.237', 'groupId': 'OG000'}, {'value': '-0.018', 'spread': '0.237', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 9, Week 51, Week 51 Last Observation Carried Forward', 'description': 'Change from Baseline in Pre-Insulin Forced Expiratory Volume in one second (FEV1) measured in liters (L): change = FEV1 at observation minus FEV1 at Baseline.', 'unitOfMeasure': 'liters', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set (FAS); LOCF: last observation carried forward.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Pre-Insulin Carbon Monoxide Diffusing Capacity (DLco)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '128', 'groupId': 'OG000'}, {'value': '131', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Inhaled Insulin', 'description': 'Inhaled insulin (Exubera®) with dose adjusted according to premeal blood glucose plus basal insulin.'}, {'id': 'OG001', 'title': 'Subcutaneous Insulin', 'description': 'Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.'}], 'classes': [{'title': 'Baseline (n=128, 131)', 'categories': [{'measurements': [{'value': '22.836', 'spread': '6.087', 'groupId': 'OG000'}, {'value': '22.718', 'spread': '6.128', 'groupId': 'OG001'}]}]}, {'title': 'Week 9 (n=109, 106)', 'categories': [{'measurements': [{'value': '-1.130', 'spread': '1.663', 'groupId': 'OG000'}, {'value': '-0.663', 'spread': '1.549', 'groupId': 'OG001'}]}]}, {'title': 'Week 51 (n=102, 116)', 'categories': [{'measurements': [{'value': '-1.156', 'spread': '1.825', 'groupId': 'OG000'}, {'value': '-0.630', 'spread': '2.023', 'groupId': 'OG001'}]}]}, {'title': 'Week 51 LOCF (n=128, 131)', 'categories': [{'measurements': [{'value': '-1.185', 'spread': '1.804', 'groupId': 'OG000'}, {'value': '-0.533', 'spread': '1.990', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 9, Week 51, Week 51 Last Observation Carried Forward (LOCF)', 'description': 'Change From Baseline in Pre-Insulin Carbon Monoxide Diffusing Capacity (DLco) measured in milliters/minutes/millimeters of mercury (mL/min/mmHg): change = DLco at observation minus DLco at Baseline.', 'unitOfMeasure': 'ml/min/mmHg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set (FAS); LOCF: last observation carried forward.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Post-bronchodilator Forced Vital Capacity (FVC)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '141', 'groupId': 'OG000'}, {'value': '139', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Inhaled Insulin', 'description': 'Inhaled insulin (Exubera®) with dose adjusted according to premeal blood glucose plus basal insulin.'}, {'id': 'OG001', 'title': 'Subcutaneous Insulin', 'description': 'Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.'}], 'classes': [{'title': 'Baseline (n=141, 139)', 'categories': [{'measurements': [{'value': '3.355', 'spread': '0.963', 'groupId': 'OG000'}, {'value': '3.341', 'spread': '0.918', 'groupId': 'OG001'}]}]}, {'title': 'Week 1 (n=123, 125)', 'categories': [{'measurements': [{'value': '-0.068', 'spread': '0.181', 'groupId': 'OG000'}, {'value': '-0.046', 'spread': '0.134', 'groupId': 'OG001'}]}]}, {'title': 'Week 2 (n=126, 115)', 'categories': [{'measurements': [{'value': '-0.057', 'spread': '0.190', 'groupId': 'OG000'}, {'value': '-0.053', 'spread': '0.169', 'groupId': 'OG001'}]}]}, {'title': 'Week 3 (n=131, 119)', 'categories': [{'measurements': [{'value': '-0.078', 'spread': '0.205', 'groupId': 'OG000'}, {'value': '-0.068', 'spread': '0.174', 'groupId': 'OG001'}]}]}, {'title': 'Week 4 (n=121, 129)', 'categories': [{'measurements': [{'value': '-0.065', 'spread': '0.193', 'groupId': 'OG000'}, {'value': '-0.051', 'spread': '0.176', 'groupId': 'OG001'}]}]}, {'title': 'Week 6 (n=130, 135)', 'categories': [{'measurements': [{'value': '-0.092', 'spread': '0.287', 'groupId': 'OG000'}, {'value': '-0.043', 'spread': '0.173', 'groupId': 'OG001'}]}]}, {'title': 'Week 12 (n=125, 129)', 'categories': [{'measurements': [{'value': '-0.045', 'spread': '0.222', 'groupId': 'OG000'}, {'value': '-0.056', 'spread': '0.190', 'groupId': 'OG001'}]}]}, {'title': 'Week 18 (n=124, 125)', 'categories': [{'measurements': [{'value': '-0.053', 'spread': '0.225', 'groupId': 'OG000'}, {'value': '-0.069', 'spread': '0.179', 'groupId': 'OG001'}]}]}, {'title': 'Week 26 (n=120, 128)', 'categories': [{'measurements': [{'value': '-0.061', 'spread': '0.215', 'groupId': 'OG000'}, {'value': '-0.052', 'spread': '0.186', 'groupId': 'OG001'}]}]}, {'title': 'Week 39 (n=107, 124)', 'categories': [{'measurements': [{'value': '-0.080', 'spread': '0.209', 'groupId': 'OG000'}, {'value': '-0.057', 'spread': '0.213', 'groupId': 'OG001'}]}]}, {'title': 'Week 52 (n=106, 112)', 'categories': [{'measurements': [{'value': '-0.105', 'spread': '0.288', 'groupId': 'OG000'}, {'value': '-0.088', 'spread': '0.259', 'groupId': 'OG001'}]}]}, {'title': 'Week 52 LOCF (n=141, 139)', 'categories': [{'measurements': [{'value': '-0.097', 'spread': '0.278', 'groupId': 'OG000'}, {'value': '-0.083', 'spread': '0.247', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '90', 'paramValue': '-0.021', 'ciLowerLimit': '-0.066', 'ciUpperLimit': '0.023', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.027', 'groupDescription': 'Week 1; Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model): includes terms of Treatment, Week, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '90', 'paramValue': '-0.000', 'ciLowerLimit': '-0.044', 'ciUpperLimit': '0.044', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.027', 'groupDescription': 'Week 2; Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model): includes terms of Treatment, Week, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '90', 'paramValue': '-0.012', 'ciLowerLimit': '-0.056', 'ciUpperLimit': '0.032', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.027', 'groupDescription': 'Week 3; Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model): includes terms of Treatment, Week, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '90', 'paramValue': '-0.004', 'ciLowerLimit': '-0.048', 'ciUpperLimit': '0.041', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.027', 'groupDescription': 'Week 4; Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model): includes terms of Treatment, Week, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '90', 'paramValue': '-0.045', 'ciLowerLimit': '-0.089', 'ciUpperLimit': '-0.001', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.027', 'groupDescription': 'Week 6; Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model): includes terms of Treatment, Week, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '90', 'paramValue': '0.010', 'ciLowerLimit': '-0.035', 'ciUpperLimit': '0.056', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.028', 'groupDescription': 'Week 12; Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model): includes terms of Treatment, Week, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '90', 'paramValue': '0.018', 'ciLowerLimit': '-0.028', 'ciUpperLimit': '0.064', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.028', 'groupDescription': 'Week 18; Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model): includes terms of Treatment, Week, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '90', 'paramValue': '-0.005', 'ciLowerLimit': '-0.051', 'ciUpperLimit': '0.041', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.028', 'groupDescription': 'Week 26; Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model): includes terms of Treatment, Week, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '90', 'paramValue': '-0.022', 'ciLowerLimit': '-0.070', 'ciUpperLimit': '0.026', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.029', 'groupDescription': 'Week 39; Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model): includes terms of Treatment, Week, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '90', 'paramValue': '-0.015', 'ciLowerLimit': '-0.064', 'ciUpperLimit': '0.034', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.030', 'groupDescription': 'Week 52; Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model): includes terms of Treatment, Week, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '90', 'paramValue': '-0.015', 'ciLowerLimit': '-0.067', 'ciUpperLimit': '0.037', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.031', 'groupDescription': 'Week 52 (LOCF); Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model): includes terms of Treatment, Week, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 1, Week 2, Week 3, Week 4, Week 6, Week 12, Week 18, Week 26, Week 39, Week 52, Week 52 Last Observation Carried Forward (LOCF)', 'description': 'Change from baseline in Post-bronchodilator Forced Vital Capacity (FVC) measured in liters (L) 30 minutes following the administration of albuterol: change = FVC at observation minus FVC at Baseline.', 'unitOfMeasure': 'liters', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set (FAS); LOCF: last observation carried forward.'}, {'type': 'SECONDARY', 'title': 'Bronchodilator Responsiveness as Determined by the Change in Forced Expiratory Volume in 1 Second (FEV1) Pre-albuterol and 30 Minutes Post-albuterol', 'denoms': [{'units': 'Participants', 'counts': [{'value': '141', 'groupId': 'OG000'}, {'value': '139', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Inhaled Insulin', 'description': 'Inhaled insulin (Exubera®) with dose adjusted according to premeal blood glucose plus basal insulin.'}, {'id': 'OG001', 'title': 'Subcutaneous Insulin', 'description': 'Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.'}], 'classes': [{'title': 'Baseline (n=141, 139)', 'categories': [{'measurements': [{'value': '5.487', 'spread': '5.163', 'groupId': 'OG000'}, {'value': '5.102', 'spread': '6.416', 'groupId': 'OG001'}]}]}, {'title': 'Week 1 (n=123, 125)', 'categories': [{'measurements': [{'value': '-0.015', 'spread': '5.452', 'groupId': 'OG000'}, {'value': '0.347', 'spread': '5.429', 'groupId': 'OG001'}]}]}, {'title': 'Week 2 (n=126, 115)', 'categories': [{'measurements': [{'value': '0.683', 'spread': '5.984', 'groupId': 'OG000'}, {'value': '0.347', 'spread': '6.354', 'groupId': 'OG001'}]}]}, {'title': 'Week 3 (n=130, 119)', 'categories': [{'measurements': [{'value': '-0.055', 'spread': '6.082', 'groupId': 'OG000'}, {'value': '0.823', 'spread': '5.449', 'groupId': 'OG001'}]}]}, {'title': 'Week 4 (n=121, 129)', 'categories': [{'measurements': [{'value': '0.056', 'spread': '6.361', 'groupId': 'OG000'}, {'value': '0.559', 'spread': '5.733', 'groupId': 'OG001'}]}]}, {'title': 'Week 6 (n=130, 135)', 'categories': [{'measurements': [{'value': '-0.460', 'spread': '5.480', 'groupId': 'OG000'}, {'value': '0.504', 'spread': '6.350', 'groupId': 'OG001'}]}]}, {'title': 'Week 12 (n=124, 129)', 'categories': [{'measurements': [{'value': '0.721', 'spread': '5.972', 'groupId': 'OG000'}, {'value': '-0.100', 'spread': '6.783', 'groupId': 'OG001'}]}]}, {'title': 'Week 18 (n=124, 125)', 'categories': [{'measurements': [{'value': '-0.095', 'spread': '5.909', 'groupId': 'OG000'}, {'value': '0.154', 'spread': '7.649', 'groupId': 'OG001'}]}]}, {'title': 'Week 26 (n=120, 128)', 'categories': [{'measurements': [{'value': '-0.186', 'spread': '5.624', 'groupId': 'OG000'}, {'value': '0.211', 'spread': '5.080', 'groupId': 'OG001'}]}]}, {'title': 'Week 39 (n=107, 124)', 'categories': [{'measurements': [{'value': '-0.283', 'spread': '5.368', 'groupId': 'OG000'}, {'value': '0.133', 'spread': '5.089', 'groupId': 'OG001'}]}]}, {'title': 'Week 52 (n=106, 112)', 'categories': [{'measurements': [{'value': '0.640', 'spread': '5.338', 'groupId': 'OG000'}, {'value': '-0.035', 'spread': '6.156', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '90', 'paramValue': '-0.632', 'ciLowerLimit': '-1.778', 'ciUpperLimit': '0.514', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.697', 'groupDescription': 'Week 1; Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model): includes terms of Treatment, Week, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '90', 'paramValue': '0.020', 'ciLowerLimit': '-1.079', 'ciUpperLimit': '1.120', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.668', 'groupDescription': 'Week 2; Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model): includes terms of Treatment, Week, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '90', 'paramValue': '0.582', 'ciLowerLimit': '-0.535', 'ciUpperLimit': '1.700', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.679', 'groupDescription': 'Week 3; Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model): includes terms of Treatment, Week, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '90', 'paramValue': '-0.054', 'ciLowerLimit': '-1.184', 'ciUpperLimit': '1.077', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.687', 'groupDescription': 'Week 4; Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model): includes terms of Treatment, Week, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '90', 'paramValue': '-0.535', 'ciLowerLimit': '-1.677', 'ciUpperLimit': '0.608', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.694', 'groupDescription': 'Week 6; Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model): includes terms of Treatment, Week, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '90', 'paramValue': '-0.905', 'ciLowerLimit': '-2.014', 'ciUpperLimit': '0.203', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.674', 'groupDescription': 'Week 12; Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model): includes terms of Treatment, Week, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '90', 'paramValue': '0.212', 'ciLowerLimit': '-0.899', 'ciUpperLimit': '1.323', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.675', 'groupDescription': 'Week 18; Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model): includes terms of Treatment, Week, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '90', 'paramValue': '0.044', 'ciLowerLimit': '-1.080', 'ciUpperLimit': '1.169', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.683', 'groupDescription': 'Week 26; Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model): includes terms of Treatment, Week, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '90', 'paramValue': '-0.240', 'ciLowerLimit': '-1.382', 'ciUpperLimit': '0.902', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.694', 'groupDescription': 'Week 39; Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model): includes terms of Treatment, Week, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '90', 'paramValue': '-0.503', 'ciLowerLimit': '-1.673', 'ciUpperLimit': '0.668', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.711', 'groupDescription': 'Week 52; Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model): includes terms of Treatment, Week, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 1, Week 2, Week 3, Week 4, Week 6, Week 12, Week 18, Week 26, Week 39, Week 52', 'description': 'Responsiveness was the percent change from the forced expiratory volume in 1 second (FEV1) value before bronchodilator use to the FEV1 value 30 minutes after bronchodilator use, operationally defined as \\[(post-bronchodilator FEV1 minus pre-bronchodilator FEV1 divided by pre-bronchodilator FEV1\\] multiplied by 100.', 'unitOfMeasure': 'percent change in FEV1', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set (FAS)'}, {'type': 'SECONDARY', 'title': 'Percent Predicted and Percent Change From Baseline in Post-Bronchdilator Forced Expiratory Volume in One Second (FEV1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '141', 'groupId': 'OG000'}, {'value': '139', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Inhaled Insulin', 'description': 'Inhaled insulin (Exubera®) with dose adjusted according to premeal blood glucose plus basal insulin.'}, {'id': 'OG001', 'title': 'Subcutaneous Insulin', 'description': 'Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.'}], 'classes': [{'title': 'Baseline (n=141, 139)', 'categories': [{'measurements': [{'value': '83.698', 'spread': '14.096', 'groupId': 'OG000'}, {'value': '82.833', 'spread': '15.219', 'groupId': 'OG001'}]}]}, {'title': 'Week 1: % of Predicted Value (n=123, 125)', 'categories': [{'measurements': [{'value': '81.987', 'spread': '14.441', 'groupId': 'OG000'}, {'value': '82.878', 'spread': '15.438', 'groupId': 'OG001'}]}]}, {'title': 'Week 2: % of Predicted Value (n=126, 115)', 'categories': [{'measurements': [{'value': '81.655', 'spread': '13.985', 'groupId': 'OG000'}, {'value': '81.881', 'spread': '15.017', 'groupId': 'OG001'}]}]}, {'title': 'Week 3: % of Predicted Value (n=131, 119)', 'categories': [{'measurements': [{'value': '80.711', 'spread': '13.854', 'groupId': 'OG000'}, {'value': '82.036', 'spread': '15.354', 'groupId': 'OG001'}]}]}, {'title': 'Week 4: % of Predicted Value (n=121, 129)', 'categories': [{'measurements': [{'value': '81.093', 'spread': '15.145', 'groupId': 'OG000'}, {'value': '82.029', 'spread': '14.914', 'groupId': 'OG001'}]}]}, {'title': 'Week 6: % of Predicted Value (n=130, 135)', 'categories': [{'measurements': [{'value': '81.611', 'spread': '14.553', 'groupId': 'OG000'}, {'value': '82.016', 'spread': '15.509', 'groupId': 'OG001'}]}]}, {'title': 'Week 12: % of Predicted Value (n=125, 129)', 'categories': [{'measurements': [{'value': '82.145', 'spread': '13.885', 'groupId': 'OG000'}, {'value': '81.640', 'spread': '14.673', 'groupId': 'OG001'}]}]}, {'title': 'Week 18: % of Predicted Value (n=124, 125)', 'categories': [{'measurements': [{'value': '82.187', 'spread': '14.405', 'groupId': 'OG000'}, {'value': '81.723', 'spread': '14.505', 'groupId': 'OG001'}]}]}, {'title': 'Week 26: % of Predicted Value (n=120, 128)', 'categories': [{'measurements': [{'value': '82.941', 'spread': '14.291', 'groupId': 'OG000'}, {'value': '82.227', 'spread': '14.305', 'groupId': 'OG001'}]}]}, {'title': 'Week 39: % of Predicted Value (n=107, 124)', 'categories': [{'measurements': [{'value': '82.851', 'spread': '14.447', 'groupId': 'OG000'}, {'value': '81.847', 'spread': '14.794', 'groupId': 'OG001'}]}]}, {'title': 'Week 52: % of Predicted Value (n=106, 112)', 'categories': [{'measurements': [{'value': '80.869', 'spread': '14.934', 'groupId': 'OG000'}, {'value': '81.138', 'spread': '14.461', 'groupId': 'OG001'}]}]}, {'title': 'Week 52 LOCF: % of Predicted Value (n=141, 139)', 'categories': [{'measurements': [{'value': '80.136', 'spread': '14.528', 'groupId': 'OG000'}, {'value': '80.687', 'spread': '14.671', 'groupId': 'OG001'}]}]}, {'title': 'Week 1: % Change from Baseline (n=123, 125)', 'categories': [{'measurements': [{'value': '-2.682', 'spread': '5.780', 'groupId': 'OG000'}, {'value': '-1.238', 'spread': '5.307', 'groupId': 'OG001'}]}]}, {'title': 'Week 2: % Change from Baseline (n=126, 115)', 'categories': [{'measurements': [{'value': '-2.355', 'spread': '5.909', 'groupId': 'OG000'}, {'value': '-1.142', 'spread': '5.273', 'groupId': 'OG001'}]}]}, {'title': 'Week 3: % Change from Baseline (n=131, 119)', 'categories': [{'measurements': [{'value': '-2.943', 'spread': '7.583', 'groupId': 'OG000'}, {'value': '-1.057', 'spread': '5.292', 'groupId': 'OG001'}]}]}, {'title': 'Week 4: % Change from Baseline (n=121, 129)', 'categories': [{'measurements': [{'value': '-3.063', 'spread': '6.926', 'groupId': 'OG000'}, {'value': '-0.833', 'spread': '6.172', 'groupId': 'OG001'}]}]}, {'title': 'Week 6: % Change from Baseline (n=130, 135)', 'categories': [{'measurements': [{'value': '-2.559', 'spread': '8.725', 'groupId': 'OG000'}, {'value': '-0.957', 'spread': '6.180', 'groupId': 'OG001'}]}]}, {'title': 'Week 12: % Change from Baseline (n=125, 129)', 'categories': [{'measurements': [{'value': '-1.975', 'spread': '8.495', 'groupId': 'OG000'}, {'value': '-1.226', 'spread': '7.603', 'groupId': 'OG001'}]}]}, {'title': 'Week 18: % Change from Baseline (n=124, 125)', 'categories': [{'measurements': [{'value': '-2.437', 'spread': '8.713', 'groupId': 'OG000'}, {'value': '-1.247', 'spread': '6.688', 'groupId': 'OG001'}]}]}, {'title': 'Week 26: % Change from Baseline (n=120, 128)', 'categories': [{'measurements': [{'value': '-2.006', 'spread': '6.891', 'groupId': 'OG000'}, {'value': '-1.189', 'spread': '8.013', 'groupId': 'OG001'}]}]}, {'title': 'Week 39: % Change from Baseline (n=107, 124)', 'categories': [{'measurements': [{'value': '-3.144', 'spread': '7.507', 'groupId': 'OG000'}, {'value': '-1.466', 'spread': '8.332', 'groupId': 'OG001'}]}]}, {'title': 'Week 52: % Change from Baseline (n=106, 112)', 'categories': [{'measurements': [{'value': '-4.777', 'spread': '8.794', 'groupId': 'OG000'}, {'value': '-2.002', 'spread': '10.040', 'groupId': 'OG001'}]}]}, {'title': 'Week 52 LOCF: % Change from Baseline (n=141, 139)', 'categories': [{'measurements': [{'value': '-4.129', 'spread': '9.673', 'groupId': 'OG000'}, {'value': '-2.108', 'spread': '9.652', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 1, Week 2, Week 3, Week 4, Week 6, Week 12, Week 18, Week 26, Week 39, Week 52, Week 52 Last Observation Carried Forward (LOCF)', 'description': 'Percent predicted change from Baseline in post-bronchodilator forced expiratory volume in one second (FEV1) measured in liters (L): National Health and Nutrition Examination Survey (NHANES III) reference standard. Percent change from Baseline in post-bronchdilator FEV1 measured in liters (L): (observed value minus Baseline value) divided by Baseline value \\*100%.', 'unitOfMeasure': 'percentage of FEV1', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set (FAS); LOCF: last observation carried forward.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Insulin Dose Responsiveness for Forced Expiratory Volume in One Second (FEV1) Measured 10 and 60 Minutes After the First Daily Dose of Insulin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '124', 'groupId': 'OG000'}, {'value': '131', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Inhaled Insulin', 'description': 'Inhaled insulin (Exubera®) with dose adjusted according to premeal blood glucose plus basal insulin.'}, {'id': 'OG001', 'title': 'Subcutaneous Insulin', 'description': 'Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.'}], 'classes': [{'title': 'Baseline: 10 minutes (n=124, 131)', 'categories': [{'measurements': [{'value': '-0.004', 'spread': '0.085', 'groupId': 'OG000'}, {'value': '0.003', 'spread': '0.086', 'groupId': 'OG001'}]}]}, {'title': 'Week 9: 10 minutes (n=105, 106)', 'categories': [{'measurements': [{'value': '-0.008', 'spread': '0.130', 'groupId': 'OG000'}, {'value': '0.005', 'spread': '0.111', 'groupId': 'OG001'}]}]}, {'title': 'Week 51: 10 minutes (n=96, 113)', 'categories': [{'measurements': [{'value': '0.000', 'spread': '0.113', 'groupId': 'OG000'}, {'value': '0.013', 'spread': '0.104', 'groupId': 'OG001'}]}]}, {'title': 'Baseline: 60 minutes (n=125, 131)', 'categories': [{'measurements': [{'value': '-0.004', 'spread': '0.120', 'groupId': 'OG000'}, {'value': '0.016', 'spread': '0.130', 'groupId': 'OG001'}]}]}, {'title': 'Week 9: 60 minutes (n=105, 105)', 'categories': [{'measurements': [{'value': '0.013', 'spread': '0.113', 'groupId': 'OG000'}, {'value': '0.028', 'spread': '0.137', 'groupId': 'OG001'}]}]}, {'title': 'Week 51: 60 minutes (n=99, 112)', 'categories': [{'measurements': [{'value': '0.029', 'spread': '0.139', 'groupId': 'OG000'}, {'value': '0.020', 'spread': '0.123', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 9, Week 51', 'description': 'Change from Baseline in Insulin Dose Responsiveness for Forced Expiratory Volume in one second (FEV1) measured 10 and 60 minutes after the first daily dose of insulin. Insulin dose responsiveness = the difference between FEV1 value following a dose of insulin and FEV1 value before a dose of insulin, operationally defined as the post dose FEV1 value minus predose FEV1 value.', 'unitOfMeasure': 'liters', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set (FAS)'}, {'type': 'SECONDARY', 'title': 'Percent Predicted and Percent Change From Baseline in 10 Minute and 60 Minute Post-Insulin Forced Expiratory Volume in One Second (FEV1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '124', 'groupId': 'OG000'}, {'value': '131', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Inhaled Insulin', 'description': 'Inhaled insulin (Exubera®) with dose adjusted according to premeal blood glucose plus basal insulin.'}, {'id': 'OG001', 'title': 'Subcutaneous Insulin', 'description': 'Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.'}], 'classes': [{'title': 'Baseline: 10 minutes (n=124, 131)', 'categories': [{'measurements': [{'value': '94.402', 'spread': '6.532', 'groupId': 'OG000'}, {'value': '94.391', 'spread': '6.168', 'groupId': 'OG001'}]}]}, {'title': 'Week 9: 10 min.; % of Predicted Value (n=105, 106)', 'categories': [{'measurements': [{'value': '92.698', 'spread': '9.187', 'groupId': 'OG000'}, {'value': '94.190', 'spread': '7.190', 'groupId': 'OG001'}]}]}, {'title': 'Week 9: 10 min;% Change from Baseline (n=105, 106)', 'categories': [{'measurements': [{'value': '-1.864', 'spread': '9.684', 'groupId': 'OG000'}, {'value': '-0.456', 'spread': '8.638', 'groupId': 'OG001'}]}]}, {'title': 'Week 51: 10 min.;% of Predicted Value (n=96, 113)', 'categories': [{'measurements': [{'value': '91.668', 'spread': '8.223', 'groupId': 'OG000'}, {'value': '93.717', 'spread': '9.305', 'groupId': 'OG001'}]}]}, {'title': 'Week 51:10 min;% Change from Baseline (n=96, 113)', 'categories': [{'measurements': [{'value': '-2.760', 'spread': '8.789', 'groupId': 'OG000'}, {'value': '0.228', 'spread': '13.653', 'groupId': 'OG001'}]}]}, {'title': 'Week 51 LOCF:10 min;% Predicted Value (n=124, 131)', 'categories': [{'measurements': [{'value': '91.196', 'spread': '8.366', 'groupId': 'OG000'}, {'value': '93.882', 'spread': '9.013', 'groupId': 'OG001'}]}]}, {'title': 'Week 51 LOCF:10 min;% Change from BL (n=124, 131)', 'categories': [{'measurements': [{'value': '-3.176', 'spread': '8.825', 'groupId': 'OG000'}, {'value': '-0.029', 'spread': '12.946', 'groupId': 'OG001'}]}]}, {'title': 'Baseline: 60 minutes (n=125, 131)', 'categories': [{'measurements': [{'value': '94.284', 'spread': '6.548', 'groupId': 'OG000'}, {'value': '94.688', 'spread': '5.260', 'groupId': 'OG001'}]}]}, {'title': 'Week 9: 60 min.; % of Predicted Value (n=105, 105)', 'categories': [{'measurements': [{'value': '93.586', 'spread': '8.219', 'groupId': 'OG000'}, {'value': '94.950', 'spread': '7.526', 'groupId': 'OG001'}]}]}, {'title': 'Week 9: 60 min;% Change from Baseline (n=105, 105)', 'categories': [{'measurements': [{'value': '-0.450', 'spread': '9.464', 'groupId': 'OG000'}, {'value': '-0.031', 'spread': '7.497', 'groupId': 'OG001'}]}]}, {'title': 'Week 51: 60 min.; % of Predicted Value (n=99, 112)', 'categories': [{'measurements': [{'value': '92.302', 'spread': '7.949', 'groupId': 'OG000'}, {'value': '94.084', 'spread': '9.069', 'groupId': 'OG001'}]}]}, {'title': 'Week 51:60 min.;% Change from Baseline (n=99, 112)', 'categories': [{'measurements': [{'value': '-1.699', 'spread': '9.015', 'groupId': 'OG000'}, {'value': '-0.247', 'spread': '10.349', 'groupId': 'OG001'}]}]}, {'title': 'Week 51 LOCF:60 min;% Predicted Value (n=125, 131)', 'categories': [{'measurements': [{'value': '92.418', 'spread': '8.544', 'groupId': 'OG000'}, {'value': '94.300', 'spread': '8.823', 'groupId': 'OG001'}]}]}, {'title': 'Week 51 LOCF:60 min;% Change from BL (n=125, 131)', 'categories': [{'measurements': [{'value': '-1.714', 'spread': '9.512', 'groupId': 'OG000'}, {'value': '-0.222', 'spread': '9.816', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 9, Week 51, Week 51 Last Observation Carried Forward (LOCF)', 'description': 'Percent predicted change from Baseline in 10 Minute and 60 Minute post-insulin forced expiratory volume in one second (FEV1) measured in liters (L): National Health and Nutrition Examination Survey (NHANES III) reference standard. Percent change from Baseline in FEV1 measured in liters (L) 10 and 60 Minutes post-insulin. Percent change = (value at observation minus Baseline value) divided by Baseline value \\*100%.', 'unitOfMeasure': 'percent', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set (FAS); LOCF: last observation carried forward.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Insulin Dose Responsiveness for Carbon Monoxide Diffusing Capacity (DLco) Measured 10 and 60 Minutes After the First Daily Dose of Insulin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '122', 'groupId': 'OG000'}, {'value': '129', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Inhaled Insulin', 'description': 'Inhaled insulin (Exubera®) with dose adjusted according to premeal blood glucose plus basal insulin.'}, {'id': 'OG001', 'title': 'Subcutaneous Insulin', 'description': 'Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.'}], 'classes': [{'title': 'Baseline: 10 minutes (n=122, 129)', 'categories': [{'measurements': [{'value': '-0.163', 'spread': '0.992', 'groupId': 'OG000'}, {'value': '-0.184', 'spread': '0.985', 'groupId': 'OG001'}]}]}, {'title': 'Week 9: 10 minutes (n=102, 104)', 'categories': [{'measurements': [{'value': '-0.241', 'spread': '1.390', 'groupId': 'OG000'}, {'value': '-0.131', 'spread': '1.006', 'groupId': 'OG001'}]}]}, {'title': 'Week 51: 10 minutes (n=95, 109)', 'categories': [{'measurements': [{'value': '-0.139', 'spread': '0.893', 'groupId': 'OG000'}, {'value': '-0.171', 'spread': '0.820', 'groupId': 'OG001'}]}]}, {'title': 'Baseline: 60 minutes (n=135, 133)', 'categories': [{'measurements': [{'value': '-0.446', 'spread': '1.115', 'groupId': 'OG000'}, {'value': '-0.451', 'spread': '1.258', 'groupId': 'OG001'}]}]}, {'title': 'Week 9: 60 minutes (n=104, 108)', 'categories': [{'measurements': [{'value': '-0.338', 'spread': '1.416', 'groupId': 'OG000'}, {'value': '-0.159', 'spread': '1.126', 'groupId': 'OG001'}]}]}, {'title': 'Week 51: 60 minutes (n=101, 110)', 'categories': [{'measurements': [{'value': '-0.216', 'spread': '1.458', 'groupId': 'OG000'}, {'value': '-0.383', 'spread': '1.030', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 9, Week 51', 'description': 'Carbon Monoxide Diffusing Capacity (DLco) dose responsivness 10 and 60 minutes after insulin. DLco dose-responsiveness to insulin was defined as the difference between the DLco value following a dose of insulin and DLco value before a dose of insulin, operationally defined as the post-dose DLco value minus pre-dose DLco value.', 'unitOfMeasure': 'ml/min/mmHg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set (FAS)'}, {'type': 'SECONDARY', 'title': 'Methacholine Challenge', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Inhaled Insulin', 'description': 'Inhaled insulin (Exubera®) with dose adjusted according to premeal blood glucose plus basal insulin.'}, {'id': 'OG001', 'title': 'Subcutaneous Insulin', 'description': 'Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.'}], 'paramType': 'MEAN', 'timeFrame': '1 to 2 days following Weeks -3 and -1 visits, and at Week 11, Week 50, and Week 52 (+5)', 'description': 'Methacholine Challange: performed on a subset of subjects using the 5-breath dosimeter method. Subjects were challenged with ascending doses of nebulized methacholine; dosing schedule: 0.03, 0.06, 0.12, 0.25, 0.5, 1.0, 2.0, 4.0, 8.0, 16.0, 32.0 milligrams per milliliter (mg/ml) administered in 5-minute intervals. Forced expiratory volume in 1 second (FEV1) was measured 1-3 minutes after each inhalation of methacholine solution. Testing continued until highest FEV1 decreased by ≥20% from the challenge (post-diluent) reference, or until completion all doses.', 'unitOfMeasure': 'liters', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'There were no methacholine challenges performed in subjects using inhaled insulin due to protocol-defined exclusion criteria for methacholine challenge testing, and methacholine provocative concentration \\[of methacholine\\] causing a 20% fall in FEV1 (PC20) data were not analyzed.'}, {'type': 'SECONDARY', 'title': 'Mean Weekly Morning and Evening Peak Expiratory Flow Rate (PEFR) and Forced Expiratory Volume in 1 Second (FEV1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Inhaled Insulin', 'description': 'Inhaled insulin (Exubera®) with dose adjusted according to premeal blood glucose plus basal insulin.'}, {'id': 'OG001', 'title': 'Subcutaneous Insulin', 'description': 'Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.'}], 'paramType': 'MEAN', 'timeFrame': 'Week -3 through Week 52', 'description': 'Subjects measured peak expiratory flow rate (PEFR) and forced expiratory volume in 1 second (FEV1) twice daily and entered the results in an electronic diary. Daily data were used to calculate the mean PEFR and FEV1 for each week (observed weekly mean and change from baseline in weekly mean). For each subject, the mean weekly morning (and evening) PEFR and FEV1 was defined as the sum of the daily morning (and evening) PEFR (and FEV1) measurements during the week divided by the number of non-missing PEFR (and FEV1) measurements during the week.', 'unitOfMeasure': 'liters', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Mean weekly morning and evening peak expiratory flow rate (PEFR) and forced expiratory volume in 1 second (FEV1) were not presented due to lack of resource resulting from scaling down of Exubera® (inhaled insulin) development.'}, {'type': 'SECONDARY', 'title': 'Mean Weekly Number of Puffs of Albuterol Used (Rescue Medication)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Inhaled Insulin', 'description': 'Inhaled insulin (Exubera®) with dose adjusted according to premeal blood glucose plus basal insulin.'}, {'id': 'OG001', 'title': 'Subcutaneous Insulin', 'description': 'Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.'}], 'paramType': 'MEAN', 'timeFrame': 'Daily: Baseline to end of study', 'description': 'All subjects used an electronic symptom diary to record their daily use of short-acting bronchodilators. Subjects recorded the sum of their short-acting bronchodilator use (puffs of albuterol) daily, immediately upon arising, and again in the evening or before bed.', 'unitOfMeasure': 'number of puffs', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Mean weekly number of puffs of albuterol was not presented due to lack of resource resulting from scaling down of Exubera® (inhaled insulin) development.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With Step-up and Step-down Changes in Classification of Asthma Severity by Medication Usage', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Inhaled Insulin', 'description': 'Inhaled insulin (Exubera®) with dose adjusted according to premeal blood glucose plus basal insulin.'}, {'id': 'OG001', 'title': 'Subcutaneous Insulin', 'description': 'Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.'}], 'paramType': 'NUMBER', 'timeFrame': 'Week 1, Week 2, Week 3, Week 4, Week 6, Week 9, Week 12, Week 18, Week 26, Week 39, Week 52, Week 54, Week 58', 'description': 'All asthma medication changes during the study were classified as step-up or step-down according to treatment guidelines. Step 1: Intermittant Asthma; Step 2: Mild Persistent Asthma; Step 3: Moderate Persistent Asthma; Step 4: Severe Persistent Asthma. The number of subjects in each step classification of asthma severity were provided at each assessment timepoint for each treatment group, with a shift table indicating the number of subjects moving from each step classification at each timepoint.', 'unitOfMeasure': 'subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'Data for the number of step-up and step-down changes in classification of asthma severity by medication usage were not tabulated or analyzed as accurate dose information data for all concomitant medications were not available due to inconsistencies in the way concomitant medication data were collected.'}, {'type': 'SECONDARY', 'title': 'Step Classification of Asthma Severity by Medication Usage', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Inhaled Insulin', 'description': 'Inhaled insulin (Exubera®) with dose adjusted according to premeal blood glucose plus basal insulin.'}, {'id': 'OG001', 'title': 'Subcutaneous Insulin', 'description': 'Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.'}], 'paramType': 'NUMBER', 'timeFrame': 'Week 1, Week 2, Week 3, Week 4, Week 6, Week 9, Week 12, Week 18, Week 26, Week 39, Week 52, Week 54, Week 58', 'description': 'Step classification of asthma severity by medication usage. Subjects were classified at each visit according to the medication used on the day of the particular time-point; Step 1: intermittent asthma, Step 2: mild persistent asthma, Step 3: moderate persistent asthma, Step 4: severe persistent asthma. The number (%) of subjects in each step classification were provided at each assessment timepoint with a shift table indicating the number (%) of subjects moving from each step classification at each time-point.', 'unitOfMeasure': 'subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'Data for step classification of asthma severity by medication usage were not tabulated or analyzed as accurate dose information data for all concomitant medications were not available due to inconsistencies in the way concomitant medication data were collected.'}, {'type': 'SECONDARY', 'title': 'Mean Weekly Asthma Symptom Scores', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Inhaled Insulin', 'description': 'Inhaled insulin (Exubera®) with dose adjusted according to premeal blood glucose plus basal insulin.'}, {'id': 'OG001', 'title': 'Subcutaneous Insulin', 'description': 'Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline through end of study', 'description': 'Mean weekly asthma symptom scores: subjects recorded their asthma symptom scores in an electronic symptom diary twice daily throughout the study, immediately upon awakening (5-10 AM) and in the evening or at bedtime (7-12 PM). Questions included extent of albuterol use, symptoms of wheezing, coughing, activity limitations and sleep; scale 0 (none/fine) to 3 (severe/ continuous/bad night).', 'unitOfMeasure': 'scores on scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Data for mean weekly asthma symptom scores were not presented due to lack of resource resulting from scaling down of Exubera® (inhaled insulin) development.'}, {'type': 'SECONDARY', 'title': 'Incidence of Non-severe Asthma Exacerbations', 'denoms': [{'units': 'Participants', 'counts': [{'value': '141', 'groupId': 'OG000'}, {'value': '139', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Inhaled Insulin', 'description': 'Inhaled insulin (Exubera®) with dose adjusted according to premeal blood glucose plus basal insulin.'}, {'id': 'OG001', 'title': 'Subcutaneous Insulin', 'description': 'Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.'}], 'classes': [{'title': '0 to 1 Week (n=141, 139)', 'categories': [{'measurements': [{'value': '0.43', 'groupId': 'OG000'}, {'value': '0.41', 'groupId': 'OG001'}]}]}, {'title': '>1 to 2 Weeks (n=141, 139)', 'categories': [{'measurements': [{'value': '0.28', 'groupId': 'OG000'}, {'value': '0.38', 'groupId': 'OG001'}]}]}, {'title': '>2 to 3 Weeks (n=141, 139)', 'categories': [{'measurements': [{'value': '0.22', 'groupId': 'OG000'}, {'value': '0.31', 'groupId': 'OG001'}]}]}, {'title': '>3 to 4 Weeks (n=141, 139)', 'categories': [{'measurements': [{'value': '0.37', 'groupId': 'OG000'}, {'value': '0.41', 'groupId': 'OG001'}]}]}, {'title': '>4 to 6 Weeks (n=141, 139)', 'categories': [{'measurements': [{'value': '0.52', 'groupId': 'OG000'}, {'value': '0.36', 'groupId': 'OG001'}]}]}, {'title': '>6 to 9 Weeks (n=138, 139)', 'categories': [{'measurements': [{'value': '0.53', 'groupId': 'OG000'}, {'value': '0.51', 'groupId': 'OG001'}]}]}, {'title': '>9 to 12 Weeks (n=134, 138)', 'categories': [{'measurements': [{'value': '0.35', 'groupId': 'OG000'}, {'value': '0.46', 'groupId': 'OG001'}]}]}, {'title': '>3 Months (n=133, 137)', 'categories': [{'measurements': [{'value': '0.40', 'groupId': 'OG000'}, {'value': '0.40', 'groupId': 'OG001'}]}]}, {'title': '>6 to 9 Months (n=121, 133)', 'categories': [{'measurements': [{'value': '0.30', 'groupId': 'OG000'}, {'value': '0.49', 'groupId': 'OG001'}]}]}, {'title': '>9 to 12 Months (n=114, 131)', 'categories': [{'measurements': [{'value': '0.27', 'groupId': 'OG000'}, {'value': '0.43', 'groupId': 'OG001'}]}]}, {'title': '>12 Months (n=67, 81)', 'categories': [{'measurements': [{'value': '0.34', 'groupId': 'OG000'}, {'value': '0.21', 'groupId': 'OG001'}]}]}, {'title': 'Overall (n=141, 139)', 'categories': [{'measurements': [{'value': '0.35', 'groupId': 'OG000'}, {'value': '0.43', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '0 to 1 week to > 12 months', 'description': 'Non-severe asthma exacerbation = one of the following: any home monitored morning (4:45 am - 10:15 am) forced expiratory volume in 1 second (FEV1) \\<80% of the morning baseline for 2 or more consecutive days; or home monitored FEV1 \\<60% of Baseline at any time. Percent of Baseline = 100\\*(daily FEV1)/Baseline weekly FEV1. Subject-months=elapsed number of months a subject was in the study in each time interval. Crude event rate = total events divided by subject-months.', 'unitOfMeasure': 'events/subject-months', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS; review of source data for this endpoint showed excessive data variability for home-monitored FEV1 with outliers ranging from 0.01 to \\>100, and many subjects with random peaks and dips of 100% or more of their baseline. It is unlikely that the protocol definition is robust enough to provide real information about exacerbation frequencies.'}, {'type': 'SECONDARY', 'title': 'Incidence of Severe Asthma Exacerbations', 'denoms': [{'units': 'Participants', 'counts': [{'value': '141', 'groupId': 'OG000'}, {'value': '139', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Inhaled Insulin', 'description': 'Inhaled insulin (Exubera®) with dose adjusted according to premeal blood glucose plus basal insulin.'}, {'id': 'OG001', 'title': 'Subcutaneous Insulin', 'description': 'Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.'}], 'classes': [{'title': '0 to 1 Week (n=141, 139)', 'categories': [{'measurements': [{'value': '0.00', 'groupId': 'OG000'}, {'value': '0.00', 'groupId': 'OG001'}]}]}, {'title': '>1 to 2 Weeks (n=141, 139)', 'categories': [{'measurements': [{'value': '0.00', 'groupId': 'OG000'}, {'value': '3.13', 'groupId': 'OG001'}]}]}, {'title': '>2 to 3 Weeks (n=141, 139)', 'categories': [{'measurements': [{'value': '0.00', 'groupId': 'OG000'}, {'value': '9.39', 'groupId': 'OG001'}]}]}, {'title': '>3 to 4 Weeks (n=141, 139)', 'categories': [{'measurements': [{'value': '3.08', 'groupId': 'OG000'}, {'value': '0.00', 'groupId': 'OG001'}]}]}, {'title': '>4 to 6 Weeks (n=141, 139)', 'categories': [{'measurements': [{'value': '4.63', 'groupId': 'OG000'}, {'value': '1.56', 'groupId': 'OG001'}]}]}, {'title': '>6 to 9 Weeks (n=138, 139)', 'categories': [{'measurements': [{'value': '1.06', 'groupId': 'OG000'}, {'value': '0.00', 'groupId': 'OG001'}]}]}, {'title': '>9 to 12 Weeks (n=134, 138)', 'categories': [{'measurements': [{'value': '1.09', 'groupId': 'OG000'}, {'value': '0.00', 'groupId': 'OG001'}]}]}, {'title': '>3 Months (n=133, 137)', 'categories': [{'measurements': [{'value': '1.20', 'groupId': 'OG000'}, {'value': '2.27', 'groupId': 'OG001'}]}]}, {'title': '>6 to 9 Months (n=121, 133)', 'categories': [{'measurements': [{'value': '1.43', 'groupId': 'OG000'}, {'value': '1.01', 'groupId': 'OG001'}]}]}, {'title': '>9 to 12 Months (n=114, 131)', 'categories': [{'measurements': [{'value': '1.53', 'groupId': 'OG000'}, {'value': '1.33', 'groupId': 'OG001'}]}]}, {'title': '>12 Months (n=67, 81)', 'categories': [{'measurements': [{'value': '3.39', 'groupId': 'OG000'}, {'value': '0.00', 'groupId': 'OG001'}]}]}, {'title': 'Overall (n=141, 139)', 'categories': [{'measurements': [{'value': '1.46', 'groupId': 'OG000'}, {'value': '1.47', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '0 to 1 Week to > 12 Months', 'description': 'Severe asthma exacerbation was defined as one of the following: subject received oral (systemic) corticosteriods for the treatment of asthma; or subject had an unscheduled visit to a physician, emergency room, or hospital for the treatment of asthma. Subject-months=elapsed number of months a subject was in the study in each time interval. Crude event rate = total events divided by subject-months \\* 100.', 'unitOfMeasure': 'events/subject months*100', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set (FAS); due to inconsistencies in data entry for systemic steroids, the protocol definition for severe asthma exacerbations, which was based on systemic corticosteroid use for asthma, could not be accurately assessed. Due the small number of events the incidence of severe asthma exacerbations was assessed per 100 months.'}, {'type': 'SECONDARY', 'title': 'Number of Systemic Corticosteroid Rescues', 'denoms': [{'units': 'Participants', 'counts': [{'value': '141', 'groupId': 'OG000'}, {'value': '139', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Inhaled Insulin', 'description': 'Inhaled insulin (Exubera®) with dose adjusted according to premeal blood glucose plus basal insulin.'}, {'id': 'OG001', 'title': 'Subcutaneous Insulin', 'description': 'Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.'}], 'classes': [{'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline through Week 52', 'description': 'Number of subjects who used a systemic corticosteroid at any time during the study, and the total number of systemic corticosteroid rescues. New rescue event = \\>=2 consecutive days between the end of one event and the start of another event.', 'unitOfMeasure': 'systemic corticosteriod rescues', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set (FAS); number of subjects with systemic corticosteroid rescues = inhaled insulin: 12, and subcutaneous insulin: 14. Due to inconsistencies in data entry, the numbers of systemic corticosteroid rescues were not considered entirely accurate.'}, {'type': 'PRIMARY', 'title': 'Annualized Rate of Change for Hemoglobin-adjusted Carbon Monoxide Diffusion Capacity (DLco)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '117', 'groupId': 'OG000'}, {'value': '127', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Inhaled Insulin', 'description': 'Inhaled insulin (Exubera®) with dose adjusted according to premeal blood glucose plus basal insulin.'}, {'id': 'OG001', 'title': 'Subcutaneous Insulin', 'description': 'Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.776', 'spread': '0.152', 'groupId': 'OG000'}, {'value': '-0.273', 'spread': '0.153', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '90', 'paramValue': '-0.503', 'ciLowerLimit': '-0.858', 'ciUpperLimit': '-0.148', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.216', 'estimateComment': 'Primary analysis model includes terms of Treatment, Time, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on day of randomization.', 'groupDescription': 'Treatment group difference (Exubera minus subcutaneous insulin): annualized rate of change over time. Longitudinal data analysis methods with random effects were used to model the pulmonary function test (PFT) measurements. Random effects included the intercept and slope with respect to time (visit); all remaining effects were fixed. The estimated rate of change over time for each treatment group was derived from this model.', 'statisticalMethod': 'Longitudinal data analysis model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Confidence interval of least squares (LS) mean difference (INH - SC) between annual rates of change for the two treatment groups.', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Weeks -3, -2, -1, 1, 2, 3, 4, 6, 12, 18, 26, 39, and 52', 'description': 'Annualized rates of change (slope throughout time from baseline to end of study\\[visit\\]) for hemoglobin-adjusted carbon monoxide diffusion capacity (DLco)in milliliters per minute/millimeters of mercury/year (ml/min/mmHg/yr) measured 30 minutes following the administration of albuterol.', 'unitOfMeasure': 'ml/min/mmHg/yr', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Primary analysis set (PAS).'}, {'type': 'SECONDARY', 'title': 'Asthma Control as Measured by the Asthma Control Questionnaire©', 'denoms': [{'units': 'Participants', 'counts': [{'value': '138', 'groupId': 'OG000'}, {'value': '138', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Inhaled Insulin', 'description': 'Inhaled insulin (Exubera®) with dose adjusted according to premeal blood glucose plus basal insulin.'}, {'id': 'OG001', 'title': 'Subcutaneous Insulin', 'description': 'Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.'}], 'classes': [{'title': 'Baseline: Subject Evaluation (n=138, 138)', 'categories': [{'measurements': [{'value': '1.04', 'spread': '0.78', 'groupId': 'OG000'}, {'value': '1.21', 'spread': '0.91', 'groupId': 'OG001'}]}]}, {'title': 'Baseline: Clinical Evaluation (n=138, 138)', 'categories': [{'measurements': [{'value': '2.50', 'spread': '1.50', 'groupId': 'OG000'}, {'value': '2.54', 'spread': '1.70', 'groupId': 'OG001'}]}]}, {'title': 'Baseline: Overall Evaluation (n=138, 138)', 'categories': [{'measurements': [{'value': '1.25', 'spread': '0.74', 'groupId': 'OG000'}, {'value': '1.40', 'spread': '0.86', 'groupId': 'OG001'}]}]}, {'title': 'Week 4: Subject Evaluation (n=123, 121)', 'categories': [{'measurements': [{'value': '1.08', 'spread': '0.81', 'groupId': 'OG000'}, {'value': '1.15', 'spread': '0.89', 'groupId': 'OG001'}]}]}, {'title': 'Week 4: Clinical Evaluation (n=123, 121)', 'categories': [{'measurements': [{'value': '2.68', 'spread': '1.52', 'groupId': 'OG000'}, {'value': '2.65', 'spread': '1.61', 'groupId': 'OG001'}]}]}, {'title': 'Week 4: Overall Evaluation (n=123, 121)', 'categories': [{'measurements': [{'value': '1.31', 'spread': '0.78', 'groupId': 'OG000'}, {'value': '1.36', 'spread': '0.81', 'groupId': 'OG001'}]}]}, {'title': 'Week 12: Subject Evaluation (n=129, 134)', 'categories': [{'measurements': [{'value': '1.04', 'spread': '0.83', 'groupId': 'OG000'}, {'value': '1.17', 'spread': '0.91', 'groupId': 'OG001'}]}]}, {'title': 'Week 12: Clinical Evaluation (n=129, 134)', 'categories': [{'measurements': [{'value': '2.55', 'spread': '1.50', 'groupId': 'OG000'}, {'value': '2.61', 'spread': '1.48', 'groupId': 'OG001'}]}]}, {'title': 'Week 12: Overall Evaluation (n=129, 134)', 'categories': [{'measurements': [{'value': '1.25', 'spread': '0.77', 'groupId': 'OG000'}, {'value': '1.37', 'spread': '0.83', 'groupId': 'OG001'}]}]}, {'title': 'Week 26: Subject Evaluation (n=121, 131)', 'categories': [{'measurements': [{'value': '1.06', 'spread': '0.80', 'groupId': 'OG000'}, {'value': '1.07', 'spread': '0.91', 'groupId': 'OG001'}]}]}, {'title': 'Week 26: Clinical Evaluation (n=121, 131)', 'categories': [{'measurements': [{'value': '2.48', 'spread': '1.43', 'groupId': 'OG000'}, {'value': '2.61', 'spread': '1.57', 'groupId': 'OG001'}]}]}, {'title': 'Week 26: Overall Evaluation (n=121, 131)', 'categories': [{'measurements': [{'value': '1.27', 'spread': '0.74', 'groupId': 'OG000'}, {'value': '1.29', 'spread': '0.85', 'groupId': 'OG001'}]}]}, {'title': 'Week 39: Subject Evaluation (n=110, 125)', 'categories': [{'measurements': [{'value': '0.94', 'spread': '0.76', 'groupId': 'OG000'}, {'value': '1.00', 'spread': '0.85', 'groupId': 'OG001'}]}]}, {'title': 'Week 39: Clinical Evaluation (n=110, 125)', 'categories': [{'measurements': [{'value': '2.54', 'spread': '1.43', 'groupId': 'OG000'}, {'value': '2.63', 'spread': '1.52', 'groupId': 'OG001'}]}]}, {'title': 'Week 39: Overall Evaluation (n=110, 125)', 'categories': [{'measurements': [{'value': '1.17', 'spread': '0.71', 'groupId': 'OG000'}, {'value': '1.23', 'spread': '0.81', 'groupId': 'OG001'}]}]}, {'title': 'Week 52: Subject Evaluation (n=107, 120)', 'categories': [{'measurements': [{'value': '1.08', 'spread': '1.07', 'groupId': 'OG000'}, {'value': '0.98', 'spread': '0.84', 'groupId': 'OG001'}]}]}, {'title': 'Week 52: Clinical Evaluation (n=107, 120)', 'categories': [{'measurements': [{'value': '2.77', 'spread': '1.54', 'groupId': 'OG000'}, {'value': '2.64', 'spread': '1.56', 'groupId': 'OG001'}]}]}, {'title': 'Week 52: Overall Evaluation (n=107, 120)', 'categories': [{'measurements': [{'value': '1.32', 'spread': '0.99', 'groupId': 'OG000'}, {'value': '1.21', 'spread': '0.80', 'groupId': 'OG001'}]}]}, {'title': 'Week 4: Subject Eval: Change from BL (n=122, 120)', 'categories': [{'measurements': [{'value': '0.02', 'spread': '0.59', 'groupId': 'OG000'}, {'value': '-0.07', 'spread': '0.59', 'groupId': 'OG001'}]}]}, {'title': 'Week 4: Clinical Eval: Change from BL (n=122, 120)', 'categories': [{'measurements': [{'value': '0.17', 'spread': '0.85', 'groupId': 'OG000'}, {'value': '0.14', 'spread': '0.85', 'groupId': 'OG001'}]}]}, {'title': 'Week 4: Overall Eval: Change from BL (n=122, 120)', 'categories': [{'measurements': [{'value': '0.04', 'spread': '0.55', 'groupId': 'OG000'}, {'value': '-0.04', 'spread': '0.53', 'groupId': 'OG001'}]}]}, {'title': 'Week 12: Subject Eval: Change from BL (n=129, 134)', 'categories': [{'measurements': [{'value': '-0.02', 'spread': '0.66', 'groupId': 'OG000'}, {'value': '-0.04', 'spread': '0.72', 'groupId': 'OG001'}]}]}, {'title': 'Week 12 Clinical Eval: Change from BL (n=129, 134)', 'categories': [{'measurements': [{'value': '0.12', 'spread': '0.94', 'groupId': 'OG000'}, {'value': '0.09', 'spread': '0.91', 'groupId': 'OG001'}]}]}, {'title': 'Week 12: Overall Eval: Change from BL (n=129, 134)', 'categories': [{'measurements': [{'value': '0.00', 'spread': '0.59', 'groupId': 'OG000'}, {'value': '-0.02', 'spread': '0.62', 'groupId': 'OG001'}]}]}, {'title': 'Week 26: Subject Eval: Change from BL (n=121, 130)', 'categories': [{'measurements': [{'value': '0.05', 'spread': '0.77', 'groupId': 'OG000'}, {'value': '-0.12', 'spread': '0.82', 'groupId': 'OG001'}]}]}, {'title': 'Week 26 Clinical Eval: Change from BL (n=121, 130)', 'categories': [{'measurements': [{'value': '0.09', 'spread': '0.78', 'groupId': 'OG000'}, {'value': '0.09', 'spread': '1.00', 'groupId': 'OG001'}]}]}, {'title': 'Week 26: Overall Eval: Change from BL (n=121, 130)', 'categories': [{'measurements': [{'value': '0.05', 'spread': '0.68', 'groupId': 'OG000'}, {'value': '-0.09', 'spread': '0.73', 'groupId': 'OG001'}]}]}, {'title': 'Week 39: Subject Eval: Change from BL (n=110, 124)', 'categories': [{'measurements': [{'value': '-0.09', 'spread': '0.65', 'groupId': 'OG000'}, {'value': '-0.19', 'spread': '0.77', 'groupId': 'OG001'}]}]}, {'title': 'Week 39 Clinical Eval: Change from BL (n=110, 124)', 'categories': [{'measurements': [{'value': '0.14', 'spread': '1.05', 'groupId': 'OG000'}, {'value': '0.11', 'spread': '0.94', 'groupId': 'OG001'}]}]}, {'title': 'Week 39: Overall Eval: Change from BL (n=110, 124)', 'categories': [{'measurements': [{'value': '-0.06', 'spread': '0.58', 'groupId': 'OG000'}, {'value': '-0.15', 'spread': '0.68', 'groupId': 'OG001'}]}]}, {'title': 'Week 52: Subject Eval: Change from BL (n=106, 119)', 'categories': [{'measurements': [{'value': '0.06', 'spread': '0.88', 'groupId': 'OG000'}, {'value': '-0.19', 'spread': '0.86', 'groupId': 'OG001'}]}]}, {'title': 'Week 52 Clinical Eval: Change from BL (n=106, 119)', 'categories': [{'measurements': [{'value': '0.38', 'spread': '0.87', 'groupId': 'OG000'}, {'value': '0.10', 'spread': '1.20', 'groupId': 'OG001'}]}]}, {'title': 'Week 52: Overall Eval: Change from BL (n=106, 119)', 'categories': [{'measurements': [{'value': '0.11', 'spread': '0.77', 'groupId': 'OG000'}, {'value': '-0.15', 'spread': '0.77', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Weeks 4, 12, 26, 39, 52', 'description': 'Asthma Control Questionnaire©: 6 self-administered questions that assess asthma control over the past week covering nocturnal waking, morning symptoms, activity limitations, shortness of breath, wheezing, and short-acting bronchodilator use; 7-point ordinal rating scale from 0 (good control) to 6 (poor control). A seventh question was completed by a health professional on forced expiratory volume in 1 second (FEV1) % predicted using a one-week recall period; scale: 0 (\\>95% predicted) to 6 (\\<50% predicted). Overall score = mean of questions 1 - 7.', 'unitOfMeasure': 'scores on scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS; abbreviations: Eval = evaluations, BL = Baseline.'}, {'type': 'SECONDARY', 'title': 'Baseline Dyspnea Index (BDI)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '139', 'groupId': 'OG000'}, {'value': '138', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Inhaled Insulin', 'description': 'Inhaled insulin (Exubera®) with dose adjusted according to premeal blood glucose plus basal insulin.'}, {'id': 'OG001', 'title': 'Subcutaneous Insulin', 'description': 'Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.'}], 'classes': [{'title': 'Functional Impairment', 'categories': [{'measurements': [{'value': '3.37', 'spread': '0.80', 'groupId': 'OG000'}, {'value': '3.36', 'spread': '0.87', 'groupId': 'OG001'}]}]}, {'title': 'Magnitude of Task', 'categories': [{'measurements': [{'value': '2.29', 'spread': '1.19', 'groupId': 'OG000'}, {'value': '2.29', 'spread': '1.25', 'groupId': 'OG001'}]}]}, {'title': 'Magnitude of Effort', 'categories': [{'measurements': [{'value': '2.49', 'spread': '1.39', 'groupId': 'OG000'}, {'value': '2.34', 'spread': '1.49', 'groupId': 'OG001'}]}]}, {'title': 'Total Score', 'categories': [{'measurements': [{'value': '8.15', 'spread': '2.98', 'groupId': 'OG000'}, {'value': '7.97', 'spread': '2.99', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'run-in period', 'description': 'Total score = the sum of the numeric grades from the three dyspnea index questions. Functional Impairment rating scale: Grade 4 (no impairment) to Grade 0 (very severe impairment); Magnitude of Task rating scale: Grade 4 (extraordinary) to Grade 0 (no task); and Magnitude of Effort rating scale: Grade 4 (extraordinary) to grade 0 (no effort).', 'unitOfMeasure': 'scores on scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set (FAS)'}, {'type': 'SECONDARY', 'title': 'Transition Dyspnea Index (TDI): Change in Total Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '131', 'groupId': 'OG000'}, {'value': '135', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Inhaled Insulin', 'description': 'Inhaled insulin (Exubera®) with dose adjusted according to premeal blood glucose plus basal insulin.'}, {'id': 'OG001', 'title': 'Subcutaneous Insulin', 'description': 'Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.'}], 'classes': [{'title': 'Week 4 (n=121, 122)', 'categories': [{'measurements': [{'value': '0.36', 'spread': '1.93', 'groupId': 'OG000'}, {'value': '0.50', 'spread': '1.92', 'groupId': 'OG001'}]}]}, {'title': 'Week 12 (n=131, 135)', 'categories': [{'measurements': [{'value': '0.51', 'spread': '1.76', 'groupId': 'OG000'}, {'value': '0.47', 'spread': '1.68', 'groupId': 'OG001'}]}]}, {'title': 'Week 26 (n=124, 131)', 'categories': [{'measurements': [{'value': '0.14', 'spread': '1.75', 'groupId': 'OG000'}, {'value': '0.13', 'spread': '1.55', 'groupId': 'OG001'}]}]}, {'title': 'Week 39 (n=112, 127)', 'categories': [{'measurements': [{'value': '0.26', 'spread': '1.56', 'groupId': 'OG000'}, {'value': '0.29', 'spread': '1.61', 'groupId': 'OG001'}]}]}, {'title': 'Week 52 (n=105, 121)', 'categories': [{'measurements': [{'value': '0.13', 'spread': '1.65', 'groupId': 'OG000'}, {'value': '0.67', 'spread': '2.01', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 4, Week 12, Week 26, Week 39, Week 52', 'description': 'Transition Dyspnea Index total score = sum of the numeric grades from the three dyspnea index questions: Change in Functional Impairment, Change in Magnitude of Task, and Change in Magnitude of Effort. Rating scale: -3 (major deterioration), -2 (moderate deterioration), -1 (minor deterioration, 0 (no change), +1 (minor improvement), +2 (moderate improvement), +3 (major improvement).', 'unitOfMeasure': 'scores on scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set (FAS)'}, {'type': 'SECONDARY', 'title': 'Glycosylated Hemoglobin (HbA1c)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '135', 'groupId': 'OG000'}, {'value': '135', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Inhaled Insulin', 'description': 'Inhaled insulin (Exubera®) with dose adjusted according to premeal blood glucose plus basal insulin.'}, {'id': 'OG001', 'title': 'Subcutaneous Insulin', 'description': 'Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.'}], 'classes': [{'title': 'Baseline (n=135, 135)', 'categories': [{'measurements': [{'value': '7.62', 'spread': '1.12', 'groupId': 'OG000'}, {'value': '7.43', 'spread': '1.08', 'groupId': 'OG001'}]}]}, {'title': 'Week 6: Observed Value (n=127, 126)', 'categories': [{'measurements': [{'value': '7.22', 'spread': '1.00', 'groupId': 'OG000'}, {'value': '6.97', 'spread': '0.90', 'groupId': 'OG001'}]}]}, {'title': 'Week 6: Change from Baseline (n=127, 126)', 'categories': [{'measurements': [{'value': '-0.38', 'spread': '0.65', 'groupId': 'OG000'}, {'value': '-0.43', 'spread': '0.49', 'groupId': 'OG001'}]}]}, {'title': 'Week 12: Observed Value (n=122, 127)', 'categories': [{'measurements': [{'value': '7.28', 'spread': '1.12', 'groupId': 'OG000'}, {'value': '6.98', 'spread': '0.97', 'groupId': 'OG001'}]}]}, {'title': 'Week 12: Change from Baseline (n=122, 127)', 'categories': [{'measurements': [{'value': '-0.32', 'spread': '0.98', 'groupId': 'OG000'}, {'value': '-0.48', 'spread': '0.69', 'groupId': 'OG001'}]}]}, {'title': 'Week 26: Observed Value (n=118, 120)', 'categories': [{'measurements': [{'value': '7.38', 'spread': '1.24', 'groupId': 'OG000'}, {'value': '7.19', 'spread': '1.18', 'groupId': 'OG001'}]}]}, {'title': 'Week 26: Change from Baseline (n=118, 120)', 'categories': [{'measurements': [{'value': '-0.12', 'spread': '1.07', 'groupId': 'OG000'}, {'value': '-0.25', 'spread': '0.93', 'groupId': 'OG001'}]}]}, {'title': 'Week 39: Observed Value (n=108, 123)', 'categories': [{'measurements': [{'value': '7.44', 'spread': '1.31', 'groupId': 'OG000'}, {'value': '7.20', 'spread': '1.16', 'groupId': 'OG001'}]}]}, {'title': 'Week 39: Change from Baseline (n=108, 123)', 'categories': [{'measurements': [{'value': '-0.08', 'spread': '1.10', 'groupId': 'OG000'}, {'value': '-0.21', 'spread': '0.91', 'groupId': 'OG001'}]}]}, {'title': 'Week 52: Observed Value (n=101, 118)', 'categories': [{'measurements': [{'value': '7.51', 'spread': '1.35', 'groupId': 'OG000'}, {'value': '7.35', 'spread': '1.28', 'groupId': 'OG001'}]}]}, {'title': 'Week 52: Change from Baseline (n=101, 118)', 'categories': [{'measurements': [{'value': '0.00', 'spread': '1.05', 'groupId': 'OG000'}, {'value': '-0.05', 'spread': '1.01', 'groupId': 'OG001'}]}]}, {'title': 'Week 52 (LOCF): Observed Value (n=135, 135)', 'categories': [{'measurements': [{'value': '7.58', 'spread': '1.35', 'groupId': 'OG000'}, {'value': '7.40', 'spread': '1.36', 'groupId': 'OG001'}]}]}, {'title': 'Week 52 (LOCF): Change from Baseline (n=135, 135)', 'categories': [{'measurements': [{'value': '-0.04', 'spread': '1.07', 'groupId': 'OG000'}, {'value': '-0.03', 'spread': '1.04', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '90', 'paramValue': '0.11', 'ciLowerLimit': '-0.06', 'ciUpperLimit': '0.28', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.10', 'groupDescription': 'Week 6; Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of treatment, Week, Baseline HbA1c, Center, and Type of Diabetes.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '90', 'paramValue': '0.21', 'ciLowerLimit': '0.04', 'ciUpperLimit': '0.38', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.10', 'groupDescription': 'Week 12; Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of treatment, Week, Baseline HbA1c, Center, and Type of Diabetes.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '90', 'paramValue': '0.17', 'ciLowerLimit': '-0.01', 'ciUpperLimit': '0.34', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.11', 'groupDescription': 'Week 26; Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of treatment, Week, Baseline HbA1c, Center, and Type of Diabetes.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '90', 'paramValue': '0.14', 'ciLowerLimit': '-0.03', 'ciUpperLimit': '0.32', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.11', 'groupDescription': 'Week 39; Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of treatment, Week, Baseline HbA1c, Center, and Type of Diabetes.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '90', 'paramValue': '0.06', 'ciLowerLimit': '-0.12', 'ciUpperLimit': '0.24', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.11', 'groupDescription': 'Week 52; Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of treatment, Week, Baseline HbA1c, Center, and Type of Diabetes.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '90', 'paramValue': '0.01', 'ciLowerLimit': '-0.19', 'ciUpperLimit': '0.22', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.12', 'groupDescription': 'Week 52 (LOCF); Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of treatment, Week, Baseline HbA1c, Center, and Type of Diabetes.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 6, Week 12, Week 26, Week 39, Week 52, Week 52 Last Observation Carried Forward (LOCF)', 'description': 'Glycosylated Hemoglobin (HbA1c): observed mean values at Baseline and each observation, and change from Baseline. Change from Baseline = mean HbA1c at observation minus mean HbA1c at Baseline.', 'unitOfMeasure': 'percent', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set (FAS)'}, {'type': 'SECONDARY', 'title': 'Fasting Plasma Glucose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '112', 'groupId': 'OG000'}, {'value': '123', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Inhaled Insulin', 'description': 'Inhaled insulin (Exubera®) with dose adjusted according to premeal blood glucose plus basal insulin.'}, {'id': 'OG001', 'title': 'Subcutaneous Insulin', 'description': 'Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.'}], 'classes': [{'title': 'Baseline (n=112, 123)', 'categories': [{'measurements': [{'value': '149.22', 'spread': '49.92', 'groupId': 'OG000'}, {'value': '149.03', 'spread': '58.33', 'groupId': 'OG001'}]}]}, {'title': 'Week 6: Observed Value (n=103, 112)', 'categories': [{'measurements': [{'value': '143.02', 'spread': '68.92', 'groupId': 'OG000'}, {'value': '136.54', 'spread': '57.98', 'groupId': 'OG001'}]}]}, {'title': 'Week 6: Change from Baseline (n=103, 112)', 'categories': [{'measurements': [{'value': '-3.34', 'spread': '68.47', 'groupId': 'OG000'}, {'value': '-15.19', 'spread': '67.16', 'groupId': 'OG001'}]}]}, {'title': 'Week 12: Observed Value (n=106, 113)', 'categories': [{'measurements': [{'value': '136.32', 'spread': '63.00', 'groupId': 'OG000'}, {'value': '144.47', 'spread': '61.22', 'groupId': 'OG001'}]}]}, {'title': 'Week 12: Change from Baseline (n=106, 113)', 'categories': [{'measurements': [{'value': '-12.16', 'spread': '65.62', 'groupId': 'OG000'}, {'value': '-5.40', 'spread': '67.71', 'groupId': 'OG001'}]}]}, {'title': 'Week 26: Observed Value (n=102, 114)', 'categories': [{'measurements': [{'value': '139.05', 'spread': '64.63', 'groupId': 'OG000'}, {'value': '143.54', 'spread': '52.09', 'groupId': 'OG001'}]}]}, {'title': 'Week 26: Change from Baseline (n=102, 114)', 'categories': [{'measurements': [{'value': '-11.86', 'spread': '76.07', 'groupId': 'OG000'}, {'value': '-4.63', 'spread': '65.10', 'groupId': 'OG001'}]}]}, {'title': 'Week 39: Observed Value (n=102, 115)', 'categories': [{'measurements': [{'value': '143.64', 'spread': '63.89', 'groupId': 'OG000'}, {'value': '142.91', 'spread': '66.26', 'groupId': 'OG001'}]}]}, {'title': 'Week 39: Change from Baseline (n=102, 115)', 'categories': [{'measurements': [{'value': '-5.67', 'spread': '67.65', 'groupId': 'OG000'}, {'value': '-7.47', 'spread': '65.55', 'groupId': 'OG001'}]}]}, {'title': 'Week 52: Observed Value (n=98, 115)', 'categories': [{'measurements': [{'value': '146.32', 'spread': '66.04', 'groupId': 'OG000'}, {'value': '145.43', 'spread': '59.35', 'groupId': 'OG001'}]}]}, {'title': 'Week 52: Change from Baseline (n=98, 115)', 'categories': [{'measurements': [{'value': '-3.86', 'spread': '60.61', 'groupId': 'OG000'}, {'value': '-2.53', 'spread': '63.23', 'groupId': 'OG001'}]}]}, {'title': 'Week 52 LOCF: Observed Value (n=112, 123)', 'categories': [{'measurements': [{'value': '148.28', 'spread': '71.07', 'groupId': 'OG000'}, {'value': '144.96', 'spread': '58.80', 'groupId': 'OG001'}]}]}, {'title': 'Week 52 LOCF: Change from Baseline (n=112, 123)', 'categories': [{'measurements': [{'value': '-0.95', 'spread': '72.53', 'groupId': 'OG000'}, {'value': '-4.07', 'spread': '62.75', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '90', 'paramValue': '10.615', 'ciLowerLimit': '-2.351', 'ciUpperLimit': '23.581', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '7.874', 'groupDescription': 'Week 6; Analysis of change from Baseline in fasting plasma glucose: Inhaled Insulin - Subcutaneouas Insulin. Adjusted (Primary Analysis Model): includes terms of Treatment, Week, Baseline, Fasting Plasma Glucose, Center, and Type of Diabetes.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Confidence interval for the LS mean of that particular treatment.', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '90', 'paramValue': '-6.942', 'ciLowerLimit': '-19.79', 'ciUpperLimit': '5.909', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '7.804', 'groupDescription': 'Week 12; Analysis of change from Baseline in fasting plasma glucose: Inhaled Insulin - Subcutaneouas Insulin. Adjusted (Primary Analysis Model): includes terms of Treatment, Week, Baseline, Fasting Plasma Glucose, Center, and Type of Diabetes.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '90', 'paramValue': '-4.622', 'ciLowerLimit': '-17.63', 'ciUpperLimit': '8.382', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '7.897', 'groupDescription': 'Week 26; Analysis of change from Baseline in fasting plasma glucose: Inhaled Insulin - Subcutaneouas Insulin. Adjusted (Primary Analysis Model): includes terms of Treatment, Week, Baseline, Fasting Plasma Glucose, Center, and Type of Diabetes.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '90', 'paramValue': '1.828', 'ciLowerLimit': '-11.16', 'ciUpperLimit': '14.817', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '7.888', 'groupDescription': 'Week 39; Analysis of change from Baseline in fasting plasma glucose: Inhaled Insulin - Subcutaneouas Insulin. Adjusted (Primary Analysis Model): includes terms of Treatment, Week, Baseline, Fasting Plasma Glucose, Center, and Type of Diabetes.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '90', 'paramValue': '1.149', 'ciLowerLimit': '-12.01', 'ciUpperLimit': '14.307', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '7.991', 'groupDescription': 'Week 52; Analysis of change from Baseline in fasting plasma glucose: Inhaled Insulin - Subcutaneouas Insulin. Adjusted (Primary Analysis Model): includes terms of Treatment, Week, Baseline, Fasting Plasma Glucose, Center, and Type of Diabetes.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '90', 'paramValue': '4.247', 'ciLowerLimit': '-8.664', 'ciUpperLimit': '17.157', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '7.816', 'groupDescription': 'Week 52 (LOCF); Analysis of change from Baseline in fasting plasma glucose: Inhaled Insulin - Subcutaneouas Insulin. Adjusted (Primary Analysis Model): includes terms of Treatment, Week, Baseline, Fasting Plasma Glucose, Center, and Type of Diabetes.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 6, Week 12, Week 26, Week 39, Week 52, Week 52 Last Observation Carried Forward (LOCF)', 'description': 'Fasting plasma glucose (milligrams per deciliter \\[mg/dL\\]) at Baseline, and change from Baseline. Change from baseline: mean of value of fasting plasma glucose in mg/dL at observation minus baseline value.', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Primary analysis set (PAS); Last Observation Carried Forward: if the end of study value was missing the last available observation for that subject was used..'}, {'type': 'SECONDARY', 'title': 'Body Weight: Mean Baseline and Change From Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '113', 'groupId': 'OG000'}, {'value': '124', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Inhaled Insulin', 'description': 'Inhaled insulin (Exubera®) with dose adjusted according to premeal blood glucose plus basal insulin.'}, {'id': 'OG001', 'title': 'Subcutaneous Insulin', 'description': 'Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.'}], 'classes': [{'title': 'Baseline (n=113, 124)', 'categories': [{'measurements': [{'value': '87.41', 'spread': '21.04', 'groupId': 'OG000'}, {'value': '87.13', 'spread': '17.58', 'groupId': 'OG001'}]}]}, {'title': 'Week 1: Change from Baseline (n=102, 113)', 'categories': [{'measurements': [{'value': '-0.02', 'spread': '1.45', 'groupId': 'OG000'}, {'value': '1.00', 'spread': '7.63', 'groupId': 'OG001'}]}]}, {'title': 'Week 2: Change from Baseline (n=104, 105)', 'categories': [{'measurements': [{'value': '0.12', 'spread': '1.31', 'groupId': 'OG000'}, {'value': '0.57', 'spread': '1.50', 'groupId': 'OG001'}]}]}, {'title': 'Week 3: Change from Baseline (n=103, 113)', 'categories': [{'measurements': [{'value': '0.18', 'spread': '1.64', 'groupId': 'OG000'}, {'value': '0.34', 'spread': '1.55', 'groupId': 'OG001'}]}]}, {'title': 'Week 4: Change from Baseline (n=101, 119)', 'categories': [{'measurements': [{'value': '0.31', 'spread': '1.74', 'groupId': 'OG000'}, {'value': '0.44', 'spread': '1.70', 'groupId': 'OG001'}]}]}, {'title': 'Week 6: Change from Baseline (n=106, 122)', 'categories': [{'measurements': [{'value': '0.13', 'spread': '1.93', 'groupId': 'OG000'}, {'value': '0.68', 'spread': '1.88', 'groupId': 'OG001'}]}]}, {'title': 'Week 9: Change from Baseline (n=101, 104)', 'categories': [{'measurements': [{'value': '0.14', 'spread': '2.31', 'groupId': 'OG000'}, {'value': '0.91', 'spread': '2.33', 'groupId': 'OG001'}]}]}, {'title': 'Week 11: Change from Baseline (n=14, 17)', 'categories': [{'measurements': [{'value': '0.71', 'spread': '1.77', 'groupId': 'OG000'}, {'value': '0.69', 'spread': '2.00', 'groupId': 'OG001'}]}]}, {'title': 'Week 12: Change from Baseline (n=106, 118)', 'categories': [{'measurements': [{'value': '0.01', 'spread': '2.96', 'groupId': 'OG000'}, {'value': '0.84', 'spread': '2.83', 'groupId': 'OG001'}]}]}, {'title': 'Week 18: Change from Baseline (n=110, 116)', 'categories': [{'measurements': [{'value': '0.35', 'spread': '3.04', 'groupId': 'OG000'}, {'value': '1.27', 'spread': '3.46', 'groupId': 'OG001'}]}]}, {'title': 'Week 26: Change from Baseline (n=111, 121)', 'categories': [{'measurements': [{'value': '0.72', 'spread': '3.52', 'groupId': 'OG000'}, {'value': '1.29', 'spread': '3.32', 'groupId': 'OG001'}]}]}, {'title': 'Week 39: Change from Baseline (n=107, 121)', 'categories': [{'measurements': [{'value': '0.77', 'spread': '4.33', 'groupId': 'OG000'}, {'value': '1.33', 'spread': '3.70', 'groupId': 'OG001'}]}]}, {'title': 'Week 50: Change from Baseline (n=19, 13)', 'categories': [{'measurements': [{'value': '0.04', 'spread': '3.67', 'groupId': 'OG000'}, {'value': '1.98', 'spread': '3.90', 'groupId': 'OG001'}]}]}, {'title': 'Week 51: Change from Baseline (n=49, 60)', 'categories': [{'measurements': [{'value': '0.24', 'spread': '3.75', 'groupId': 'OG000'}, {'value': '0.63', 'spread': '4.38', 'groupId': 'OG001'}]}]}, {'title': 'Week 52: Change from Baseline (n=90, 109)', 'categories': [{'measurements': [{'value': '1.34', 'spread': '3.98', 'groupId': 'OG000'}, {'value': '1.26', 'spread': '4.08', 'groupId': 'OG001'}]}]}, {'title': 'Week 52 LOCF: Change from Baseline (n=113, 124)', 'categories': [{'measurements': [{'value': '1.13', 'spread': '3.95', 'groupId': 'OG000'}, {'value': '1.44', 'spread': '4.13', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '90', 'paramValue': '-1.080', 'ciLowerLimit': '-1.829', 'ciUpperLimit': '-0.331', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.455', 'groupDescription': 'Week 1; adjusted mean difference between inhaled insulin and subcutaneous insulin groups. Primary analysis model includes terms of Treatment, Week, Baseline Body Weight, Center, and Type of Diabetes.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '90', 'paramValue': '-0.475', 'ciLowerLimit': '-1.233', 'ciUpperLimit': '0.284', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.461', 'groupDescription': 'Week 2; adjusted mean difference between inhaled insulin and subcutaneous insulin groups. Primary analysis model includes terms of Treatment, Week, Baseline Body Weight, Center, and Type of Diabetes.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '90', 'paramValue': '-0.185', 'ciLowerLimit': '-0.931', 'ciUpperLimit': '0.562', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.454', 'groupDescription': 'Week 3; adjusted mean difference between inhaled insulin and subcutaneous insulin groups. Primary analysis model includes terms of Treatment, Week, Baseline Body Weight, Center, and Type of Diabetes.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '90', 'paramValue': '-0.189', 'ciLowerLimit': '-0.929', 'ciUpperLimit': '0.550', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.449', 'groupDescription': 'Week 4; adjusted mean difference between inhaled insulin and subcutaneous insulin groups. Primary analysis model includes terms of Treatment, Week, Baseline Body Weight, Center, and Type of Diabetes.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '90', 'paramValue': '-0.558', 'ciLowerLimit': '-1.294', 'ciUpperLimit': '0.178', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.447', 'groupDescription': 'Week 6; adjusted mean difference between inhaled insulin and subcutaneous insulin groups. Primary analysis model includes terms of Treatment, Week, Baseline Body Weight, Center, and Type of Diabetes.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '90', 'paramValue': '-0.748', 'ciLowerLimit': '-1.517', 'ciUpperLimit': '0.022', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.467', 'groupDescription': 'Week 9; adjusted mean difference between inhaled insulin and subcutaneous insulin groups. Primary analysis model includes terms of Treatment, Week, Baseline Body Weight, Center, and Type of Diabetes.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '90', 'paramValue': '-1.053', 'ciLowerLimit': '-2.510', 'ciUpperLimit': '0.405', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.886', 'groupDescription': 'Week 11; adjusted mean difference between inhaled insulin and subcutaneous insulin groups. Primary analysis model includes terms of Treatment, Week, Baseline Body Weight, Center, and Type of Diabetes.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '90', 'paramValue': '-0.891', 'ciLowerLimit': '-1.634', 'ciUpperLimit': '-0.149', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.451', 'groupDescription': 'Week 12; adjusted mean difference between inhaled insulin and subcutaneous insulin groups. Primary analysis model includes terms of Treatment, Week, Baseline Body Weight, Center, and Type of Diabetes.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '90', 'paramValue': '-0.980', 'ciLowerLimit': '-1.725', 'ciUpperLimit': '-0.234', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.453', 'groupDescription': 'Week 18; adjusted mean difference between inhaled insulin and subcutaneous insulin groups. Primary analysis model includes terms of Treatment, Week, Baseline Body Weight, Center, and Type of Diabetes.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '90', 'paramValue': '-0.663', 'ciLowerLimit': '-1.400', 'ciUpperLimit': '0.075', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.448', 'groupDescription': 'Week 26; adjusted mean difference between inhaled insulin and subcutaneous insulin groups. Primary analysis model includes terms of Treatment, Week, Baseline Body Weight, Center, and Type of Diabetes.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '90', 'paramValue': '-0.537', 'ciLowerLimit': '-1.279', 'ciUpperLimit': '0.205', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.451', 'groupDescription': 'Week 39; adjusted mean difference between inhaled insulin and subcutaneous insulin groups. Primary analysis model includes terms of Treatment, Week, Baseline Body Weight, Center, and Type of Diabetes.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '90', 'paramValue': '-1.322', 'ciLowerLimit': '-3.012', 'ciUpperLimit': '0.369', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.027', 'groupDescription': 'Week 50; adjusted mean difference between inhaled insulin and subcutaneous insulin groups. Primary analysis model includes terms of Treatment, Week, Baseline Body Weight, Center, and Type of Diabetes.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '90', 'paramValue': '0.063', 'ciLowerLimit': '-0.847', 'ciUpperLimit': '0.972', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.552', 'groupDescription': 'Week 51; adjusted mean difference between inhaled insulin and subcutaneous insulin groups. Primary analysis model includes terms of Treatment, Week, Baseline Body Weight, Center, and Type of Diabetes.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '90', 'paramValue': '-0.193', 'ciLowerLimit': '-0.964', 'ciUpperLimit': '0.579', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.469', 'groupDescription': 'Week 52; adjusted mean difference between inhaled insulin and subcutaneous insulin groups. Primary analysis model includes terms of Treatment, Week, Baseline Body Weight, Center, and Type of Diabetes.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '90', 'paramValue': '-0.430', 'ciLowerLimit': '-1.298', 'ciUpperLimit': '0.438', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.526', 'groupDescription': 'Week 52 (LOCF); adjusted mean difference between inhaled insulin and subcutaneous insulin groups. Primary analysis model includes terms of Treatment, Week, Baseline Body Weight, Center, and Type of Diabetes.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 1, Week 2, Week 3, Week 4, Week 6, Week 9, Week 11, Week 12, Week 18, Wek 26, Week 39, Week 50, Week 51, Week 52, Week 52 Last Observation Carried Forward (LOCF)', 'description': 'Body weight: mean Baseline and change from Baseline in kilograms (kg). Change from baseline = mean body weight in kilograms (kg) at observation minus baseline value.', 'unitOfMeasure': 'kilograms', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Primary analysis set (PAS)'}, {'type': 'SECONDARY', 'title': 'Total Daily Long-Acting Insulin Dose (Unadjusted for Body Weight)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '111', 'groupId': 'OG000'}, {'value': '122', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Inhaled Insulin (mg)', 'description': 'Inhaled insulin (Exubera®) with dose adjusted according to premeal blood glucose plus basal insulin.'}, {'id': 'OG001', 'title': 'Subcutaneous Insulin (Units)', 'description': 'Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.'}], 'classes': [{'title': 'Baseline (n=105, 121)', 'categories': [{'measurements': [{'value': '41.70', 'spread': '24.61', 'groupId': 'OG000'}, {'value': '45.50', 'spread': '27.54', 'groupId': 'OG001'}]}]}, {'title': 'Week 1 (n=104, 117)', 'categories': [{'measurements': [{'value': '41.75', 'spread': '25.75', 'groupId': 'OG000'}, {'value': '45.46', 'spread': '28.69', 'groupId': 'OG001'}]}]}, {'title': 'Week 2 (n=106, 111)', 'categories': [{'measurements': [{'value': '43.48', 'spread': '26.76', 'groupId': 'OG000'}, {'value': '47.19', 'spread': '28.08', 'groupId': 'OG001'}]}]}, {'title': 'Week 3 (n=104, 117)', 'categories': [{'measurements': [{'value': '43.75', 'spread': '27.32', 'groupId': 'OG000'}, {'value': '47.61', 'spread': '29.06', 'groupId': 'OG001'}]}]}, {'title': 'Week 4 (n=104, 120)', 'categories': [{'measurements': [{'value': '44.70', 'spread': '28.06', 'groupId': 'OG000'}, {'value': '48.54', 'spread': '29.91', 'groupId': 'OG001'}]}]}, {'title': 'Week 6 (n=106, 122)', 'categories': [{'measurements': [{'value': '45.89', 'spread': '29.31', 'groupId': 'OG000'}, {'value': '48.59', 'spread': '30.68', 'groupId': 'OG001'}]}]}, {'title': 'Week 9 (n=104, 109)', 'categories': [{'measurements': [{'value': '46.01', 'spread': '30.57', 'groupId': 'OG000'}, {'value': '47.68', 'spread': '29.16', 'groupId': 'OG001'}]}]}, {'title': 'Week 12 (n=110, 122)', 'categories': [{'measurements': [{'value': '46.05', 'spread': '30.82', 'groupId': 'OG000'}, {'value': '49.04', 'spread': '30.99', 'groupId': 'OG001'}]}]}, {'title': 'Week 18 (n=110, 120)', 'categories': [{'measurements': [{'value': '47.15', 'spread': '32.34', 'groupId': 'OG000'}, {'value': '49.94', 'spread': '30.95', 'groupId': 'OG001'}]}]}, {'title': 'Week 26 (n=111, 122)', 'categories': [{'measurements': [{'value': '47.65', 'spread': '33.87', 'groupId': 'OG000'}, {'value': '49.98', 'spread': '31.32', 'groupId': 'OG001'}]}]}, {'title': 'Week 39 (n=107, 121)', 'categories': [{'measurements': [{'value': '48.97', 'spread': '33.28', 'groupId': 'OG000'}, {'value': '50.32', 'spread': '31.58', 'groupId': 'OG001'}]}]}, {'title': 'Week 52 (n=101, 119)', 'categories': [{'measurements': [{'value': '50.17', 'spread': '34.17', 'groupId': 'OG000'}, {'value': '50.07', 'spread': '31.62', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 1, Week 2, Week 3, Week 4, Week 6, Week 9, Week 12, Week 18, Week 26, Week 39, Week 52', 'description': 'Total Daily Long-Acting Insulin Dose Unadjusted for Body Weight: long-acting insulin included Insulin NPH, Ultralente, and Insulin Glargine for both groups.\n\nInhaled Insulin reported in mg. Subcutaneous Insulin reported in units.', 'unitOfMeasure': 'mg, units', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Primary analysis set (PAS)'}, {'type': 'SECONDARY', 'title': 'Total Daily Long-Acting Insulin Dose Adjusted for Body Weight', 'denoms': [{'units': 'Participants', 'counts': [{'value': '109', 'groupId': 'OG000'}, {'value': '121', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Inhaled Insulin (mg/kg)', 'description': 'Inhaled insulin (Exubera®) with dose adjusted according to premeal blood glucose plus basal insulin.'}, {'id': 'OG001', 'title': 'Subcutaneous Insulin (Units/kg)', 'description': 'Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.'}], 'classes': [{'title': 'Baseline (n=105, 121)', 'categories': [{'measurements': [{'value': '0.47', 'spread': '0.25', 'groupId': 'OG000'}, {'value': '0.52', 'spread': '0.30', 'groupId': 'OG001'}]}]}, {'title': 'Week 1 (n=100, 112)', 'categories': [{'measurements': [{'value': '0.47', 'spread': '0.27', 'groupId': 'OG000'}, {'value': '0.53', 'spread': '0.31', 'groupId': 'OG001'}]}]}, {'title': 'Week 2 (n=103, 104)', 'categories': [{'measurements': [{'value': '0.49', 'spread': '0.29', 'groupId': 'OG000'}, {'value': '0.52', 'spread': '0.28', 'groupId': 'OG001'}]}]}, {'title': 'Week 3 (n=101, 113)', 'categories': [{'measurements': [{'value': '0.49', 'spread': '0.29', 'groupId': 'OG000'}, {'value': '0.54', 'spread': '0.31', 'groupId': 'OG001'}]}]}, {'title': 'Week 4 (n=99, 118)', 'categories': [{'measurements': [{'value': '0.49', 'spread': '0.27', 'groupId': 'OG000'}, {'value': '0.54', 'spread': '0.31', 'groupId': 'OG001'}]}]}, {'title': 'Week 6 (n=104, 121)', 'categories': [{'measurements': [{'value': '0.52', 'spread': '0.31', 'groupId': 'OG000'}, {'value': '0.55', 'spread': '0.32', 'groupId': 'OG001'}]}]}, {'title': 'Week 9 (n=99, 103)', 'categories': [{'measurements': [{'value': '0.51', 'spread': '0.31', 'groupId': 'OG000'}, {'value': '0.54', 'spread': '0.32', 'groupId': 'OG001'}]}]}, {'title': 'Week 12 (n=104, 117)', 'categories': [{'measurements': [{'value': '0.52', 'spread': '0.32', 'groupId': 'OG000'}, {'value': '0.55', 'spread': '0.32', 'groupId': 'OG001'}]}]}, {'title': 'Week 18 (n=108, 115)', 'categories': [{'measurements': [{'value': '0.53', 'spread': '0.33', 'groupId': 'OG000'}, {'value': '0.55', 'spread': '0.32', 'groupId': 'OG001'}]}]}, {'title': 'Week 26 (n=109, 120)', 'categories': [{'measurements': [{'value': '0.52', 'spread': '0.33', 'groupId': 'OG000'}, {'value': '0.55', 'spread': '0.32', 'groupId': 'OG001'}]}]}, {'title': 'Week 39 (n=105, 120)', 'categories': [{'measurements': [{'value': '0.54', 'spread': '0.37', 'groupId': 'OG000'}, {'value': '0.56', 'spread': '0.32', 'groupId': 'OG001'}]}]}, {'title': 'Week 52 (n=88, 108)', 'categories': [{'measurements': [{'value': '0.53', 'spread': '0.36', 'groupId': 'OG000'}, {'value': '0.55', 'spread': '0.31', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 1, Week 2, Week 3, Week 4, Week 6, Week 9, Week 12, Week 18, Week 26, Week 39, Week 52', 'description': 'Total daily dose of long-acting insulin adjusted for body weight (units per kilogram \\[kg\\]). Long-acting insulin included Insulin NPH, Ultralente, and Insulin Glargine for both groups.\n\nInhaled Insulin reported in mg/kg. Subcutaneous Insulin reported in units/kg.', 'unitOfMeasure': 'mg/kg, units/kg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Primary analysis set (PAS)'}, {'type': 'SECONDARY', 'title': 'Total Daily Short-Acting Insulin Dose (Unadjusted for Body Weight)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '113', 'groupId': 'OG000'}, {'value': '141', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Inhaled Insulin (mg)', 'description': 'Inhaled insulin (Exubera®) with dose adjusted according to premeal blood glucose plus basal insulin.'}, {'id': 'OG001', 'title': 'Subcutaneous Insulin (Units)', 'description': 'Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.'}], 'classes': [{'title': 'Baseline (n=109, 122)', 'categories': [{'measurements': [{'value': '30.56', 'spread': '22.69', 'groupId': 'OG000'}, {'value': '30.74', 'spread': '19.50', 'groupId': 'OG001'}]}]}, {'title': 'Week 1 (n=106, 118)', 'categories': [{'measurements': [{'value': '11.03', 'spread': '5.51', 'groupId': 'OG000'}, {'value': '29.52', 'spread': '19.95', 'groupId': 'OG001'}]}]}, {'title': 'Week 2 (n=108, 111)', 'categories': [{'measurements': [{'value': '12.13', 'spread': '6.03', 'groupId': 'OG000'}, {'value': '31.24', 'spread': '21.69', 'groupId': 'OG001'}]}]}, {'title': 'Week 3 (n=106, 116)', 'categories': [{'measurements': [{'value': '12.96', 'spread': '6.68', 'groupId': 'OG000'}, {'value': '30.58', 'spread': '20.70', 'groupId': 'OG001'}]}]}, {'title': 'Week 4 (n=106, 120)', 'categories': [{'measurements': [{'value': '13.44', 'spread': '6.82', 'groupId': 'OG000'}, {'value': '31.87', 'spread': '22.23', 'groupId': 'OG001'}]}]}, {'title': 'Week 6 (n=108, 122)', 'categories': [{'measurements': [{'value': '14.04', 'spread': '7.06', 'groupId': 'OG000'}, {'value': '31.81', 'spread': '21.94', 'groupId': 'OG001'}]}]}, {'title': 'Week 9 (n=106, 110)', 'categories': [{'measurements': [{'value': '14.03', 'spread': '7.76', 'groupId': 'OG000'}, {'value': '31.55', 'spread': '23.93', 'groupId': 'OG001'}]}]}, {'title': 'Week 12 (n=112, 122)', 'categories': [{'measurements': [{'value': '14.42', 'spread': '8.11', 'groupId': 'OG000'}, {'value': '32.71', 'spread': '23.70', 'groupId': 'OG001'}]}]}, {'title': 'Week 18 (n=112, 120)', 'categories': [{'measurements': [{'value': '15.11', 'spread': '8.68', 'groupId': 'OG000'}, {'value': '33.49', 'spread': '23.81', 'groupId': 'OG001'}]}]}, {'title': 'Week 26 (n=113, 122)', 'categories': [{'measurements': [{'value': '15.95', 'spread': '9.14', 'groupId': 'OG000'}, {'value': '33.80', 'spread': '24.37', 'groupId': 'OG001'}]}]}, {'title': 'Week 39 (n=109, 121)', 'categories': [{'measurements': [{'value': '16.17', 'spread': '10.25', 'groupId': 'OG000'}, {'value': '33.12', 'spread': '24.62', 'groupId': 'OG001'}]}]}, {'title': 'Week 52 (n= 103, 119)', 'categories': [{'measurements': [{'value': '17.20', 'spread': '10.95', 'groupId': 'OG000'}, {'value': '33.04', 'spread': '26.09', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 1, Week 2, Week 3, Week 4, Week 6, Week 9, Week 12, Week 18, Week 26, Week 39, Week 52', 'description': 'Average Total Daily Insulin Dose: short-acting insulin (milligrams \\[mg\\]). Short-acting insulin (mg) for the Inhaled Insulin group was Inhaled Insulin. Short-acting insulin (unit) for the Subcutaneous Insulin group included Insulin Lispro, Insulin Aspart, and Regular Insulin.', 'unitOfMeasure': 'mg, units', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Primary analysis set (PAS)'}, {'type': 'SECONDARY', 'title': 'Total Daily Short-Acting Insulin Dose Adjusted for Body Weight', 'denoms': [{'units': 'Participants', 'counts': [{'value': '111', 'groupId': 'OG000'}, {'value': '122', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Inhaled Insulin (mg/kg)', 'description': 'Inhaled insulin (Exubera®) with dose adjusted according to premeal blood glucose plus basal insulin.'}, {'id': 'OG001', 'title': 'Subcutaneous Insulin (Units/kg)', 'description': 'Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.'}], 'classes': [{'title': 'Baseline (n=109, 122)', 'categories': [{'measurements': [{'value': '0.35', 'spread': '0.25', 'groupId': 'OG000'}, {'value': '0.36', 'spread': '0.22', 'groupId': 'OG001'}]}]}, {'title': 'Week 1 (n=102, 113)', 'categories': [{'measurements': [{'value': '0.12', 'spread': '0.06', 'groupId': 'OG000'}, {'value': '0.34', 'spread': '0.23', 'groupId': 'OG001'}]}]}, {'title': 'Week 2 (n=104, 104)', 'categories': [{'measurements': [{'value': '0.14', 'spread': '0.07', 'groupId': 'OG000'}, {'value': '0.36', 'spread': '0.25', 'groupId': 'OG001'}]}]}, {'title': 'Week 3 (n=103, 112)', 'categories': [{'measurements': [{'value': '0.15', 'spread': '0.07', 'groupId': 'OG000'}, {'value': '0.35', 'spread': '0.23', 'groupId': 'OG001'}]}]}, {'title': 'Week 4 (n=101, 118)', 'categories': [{'measurements': [{'value': '0.15', 'spread': '0.07', 'groupId': 'OG000'}, {'value': '0.37', 'spread': '0.26', 'groupId': 'OG001'}]}]}, {'title': 'Week 6 (n=106, 121)', 'categories': [{'measurements': [{'value': '0.16', 'spread': '0.08', 'groupId': 'OG000'}, {'value': '0.36', 'spread': '0.24', 'groupId': 'OG001'}]}]}, {'title': 'Week 9 (n=101, 104)', 'categories': [{'measurements': [{'value': '0.16', 'spread': '0.09', 'groupId': 'OG000'}, {'value': '0.36', 'spread': '0.26', 'groupId': 'OG001'}]}]}, {'title': 'Week 12 (n=106, 117)', 'categories': [{'measurements': [{'value': '0.16', 'spread': '0.08', 'groupId': 'OG000'}, {'value': '0.38', 'spread': '0.26', 'groupId': 'OG001'}]}]}, {'title': 'Week 18 (n=110, 116)', 'categories': [{'measurements': [{'value': '0.18', 'spread': '0.10', 'groupId': 'OG000'}, {'value': '0.37', 'spread': '0.25', 'groupId': 'OG001'}]}]}, {'title': 'Week 26 (n=111, 121)', 'categories': [{'measurements': [{'value': '0.19', 'spread': '0.11', 'groupId': 'OG000'}, {'value': '0.38', 'spread': '0.27', 'groupId': 'OG001'}]}]}, {'title': 'Week 39 (n=107, 120)', 'categories': [{'measurements': [{'value': '0.19', 'spread': '0.12', 'groupId': 'OG000'}, {'value': '0.38', 'spread': '0.27', 'groupId': 'OG001'}]}]}, {'title': 'Week 52 (n=90, 108)', 'categories': [{'measurements': [{'value': '0.19', 'spread': '0.12', 'groupId': 'OG000'}, {'value': '0.36', 'spread': '0.29', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 1, Week 2, Week 3, Week 4, Week 6, Week 9, Week 12, Week 18, Week 26, Week 39, Week 52', 'description': 'Total Daily Short-Acting Insulin Dose adjusted for body weight (units divided by kg). Short-acting insulin (mg) for the Inhaled Insulin group was Inhaled Insulin. Short-acting insulin (unit) for the Subcutaneous Insulin group included Insulin Lispro, Insulin Aspart, and Regular Insulin.', 'unitOfMeasure': 'mg/kg, units/kg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Primary analysis set (PAS)'}, {'type': 'SECONDARY', 'title': 'Lipids: Median Change From Baseline to Last Observation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '110', 'groupId': 'OG000'}, {'value': '121', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Inhaled Insulin', 'description': 'Inhaled insulin (Exubera®) with dose adjusted according to premeal blood glucose plus basal insulin.'}, {'id': 'OG001', 'title': 'Subcutaneous Insulin', 'description': 'Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.'}], 'classes': [{'title': 'Cholesterol (random) (n=110, 121)', 'categories': [{'measurements': [{'value': '-0.5', 'spread': '-0.5', 'groupId': 'OG000', 'lowerLimit': '-999', 'upperLimit': '999'}, {'value': '0', 'spread': '0', 'groupId': 'OG001', 'lowerLimit': '-999', 'upperLimit': '999'}]}]}, {'title': 'Triglycerides (random) (n=105, 121)', 'categories': [{'measurements': [{'value': '9', 'spread': '9', 'groupId': 'OG000', 'lowerLimit': '-999', 'upperLimit': '999'}, {'value': '-8', 'spread': '-8', 'groupId': 'OG001', 'lowerLimit': '-999', 'upperLimit': '999'}]}]}, {'title': 'HDL Cholesterol (n=110, 121)', 'categories': [{'measurements': [{'value': '-3', 'spread': '-3', 'groupId': 'OG000', 'lowerLimit': '-999', 'upperLimit': '999'}, {'value': '1', 'spread': '1', 'groupId': 'OG001', 'lowerLimit': '-999', 'upperLimit': '999'}]}]}, {'title': 'LDL Cholesterol (n=97, 110)', 'categories': [{'measurements': [{'value': '0', 'spread': '0', 'groupId': 'OG000', 'lowerLimit': '-999', 'upperLimit': '999'}, {'value': '0', 'spread': '0', 'groupId': 'OG001', 'lowerLimit': '-999', 'upperLimit': '999'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline to Last Observation', 'description': 'Lipids: median changes (milligrams per deciliter \\[mg/dL\\]) from Baseline median to last observation in cholesterol (random), triglycerides (random), high density lipoprotein (HDL) cholesterol and low density lipoprotein (LDL) cholesterol. Normalized data was used in the computations. Last observation = last observation while on study drug or during the lag. Measures of dispersion for median changes in lipids were not determined.', 'unitOfMeasure': 'mg/dL', 'reportingStatus': 'POSTED', 'populationDescription': 'Primary analysis set (PAS); median change from Baseline to last observation. Last observation was defined as last observation while on study drug or during the lag. Full range (-999 to 999) was not calculated.'}, {'type': 'SECONDARY', 'title': 'Hypoglycemic Event Rates', 'denoms': [{'units': 'Participants', 'counts': [{'value': '135', 'groupId': 'OG000'}, {'value': '135', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Inhaled Insulin', 'description': 'Inhaled insulin (Exubera®) with dose adjusted according to premeal blood glucose plus basal insulin.'}, {'id': 'OG001', 'title': 'Subcutaneous Insulin', 'description': 'Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.'}], 'classes': [{'title': '0 to 1 month (n=135, 135)', 'categories': [{'measurements': [{'value': '2.99', 'groupId': 'OG000'}, {'value': '2.48', 'groupId': 'OG001'}]}]}, {'title': '> 1 to 2 months (n=135, 135)', 'categories': [{'measurements': [{'value': '2.52', 'groupId': 'OG000'}, {'value': '2.34', 'groupId': 'OG001'}]}]}, {'title': '> 2 to 3 months (n=131, 134)', 'categories': [{'measurements': [{'value': '2.12', 'groupId': 'OG000'}, {'value': '1.84', 'groupId': 'OG001'}]}]}, {'title': '> 3 to 4 months (n=128, 134)', 'categories': [{'measurements': [{'value': '1.84', 'groupId': 'OG000'}, {'value': '1.61', 'groupId': 'OG001'}]}]}, {'title': '> 4 to 5 months (n=126, 134)', 'categories': [{'measurements': [{'value': '1.94', 'groupId': 'OG000'}, {'value': '1.69', 'groupId': 'OG001'}]}]}, {'title': '> 5 to 6 months (n=121, 131)', 'categories': [{'measurements': [{'value': '1.51', 'groupId': 'OG000'}, {'value': '1.84', 'groupId': 'OG001'}]}]}, {'title': '> 6 to 7 months (n=119, 131)', 'categories': [{'measurements': [{'value': '1.50', 'groupId': 'OG000'}, {'value': '1.67', 'groupId': 'OG001'}]}]}, {'title': '> 7 to 8 months (n=115, 129)', 'categories': [{'measurements': [{'value': '1.45', 'groupId': 'OG000'}, {'value': '1.26', 'groupId': 'OG001'}]}]}, {'title': '> 8 to 9 months (n=111, 129)', 'categories': [{'measurements': [{'value': '1.62', 'groupId': 'OG000'}, {'value': '1.26', 'groupId': 'OG001'}]}]}, {'title': '> 9 to 10 months (n=110, 129)', 'categories': [{'measurements': [{'value': '1.26', 'groupId': 'OG000'}, {'value': '1.55', 'groupId': 'OG001'}]}]}, {'title': '> 10 to 11 months (n=109, 125)', 'categories': [{'measurements': [{'value': '1.12', 'groupId': 'OG000'}, {'value': '1.37', 'groupId': 'OG001'}]}]}, {'title': '> 11 to 12 months (n=104, 123)', 'categories': [{'measurements': [{'value': '1.18', 'groupId': 'OG000'}, {'value': '1.23', 'groupId': 'OG001'}]}]}, {'title': 'Overall (n=135, 135)', 'categories': [{'measurements': [{'value': '1.79', 'groupId': 'OG000'}, {'value': '1.68', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '0 to 1 month to 11 to 12 months, and Overall', 'description': 'A Hypoglycemic event was identified by characteristic symptoms of hypoglycemia with no blood glucose check with prompt resolution with food intake, subcutaneous glucagon, or intravenouus glucose; characteristic symptoms with blood glucose of 59 milligrams per deciliter (mg/dL) (3.2 mmol/L) or less with blood glucose check; or any glucose measurement of 49 mg/dL (2.7 mmol/L) or less, with or without symptoms. Crude event rate = total events divided by subject months. Subject months = elapsed number of months a subject was in the study in each time interval.', 'unitOfMeasure': 'events / subject-months', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set (FAS)'}, {'type': 'SECONDARY', 'title': 'Severe Hypoglycemic Event Rates', 'denoms': [{'units': 'Participants', 'counts': [{'value': '135', 'groupId': 'OG000'}, {'value': '135', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Inhaled Insulin', 'description': 'Inhaled insulin (Exubera®) with dose adjusted according to premeal blood glucose plus basal insulin.'}, {'id': 'OG001', 'title': 'Subcutaneous Insulin', 'description': 'Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.'}], 'classes': [{'title': '0 to 1 month (n=135, 135)', 'categories': [{'measurements': [{'value': '2.91', 'groupId': 'OG000'}, {'value': '1.48', 'groupId': 'OG001'}]}]}, {'title': '> 1 to 2 months (n=135, 135)', 'categories': [{'measurements': [{'value': '5.22', 'groupId': 'OG000'}, {'value': '1.49', 'groupId': 'OG001'}]}]}, {'title': '> 2 to 3 months (n=131, 134)', 'categories': [{'measurements': [{'value': '4.64', 'groupId': 'OG000'}, {'value': '2.99', 'groupId': 'OG001'}]}]}, {'title': '> 3 to 4 months (n=128, 134)', 'categories': [{'measurements': [{'value': '0.78', 'groupId': 'OG000'}, {'value': '2.24', 'groupId': 'OG001'}]}]}, {'title': '> 4 to 5 months (n=126, 134)', 'categories': [{'measurements': [{'value': '4.05', 'groupId': 'OG000'}, {'value': '1.51', 'groupId': 'OG001'}]}]}, {'title': '> 5 to 6 months (n=121, 131)', 'categories': [{'measurements': [{'value': '3.33', 'groupId': 'OG000'}, {'value': '2.29', 'groupId': 'OG001'}]}]}, {'title': '> 6 to 7 months (n=119, 131)', 'categories': [{'measurements': [{'value': '0.00', 'groupId': 'OG000'}, {'value': '0.77', 'groupId': 'OG001'}]}]}, {'title': '> 7 to 8 months (n=115, 129)', 'categories': [{'measurements': [{'value': '0.89', 'groupId': 'OG000'}, {'value': '2.33', 'groupId': 'OG001'}]}]}, {'title': '> 8 to 9 months (n=111, 129)', 'categories': [{'measurements': [{'value': '5.42', 'groupId': 'OG000'}, {'value': '1.55', 'groupId': 'OG001'}]}]}, {'title': '> 9 to 10 months (n=110, 129)', 'categories': [{'measurements': [{'value': '0.91', 'groupId': 'OG000'}, {'value': '3.18', 'groupId': 'OG001'}]}]}, {'title': '> 10 to 11 months (n=109, 125)', 'categories': [{'measurements': [{'value': '1.88', 'groupId': 'OG000'}, {'value': '2.41', 'groupId': 'OG001'}]}]}, {'title': '> 11 to 12 months (n=104, 123)', 'categories': [{'measurements': [{'value': '3.95', 'groupId': 'OG000'}, {'value': '3.10', 'groupId': 'OG001'}]}]}, {'title': 'Overall (n=135, 135)', 'categories': [{'measurements': [{'value': '2.89', 'groupId': 'OG000'}, {'value': '2.13', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '0 to 1 month to 11 to 12 months, and Overall', 'description': 'Severe hypoglycemic event = all 3 of the following criteria were met: subject unable to treat self, exhbited at least 1 neurological symptom (memory loss, confusion, uncontrollable behavior, irrational behavior, unusual difficulty in awakening, suspected seizure, loss of consciousness); blood glucose measurement was ≤ 49 mg/dL, or not measured but clinical manifestations reversed by oral carbohydrates, subcutaneous glucagon, or i.v. glucose. Crude event rate = number of events divided by 100 subject-months. Subject months = elapsed number of months subject was in study in each time interval.', 'unitOfMeasure': 'Number of events/100 subject-months.', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set (FAS). Due the small number of events severe hypoglycemic event rates were assessed per 100 months.'}, {'type': 'PRIMARY', 'title': 'Change From Baseline in Post-Bronchodilator Forced Expiratory Volume in One Second (FEV1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '141', 'groupId': 'OG000'}, {'value': '139', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Inhaled Insulin', 'description': 'Inhaled insulin (Exubera®) with dose adjusted according to premeal blood glucose plus basal insulin.'}, {'id': 'OG001', 'title': 'Subcutaneous Insulin', 'description': 'Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.'}], 'classes': [{'title': 'Baseline (n=141, 139)', 'categories': [{'measurements': [{'value': '2.559', 'spread': '0.771', 'groupId': 'OG000'}, {'value': '2.524', 'spread': '0.742', 'groupId': 'OG001'}]}]}, {'title': 'Week 1 (n=123, 125)', 'categories': [{'measurements': [{'value': '-0.066', 'spread': '0.150', 'groupId': 'OG000'}, {'value': '-0.027', 'spread': '0.126', 'groupId': 'OG001'}]}]}, {'title': 'Week 2 (n=126, 115)', 'categories': [{'measurements': [{'value': '-0.056', 'spread': '0.150', 'groupId': 'OG000'}, {'value': '-0.031', 'spread': '0.128', 'groupId': 'OG001'}]}]}, {'title': 'Week 3 (n=131, 119)', 'categories': [{'measurements': [{'value': '-0.077', 'spread': '0.185', 'groupId': 'OG000'}, {'value': '-0.030', 'spread': '0.130', 'groupId': 'OG001'}]}]}, {'title': 'Week 4 (n=121, 129)', 'categories': [{'measurements': [{'value': '-0.074', 'spread': '0.161', 'groupId': 'OG000'}, {'value': '-0.022', 'spread': '0.155', 'groupId': 'OG001'}]}]}, {'title': 'Week 6 (n=130, 135)', 'categories': [{'measurements': [{'value': '-0.070', 'spread': '0.248', 'groupId': 'OG000'}, {'value': '-0.025', 'spread': '0.146', 'groupId': 'OG001'}]}]}, {'title': 'Week 12 (n=125, 129)', 'categories': [{'measurements': [{'value': '-0.053', 'spread': '0.212', 'groupId': 'OG000'}, {'value': '-0.031', 'spread': '0.182', 'groupId': 'OG001'}]}]}, {'title': 'Week 18 (n=124, 125)', 'categories': [{'measurements': [{'value': '-0.066', 'spread': '0.226', 'groupId': 'OG000'}, {'value': '-0.040', 'spread': '0.165', 'groupId': 'OG001'}]}]}, {'title': 'Week 26 (n=120, 128)', 'categories': [{'measurements': [{'value': '-0.056', 'spread': '0.175', 'groupId': 'OG000'}, {'value': '-0.038', 'spread': '0.184', 'groupId': 'OG001'}]}]}, {'title': 'Week 39 (n=107, 124)', 'categories': [{'measurements': [{'value': '-0.088', 'spread': '0.191', 'groupId': 'OG000'}, {'value': '-0.039', 'spread': '0.194', 'groupId': 'OG001'}]}]}, {'title': 'Week 52 (n=106, 112)', 'categories': [{'measurements': [{'value': '-0.131', 'spread': '0.259', 'groupId': 'OG000'}, {'value': '-0.059', 'spread': '0.234', 'groupId': 'OG001'}]}]}, {'title': 'Week 52 LOCF (n=141, 139)', 'categories': [{'measurements': [{'value': '-0.113', 'spread': '0.261', 'groupId': 'OG000'}, {'value': '-0.062', 'spread': '0.225', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '90', 'paramValue': '-0.039', 'ciLowerLimit': '-0.079', 'ciUpperLimit': '-0.000', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.024', 'groupDescription': 'Week 1; Inhaled Insulin - Subcutaneous Insulin. Adjusted (primary analysis model) includes terms of Treatment, Week, Baseline pulmonary function test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '90', 'paramValue': '-0.029', 'ciLowerLimit': '-0.068', 'ciUpperLimit': '0.010', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.024', 'groupDescription': 'Week 2; Inhaled Insulin - Subcutaneous Insulin. Adjusted (primary analysis model) includes terms of Treatment, Week, Baseline pulmonary function test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '90', 'paramValue': '-0.045', 'ciLowerLimit': '-0.084', 'ciUpperLimit': '-0.006', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.024', 'groupDescription': 'Week 3; Inhaled Insulin - Subcutaneous Insulin. Adjusted (primary analysis model) includes terms of Treatment, Week, Baseline pulmonary function test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '90', 'paramValue': '-0.046', 'ciLowerLimit': '-0.085', 'ciUpperLimit': '-0.007', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.024', 'groupDescription': 'Week 4; Inhaled Insulin - Subcutaneous Insulin. Adjusted (primary analysis model) includes terms of Treatment, Week, Baseline pulmonary function test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '90', 'paramValue': '-0.046', 'ciLowerLimit': '-0.085', 'ciUpperLimit': '-0.007', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.024', 'groupDescription': 'Week 6; Inhaled Insulin - Subcutaneous Insulin. Adjusted (primary analysis model) includes terms of Treatment, Week, Baseline pulmonary function test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '90', 'paramValue': '-0.023', 'ciLowerLimit': '-0.063', 'ciUpperLimit': '0.017', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.024', 'groupDescription': 'Week 12; Inhaled Insulin - Subcutaneous Insulin. Adjusted (primary analysis model) includes terms of Treatment, Week, Baseline pulmonary function test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '90', 'paramValue': '-0.021', 'ciLowerLimit': '-0.062', 'ciUpperLimit': '0.020', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.025', 'groupDescription': 'Week 18; Inhaled Insulin - Subcutaneous Insulin. Adjusted (primary analysis model) includes terms of Treatment, Week, Baseline pulmonary function test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '90', 'paramValue': '-0.014', 'ciLowerLimit': '-0.055', 'ciUpperLimit': '0.027', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.025', 'groupDescription': 'Week 26; Inhaled Insulin - Subcutaneous Insulin. Adjusted (primary analysis model) includes terms of Treatment, Week, Baseline pulmonary function test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '90', 'paramValue': '-0.042', 'ciLowerLimit': '-0.085', 'ciUpperLimit': '0.000', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.026', 'groupDescription': 'Week 39; Inhaled Insulin - Subcutaneous Insulin. Adjusted (primary analysis model) includes terms of Treatment, Week, Baseline pulmonary function test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '90', 'paramValue': '-0.065', 'ciLowerLimit': '-0.109', 'ciUpperLimit': '-0.022', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.027', 'groupDescription': 'Week 52; Inhaled Insulin - Subcutaneous Insulin. Adjusted (primary analysis model) includes terms of Treatment, Week, Baseline pulmonary function test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '90', 'paramValue': '-0.050', 'ciLowerLimit': '-0.097', 'ciUpperLimit': '-0.003', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.028', 'groupDescription': 'Week 52 Last Observation Carried Forward (LOCF; Inhaled Insulin - Subcutaneous Insulin. Adjusted (primary analysis model) includes terms of Treatment, Week, Baseline pulmonary function test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline through Week 52 Last Observation Carried Forward (LOCF)', 'description': 'Change from Baseline at each visit in post-bronchodilator forced expiratory volume in one second (FEV1). FEV1 was measured in liters (L) 30 minutes following the administration of albuterol. Change from baseline: mean FEV1 (L) at observation minus baseline value.', 'unitOfMeasure': 'liters', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set (FAS): all subjects who were randomized, had a baseline post-albuterol pulmonary function test (PFT) measurement, and had at least two post-baseline, post-albuterol PFT measurements. LOCF: last observation carried forward.'}, {'type': 'PRIMARY', 'title': 'Change From Baseline in Post-Bronchodilator Carbon Monoxide Diffusing Capacity (DLco)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '141', 'groupId': 'OG000'}, {'value': '139', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Inhaled Insulin', 'description': 'Inhaled insulin (Exubera®) with dose adjusted according to premeal blood glucose plus basal insulin.'}, {'id': 'OG001', 'title': 'Subcutaneous Insulin', 'description': 'Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.'}], 'classes': [{'title': 'Baseline (n=141, 139)', 'categories': [{'measurements': [{'value': '23.023', 'spread': '5.914', 'groupId': 'OG000'}, {'value': '22.883', 'spread': '6.079', 'groupId': 'OG001'}]}]}, {'title': 'Week 1 (n=122, 124)', 'categories': [{'measurements': [{'value': '-0.574', 'spread': '1.392', 'groupId': 'OG000'}, {'value': '-0.333', 'spread': '1.405', 'groupId': 'OG001'}]}]}, {'title': 'Week 2 (n=126, 112)', 'categories': [{'measurements': [{'value': '-0.777', 'spread': '1.631', 'groupId': 'OG000'}, {'value': '-0.481', 'spread': '1.290', 'groupId': 'OG001'}]}]}, {'title': 'Week 3 (n=129, 118)', 'categories': [{'measurements': [{'value': '-0.811', 'spread': '1.244', 'groupId': 'OG000'}, {'value': '-0.506', 'spread': '1.388', 'groupId': 'OG001'}]}]}, {'title': 'Week 4 (n=120, 128)', 'categories': [{'measurements': [{'value': '-1.075', 'spread': '1.425', 'groupId': 'OG000'}, {'value': '-0.576', 'spread': '1.397', 'groupId': 'OG001'}]}]}, {'title': 'Week 6 (n=129, 135)', 'categories': [{'measurements': [{'value': '-1.017', 'spread': '1.633', 'groupId': 'OG000'}, {'value': '-0.602', 'spread': '1.488', 'groupId': 'OG001'}]}]}, {'title': 'Week 12 (n=125, 125)', 'categories': [{'measurements': [{'value': '-0.961', 'spread': '1.738', 'groupId': 'OG000'}, {'value': '-0.477', 'spread': '1.588', 'groupId': 'OG001'}]}]}, {'title': 'Week 18 (n=124, 123)', 'categories': [{'measurements': [{'value': '-1.024', 'spread': '1.774', 'groupId': 'OG000'}, {'value': '-0.549', 'spread': '1.601', 'groupId': 'OG001'}]}]}, {'title': 'Week 26 (n=119, 127)', 'categories': [{'measurements': [{'value': '-0.849', 'spread': '1.914', 'groupId': 'OG000'}, {'value': '-0.477', 'spread': '1.706', 'groupId': 'OG001'}]}]}, {'title': 'Week 39 (n=107, 123)', 'categories': [{'measurements': [{'value': '-1.016', 'spread': '1.649', 'groupId': 'OG000'}, {'value': '-0.395', 'spread': '1.767', 'groupId': 'OG001'}]}]}, {'title': 'Week 52 (n=105, 110)', 'categories': [{'measurements': [{'value': '-1.483', 'spread': '1.944', 'groupId': 'OG000'}, {'value': '-0.798', 'spread': '1.967', 'groupId': 'OG001'}]}]}, {'title': 'Week 52 LOCF (n=141, 139)', 'categories': [{'measurements': [{'value': '-1.426', 'spread': '1.856', 'groupId': 'OG000'}, {'value': '-0.682', 'spread': '1.958', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '90', 'paramValue': '-0.279', 'ciLowerLimit': '-0.606', 'ciUpperLimit': '0.048', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.199', 'groupDescription': 'Week 1; Inhaled Insulin - Subcutaneous Insulin. Adjusted (primary analysis model) includes terms of Treatment, Week, Baseline pulmonary function test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '90', 'paramValue': '-0.336', 'ciLowerLimit': '-0.661', 'ciUpperLimit': '-0.011', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.198', 'groupDescription': 'Week 2; Inhaled Insulin - Subcutaneous Insulin. Adjusted (primary analysis model) includes terms of Treatment, Week, Baseline pulmonary function test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '90', 'paramValue': '-0.384', 'ciLowerLimit': '-0.707', 'ciUpperLimit': '-0.061', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.196', 'groupDescription': 'Week 3; Inhaled Insulin - Subcutaneous Insulin. Adjusted (primary analysis model) includes terms of Treatment, Week, Baseline pulmonary function test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '90', 'paramValue': '-0.516', 'ciLowerLimit': '-0.842', 'ciUpperLimit': '-0.191', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.198', 'groupDescription': 'Week 4; Inhaled Insulin - Subcutaneous Insulin. Adjusted (primary analysis model) includes terms of Treatment, Week, Baseline pulmonary function test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '90', 'paramValue': '-0.474', 'ciLowerLimit': '-0.797', 'ciUpperLimit': '-0.152', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.196', 'groupDescription': 'Week 6; Inhaled Insulin - Subcutaneous Insulin. Adjusted (primary analysis model) includes terms of Treatment, Week, Baseline pulmonary function test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '90', 'paramValue': '-0.533', 'ciLowerLimit': '-0.866', 'ciUpperLimit': '-0.200', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.202', 'groupDescription': 'Week 12; Inhaled Insulin - Subcutaneous Insulin. Adjusted (primary analysis model) includes terms of Treatment, Week, Baseline pulmonary function test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '90', 'paramValue': '-0.509', 'ciLowerLimit': '-0.845', 'ciUpperLimit': '-0.174', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.204', 'groupDescription': 'Week 18; Inhaled Insulin - Subcutaneous Insulin. Adjusted (primary analysis model) includes terms of Treatment, Week, Baseline pulmonary function test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '90', 'paramValue': '-0.412', 'ciLowerLimit': '-0.749', 'ciUpperLimit': '-0.076', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.204', 'groupDescription': 'Week 26; Inhaled Insulin - Subcutaneous Insulin. Adjusted (primary analysis model) includes terms of Treatment, Week, Baseline pulmonary function test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '90', 'paramValue': '-0.707', 'ciLowerLimit': '-1.056', 'ciUpperLimit': '-0.358', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.212', 'groupDescription': 'Week 39; Inhaled Insulin - Subcutaneous Insulin. Adjusted (primary analysis model) includes terms of Treatment, Week, Baseline pulmonary function test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '90', 'paramValue': '-0.680', 'ciLowerLimit': '-1.040', 'ciUpperLimit': '-0.320', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.219', 'groupDescription': 'Week 52; Inhaled Insulin - Subcutaneous Insulin. Adjusted (primary analysis model) includes terms of Treatment, Week, Baseline pulmonary function test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '90', 'paramValue': '-0.765', 'ciLowerLimit': '-1.116', 'ciUpperLimit': '-0.415', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.212', 'groupDescription': 'Week 52 Last Observation Carried Forward (LOCF); Inhaled Insulin - Subcutaneous Insulin. Adjusted (primary analysis model) includes terms of Treatment, Week, Baseline pulmonary function test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 1, Week 2, Week 3, Week 4, Week 6, Week 12, Week 18, Week 26, Week 39, Week 52, Week 52 Last Observation Carried Forward (LOCF)', 'description': 'Carbon Monoxide Diffusing Capacity (DLco) measured in milliters/minutes/millimeters of mercury (mL/min/mmHg) 30 minutes following the administration of albuterol. Change from Baseline: mean DLco (mL/min/mmHg) at observation minus baseline value.', 'unitOfMeasure': 'mL/min/mmHg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set (FAS); LOCF: last observation carried forward.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Inhaled Insulin', 'description': 'Inhaled insulin (Exubera®) with dose adjusted according to premeal blood glucose plus basal insulin.'}, {'id': 'FG001', 'title': 'Subcutaneous Insulin', 'description': 'Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': "1 subject randomized was DC'd prior to receiving inhaled insulin but received subcutaneous insulin", 'groupId': 'FG000', 'numSubjects': '146'}, {'comment': "1 subject randomized DC'd before receiving subcutaneous insulin and is not included in # of subjects", 'groupId': 'FG001', 'numSubjects': '141'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '106'}, {'groupId': 'FG001', 'numSubjects': '123'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '40'}, {'groupId': 'FG001', 'numSubjects': '18'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Reason not Specified', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '10'}]}]}], 'recruitmentDetails': 'Subjects were recruited at 63 centers and participated in the study between 10 January 2003 and 22 October 2008.', 'preAssignmentDetails': "544 subjects were screened for the study. Prior to randomization subjects completed a 3-week run-in period during which all subjects received subcutaneous insulin. Of 288 subjects randomized, only 286 received randomized treatment; one subject assigned to inhaled insulin received subcutaneous insulin, and 1 subject DC'd prior to treatment."}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '146', 'groupId': 'BG000'}, {'value': '141', 'groupId': 'BG001'}, {'value': '287', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Inhaled Insulin', 'description': 'Inhaled insulin (Exubera®) with dose adjusted according to premeal blood glucose plus basal insulin.'}, {'id': 'BG001', 'title': 'Subcutaneous Insulin', 'description': 'Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': '18-25 years', 'categories': [{'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}]}]}, {'title': '26-35 years', 'categories': [{'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '31', 'groupId': 'BG002'}]}]}, {'title': '36-45 years', 'categories': [{'measurements': [{'value': '23', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '48', 'groupId': 'BG002'}]}]}, {'title': '46-55 years', 'categories': [{'measurements': [{'value': '33', 'groupId': 'BG000'}, {'value': '41', 'groupId': 'BG001'}, {'value': '74', 'groupId': 'BG002'}]}]}, {'title': '56-65 years', 'categories': [{'measurements': [{'value': '40', 'groupId': 'BG000'}, {'value': '37', 'groupId': 'BG001'}, {'value': '77', 'groupId': 'BG002'}]}]}, {'title': '66-75 years', 'categories': [{'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '37', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '97', 'groupId': 'BG000'}, {'value': '91', 'groupId': 'BG001'}, {'value': '188', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '49', 'groupId': 'BG000'}, {'value': '50', 'groupId': 'BG001'}, {'value': '99', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 288}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2003-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-10', 'completionDateStruct': {'date': '2008-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-05-26', 'studyFirstSubmitDate': '2005-08-29', 'resultsFirstSubmitDate': '2009-10-21', 'studyFirstSubmitQcDate': '2005-08-29', 'lastUpdatePostDateStruct': {'date': '2010-06-02', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2010-04-10', 'studyFirstPostDateStruct': {'date': '2005-08-31', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2010-05-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Annualized Rate of Change for Forced Expiratory Volume in 1 Second (FEV1)', 'timeFrame': 'Weeks -3, -2, -1, 1, 2, 3, 4, 6, 12, 18, 26, 39, and 52', 'description': 'Annualized rates of change (slope throughout time from baseline to end of study\\[visit\\]) for forced expiratory volume in 1 second (FEV1) (liters per year \\[L/yr\\]) measured 30 minutes following the administration of albuterol.'}, {'measure': 'Annualized Rate of Change for Hemoglobin-adjusted Carbon Monoxide Diffusion Capacity (DLco)', 'timeFrame': 'Weeks -3, -2, -1, 1, 2, 3, 4, 6, 12, 18, 26, 39, and 52', 'description': 'Annualized rates of change (slope throughout time from baseline to end of study\\[visit\\]) for hemoglobin-adjusted carbon monoxide diffusion capacity (DLco)in milliliters per minute/millimeters of mercury/year (ml/min/mmHg/yr) measured 30 minutes following the administration of albuterol.'}, {'measure': 'Change From Baseline in Post-Bronchodilator Forced Expiratory Volume in One Second (FEV1)', 'timeFrame': 'Baseline through Week 52 Last Observation Carried Forward (LOCF)', 'description': 'Change from Baseline at each visit in post-bronchodilator forced expiratory volume in one second (FEV1). FEV1 was measured in liters (L) 30 minutes following the administration of albuterol. Change from baseline: mean FEV1 (L) at observation minus baseline value.'}, {'measure': 'Change From Baseline in Post-Bronchodilator Carbon Monoxide Diffusing Capacity (DLco)', 'timeFrame': 'Baseline, Week 1, Week 2, Week 3, Week 4, Week 6, Week 12, Week 18, Week 26, Week 39, Week 52, Week 52 Last Observation Carried Forward (LOCF)', 'description': 'Carbon Monoxide Diffusing Capacity (DLco) measured in milliters/minutes/millimeters of mercury (mL/min/mmHg) 30 minutes following the administration of albuterol. Change from Baseline: mean DLco (mL/min/mmHg) at observation minus baseline value.'}], 'secondaryOutcomes': [{'measure': 'Change From Baseline in Pre-Bronchodilator Forced Expiratory Volume in One Second (FEV1)', 'timeFrame': 'Week 1, Week 2, Week 3, Week 4, Week 6, Week 12, Week 18, Week 26, Week 39, Week 52, Week 52 Last Observation Carried Forward (LOCF)', 'description': 'Change from Baseline in Pre-Bronchodilator Forced Expiratory Volume in One Second (FEV1) at each visit. FEV1 was measured in liters (L) before the administration of albuterol. Change from baseline: mean FEV1 (L) at observation minus mean baseline value.'}, {'measure': 'Change From Baseline in Pre-Bronchodilator Carbon Monoxide Diffusing Capacity (DLco)', 'timeFrame': 'Baseline, Week 1, Week 2, Week 3, Week 4, Week 6, Week 12, Week 18, Week 26, Week 39, Week 52, Week 52 Last Observation carried Forward (LOCF)', 'description': 'Change From Baseline in Pre-Bronchodilator Carbon Monoxide Diffusing Capacity (DLco) measured in milliters/minutes/millimeters of mercury (mL/min/mmHg): change = DLco at observation minus DLco at Baseline.'}, {'measure': 'Change From Baseline in Pre-Insulin Forced Expiratory Volume in One Second (FEV1)', 'timeFrame': 'Baseline, Week 9, Week 51, Week 51 Last Observation Carried Forward', 'description': 'Change from Baseline in Pre-Insulin Forced Expiratory Volume in one second (FEV1) measured in liters (L): change = FEV1 at observation minus FEV1 at Baseline.'}, {'measure': 'Change From Baseline in Pre-Insulin Carbon Monoxide Diffusing Capacity (DLco)', 'timeFrame': 'Baseline, Week 9, Week 51, Week 51 Last Observation Carried Forward (LOCF)', 'description': 'Change From Baseline in Pre-Insulin Carbon Monoxide Diffusing Capacity (DLco) measured in milliters/minutes/millimeters of mercury (mL/min/mmHg): change = DLco at observation minus DLco at Baseline.'}, {'measure': 'Change From Baseline in Post-bronchodilator Forced Vital Capacity (FVC)', 'timeFrame': 'Baseline, Week 1, Week 2, Week 3, Week 4, Week 6, Week 12, Week 18, Week 26, Week 39, Week 52, Week 52 Last Observation Carried Forward (LOCF)', 'description': 'Change from baseline in Post-bronchodilator Forced Vital Capacity (FVC) measured in liters (L) 30 minutes following the administration of albuterol: change = FVC at observation minus FVC at Baseline.'}, {'measure': 'Bronchodilator Responsiveness as Determined by the Change in Forced Expiratory Volume in 1 Second (FEV1) Pre-albuterol and 30 Minutes Post-albuterol', 'timeFrame': 'Baseline, Week 1, Week 2, Week 3, Week 4, Week 6, Week 12, Week 18, Week 26, Week 39, Week 52', 'description': 'Responsiveness was the percent change from the forced expiratory volume in 1 second (FEV1) value before bronchodilator use to the FEV1 value 30 minutes after bronchodilator use, operationally defined as \\[(post-bronchodilator FEV1 minus pre-bronchodilator FEV1 divided by pre-bronchodilator FEV1\\] multiplied by 100.'}, {'measure': 'Percent Predicted and Percent Change From Baseline in Post-Bronchdilator Forced Expiratory Volume in One Second (FEV1)', 'timeFrame': 'Baseline, Week 1, Week 2, Week 3, Week 4, Week 6, Week 12, Week 18, Week 26, Week 39, Week 52, Week 52 Last Observation Carried Forward (LOCF)', 'description': 'Percent predicted change from Baseline in post-bronchodilator forced expiratory volume in one second (FEV1) measured in liters (L): National Health and Nutrition Examination Survey (NHANES III) reference standard. Percent change from Baseline in post-bronchdilator FEV1 measured in liters (L): (observed value minus Baseline value) divided by Baseline value \\*100%.'}, {'measure': 'Change From Baseline in Insulin Dose Responsiveness for Forced Expiratory Volume in One Second (FEV1) Measured 10 and 60 Minutes After the First Daily Dose of Insulin', 'timeFrame': 'Baseline, Week 9, Week 51', 'description': 'Change from Baseline in Insulin Dose Responsiveness for Forced Expiratory Volume in one second (FEV1) measured 10 and 60 minutes after the first daily dose of insulin. Insulin dose responsiveness = the difference between FEV1 value following a dose of insulin and FEV1 value before a dose of insulin, operationally defined as the post dose FEV1 value minus predose FEV1 value.'}, {'measure': 'Percent Predicted and Percent Change From Baseline in 10 Minute and 60 Minute Post-Insulin Forced Expiratory Volume in One Second (FEV1)', 'timeFrame': 'Baseline, Week 9, Week 51, Week 51 Last Observation Carried Forward (LOCF)', 'description': 'Percent predicted change from Baseline in 10 Minute and 60 Minute post-insulin forced expiratory volume in one second (FEV1) measured in liters (L): National Health and Nutrition Examination Survey (NHANES III) reference standard. Percent change from Baseline in FEV1 measured in liters (L) 10 and 60 Minutes post-insulin. Percent change = (value at observation minus Baseline value) divided by Baseline value \\*100%.'}, {'measure': 'Change From Baseline in Insulin Dose Responsiveness for Carbon Monoxide Diffusing Capacity (DLco) Measured 10 and 60 Minutes After the First Daily Dose of Insulin', 'timeFrame': 'Baseline, Week 9, Week 51', 'description': 'Carbon Monoxide Diffusing Capacity (DLco) dose responsivness 10 and 60 minutes after insulin. DLco dose-responsiveness to insulin was defined as the difference between the DLco value following a dose of insulin and DLco value before a dose of insulin, operationally defined as the post-dose DLco value minus pre-dose DLco value.'}, {'measure': 'Methacholine Challenge', 'timeFrame': '1 to 2 days following Weeks -3 and -1 visits, and at Week 11, Week 50, and Week 52 (+5)', 'description': 'Methacholine Challange: performed on a subset of subjects using the 5-breath dosimeter method. Subjects were challenged with ascending doses of nebulized methacholine; dosing schedule: 0.03, 0.06, 0.12, 0.25, 0.5, 1.0, 2.0, 4.0, 8.0, 16.0, 32.0 milligrams per milliliter (mg/ml) administered in 5-minute intervals. Forced expiratory volume in 1 second (FEV1) was measured 1-3 minutes after each inhalation of methacholine solution. Testing continued until highest FEV1 decreased by ≥20% from the challenge (post-diluent) reference, or until completion all doses.'}, {'measure': 'Mean Weekly Morning and Evening Peak Expiratory Flow Rate (PEFR) and Forced Expiratory Volume in 1 Second (FEV1)', 'timeFrame': 'Week -3 through Week 52', 'description': 'Subjects measured peak expiratory flow rate (PEFR) and forced expiratory volume in 1 second (FEV1) twice daily and entered the results in an electronic diary. Daily data were used to calculate the mean PEFR and FEV1 for each week (observed weekly mean and change from baseline in weekly mean). For each subject, the mean weekly morning (and evening) PEFR and FEV1 was defined as the sum of the daily morning (and evening) PEFR (and FEV1) measurements during the week divided by the number of non-missing PEFR (and FEV1) measurements during the week.'}, {'measure': 'Mean Weekly Number of Puffs of Albuterol Used (Rescue Medication)', 'timeFrame': 'Daily: Baseline to end of study', 'description': 'All subjects used an electronic symptom diary to record their daily use of short-acting bronchodilators. Subjects recorded the sum of their short-acting bronchodilator use (puffs of albuterol) daily, immediately upon arising, and again in the evening or before bed.'}, {'measure': 'Number of Subjects With Step-up and Step-down Changes in Classification of Asthma Severity by Medication Usage', 'timeFrame': 'Week 1, Week 2, Week 3, Week 4, Week 6, Week 9, Week 12, Week 18, Week 26, Week 39, Week 52, Week 54, Week 58', 'description': 'All asthma medication changes during the study were classified as step-up or step-down according to treatment guidelines. Step 1: Intermittant Asthma; Step 2: Mild Persistent Asthma; Step 3: Moderate Persistent Asthma; Step 4: Severe Persistent Asthma. The number of subjects in each step classification of asthma severity were provided at each assessment timepoint for each treatment group, with a shift table indicating the number of subjects moving from each step classification at each timepoint.'}, {'measure': 'Step Classification of Asthma Severity by Medication Usage', 'timeFrame': 'Week 1, Week 2, Week 3, Week 4, Week 6, Week 9, Week 12, Week 18, Week 26, Week 39, Week 52, Week 54, Week 58', 'description': 'Step classification of asthma severity by medication usage. Subjects were classified at each visit according to the medication used on the day of the particular time-point; Step 1: intermittent asthma, Step 2: mild persistent asthma, Step 3: moderate persistent asthma, Step 4: severe persistent asthma. The number (%) of subjects in each step classification were provided at each assessment timepoint with a shift table indicating the number (%) of subjects moving from each step classification at each time-point.'}, {'measure': 'Mean Weekly Asthma Symptom Scores', 'timeFrame': 'Baseline through end of study', 'description': 'Mean weekly asthma symptom scores: subjects recorded their asthma symptom scores in an electronic symptom diary twice daily throughout the study, immediately upon awakening (5-10 AM) and in the evening or at bedtime (7-12 PM). Questions included extent of albuterol use, symptoms of wheezing, coughing, activity limitations and sleep; scale 0 (none/fine) to 3 (severe/ continuous/bad night).'}, {'measure': 'Incidence of Non-severe Asthma Exacerbations', 'timeFrame': '0 to 1 week to > 12 months', 'description': 'Non-severe asthma exacerbation = one of the following: any home monitored morning (4:45 am - 10:15 am) forced expiratory volume in 1 second (FEV1) \\<80% of the morning baseline for 2 or more consecutive days; or home monitored FEV1 \\<60% of Baseline at any time. Percent of Baseline = 100\\*(daily FEV1)/Baseline weekly FEV1. Subject-months=elapsed number of months a subject was in the study in each time interval. Crude event rate = total events divided by subject-months.'}, {'measure': 'Incidence of Severe Asthma Exacerbations', 'timeFrame': '0 to 1 Week to > 12 Months', 'description': 'Severe asthma exacerbation was defined as one of the following: subject received oral (systemic) corticosteriods for the treatment of asthma; or subject had an unscheduled visit to a physician, emergency room, or hospital for the treatment of asthma. Subject-months=elapsed number of months a subject was in the study in each time interval. Crude event rate = total events divided by subject-months \\* 100.'}, {'measure': 'Number of Systemic Corticosteroid Rescues', 'timeFrame': 'Baseline through Week 52', 'description': 'Number of subjects who used a systemic corticosteroid at any time during the study, and the total number of systemic corticosteroid rescues. New rescue event = \\>=2 consecutive days between the end of one event and the start of another event.'}, {'measure': 'Asthma Control as Measured by the Asthma Control Questionnaire©', 'timeFrame': 'Baseline, Weeks 4, 12, 26, 39, 52', 'description': 'Asthma Control Questionnaire©: 6 self-administered questions that assess asthma control over the past week covering nocturnal waking, morning symptoms, activity limitations, shortness of breath, wheezing, and short-acting bronchodilator use; 7-point ordinal rating scale from 0 (good control) to 6 (poor control). A seventh question was completed by a health professional on forced expiratory volume in 1 second (FEV1) % predicted using a one-week recall period; scale: 0 (\\>95% predicted) to 6 (\\<50% predicted). Overall score = mean of questions 1 - 7.'}, {'measure': 'Baseline Dyspnea Index (BDI)', 'timeFrame': 'run-in period', 'description': 'Total score = the sum of the numeric grades from the three dyspnea index questions. Functional Impairment rating scale: Grade 4 (no impairment) to Grade 0 (very severe impairment); Magnitude of Task rating scale: Grade 4 (extraordinary) to Grade 0 (no task); and Magnitude of Effort rating scale: Grade 4 (extraordinary) to grade 0 (no effort).'}, {'measure': 'Transition Dyspnea Index (TDI): Change in Total Score', 'timeFrame': 'Week 4, Week 12, Week 26, Week 39, Week 52', 'description': 'Transition Dyspnea Index total score = sum of the numeric grades from the three dyspnea index questions: Change in Functional Impairment, Change in Magnitude of Task, and Change in Magnitude of Effort. Rating scale: -3 (major deterioration), -2 (moderate deterioration), -1 (minor deterioration, 0 (no change), +1 (minor improvement), +2 (moderate improvement), +3 (major improvement).'}, {'measure': 'Glycosylated Hemoglobin (HbA1c)', 'timeFrame': 'Baseline, Week 6, Week 12, Week 26, Week 39, Week 52, Week 52 Last Observation Carried Forward (LOCF)', 'description': 'Glycosylated Hemoglobin (HbA1c): observed mean values at Baseline and each observation, and change from Baseline. Change from Baseline = mean HbA1c at observation minus mean HbA1c at Baseline.'}, {'measure': 'Fasting Plasma Glucose', 'timeFrame': 'Baseline, Week 6, Week 12, Week 26, Week 39, Week 52, Week 52 Last Observation Carried Forward (LOCF)', 'description': 'Fasting plasma glucose (milligrams per deciliter \\[mg/dL\\]) at Baseline, and change from Baseline. Change from baseline: mean of value of fasting plasma glucose in mg/dL at observation minus baseline value.'}, {'measure': 'Body Weight: Mean Baseline and Change From Baseline', 'timeFrame': 'Baseline, Week 1, Week 2, Week 3, Week 4, Week 6, Week 9, Week 11, Week 12, Week 18, Wek 26, Week 39, Week 50, Week 51, Week 52, Week 52 Last Observation Carried Forward (LOCF)', 'description': 'Body weight: mean Baseline and change from Baseline in kilograms (kg). Change from baseline = mean body weight in kilograms (kg) at observation minus baseline value.'}, {'measure': 'Total Daily Long-Acting Insulin Dose (Unadjusted for Body Weight)', 'timeFrame': 'Baseline, Week 1, Week 2, Week 3, Week 4, Week 6, Week 9, Week 12, Week 18, Week 26, Week 39, Week 52', 'description': 'Total Daily Long-Acting Insulin Dose Unadjusted for Body Weight: long-acting insulin included Insulin NPH, Ultralente, and Insulin Glargine for both groups.\n\nInhaled Insulin reported in mg. Subcutaneous Insulin reported in units.'}, {'measure': 'Total Daily Long-Acting Insulin Dose Adjusted for Body Weight', 'timeFrame': 'Week 1, Week 2, Week 3, Week 4, Week 6, Week 9, Week 12, Week 18, Week 26, Week 39, Week 52', 'description': 'Total daily dose of long-acting insulin adjusted for body weight (units per kilogram \\[kg\\]). Long-acting insulin included Insulin NPH, Ultralente, and Insulin Glargine for both groups.\n\nInhaled Insulin reported in mg/kg. Subcutaneous Insulin reported in units/kg.'}, {'measure': 'Total Daily Short-Acting Insulin Dose (Unadjusted for Body Weight)', 'timeFrame': 'Week 1, Week 2, Week 3, Week 4, Week 6, Week 9, Week 12, Week 18, Week 26, Week 39, Week 52', 'description': 'Average Total Daily Insulin Dose: short-acting insulin (milligrams \\[mg\\]). Short-acting insulin (mg) for the Inhaled Insulin group was Inhaled Insulin. Short-acting insulin (unit) for the Subcutaneous Insulin group included Insulin Lispro, Insulin Aspart, and Regular Insulin.'}, {'measure': 'Total Daily Short-Acting Insulin Dose Adjusted for Body Weight', 'timeFrame': 'Week 1, Week 2, Week 3, Week 4, Week 6, Week 9, Week 12, Week 18, Week 26, Week 39, Week 52', 'description': 'Total Daily Short-Acting Insulin Dose adjusted for body weight (units divided by kg). Short-acting insulin (mg) for the Inhaled Insulin group was Inhaled Insulin. Short-acting insulin (unit) for the Subcutaneous Insulin group included Insulin Lispro, Insulin Aspart, and Regular Insulin.'}, {'measure': 'Lipids: Median Change From Baseline to Last Observation', 'timeFrame': 'Baseline to Last Observation', 'description': 'Lipids: median changes (milligrams per deciliter \\[mg/dL\\]) from Baseline median to last observation in cholesterol (random), triglycerides (random), high density lipoprotein (HDL) cholesterol and low density lipoprotein (LDL) cholesterol. Normalized data was used in the computations. Last observation = last observation while on study drug or during the lag. Measures of dispersion for median changes in lipids were not determined.'}, {'measure': 'Hypoglycemic Event Rates', 'timeFrame': '0 to 1 month to 11 to 12 months, and Overall', 'description': 'A Hypoglycemic event was identified by characteristic symptoms of hypoglycemia with no blood glucose check with prompt resolution with food intake, subcutaneous glucagon, or intravenouus glucose; characteristic symptoms with blood glucose of 59 milligrams per deciliter (mg/dL) (3.2 mmol/L) or less with blood glucose check; or any glucose measurement of 49 mg/dL (2.7 mmol/L) or less, with or without symptoms. Crude event rate = total events divided by subject months. Subject months = elapsed number of months a subject was in the study in each time interval.'}, {'measure': 'Severe Hypoglycemic Event Rates', 'timeFrame': '0 to 1 month to 11 to 12 months, and Overall', 'description': 'Severe hypoglycemic event = all 3 of the following criteria were met: subject unable to treat self, exhbited at least 1 neurological symptom (memory loss, confusion, uncontrollable behavior, irrational behavior, unusual difficulty in awakening, suspected seizure, loss of consciousness); blood glucose measurement was ≤ 49 mg/dL, or not measured but clinical manifestations reversed by oral carbohydrates, subcutaneous glucagon, or i.v. glucose. Crude event rate = number of events divided by 100 subject-months. Subject months = elapsed number of months subject was in study in each time interval.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Asthma', 'Diabetes Mellitus']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A2171028&StudyName=A%20One%20Year%20Clinical%20Trial%20Assessing%20the%20Usefulness%20and%20Safety%20of%20Inhaled%20Insulin%20in%20Diabetics%20with%20Asthma', 'label': 'To obtain contact information for a study center near you, click here.'}]}, 'descriptionModule': {'briefSummary': 'A One Year Clinical Trial Assessing the Usefulness and Safety of Inhaled Insulin in Diabetics with Asthma'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '77 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diabetes Mellitus (Type 1 or Type 2) currently controlled with injected insulin\n* Mild intermittent or mild to moderate persistent asthma\n\nExclusion Criteria:\n\n* Poorly controlled, unstable or steroid-dependent asthma, insulin pump therapy, smoking'}, 'identificationModule': {'nctId': 'NCT00139659', 'briefTitle': 'A One Year Clinical Trial Assessing the Usefulness and Safety of Inhaled Insulin in Diabetics With Asthma', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pfizer'}, 'officialTitle': 'Efficacy and Safety of Inhaled Human Insulin (Exubera) Compared With Subcutaneous Human Insulin in the Therapy of Adult Subjects With Type 1 or Type 2 Diabetes Mellitus and Chronic Asthma: A One-Year, Multicenter, Randomized, Outpatient, Open-Label, Parallel-Group Comparative Trial', 'orgStudyIdInfo': {'id': 'A2171028'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Inhaled Insulin', 'interventionNames': ['Drug: Inhaled Insulin']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Subcutaneous Insulin', 'interventionNames': ['Drug: Subcutaneous 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