Ignite Creation Date:
2025-12-24 @ 11:47 PM
Ignite Modification Date:
2026-02-24 @ 10:20 PM
Study NCT ID:
NCT01106651
Status:
COMPLETED
Last Update Posted:
2014-11-04
First Post:
2010-04-01
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Safety and Efficacy Study of Canagliflozin in Older Patients (55 to 80 Years of Age) With Type 2 Diabetes Mellitus
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Brazil', 'Estonia']}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}], 'ancestors': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068896', 'term': 'Canagliflozin'}], 'ancestors': [{'id': 'D013876', 'term': 'Thiophenes'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D005960', 'term': 'Glucosides'}, {'id': 'D006027', 'term': 'Glycosides'}, {'id': 'D002241', 'term': 'Carbohydrates'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrialDisclosure@its.jnj.com', 'title': 'Vice President, Franchise Medical Leader, Cardiovascular & Metabolism Franchise', 'organization': 'Janssen Research & Development, LLC'}, 'certainAgreement': {'otherDetails': 'A copy of the manuscript must be provided to the sponsor for review at least 60 days before submission for publication or presentation. If requested in writing, such publication will be withheld for up to an additional 60 days.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Adverse event data was collected for the duration of the study (104 weeks).', 'description': 'The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.0 used for Week 26 results/ MEDDRA 16.0 used for Week 104 results.', 'eventGroups': [{'id': 'EG000', 'title': 'Placebo: Baseline to Week 26', 'description': 'Each patient received matching placebo once daily for 104 weeks in addition to being on a stable antihyperglycemic (AHA) regimen at the time of study entry. Data are presented for Baseline to Week 26.', 'otherNumAtRisk': 237, 'otherNumAffected': 99, 'seriousNumAtRisk': 237, 'seriousNumAffected': 12}, {'id': 'EG001', 'title': 'Canagliflozin 100 mg: Baseline to Week 26', 'description': 'Each patient received 100 mg of canagliflozin once daily for 104 weeks in addition to being on a stable antihyperglycemic (AHA) regimen at the time of study entry. Data are presented for Baseline to Week 26.', 'otherNumAtRisk': 241, 'otherNumAffected': 92, 'seriousNumAtRisk': 241, 'seriousNumAffected': 10}, {'id': 'EG002', 'title': 'Canagliflozin 300 mg: Baseline to Week 26', 'description': 'Each patient received 300 mg of canagliflozin once daily for 104 weeks in addition to being on a stable antihyperglycemic (AHA) regimen at the time of study entry. Data are presented for Baseline to Week 26.', 'otherNumAtRisk': 236, 'otherNumAffected': 98, 'seriousNumAtRisk': 236, 'seriousNumAffected': 8}, {'id': 'EG003', 'title': 'Placebo: Baseline to Week 104', 'description': 'Each patient received matching placebo once daily for 104 weeks in addition to being on a stable antihyperglycemic (AHA) regimen at the time of study entry. Data are presented for Baseline to Week 104.', 'otherNumAtRisk': 237, 'otherNumAffected': 166, 'seriousNumAtRisk': 237, 'seriousNumAffected': 41}, {'id': 'EG004', 'title': 'Canagliflozin 100 mg: Baseline to Week 104', 'description': 'Each patient received 100 mg of canagliflozin once daily for 104 weeks in addition to being on a stable antihyperglycemic (AHA) regimen at the time of study entry. Data are presented for Baseline to Week 104', 'otherNumAtRisk': 241, 'otherNumAffected': 169, 'seriousNumAtRisk': 241, 'seriousNumAffected': 40}, {'id': 'EG005', 'title': 'Canagliflozin 300 mg: Baseline to Week 104', 'description': 'Each patient received 300 mg of canagliflozin once daily for 104 weeks in addition to being on a stable antihyperglycemic (AHA) regimen at the time of study entry. Data are presented for Baseline to Week 104', 'otherNumAtRisk': 236, 'otherNumAffected': 169, 'seriousNumAtRisk': 236, 'seriousNumAffected': 43}], 'otherEvents': [{'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 237, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 241, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 236, 'numAffected': 11}, {'groupId': 'EG003', 'numAtRisk': 237, 'numAffected': 24}, {'groupId': 'EG004', 'numAtRisk': 241, 'numAffected': 14}, {'groupId': 'EG005', 'numAtRisk': 236, 'numAffected': 24}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 14.0 / 16.0'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 237, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 241, 'numAffected': 14}, {'groupId': 'EG002', 'numAtRisk': 236, 'numAffected': 9}, {'groupId': 'EG003', 'numAtRisk': 237, 'numAffected': 18}, {'groupId': 'EG004', 'numAtRisk': 241, 'numAffected': 25}, {'groupId': 'EG005', 'numAtRisk': 236, 'numAffected': 18}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 14.0 / 16.0'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 237, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 241, 'numAffected': 23}, {'groupId': 'EG002', 'numAtRisk': 236, 'numAffected': 19}, {'groupId': 'EG003', 'numAtRisk': 237, 'numAffected': 36}, {'groupId': 'EG004', 'numAtRisk': 241, 'numAffected': 45}, {'groupId': 'EG005', 'numAtRisk': 236, 'numAffected': 44}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 14.0 / 16.0'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 237, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 241, 'numAffected': 13}, {'groupId': 'EG002', 'numAtRisk': 236, 'numAffected': 10}, {'groupId': 'EG003', 'numAtRisk': 237, 'numAffected': 29}, {'groupId': 'EG004', 'numAtRisk': 241, 'numAffected': 23}, {'groupId': 'EG005', 'numAtRisk': 236, 'numAffected': 25}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 14.0 / 16.0'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 237, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 241, 'numAffected': 14}, {'groupId': 'EG002', 'numAtRisk': 236, 'numAffected': 17}, {'groupId': 'EG003', 'numAtRisk': 237, 'numAffected': 21}, {'groupId': 'EG004', 'numAtRisk': 241, 'numAffected': 32}, {'groupId': 'EG005', 'numAtRisk': 236, 'numAffected': 35}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 14.0 / 16.0'}, {'term': 'Hypoglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 237, 'numAffected': 34}, {'groupId': 'EG001', 'numAtRisk': 241, 'numAffected': 25}, {'groupId': 'EG002', 'numAtRisk': 236, 'numAffected': 23}, {'groupId': 'EG003', 'numAtRisk': 237, 'numAffected': 47}, {'groupId': 'EG004', 'numAtRisk': 241, 'numAffected': 37}, {'groupId': 'EG005', 'numAtRisk': 236, 'numAffected': 36}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 14.0 / 16.0'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 237, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 241, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 236, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 237, 'numAffected': 24}, {'groupId': 'EG004', 'numAtRisk': 241, 'numAffected': 21}, {'groupId': 'EG005', 'numAtRisk': 236, 'numAffected': 9}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 14.0 / 16.0'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 237, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 241, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 236, 'numAffected': 12}, {'groupId': 'EG003', 'numAtRisk': 237, 'numAffected': 19}, {'groupId': 'EG004', 'numAtRisk': 241, 'numAffected': 24}, {'groupId': 'EG005', 'numAtRisk': 236, 'numAffected': 28}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 14.0 / 16.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 237, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 241, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 236, 'numAffected': 13}, {'groupId': 'EG003', 'numAtRisk': 237, 'numAffected': 25}, {'groupId': 'EG004', 'numAtRisk': 241, 'numAffected': 14}, {'groupId': 'EG005', 'numAtRisk': 236, 'numAffected': 22}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 14.0 / 16.0'}, {'term': 'Pollakiuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 237, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 241, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 236, 'numAffected': 12}, {'groupId': 'EG003', 'numAtRisk': 237, 'numAffected': 10}, {'groupId': 'EG004', 'numAtRisk': 241, 'numAffected': 11}, {'groupId': 'EG005', 'numAtRisk': 236, 'numAffected': 15}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 14.0 / 16.0'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 237, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 241, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 236, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 237, 'numAffected': 8}, {'groupId': 'EG004', 'numAtRisk': 241, 'numAffected': 18}, {'groupId': 'EG005', 'numAtRisk': 236, 'numAffected': 13}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 14.0 / 16.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 237, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 241, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 236, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 237, 'numAffected': 16}, {'groupId': 'EG004', 'numAtRisk': 241, 'numAffected': 11}, {'groupId': 'EG005', 'numAtRisk': 236, 'numAffected': 13}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 14.0 / 16.0'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 237, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 241, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 236, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 237, 'numAffected': 17}, {'groupId': 'EG004', 'numAtRisk': 241, 'numAffected': 6}, {'groupId': 'EG005', 'numAtRisk': 236, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 14.0 / 16.0'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 237, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 241, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 236, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 237, 'numAffected': 8}, {'groupId': 'EG004', 'numAtRisk': 241, 'numAffected': 15}, {'groupId': 'EG005', 'numAtRisk': 236, 'numAffected': 11}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 14.0 / 16.0'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 237, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 241, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 236, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 237, 'numAffected': 13}, {'groupId': 'EG004', 'numAtRisk': 241, 'numAffected': 9}, {'groupId': 'EG005', 'numAtRisk': 236, 'numAffected': 6}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 14.0 / 16.0'}, {'term': 'Vulvovaginal mycotic infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 237, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 241, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 236, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 237, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 241, 'numAffected': 13}, {'groupId': 'EG005', 'numAtRisk': 236, 'numAffected': 11}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 14.0 / 16.0'}, {'term': 'Hyperglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 237, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 241, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 236, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 237, 'numAffected': 19}, {'groupId': 'EG004', 'numAtRisk': 241, 'numAffected': 6}, {'groupId': 'EG005', 'numAtRisk': 236, 'numAffected': 6}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 14.0 / 16.0'}, {'term': 'Muscle spasms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 237, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 241, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 236, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 237, 'numAffected': 13}, {'groupId': 'EG004', 'numAtRisk': 241, 'numAffected': 4}, {'groupId': 'EG005', 'numAtRisk': 236, 'numAffected': 6}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 14.0 / 16.0'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 237, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 241, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 236, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 237, 'numAffected': 11}, {'groupId': 'EG004', 'numAtRisk': 241, 'numAffected': 16}, {'groupId': 'EG005', 'numAtRisk': 236, 'numAffected': 11}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 14.0 / 16.0'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 237, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 241, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 236, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 237, 'numAffected': 13}, {'groupId': 'EG004', 'numAtRisk': 241, 'numAffected': 9}, {'groupId': 'EG005', 'numAtRisk': 236, 'numAffected': 6}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 14.0 / 16.0'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 237, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 241, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 236, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 237, 'numAffected': 6}, {'groupId': 'EG004', 'numAtRisk': 241, 'numAffected': 5}, {'groupId': 'EG005', 'numAtRisk': 236, 'numAffected': 12}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 14.0 / 16.0'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 237, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 241, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 236, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 237, 'numAffected': 22}, {'groupId': 'EG004', 'numAtRisk': 241, 'numAffected': 17}, {'groupId': 'EG005', 'numAtRisk': 236, 'numAffected': 18}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 14.0 / 16.0'}, {'term': 'Oropharyngeal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 237, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 241, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 236, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 237, 'numAffected': 15}, {'groupId': 'EG004', 'numAtRisk': 241, 'numAffected': 11}, {'groupId': 'EG005', 'numAtRisk': 236, 'numAffected': 7}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 14.0 / 16.0'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 237, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 241, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 236, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 237, 'numAffected': 12}, {'groupId': 'EG004', 'numAtRisk': 241, 'numAffected': 5}, {'groupId': 'EG005', 'numAtRisk': 236, 'numAffected': 7}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 14.0 / 16.0'}], 'seriousEvents': [{'term': 'Angina pectoris', 'stats': [{'groupId': 'EG000', 'numAtRisk': 237, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 241, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 236, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 237, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 241, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 236, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 14.0 / 16.0'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 237, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 241, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 236, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 237, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 241, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 236, 'numAffected': 3}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 14.0 / 16.0'}, {'term': 'Bradycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 237, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 241, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 236, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 237, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 241, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 236, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 14.0 / 16.0'}, {'term': 'Cardiac failure congestive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 237, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 241, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 236, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 237, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 241, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 236, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 14.0 / 16.0'}, {'term': 'Coronary artery disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 237, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 241, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 236, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 237, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 241, 'numAffected': 3}, {'groupId': 'EG005', 'numAtRisk': 236, 'numAffected': 3}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 14.0 / 16.0'}, {'term': 'Myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 237, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 241, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 236, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 237, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 241, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 236, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 14.0 / 16.0'}, {'term': 'Myocarditis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 237, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 241, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 236, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 237, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 241, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 236, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 14.0 / 16.0'}, {'term': 'Haematochezia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 237, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 241, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 236, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 237, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 241, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 236, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 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'EG004', 'numAtRisk': 241, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 236, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 14.0 / 16.0'}, {'term': 'Calculus ureteric', 'stats': [{'groupId': 'EG000', 'numAtRisk': 237, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 241, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 236, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 237, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 241, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 236, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 14.0 / 16.0'}, {'term': 'Nephrolithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 237, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 241, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 236, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 237, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 241, 'numAffected': 3}, {'groupId': 'EG005', 'numAtRisk': 236, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 14.0 / 16.0'}, {'term': 'Balanoposthitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 237, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 241, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 236, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 237, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 241, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 236, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 14.0 / 16.0'}, {'term': 'Benign prostatic hyperplasia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 237, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 241, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 236, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 237, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 241, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 236, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 14.0 / 16.0'}, {'term': 'Genital prolapse', 'stats': [{'groupId': 'EG000', 'numAtRisk': 237, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 241, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 236, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 237, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 241, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 236, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 14.0 / 16.0'}, {'term': 'Asthma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 237, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 241, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 236, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 237, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 241, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 236, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 14.0 / 16.0'}, {'term': 'Hypoventilation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 237, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 241, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 236, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 237, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 241, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 236, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 14.0 / 16.0'}, {'term': 'Nasal septum deviation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 237, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 241, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 236, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 237, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 241, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 236, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 14.0 / 16.0'}, {'term': 'Pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 237, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 241, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 236, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 237, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 241, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 236, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 14.0 / 16.0'}, {'term': 'Pulmonary fibrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 237, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 241, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 236, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 237, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 241, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 236, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 14.0 / 16.0'}, {'term': 'Sinus polyp', 'stats': [{'groupId': 'EG000', 'numAtRisk': 237, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 241, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 236, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 237, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 241, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 236, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 14.0 / 16.0'}, {'term': 'Psoriasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 237, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 241, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 236, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 237, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 241, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 236, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 14.0 / 16.0'}, {'term': 'Deep vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 237, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 241, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 236, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 237, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 241, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 236, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 14.0 / 16.0'}, {'term': 'Embolism arterial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 237, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 241, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 236, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 237, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 241, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 236, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 14.0 / 16.0'}, {'term': 'Haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 237, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 241, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 236, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 237, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 241, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 236, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 14.0 / 16.0'}, {'term': 'Peripheral vascular disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 237, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 241, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 236, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 237, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 241, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 236, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 14.0 / 16.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in HbA1c From Baseline to Week 26', 'denoms': [{'units': 'Participants', 'counts': [{'value': '232', 'groupId': 'OG000'}, {'value': '239', 'groupId': 'OG001'}, {'value': '229', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Each patient received matching placebo once daily for 104 weeks in addition to being on a stable antihyperglycemic (AHA) regimen at the time of study entry.'}, {'id': 'OG001', 'title': 'Canagliflozin 100 mg', 'description': 'Each patient received 100 mg of canagliflozin once daily for 104 weeks in addition to being on a stable antihyperglycemic (AHA) regimen at the time of study entry.'}, {'id': 'OG002', 'title': 'Canagliflozin 300 mg', 'description': 'Each patient received 300 mg of canagliflozin once daily for 104 weeks in addition to being on a stable antihyperglycemic (AHA) regimen at the time of study entry.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.03', 'spread': '0.063', 'groupId': 'OG000'}, {'value': '-0.60', 'spread': '0.063', 'groupId': 'OG001'}, {'value': '-0.73', 'spread': '0.064', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least-Squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.57', 'ciLowerLimit': '-0.708', 'ciUpperLimit': '-0.436', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.069', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Least-Squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.70', 'ciLowerLimit': '-0.841', 'ciUpperLimit': '-0.566', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.070', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Day 1 (Baseline) and Week 26', 'description': 'The table below shows the least-squares (LS) mean change in HbA1c from Baseline to Week 26 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the LS mean change.', 'unitOfMeasure': 'Percent', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis used mITT analysis set (all randomized patients who received at least 1 dose of study drug). Last-observation-carried-forward method used for missing Week 26 values. Measurements taken pre-rescue used as last observation in patients receiving glycemic rescue therapy. Table includes only patients with both baseline and post baseline values.'}, {'type': 'SECONDARY', 'title': 'Percentage of Patients With HbA1c <7% at Week 26', 'denoms': [{'units': 'Participants', 'counts': [{'value': '232', 'groupId': 'OG000'}, {'value': '239', 'groupId': 'OG001'}, {'value': '229', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Each patient received matching placebo once daily for 104 weeks in addition to being on a stable antihyperglycemic (AHA) regimen at the time of study entry.'}, {'id': 'OG001', 'title': 'Canagliflozin 100 mg', 'description': 'Each patient received 100 mg of canagliflozin once daily for 104 weeks in addition to being on a stable antihyperglycemic (AHA) regimen at the time of study entry.'}, {'id': 'OG002', 'title': 'Canagliflozin 300 mg', 'description': 'Each patient received 300 mg of canagliflozin once daily for 104 weeks in addition to being on a stable antihyperglycemic (AHA) regimen at the time of study entry.'}], 'classes': [{'categories': [{'measurements': [{'value': '28.0', 'groupId': 'OG000'}, {'value': '47.7', 'groupId': 'OG001'}, {'value': '58.5', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciPctValue': '95', 'paramValue': '2.96', 'ciLowerLimit': '1.93', 'ciUpperLimit': '4.56', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Odds Ratio (OR)', 'ciPctValue': '95', 'paramValue': '4.48', 'ciLowerLimit': '2.89', 'ciUpperLimit': '6.95', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Week 26', 'description': 'The table below shows the percentage of patients with HbA1c \\<7% at Week 26 in each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the percentage.', 'unitOfMeasure': 'Percentage of patients', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis used mITT analysis set (all randomized patients who received at least 1 dose of study drug). Last-observation-carried-forward method used for missing Week 26 values. Measurements taken pre-rescue used as last observation in patients receiving glycemic rescue therapy. Table includes only patients with both baseline and post baseline values.'}, {'type': 'SECONDARY', 'title': 'Change in Fasting Plasma Glucose (FPG) From Baseline to Week 26', 'denoms': [{'units': 'Participants', 'counts': [{'value': '231', 'groupId': 'OG000'}, {'value': '239', 'groupId': 'OG001'}, {'value': '229', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Each patient received matching placebo once daily for 104 weeks in addition to being on a stable antihyperglycemic (AHA) regimen at the time of study entry.'}, {'id': 'OG001', 'title': 'Canagliflozin 100 mg', 'description': 'Each patient received 100 mg of canagliflozin once daily for 104 weeks in addition to being on a stable antihyperglycemic (AHA) regimen at the time of study entry.'}, {'id': 'OG002', 'title': 'Canagliflozin 300 mg', 'description': 'Each patient received 300 mg of canagliflozin once daily for 104 weeks in addition to being on a stable antihyperglycemic (AHA) regimen at the time of study entry.'}], 'classes': [{'categories': [{'measurements': [{'value': '7.39', 'spread': '2.875', 'groupId': 'OG000'}, {'value': '-18.1', 'spread': '2.860', 'groupId': 'OG001'}, {'value': '-20.3', 'spread': '2.920', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least-Squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-25.5', 'ciLowerLimit': '-31.68', 'ciUpperLimit': '-19.32', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '3.147', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Least-Squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-27.7', 'ciLowerLimit': '-33.97', 'ciUpperLimit': '-21.49', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '3.179', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Day 1 (Baseline) and Week 26', 'description': 'The table below shows the least-squares (LS) mean change in FPG from Baseline to Week 26 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the LS mean change.', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis used mITT analysis set (all randomized patients who received at least 1 dose of study drug). Last-observation-carried-forward method used for missing Week 26 values. Measurements taken pre-rescue used as last observation in patients receiving glycemic rescue therapy. Table includes only patients with both baseline and post baseline values.'}, {'type': 'SECONDARY', 'title': 'Percent Change in Body Weight From Baseline to Week 26', 'denoms': [{'units': 'Participants', 'counts': [{'value': '234', 'groupId': 'OG000'}, {'value': '240', 'groupId': 'OG001'}, {'value': '229', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Each patient received matching placebo once daily for 104 weeks in addition to being on a stable antihyperglycemic (AHA) regimen at the time of study entry.'}, {'id': 'OG001', 'title': 'Canagliflozin 100 mg', 'description': 'Each patient received 100 mg of canagliflozin once daily for 104 weeks in addition to being on a stable antihyperglycemic (AHA) regimen at the time of study entry.'}, {'id': 'OG002', 'title': 'Canagliflozin 300 mg', 'description': 'Each patient received 300 mg of canagliflozin once daily for 104 weeks in addition to being on a stable antihyperglycemic (AHA) regimen at the time of study entry.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.1', 'spread': '0.3', 'groupId': 'OG000'}, {'value': '-2.4', 'spread': '0.3', 'groupId': 'OG001'}, {'value': '-3.1', 'spread': '0.3', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least-Squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.3', 'ciLowerLimit': '-2.8', 'ciUpperLimit': '-1.7', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.3', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Least-Squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-3.0', 'ciLowerLimit': '-3.5', 'ciUpperLimit': '-2.4', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.3', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Day 1 (Baseline) and Week 26', 'description': 'The table below shows the least-squares (LS) mean percent change in body weight from Baseline to Week 26 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the LS mean change.', 'unitOfMeasure': 'Percent change', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis used mITT analysis set (all randomized patients who received at least 1 dose of study drug). Last-observation-carried-forward method used for missing Week 26 values. Measurements taken pre-rescue used as last observation in patients receiving glycemic rescue therapy. Table includes only patients with both baseline and post baseline values.'}, {'type': 'SECONDARY', 'title': 'Change in Total Fat From Baseline to Week 26 in a Subset of Patients Undergoing Specific Dual-energy X-ray Absorptiometry (DXA) Analysis for Body Composition', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}, {'value': '60', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Each patient received matching placebo once daily for 104 weeks in addition to being on a stable antihyperglycemic (AHA) regimen at the time of study entry.'}, {'id': 'OG001', 'title': 'Canagliflozin 100 mg', 'description': 'Each patient received 100 mg of canagliflozin once daily for 104 weeks in addition to being on a stable antihyperglycemic (AHA) regimen at the time of study entry.'}, {'id': 'OG002', 'title': 'Canagliflozin 300 mg', 'description': 'Each patient received 300 mg of canagliflozin once daily for 104 weeks in addition to being on a stable antihyperglycemic (AHA) regimen at the time of study entry.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.28', 'spread': '0.336', 'groupId': 'OG000'}, {'value': '-1.87', 'spread': '0.332', 'groupId': 'OG001'}, {'value': '-2.38', 'spread': '0.323', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least-Squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.59', 'ciLowerLimit': '-2.339', 'ciUpperLimit': '-0.842', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.379', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Least-Squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.10', 'ciLowerLimit': '-2.833', 'ciUpperLimit': '-1.368', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.371', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Day 1 (Baseline) and Week 26', 'description': 'The table below shows the least-squares (LS) mean change in total fat from Baseline to Week 26 for each treatment group in patients randomized to the subset of patients undergoing specific DXA analysis for body composition. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the LS mean change.', 'unitOfMeasure': 'kg', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis used mITT analysis set (all randomized patients who received at least 1 dose of study drug). Last-observation-carried-forward method used for missing Week 26 values. Measurements taken pre-rescue used as last observation in patients receiving glycemic rescue therapy. Table includes only patients with both baseline and post baseline values.'}, {'type': 'SECONDARY', 'title': 'Change in Region Percent Total Fat From Baseline to Week 26 in a Subset of Patients Undergoing Specific Dual-energy X-ray Absorptiometry (DXA) Analysis for Body Composition', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}, {'value': '60', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Each patient received matching placebo once daily for 104 weeks in addition to being on a stable antihyperglycemic (AHA) regimen at the time of study entry.'}, {'id': 'OG001', 'title': 'Canagliflozin 100 mg', 'description': 'Each patient received 100 mg of canagliflozin once daily for 104 weeks in addition to being on a stable antihyperglycemic (AHA) regimen at the time of study entry.'}, {'id': 'OG002', 'title': 'Canagliflozin 300 mg', 'description': 'Each patient received 300 mg of canagliflozin once daily for 104 weeks in addition to being on a stable antihyperglycemic (AHA) regimen at the time of study entry.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.00', 'spread': '0.270', 'groupId': 'OG000'}, {'value': '-1.03', 'spread': '0.268', 'groupId': 'OG001'}, {'value': '-1.18', 'spread': '0.261', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least-Squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.03', 'ciLowerLimit': '-1.633', 'ciUpperLimit': '-0.428', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.305', 'groupDescription': 'Region percent total fat', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Least-Squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.18', 'ciLowerLimit': '-1.772', 'ciUpperLimit': '-0.587', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.300', 'groupDescription': 'Region percent total fat', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Day 1 (Baseline) and Week 26', 'description': 'Region percent total fat = body fat as a percentage of (body fat + lean body mass + bone mass content). The table below shows the least-squares (LS) mean change in region percent total fat from Baseline to Week 26 for each treatment group in patients randomized to the subset of patients undergoing specific dual-energy X-ray absorptiometry (DXA) analysis for body composition. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the LS mean change.', 'unitOfMeasure': 'Percent', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis used mITT analysis set (all randomized patients who received at least 1 dose of study drug). Last-observation-carried-forward method used for missing Week 26 values. Measurements taken pre-rescue used as last observation in patients receiving glycemic rescue therapy. Table includes only patients with both baseline and post baseline values.'}, {'type': 'SECONDARY', 'title': 'Change in Tissue Percent Total Fat From Baseline to Week 26 in a Subset of Patients Undergoing Specific Dual-energy X-ray Absorptiometry (DXA) Analysis for Body Composition', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}, {'value': '60', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Each patient received matching placebo once daily for 104 weeks in addition to being on a stable antihyperglycemic (AHA) regimen at the time of study entry.'}, {'id': 'OG001', 'title': 'Canagliflozin 100 mg', 'description': 'Each patient received 100 mg of canagliflozin once daily for 104 weeks in addition to being on a stable antihyperglycemic (AHA) regimen at the time of study entry.'}, {'id': 'OG002', 'title': 'Canagliflozin 300 mg', 'description': 'Each patient received 300 mg of canagliflozin once daily for 104 weeks in addition to being on a stable antihyperglycemic (AHA) regimen at the time of study entry.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.02', 'spread': '0.280', 'groupId': 'OG000'}, {'value': '-1.04', 'spread': '0.278', 'groupId': 'OG001'}, {'value': '-1.18', 'spread': '0.270', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least-Squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.05', 'ciLowerLimit': '-1.677', 'ciUpperLimit': '-0.430', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.316', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Least-Squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.20', 'ciLowerLimit': '-1.812', 'ciUpperLimit': '-0.584', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.311', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Day 1 (Baseline) and Week 26', 'description': 'Tissue percent total fat = body fat as a percentage of body fat + lean body mass. The table below shows the least-squares (LS) mean change in tissue percent total fat from Baseline to Week 26 for each treatment group in patients randomized to the subset of patients undergoing specific DXA analysis for body composition. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the LS mean change.', 'unitOfMeasure': 'Percent', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis used mITT analysis set (all randomized patients who received at least 1 dose of study drug). Last-observation-carried-forward method used for missing Week 26 values. Measurements taken pre-rescue used as last observation in patients receiving glycemic rescue therapy. Table includes only patients with both baseline and post baseline values.'}, {'type': 'SECONDARY', 'title': 'Change in Systolic Blood Pressure (SBP) From Baseline to Week 26', 'denoms': [{'units': 'Participants', 'counts': [{'value': '234', 'groupId': 'OG000'}, {'value': '240', 'groupId': 'OG001'}, {'value': '229', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Each patient received matching placebo once daily for 104 weeks in addition to being on a stable antihyperglycemic (AHA) regimen at the time of study entry.'}, {'id': 'OG001', 'title': 'Canagliflozin 100 mg', 'description': 'Each patient received 100 mg of canagliflozin once daily for 104 weeks in addition to being on a stable antihyperglycemic (AHA) regimen at the time of study entry.'}, {'id': 'OG002', 'title': 'Canagliflozin 300 mg', 'description': 'Each patient received 300 mg of canagliflozin once daily for 104 weeks in addition to being on a stable antihyperglycemic (AHA) regimen at the time of study entry.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.10', 'spread': '1.039', 'groupId': 'OG000'}, {'value': '-3.52', 'spread': '1.035', 'groupId': 'OG001'}, {'value': '-6.79', 'spread': '1.056', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least-Squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-4.63', 'ciLowerLimit': '-6.854', 'ciUpperLimit': '-2.401', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.134', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Least-Squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-7.89', 'ciLowerLimit': '-10.14', 'ciUpperLimit': '-5.641', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.147', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Day 1 (Baseline) and Week 26', 'description': 'The table below shows the least-squares (LS) mean change in SBP from Baseline to Week 26 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the LS mean change.', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis used mITT analysis set (all randomized patients who received at least 1 dose of study drug). Last-observation-carried-forward method used for missing Week 26 values. Measurements taken pre-rescue used as last observation in patients receiving glycemic rescue therapy. Table includes only patients with both baseline and post baseline values.'}, {'type': 'SECONDARY', 'title': 'Percent Change in Triglycerides From Baseline to Week 26', 'denoms': [{'units': 'Participants', 'counts': [{'value': '206', 'groupId': 'OG000'}, {'value': '227', 'groupId': 'OG001'}, {'value': '222', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Each patient received matching placebo once daily for 104 weeks in addition to being on a stable antihyperglycemic (AHA) regimen at the time of study entry.'}, {'id': 'OG001', 'title': 'Canagliflozin 100 mg', 'description': 'Each patient received 100 mg of canagliflozin once daily for 104 weeks in addition to being on a stable antihyperglycemic (AHA) regimen at the time of study entry.'}, {'id': 'OG002', 'title': 'Canagliflozin 300 mg', 'description': 'Each patient received 300 mg of canagliflozin once daily for 104 weeks in addition to being on a stable antihyperglycemic (AHA) regimen at the time of study entry.'}], 'classes': [{'categories': [{'measurements': [{'value': '7.7', 'spread': '3.4', 'groupId': 'OG000'}, {'value': '2.8', 'spread': '3.3', 'groupId': 'OG001'}, {'value': '8.4', 'spread': '3.4', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.194', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least-Squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-4.8', 'ciLowerLimit': '-12.1', 'ciUpperLimit': '2.5', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '3.7', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.846', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Least-Squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.7', 'ciLowerLimit': '-6.6', 'ciUpperLimit': '8.1', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '3.7', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Day 1 (Baseline) and Week 26', 'description': 'The table below shows the least-squares (LS) mean percent change in triglycerides from Baseline to Week 26 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the LS mean change.', 'unitOfMeasure': 'Percent change', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis used mITT analysis set (all randomized patients who received at least 1 dose of study drug). Last-observation-carried-forward method used for missing Week 26 values. Measurements taken pre-rescue used as last observation in patients receiving glycemic rescue therapy. Table includes only patients with both baseline and post baseline values.'}, {'type': 'SECONDARY', 'title': 'Percent Change in High-density Lipoprotein Cholesterol (HDL-C) From Baseline to Week 26', 'denoms': [{'units': 'Participants', 'counts': [{'value': '206', 'groupId': 'OG000'}, {'value': '225', 'groupId': 'OG001'}, {'value': '222', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Each patient received matching placebo once daily for 104 weeks in addition to being on a stable antihyperglycemic (AHA) regimen at the time of study entry.'}, {'id': 'OG001', 'title': 'Canagliflozin 100 mg', 'description': 'Each patient received 100 mg of canagliflozin once daily for 104 weeks in addition to being on a stable antihyperglycemic (AHA) regimen at the time of study entry.'}, {'id': 'OG002', 'title': 'Canagliflozin 300 mg', 'description': 'Each patient received 300 mg of canagliflozin once daily for 104 weeks in addition to being on a stable antihyperglycemic (AHA) regimen at the time of study entry.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.5', 'spread': '1.2', 'groupId': 'OG000'}, {'value': '6.8', 'spread': '1.2', 'groupId': 'OG001'}, {'value': '6.2', 'spread': '1.2', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least-Squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '5.3', 'ciLowerLimit': '2.6', 'ciUpperLimit': '7.9', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.4', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Least-Squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '4.7', 'ciLowerLimit': '2.0', 'ciUpperLimit': '7.4', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.4', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Day 1 (Baseline) and Week 26', 'description': 'The table below shows the least-squares (LS) mean percent change in HDL-C from Baseline to Week 26 or each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the LS mean change.', 'unitOfMeasure': 'Percent change', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis used mITT analysis set (all randomized patients who received at least 1 dose of study drug). Last-observation-carried-forward method used for missing Week 26 values. Measurements taken pre-rescue used as last observation in patients receiving glycemic rescue therapy. Table includes only patients with both baseline and post baseline values.'}, {'type': 'SECONDARY', 'title': 'Percent Change in Lumbar Spine Bone Mineral Density (BMD) From Baseline to Week 26', 'denoms': [{'units': 'Participants', 'counts': [{'value': '185', 'groupId': 'OG000'}, {'value': '206', 'groupId': 'OG001'}, {'value': '192', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Each patient received matching placebo once daily for 104 weeks in addition to being on a stable antihyperglycemic (AHA) regimen at the time of study entry.'}, {'id': 'OG001', 'title': 'Canagliflozin 100 mg', 'description': 'Each patient received 100 mg of canagliflozin once daily for 104 weeks in addition to being on a stable antihyperglycemic (AHA) regimen at the time of study entry.'}, {'id': 'OG002', 'title': 'Canagliflozin 300 mg', 'description': 'Each patient received 300 mg of canagliflozin once daily for 104 weeks in addition to being on a stable antihyperglycemic (AHA) regimen at the time of study entry.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.5', 'spread': '0.3', 'groupId': 'OG000'}, {'value': '0.7', 'spread': '0.3', 'groupId': 'OG001'}, {'value': '0.2', 'spread': '0.3', 'groupId': 'OG002'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Least-Squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.2', 'ciLowerLimit': '-0.4', 'ciUpperLimit': '0.8', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.3', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Least-Squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.3', 'ciLowerLimit': '-0.9', 'ciUpperLimit': '0.3', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.3', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Day 1 (Baseline) and Week 26', 'description': 'The table below shows the least-squares (LS) mean percent change from Baseline to Week 26 in lumbar spine BMD for each treatment group as assessed by dual-energy X-ray absorptiometry (DXA). The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in LS mean percent change.', 'unitOfMeasure': 'Percent change', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis used mITT analysis set (all randomized patients who received at least 1 dose of study drug). Last-observation-carried-forward method used for missing Week 26 values. Measurements taken pre-rescue used as last observation in patients receiving glycemic rescue therapy. Table includes only patients with both baseline and post baseline values.'}, {'type': 'SECONDARY', 'title': 'Percent Change in Distal Forearm Bone Mineral Density (BMD) From Baseline to Week 26', 'denoms': [{'units': 'Participants', 'counts': [{'value': '187', 'groupId': 'OG000'}, {'value': '208', 'groupId': 'OG001'}, {'value': '187', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Each patient received matching placebo once daily for 104 weeks in addition to being on a stable antihyperglycemic (AHA) regimen at the time of study entry.'}, {'id': 'OG001', 'title': 'Canagliflozin 100 mg', 'description': 'Each patient received 100 mg of canagliflozin once daily for 104 weeks in addition to being on a stable antihyperglycemic (AHA) regimen at the time of study entry.'}, {'id': 'OG002', 'title': 'Canagliflozin 300 mg', 'description': 'Each patient received 300 mg of canagliflozin once daily for 104 weeks in addition to being on a stable antihyperglycemic (AHA) regimen at the time of study entry.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.5', 'spread': '0.3', 'groupId': 'OG000'}, {'value': '-0.7', 'spread': '0.3', 'groupId': 'OG001'}, {'value': '-0.8', 'spread': '0.3', 'groupId': 'OG002'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Least-Squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.3', 'ciLowerLimit': '-0.9', 'ciUpperLimit': '0.4', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.3', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Least-Squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.4', 'ciLowerLimit': '-1.0', 'ciUpperLimit': '0.3', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.3', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Day 1 (Baseline) and Week 26', 'description': 'The table below shows the least-squares (LS) mean percent change from Baseline to Week 26 in distal forearm BMD for each treatment group as assessed by dual-energy X-ray absorptiometry (DXA). The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in LS mean percent change.', 'unitOfMeasure': 'Percent change', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis used mITT analysis set (all randomized patients who received at least 1 dose of study drug). Last-observation-carried-forward method used for missing Week 26 values. Measurements taken pre-rescue used as last observation in patients receiving glycemic rescue therapy. Table includes only patients with both baseline and post baseline values.'}, {'type': 'SECONDARY', 'title': 'Percent Change in Femoral Neck Bone Mineral Density (BMD) From Baseline to Week 26', 'denoms': [{'units': 'Participants', 'counts': [{'value': '183', 'groupId': 'OG000'}, {'value': '209', 'groupId': 'OG001'}, {'value': '190', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Each patient received matching placebo once daily for 104 weeks in addition to being on a stable antihyperglycemic (AHA) regimen at the time of study entry.'}, {'id': 'OG001', 'title': 'Canagliflozin 100 mg', 'description': 'Each patient received 100 mg of canagliflozin once daily for 104 weeks in addition to being on a stable antihyperglycemic (AHA) regimen at the time of study entry.'}, {'id': 'OG002', 'title': 'Canagliflozin 300 mg', 'description': 'Each patient received 300 mg of canagliflozin once daily for 104 weeks in addition to being on a stable antihyperglycemic (AHA) regimen at the time of study entry.'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.0', 'spread': '0.3', 'groupId': 'OG000'}, {'value': '-0.7', 'spread': '0.3', 'groupId': 'OG001'}, {'value': '-0.6', 'spread': '0.3', 'groupId': 'OG002'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Least-Squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.3', 'ciLowerLimit': '-0.3', 'ciUpperLimit': '1.0', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.3', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Least-Squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.4', 'ciLowerLimit': '-0.3', 'ciUpperLimit': '1.1', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.3', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Day 1 (Baseline) and Week 26', 'description': 'The table below shows the least-squares (LS) mean percent change from Baseline to Week 26 in femoral neck BMD for each treatment group as assessed by dual-energy X-ray absorptiometry (DXA). The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in LS mean percent change.', 'unitOfMeasure': 'Percent change', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis used mITT analysis set (all randomized patients who received at least 1 dose of study drug). Last-observation-carried-forward method used for missing Week 26 values. Measurements taken pre-rescue used as last observation in patients receiving glycemic rescue therapy. Table includes only patients with both baseline and post baseline values.'}, {'type': 'SECONDARY', 'title': 'Percent Change in Total Hip Bone Mineral Density (BMD) From Baseline to Week 26', 'denoms': [{'units': 'Participants', 'counts': [{'value': '183', 'groupId': 'OG000'}, {'value': '209', 'groupId': 'OG001'}, {'value': '190', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Each patient received matching placebo once daily for 104 weeks in addition to being on a stable antihyperglycemic (AHA) regimen at the time of study entry.'}, {'id': 'OG001', 'title': 'Canagliflozin 100 mg', 'description': 'Each patient received 100 mg of canagliflozin once daily for 104 weeks in addition to being on a stable antihyperglycemic (AHA) regimen at the time of study entry.'}, {'id': 'OG002', 'title': 'Canagliflozin 300 mg', 'description': 'Each patient received 300 mg of canagliflozin once daily for 104 weeks in addition to being on a stable antihyperglycemic (AHA) regimen at the time of study entry.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.5', 'spread': '0.2', 'groupId': 'OG000'}, {'value': '-0.9', 'spread': '0.2', 'groupId': 'OG001'}, {'value': '-1.0', 'spread': '0.2', 'groupId': 'OG002'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Least-Squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.4', 'ciLowerLimit': '-0.8', 'ciUpperLimit': '-0.0', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.2', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Least-Squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.5', 'ciLowerLimit': '-0.9', 'ciUpperLimit': '-0.1', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.2', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Day 1 (Baseline) and Week 26', 'description': 'The table below shows the least-squares (LS) mean percent change from Baseline to Week 26 in total hip BMD for each treatment group as assessed by dual-energy X-ray absorptiometry (DXA). The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in LS mean percent change.', 'unitOfMeasure': 'Percent change', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis used mITT analysis set (all randomized patients who received at least 1 dose of study drug). Last-observation-carried-forward method used for missing Week 26 values. Measurements taken pre-rescue used as last observation in patients receiving glycemic rescue therapy. Table includes only patients with both baseline and post baseline values.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Placebo', 'description': 'Each patient received matching placebo once daily for 104 weeks in addition to being on a stable antihyperglycemic (AHA) regimen at the time of study entry.'}, {'id': 'FG001', 'title': 'Canagliflozin 100 mg', 'description': 'Each patient received 100 mg of canagliflozin once daily for 104 weeks in addition to being on a stable antihyperglycemic (AHA) regimen at the time of study entry.'}, {'id': 'FG002', 'title': 'Canagliflozin 300 mg', 'description': 'Each patient received 300 mg of canagliflozin once daily for 104 weeks in addition to being on a stable antihyperglycemic (AHA) regimen at the time of study entry.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '237'}, {'groupId': 'FG001', 'numSubjects': '241'}, {'groupId': 'FG002', 'numSubjects': '236'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '158'}, {'groupId': 'FG001', 'numSubjects': '184'}, {'groupId': 'FG002', 'numSubjects': '178'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '79'}, {'groupId': 'FG001', 'numSubjects': '57'}, {'groupId': 'FG002', 'numSubjects': '58'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '17'}, {'groupId': 'FG001', 'numSubjects': '9'}, {'groupId': 'FG002', 'numSubjects': '23'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '6'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '7'}, {'groupId': 'FG002', 'numSubjects': '4'}]}, {'type': 'Noncompliance with study drug', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '2'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '34'}, {'groupId': 'FG001', 'numSubjects': '31'}, {'groupId': 'FG002', 'numSubjects': '21'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'This study evaluated the efficacy and safety of canagliflozin in older patients with type 2 diabetes mellitus with inadequate control on their current diabetes treatment regimen. The study began on 07 June 2010 and ended on 23 May 2013. Patients were recruited from 90 study centers located in 17 countries worldwide.', 'preAssignmentDetails': '716 patients were randomly allocated to the 3 treatment arms. 714 patients received at least 1 dose of study drug and were included in the modified intent-to-treat (mITT) analysis set and safety analysis set. Participant flow is presented for Baseline to Week 104 (Overall Study).'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '237', 'groupId': 'BG000'}, {'value': '241', 'groupId': 'BG001'}, {'value': '236', 'groupId': 'BG002'}, {'value': '714', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Placebo', 'description': 'Each patient received matching placebo once daily for 104 weeks in addition to being on a stable antihyperglycemic (AHA) regimen at the time of study entry.'}, {'id': 'BG001', 'title': 'Canagliflozin 100 mg', 'description': 'Each patient received 100 mg of canagliflozin once daily for 104 weeks in addition to being on a stable antihyperglycemic (AHA) regimen at the time of study entry.'}, {'id': 'BG002', 'title': 'Canagliflozin 300 mg', 'description': 'Each patient received 300 mg of canagliflozin once daily for 104 weeks in addition to being on a stable antihyperglycemic (AHA) regimen at the time of study entry.'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '151', 'groupId': 'BG000'}, {'value': '141', 'groupId': 'BG001'}, {'value': '149', 'groupId': 'BG002'}, {'value': '441', 'groupId': 'BG003'}]}, {'title': '>=65 years', 'measurements': [{'value': '86', 'groupId': 'BG000'}, {'value': '100', 'groupId': 'BG001'}, {'value': '87', 'groupId': 'BG002'}, {'value': '273', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '63.2', 'spread': '6.21', 'groupId': 'BG000'}, {'value': '64.3', 'spread': '6.46', 'groupId': 'BG001'}, {'value': '63.4', 'spread': '5.99', 'groupId': 'BG002'}, {'value': '63.6', 'spread': '6.24', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '94', 'groupId': 'BG000'}, {'value': '117', 'groupId': 'BG001'}, {'value': '107', 'groupId': 'BG002'}, {'value': '318', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '143', 'groupId': 'BG000'}, {'value': '124', 'groupId': 'BG001'}, {'value': '129', 'groupId': 'BG002'}, {'value': '396', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'AUSTRALIA', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}, {'value': '23', 'groupId': 'BG003'}]}]}, {'title': 'CANADA', 'categories': [{'measurements': [{'value': '24', 'groupId': 'BG000'}, {'value': '32', 'groupId': 'BG001'}, {'value': '28', 'groupId': 'BG002'}, {'value': '84', 'groupId': 'BG003'}]}]}, {'title': 'COLOMBIA', 'categories': [{'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}, {'value': '53', 'groupId': 'BG003'}]}]}, {'title': 'FRANCE', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '7', 'groupId': 'BG003'}]}]}, {'title': 'GREECE', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}]}]}, {'title': 'HONG KONG', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}]}]}, {'title': 'INDIA', 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}, {'value': '22', 'groupId': 'BG003'}]}]}, {'title': 'NEW ZEALAND', 'categories': [{'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}, {'value': '37', 'groupId': 'BG003'}]}]}, {'title': 'POLAND', 'categories': [{'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}, {'value': '37', 'groupId': 'BG003'}]}]}, {'title': 'ROMANIA', 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '25', 'groupId': 'BG003'}]}]}, {'title': 'SOUTH AFRICA', 'categories': [{'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}, {'value': '31', 'groupId': 'BG003'}]}]}, {'title': 'SPAIN', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '13', 'groupId': 'BG003'}]}]}, {'title': 'SWEDEN', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '10', 'groupId': 'BG003'}]}]}, {'title': 'SWITZERLAND', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}]}]}, {'title': 'UKRAINE', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '14', 'groupId': 'BG003'}]}]}, {'title': 'UNITED KINGDOM', 'categories': [{'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '49', 'groupId': 'BG003'}]}]}, {'title': 'UNITED STATES', 'categories': [{'measurements': [{'value': '103', 'groupId': 'BG000'}, {'value': '98', 'groupId': 'BG001'}, {'value': '97', 'groupId': 'BG002'}, {'value': '298', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 716}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-10', 'dispFirstSubmitDate': '2012-03-30', 'completionDateStruct': {'date': '2013-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-10-27', 'studyFirstSubmitDate': '2010-04-01', 'dispFirstSubmitQcDate': '2012-04-24', 'resultsFirstSubmitDate': '2013-04-01', 'studyFirstSubmitQcDate': '2010-04-16', 'dispFirstPostDateStruct': {'date': '2012-04-25', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2014-11-04', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2013-04-01', 'studyFirstPostDateStruct': {'date': '2010-04-20', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2013-05-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in HbA1c From Baseline to Week 26', 'timeFrame': 'Day 1 (Baseline) and Week 26', 'description': 'The table below shows the least-squares (LS) mean change in HbA1c from Baseline to Week 26 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the LS mean change.'}], 'secondaryOutcomes': [{'measure': 'Percentage of Patients With HbA1c <7% at Week 26', 'timeFrame': 'Week 26', 'description': 'The table below shows the percentage of patients with HbA1c \\<7% at Week 26 in each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the percentage.'}, {'measure': 'Change in Fasting Plasma Glucose (FPG) From Baseline to Week 26', 'timeFrame': 'Day 1 (Baseline) and Week 26', 'description': 'The table below shows the least-squares (LS) mean change in FPG from Baseline to Week 26 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the LS mean change.'}, {'measure': 'Percent Change in Body Weight From Baseline to Week 26', 'timeFrame': 'Day 1 (Baseline) and Week 26', 'description': 'The table below shows the least-squares (LS) mean percent change in body weight from Baseline to Week 26 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the LS mean change.'}, {'measure': 'Change in Total Fat From Baseline to Week 26 in a Subset of Patients Undergoing Specific Dual-energy X-ray Absorptiometry (DXA) Analysis for Body Composition', 'timeFrame': 'Day 1 (Baseline) and Week 26', 'description': 'The table below shows the least-squares (LS) mean change in total fat from Baseline to Week 26 for each treatment group in patients randomized to the subset of patients undergoing specific DXA analysis for body composition. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the LS mean change.'}, {'measure': 'Change in Region Percent Total Fat From Baseline to Week 26 in a Subset of Patients Undergoing Specific Dual-energy X-ray Absorptiometry (DXA) Analysis for Body Composition', 'timeFrame': 'Day 1 (Baseline) and Week 26', 'description': 'Region percent total fat = body fat as a percentage of (body fat + lean body mass + bone mass content). The table below shows the least-squares (LS) mean change in region percent total fat from Baseline to Week 26 for each treatment group in patients randomized to the subset of patients undergoing specific dual-energy X-ray absorptiometry (DXA) analysis for body composition. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the LS mean change.'}, {'measure': 'Change in Tissue Percent Total Fat From Baseline to Week 26 in a Subset of Patients Undergoing Specific Dual-energy X-ray Absorptiometry (DXA) Analysis for Body Composition', 'timeFrame': 'Day 1 (Baseline) and Week 26', 'description': 'Tissue percent total fat = body fat as a percentage of body fat + lean body mass. The table below shows the least-squares (LS) mean change in tissue percent total fat from Baseline to Week 26 for each treatment group in patients randomized to the subset of patients undergoing specific DXA analysis for body composition. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the LS mean change.'}, {'measure': 'Change in Systolic Blood Pressure (SBP) From Baseline to Week 26', 'timeFrame': 'Day 1 (Baseline) and Week 26', 'description': 'The table below shows the least-squares (LS) mean change in SBP from Baseline to Week 26 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the LS mean change.'}, {'measure': 'Percent Change in Triglycerides From Baseline to Week 26', 'timeFrame': 'Day 1 (Baseline) and Week 26', 'description': 'The table below shows the least-squares (LS) mean percent change in triglycerides from Baseline to Week 26 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the LS mean change.'}, {'measure': 'Percent Change in High-density Lipoprotein Cholesterol (HDL-C) From Baseline to Week 26', 'timeFrame': 'Day 1 (Baseline) and Week 26', 'description': 'The table below shows the least-squares (LS) mean percent change in HDL-C from Baseline to Week 26 or each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the LS mean change.'}, {'measure': 'Percent Change in Lumbar Spine Bone Mineral Density (BMD) From Baseline to Week 26', 'timeFrame': 'Day 1 (Baseline) and Week 26', 'description': 'The table below shows the least-squares (LS) mean percent change from Baseline to Week 26 in lumbar spine BMD for each treatment group as assessed by dual-energy X-ray absorptiometry (DXA). The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in LS mean percent change.'}, {'measure': 'Percent Change in Distal Forearm Bone Mineral Density (BMD) From Baseline to Week 26', 'timeFrame': 'Day 1 (Baseline) and Week 26', 'description': 'The table below shows the least-squares (LS) mean percent change from Baseline to Week 26 in distal forearm BMD for each treatment group as assessed by dual-energy X-ray absorptiometry (DXA). The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in LS mean percent change.'}, {'measure': 'Percent Change in Femoral Neck Bone Mineral Density (BMD) From Baseline to Week 26', 'timeFrame': 'Day 1 (Baseline) and Week 26', 'description': 'The table below shows the least-squares (LS) mean percent change from Baseline to Week 26 in femoral neck BMD for each treatment group as assessed by dual-energy X-ray absorptiometry (DXA). The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in LS mean percent change.'}, {'measure': 'Percent Change in Total Hip Bone Mineral Density (BMD) From Baseline to Week 26', 'timeFrame': 'Day 1 (Baseline) and Week 26', 'description': 'The table below shows the least-squares (LS) mean percent change from Baseline to Week 26 in total hip BMD for each treatment group as assessed by dual-energy X-ray absorptiometry (DXA). The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in LS mean percent change.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Canagliflozin', 'Placebo', 'Hemoglobin A1c', 'Bone', 'Type 2 diabetes mellitus'], 'conditions': ['Diabetes Mellitus, Type 2']}, 'referencesModule': {'references': [{'pmid': '28619659', 'type': 'DERIVED', 'citation': 'Januzzi JL Jr, Butler J, Jarolim P, Sattar N, Vijapurkar U, Desai M, Davies MJ. Effects of Canagliflozin on Cardiovascular Biomarkers in Older Adults With Type 2 Diabetes. J Am Coll Cardiol. 2017 Aug 8;70(6):704-712. doi: 10.1016/j.jacc.2017.06.016. Epub 2017 Jun 12.'}, {'pmid': '27977934', 'type': 'DERIVED', 'citation': 'Qiu R, Balis D, Xie J, Davies MJ, Desai M, Meininger G. Longer-term safety and tolerability of canagliflozin in patients with type 2 diabetes: a pooled analysis. Curr Med Res Opin. 2017 Mar;33(3):553-562. doi: 10.1080/03007995.2016.1271780. Epub 2017 Jan 4.'}, {'pmid': '27002421', 'type': 'DERIVED', 'citation': 'Blonde L, Stenlof K, Fung A, Xie J, Canovatchel W, Meininger G. Effects of canagliflozin on body weight and body composition in patients with type 2 diabetes over 104 weeks. Postgrad Med. 2016 May;128(4):371-80. doi: 10.1080/00325481.2016.1169894. Epub 2016 Apr 7.'}, {'pmid': '26580237', 'type': 'DERIVED', 'citation': 'Watts NB, Bilezikian JP, Usiskin K, Edwards R, Desai M, Law G, Meininger G. Effects of Canagliflozin on Fracture Risk in Patients With Type 2 Diabetes Mellitus. J Clin Endocrinol Metab. 2016 Jan;101(1):157-66. doi: 10.1210/jc.2015-3167. Epub 2015 Nov 18.'}, {'pmid': '26580234', 'type': 'DERIVED', 'citation': 'Bilezikian JP, Watts NB, Usiskin K, Polidori D, Fung A, Sullivan D, Rosenthal N. Evaluation of Bone Mineral Density and Bone Biomarkers in Patients With Type 2 Diabetes Treated With Canagliflozin. J Clin Endocrinol Metab. 2016 Jan;101(1):44-51. doi: 10.1210/jc.2015-1860. Epub 2015 Nov 18.'}, {'pmid': '24786834', 'type': 'DERIVED', 'citation': 'Weir MR, Kline I, Xie J, Edwards R, Usiskin K. Effect of canagliflozin on serum electrolytes in patients with type 2 diabetes in relation to estimated glomerular filtration rate (eGFR). Curr Med Res Opin. 2014 Sep;30(9):1759-68. doi: 10.1185/03007995.2014.919907. Epub 2014 May 22.'}, {'pmid': '24517339', 'type': 'DERIVED', 'citation': 'Nyirjesy P, Sobel JD, Fung A, Mayer C, Capuano G, Ways K, Usiskin K. Genital mycotic infections with canagliflozin, a sodium glucose co-transporter 2 inhibitor, in patients with type 2 diabetes mellitus: a pooled analysis of clinical studies. Curr Med Res Opin. 2014 Jun;30(6):1109-19. doi: 10.1185/03007995.2014.890925. Epub 2014 Feb 21.'}, {'pmid': '23680739', 'type': 'DERIVED', 'citation': 'Bode B, Stenlof K, Sullivan D, Fung A, Usiskin K. Efficacy and safety of canagliflozin treatment in older subjects with type 2 diabetes mellitus: a randomized trial. Hosp Pract (1995). 2013 Apr;41(2):72-84. doi: 10.3810/hp.2013.04.1020.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the efficacy and safety of 2 different doses of canagliflozin compared with placebo in older patients (55 to 80 years of age) with type 2 diabetes mellitus (T2DM) with inadequate control on their current diabetes treatment regimen.', 'detailedDescription': "Canagliflozin is a drug that is being tested to see if it may be useful in treating patients diagnosed with type 2 diabetes mellitus (T2DM). This is a randomized (study drug assigned by chance), double-blind (neither the patient or the study doctor will know the name of the assigned treatment), placebo-controlled, parallel-group, 3-arm (3 treatment groups) multicenter study to determine the efficacy, safety, and tolerability of canagliflozin (100 mg and 300 mg) compared to placebo (a capsule that looks like all the other treatments but has no real medicine) in patients with T2DM who are not achieving an adequate response from current antihyperglycemic therapy to control their diabetes. Approximately 720 older (55 to 80 years of age) patients with T2DM who are either not on an antihyperglycemic agent or who are receiving treatment with a stable regimen of antihyperglycemic agent(s) and have inadequate glycemic (blood sugar) control will receive once daily treatment with canagliflozin (100 mg or 300 mg) or placebo capsules for 104 weeks (includes 26 weeks of double-blind treatment followed by a 78-week extension period). In addition, all patients will take stable doses of the antihyperglycemic agent(s) that they were taking before entry in the study for the duration of the study. Patients will participate in the study for approximately 108 weeks. During the study, if a patient's fasting blood sugar remains high despite treatment with study drug, the patient will receive treatment with an antihyperglycemic agent (rescue therapy) that is considered clinically appropriate and consistent with local prescribing information. During treatment, patients will be monitored for safety by review of adverse events, results from laboratory tests, measures of bone health, 12-lead electrocardiograms (ECGs), vital signs measurements, body weight, physical examinations, and self-monitored blood glucose (SMGB) measurements. The primary outcome measure in the study is the effect of canagliflozin relative to placebo on hemoglobin A1c (HbA1c) after 26 weeks of treatment. Study drug will be taken orally (by mouth) once daily before the first meal each day unless otherwise specified. All patients will take single-blind placebo capsules for 2 weeks before randomization. After randomization, patients will take double blind canagliflozin (100 mg or 300 mg) or matching placebo for 104 weeks."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '55 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All patients must have a diagnosis of T2DM and may be currently treated with a stable regimen of antihyperglycemic agent(s)\n* Patients in the study must have a HbA1c between \\>=7 and \\<=10.0%\n* Patients must have a fasting plasma glucose (FPG) \\<270 mg/dL (15 mmol/L)\n\nExclusion Criteria:\n\n* History of diabetic ketoacidosis, type 1 diabetes mellitus (T1DM), pancreas or beta cell transplantation, or diabetes secondary to pancreatitis or pancreatectomy, or a severe hypoglycemic episode within 6 months before screening'}, 'identificationModule': {'nctId': 'NCT01106651', 'briefTitle': 'A Safety and Efficacy Study of Canagliflozin in Older Patients (55 to 80 Years of Age) With Type 2 Diabetes Mellitus', 'organization': {'class': 'INDUSTRY', 'fullName': 'Janssen Research & Development, LLC'}, 'officialTitle': 'A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Study to Evaluate the Efficacy, Safety, and Tolerability of Canagliflozin Compared With Placebo in the Treatment of Older Subjects With Type 2 Diabetes Mellitus Inadequately Controlled on Glucose Lowering Therapy', 'orgStudyIdInfo': {'id': 'CR017014'}, 'secondaryIdInfos': [{'id': '28431754DIA3010', 'type': 'OTHER', 'domain': 'Janssen Research & Development, LLC'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Canagliflozin 100 mg', 'description': 'Each patient will receive 100 mg of canagliflozin once daily for 104 weeks with/without stable doses of antihyperglycemic agent(s) taken at the time of study entry.', 'interventionNames': ['Drug: Canagliflozin 100 mg', 'Drug: Antihyperglycemic agent(s)']}, {'type': 'EXPERIMENTAL', 'label': 'Canagliflozin 300 mg', 'description': 'Each patient will receive 300 mg of canagliflozin once daily for 104 weeks with/without stable doses of antihyperglycemic agent(s) taken at the time of study entry.', 'interventionNames': ['Drug: Canagliflozin 300 mg', 'Drug: Antihyperglycemic agent(s)']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Each patient will receive matching placebo once daily for 104 weeks with/without stable doses of antihyperglycemic agent(s) taken at the time of study entry.', 'interventionNames': ['Drug: Antihyperglycemic agent(s)', 'Drug: Placebo']}], 'interventions': [{'name': 'Canagliflozin 100 mg', 'type': 'DRUG', 'description': 'One 100 mg over-encapsulated tablet orally (by mouth) once daily for 104 weeks with/without stable doses of antihyperglycemic agent(s) taken at the time of study entry.', 'armGroupLabels': ['Canagliflozin 100 mg']}, {'name': 'Canagliflozin 300 mg', 'type': 'DRUG', 'description': 'One 300 mg over-encapsulated tablet orally (by mouth) once daily for 104 weeks with/without stable doses of antihyperglycemic agent(s) taken at the time of study entry.', 'armGroupLabels': ['Canagliflozin 300 mg']}, {'name': 'Antihyperglycemic agent(s)', 'type': 'DRUG', 'description': 'Stable doses of antihyperglycemic agents (sulfonylurea agent, thiazolidinediones, dipeptidyl peptidase 4 \\[DPP-4\\] inhibitors, metformin, insulin \\[all types\\]) and their combinations (sulfonylurea agent and insulin \\[all types\\], metformin and insulin \\[all types\\], metformin and sulfonylurea, alpha glucosidase inhibitors, thiazolidinediones, dipeptidyl peptidase 4 \\[DPP-4\\]) are used as per protocol specifications.', 'armGroupLabels': ['Canagliflozin 100 mg', 'Canagliflozin 300 mg', 'Placebo']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'One matching placebo capsule orally once daily for 104 weeks with/without stable doses of antihyperglycemic agent(s) taken at the time of study entry.', 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