Ignite Creation Date:
2025-12-25 @ 2:34 AM
Ignite Modification Date:
2025-12-29 @ 5:56 AM
Study NCT ID:
NCT01081834
Status:
COMPLETED
Last Update Posted:
2017-02-23
First Post:
2010-03-04
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
The CANTATA-M (CANagliflozin Treatment and Trial Analysis - Monotherapy) Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Costa Rica']}, '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'}, {'id': 'D000068900', 'term': 'Sitagliptin Phosphate'}], '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'}, {'id': 'D014230', 'term': 'Triazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D011719', 'term': 'Pyrazines'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'phone': '1-800-526-7736', '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 events were reported for the duration of the study; each patient participated in the study for approximately 52 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.', 'eventGroups': [{'id': 'EG000', 'title': 'Main Study (Baseline to Week 26): Placebo', 'description': 'Each patient received matching placebo once daily for 26 weeks and were then switched from placebo to 100 mg of sitagliptin once daily until Week 52. Data are presented for Baseline to Week 26.', 'otherNumAtRisk': 192, 'otherNumAffected': 38, 'seriousNumAtRisk': 192, 'seriousNumAffected': 4}, {'id': 'EG001', 'title': 'Main Study (Baseline to Week 26): Cana 100 mg', 'description': 'Each patient received 100 mg of canagliflozin (Cana) once daily for 52 weeks. Data are presented for Baseline to Week 26.', 'otherNumAtRisk': 195, 'otherNumAffected': 39, 'seriousNumAtRisk': 195, 'seriousNumAffected': 8}, {'id': 'EG002', 'title': 'Main Study (Baseline to Week 26): Cana 300 mg', 'description': 'Each patient received 300 mg of canagliflozin (Cana) once daily for 52 weeks. Data are presented for Baseline to Week 26.', 'otherNumAtRisk': 197, 'otherNumAffected': 51, 'seriousNumAtRisk': 197, 'seriousNumAffected': 2}, {'id': 'EG003', 'title': 'Main Study (Baseline to Week 52): Placebo/Sitagliptin', 'description': 'Each patient received matching placebo once daily for 26 weeks and were then switched from placebo to 100 mg of sitagliptin once daily until Week 52. Data are presented for Baseline to Week 52.', 'otherNumAtRisk': 192, 'otherNumAffected': 63, 'seriousNumAtRisk': 192, 'seriousNumAffected': 11}, {'id': 'EG004', 'title': 'Main Study (Baseline to Week 52): Cana 100 mg', 'description': 'Each patient received 100 mg of canagliflozin (Cana) once daily for 52 weeks. Data are presented for Baseline to Week 52.', 'otherNumAtRisk': 195, 'otherNumAffected': 54, 'seriousNumAtRisk': 195, 'seriousNumAffected': 11}, {'id': 'EG005', 'title': 'Main Study (Baseline to Week 52): Cana 300 mg', 'description': 'Each patient received 300 mg of canagliflozin (Cana) once daily for 52 weeks. Data are presented for Baseline to Week 52.', 'otherNumAtRisk': 197, 'otherNumAffected': 69, 'seriousNumAtRisk': 197, 'seriousNumAffected': 5}, {'id': 'EG006', 'title': 'High Glycemic Substudy (Baseline to Week 26): Cana 100 mg', 'description': 'Each patient received 100 mg of canagliflozin (Cana) once daily for 26 weeks. Data are only available for Baseline to Week 26.', 'otherNumAtRisk': 47, 'otherNumAffected': 6, 'seriousNumAtRisk': 47, 'seriousNumAffected': 0}, {'id': 'EG007', 'title': 'High Glycemic Substudy (Baseline to Week 26): Cana 300 mg', 'description': 'Each patient received 300 mg of canagliflozin (Cana) once daily for 26 weeks. Data are only available for Baseline to Week 26.', 'otherNumAtRisk': 44, 'otherNumAffected': 6, 'seriousNumAtRisk': 44, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 192, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 195, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 197, 'numAffected': 16}, {'groupId': 'EG003', 'numAtRisk': 192, 'numAffected': 15}, {'groupId': 'EG004', 'numAtRisk': 195, 'numAffected': 14}, {'groupId': 'EG005', 'numAtRisk': 197, 'numAffected': 20}, {'groupId': 'EG006', 'numAtRisk': 47, 'numAffected': 2}, {'groupId': 'EG007', 'numAtRisk': 44, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 14.0'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 192, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 195, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 197, 'numAffected': 9}, {'groupId': 'EG003', 'numAtRisk': 192, 'numAffected': 18}, {'groupId': 'EG004', 'numAtRisk': 195, 'numAffected': 8}, {'groupId': 'EG005', 'numAtRisk': 197, 'numAffected': 14}, {'groupId': 'EG006', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 44, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 14.0'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 192, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 195, 'numAffected': 14}, {'groupId': 'EG002', 'numAtRisk': 197, 'numAffected': 9}, {'groupId': 'EG003', 'numAtRisk': 192, 'numAffected': 11}, {'groupId': 'EG004', 'numAtRisk': 195, 'numAffected': 16}, {'groupId': 'EG005', 'numAtRisk': 197, 'numAffected': 12}, {'groupId': 'EG006', 'numAtRisk': 47, 'numAffected': 3}, {'groupId': 'EG007', 'numAtRisk': 44, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 14.0'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 192, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 195, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 197, 'numAffected': 12}, {'groupId': 'EG003', 'numAtRisk': 192, 'numAffected': 9}, {'groupId': 'EG004', 'numAtRisk': 195, 'numAffected': 5}, {'groupId': 'EG005', 'numAtRisk': 197, 'numAffected': 15}, {'groupId': 'EG006', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 44, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 14.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 192, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 195, 'numAffected': 14}, {'groupId': 'EG002', 'numAtRisk': 197, 'numAffected': 12}, {'groupId': 'EG003', 'numAtRisk': 192, 'numAffected': 12}, {'groupId': 'EG004', 'numAtRisk': 195, 'numAffected': 19}, {'groupId': 'EG005', 'numAtRisk': 197, 'numAffected': 17}, {'groupId': 'EG006', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 44, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 14.0'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 192, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 195, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 197, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 192, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 195, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 197, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 47, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 44, 'numAffected': 3}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 14.0'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 192, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 195, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 197, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 192, 'numAffected': 7}, {'groupId': 'EG004', 'numAtRisk': 195, 'numAffected': 12}, {'groupId': 'EG005', 'numAtRisk': 197, 'numAffected': 8}, {'groupId': 'EG006', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 44, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 14.0'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 192, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 195, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 197, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 192, 'numAffected': 13}, {'groupId': 'EG004', 'numAtRisk': 195, 'numAffected': 10}, {'groupId': 'EG005', 'numAtRisk': 197, 'numAffected': 3}, {'groupId': 'EG006', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 44, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 14.0'}], 'seriousEvents': [{'term': 'Coronary artery disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 192, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 195, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 197, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 192, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 195, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 197, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 44, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 14.0'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 192, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 195, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 197, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 192, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 195, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 197, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 44, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 14.0'}, {'term': 'Intestinal obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 192, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 195, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 197, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 192, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 195, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 197, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 44, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 14.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 192, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 195, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 197, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 192, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 195, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 197, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 44, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 14.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 192, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 195, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 197, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 192, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 195, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 197, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 44, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 14.0'}, {'term': 'Ischaemic hepatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 192, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 195, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 197, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 192, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 195, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 197, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 44, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 14.0'}, {'term': 'Abscess limb', 'stats': [{'groupId': 'EG000', 'numAtRisk': 192, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 195, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 197, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 192, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 195, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 197, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 44, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 14.0'}, {'term': 'Bacterial prostatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 192, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 195, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 197, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 192, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 195, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 197, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 44, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 14.0'}, {'term': 'Cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 192, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 195, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 197, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 192, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 195, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 197, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 44, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 14.0'}, {'term': 'Diverticulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 192, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 195, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 197, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 192, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 195, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 197, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 44, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 14.0'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 192, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 195, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 197, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 192, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 195, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 197, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 44, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 14.0'}, {'term': 'Septic shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 192, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 195, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 197, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 192, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 195, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 197, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 44, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 14.0'}, {'term': 'Ankle fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 192, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 195, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 197, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 192, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 195, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 197, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 44, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 14.0'}, {'term': 'Brain herniation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 192, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 195, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 197, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 192, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 195, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 197, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 44, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 14.0'}, {'term': 'Wound', 'stats': [{'groupId': 'EG000', 'numAtRisk': 192, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 195, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 197, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 192, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 195, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 197, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 44, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 14.0'}, {'term': 'Osteoarthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 192, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 195, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 197, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 192, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 195, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 197, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 44, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 14.0'}, {'term': 'Haemorrhage intracranial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 192, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 195, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 197, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 192, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 195, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 197, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 44, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 14.0'}, {'term': 'Renal colic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 192, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 195, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 197, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 192, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 195, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 197, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 44, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 14.0'}, {'term': 'Renal failure acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 192, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 195, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 197, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 192, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 195, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 197, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 44, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 14.0'}, {'term': 'Pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 192, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 195, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 197, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 192, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 195, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 197, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 44, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 14.0'}, {'term': 'Urticaria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 192, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 195, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 197, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 192, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 195, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 197, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 44, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 14.0'}, {'term': 'Deep vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 192, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 195, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 197, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 192, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 195, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 197, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 44, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 14.0'}, {'term': 'Thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 192, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 195, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 197, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 192, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 195, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 197, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 44, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 14.0'}, {'term': 'Myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 192, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 195, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 197, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 192, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 195, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 197, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 44, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 14.0'}, {'term': 'Pericardial effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 192, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 195, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 197, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 192, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 195, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 197, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 44, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 14.0'}, {'term': 'Abdominal hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 192, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 195, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 197, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 192, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 195, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 197, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 44, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 14.0'}, {'term': 'Inguinal hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 192, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 195, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 197, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 192, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 195, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 197, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 44, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 14.0'}, {'term': 'Umbilical hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 192, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 195, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 197, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 192, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 195, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 197, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 44, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 14.0'}, {'term': 'Liver disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 192, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 195, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 197, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 192, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 195, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 197, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 44, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 14.0'}, {'term': 'Appendicitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 192, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 195, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 197, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 192, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 195, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 197, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 44, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 14.0'}, {'term': 'Gastrointestinal infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 192, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 195, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 197, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 192, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 195, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 197, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 44, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 14.0'}, {'term': 'Pulmonary tuberculosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 192, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 195, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 197, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 192, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 195, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 197, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 44, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 14.0'}, {'term': 'Viral pericarditis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 192, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 195, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 197, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 192, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 195, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 197, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 44, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 14.0'}, {'term': 'Skeletal injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 192, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 195, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 197, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 192, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 195, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 197, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 44, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 14.0'}, {'term': 'Spinal column injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 192, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 195, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 197, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 192, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 195, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 197, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 44, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 14.0'}, {'term': 'Prostate cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 192, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 195, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 197, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 192, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 195, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 197, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 44, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 14.0'}, {'term': 'Peripheral sensory neuropathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 192, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 195, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 197, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 192, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 195, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 197, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 44, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 14.0'}, {'term': 'Asthma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 192, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 195, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 197, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 192, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 195, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 197, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 44, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 14.0'}, {'term': 'Hepatic enzyme increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 192, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 195, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 197, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 192, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 195, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 197, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 44, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 14.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in HbA1c From Baseline to Week 26 (Main Study)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '189', 'groupId': 'OG000'}, {'value': '191', 'groupId': 'OG001'}, {'value': '194', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'In the Main Study, each patient recieved matching placebo once daily for 26 weeks and were then switched from placebo to 100 mg of sitagliptin once daily until Week 52.'}, {'id': 'OG001', 'title': 'Canagliflozin 100 mg', 'description': 'In the Main Study, each patient received 100 mg of canagliflozin once daily for 52 weeks.'}, {'id': 'OG002', 'title': 'Canagliflozin 300 mg', 'description': 'In the Main Study, each pateint received 300 mg of canagliflozin once daily for 52 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.14', 'spread': '0.065', 'groupId': 'OG000'}, {'value': '-0.77', 'spread': '0.065', 'groupId': 'OG001'}, {'value': '-1.03', 'spread': '0.064', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least-Squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.91', 'ciLowerLimit': '-1.088', 'ciUpperLimit': '-0.729', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.091', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Least-Squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.16', 'ciLowerLimit': '-1.342', 'ciUpperLimit': '-0.985', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.091', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], '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': 'PRIMARY', 'title': 'Change in HbA1c From Baseline to Week 26 (High Glycemic Substudy)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}, {'value': '43', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'In the High Glycemic Substudy, no patients received placebo.'}, {'id': 'OG001', 'title': 'Canagliflozin 100 mg', 'description': 'In the High Glycemic Substudy, each patient received 100 mg of canagliflozin once daily for 26 weeks.'}, {'id': 'OG002', 'title': 'Canagliflozin 300 mg', 'description': 'In the High Glycemic Substudy, each pateint received 300 mg of canagliflozin once daily for 26 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-2.13', 'spread': '0.220', 'groupId': 'OG001'}, {'value': '-2.56', 'spread': '0.227', 'groupId': 'OG002'}]}]}], '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 in patients randomized to the High Glycemic Substudy.', '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 (Main Study)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '189', 'groupId': 'OG000'}, {'value': '191', 'groupId': 'OG001'}, {'value': '194', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'In the Main Study, each patient recieved matching placebo once daily for 26 weeks and were then switched from placebo to 100 mg of sitagliptin once daily until Week 52.'}, {'id': 'OG001', 'title': 'Canagliflozin 100 mg', 'description': 'In the Main Study, each patient received 100 mg of canagliflozin once daily for 52 weeks.'}, {'id': 'OG002', 'title': 'Canagliflozin 300 mg', 'description': 'In the Main Study, each pateint received 300 mg of canagliflozin once daily for 52 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '20.6', 'groupId': 'OG000'}, {'value': '44.5', 'groupId': 'OG001'}, {'value': '62.4', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '5.34', 'ciLowerLimit': '3.10', 'ciUpperLimit': '9.23', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '14.61', 'ciLowerLimit': '8.14', 'ciUpperLimit': '26.25', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'NUMBER', 'timeFrame': 'Week 26', 'description': 'The table below shows the percentage of patients with HbA1c \\<7% at Week 26. 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 (Main Study)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '184', 'groupId': 'OG000'}, {'value': '188', 'groupId': 'OG001'}, {'value': '192', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'In the Main Study, each patient received matching placebo once daily for 26 weeks and were then switched from placebo to 100 mg of sitagliptin once daily until Week 52.'}, {'id': 'OG001', 'title': 'Canagliflozin 100 mg', 'description': 'In the Main Study, each patient received 100 mg of canagliflozin once daily for 52 weeks.'}, {'id': 'OG002', 'title': 'Canagliflozin 300 mg', 'description': 'In the Main Study, each pateint received 300 mg of canagliflozin once daily for 52 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '8.33', 'spread': '2.448', 'groupId': 'OG000'}, {'value': '-27.2', 'spread': '2.412', 'groupId': 'OG001'}, {'value': '-35.0', 'spread': '2.391', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least-Squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-35.5', 'ciLowerLimit': '-42.22', 'ciUpperLimit': '-28.78', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '3.420', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Least-Squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-43.4', 'ciLowerLimit': '-50.06', 'ciUpperLimit': '-36.69', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '3.402', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], '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': 'Change in 2-hour Post-prandial Glucose From Baseline to Week 26 (Main Study)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '126', 'groupId': 'OG000'}, {'value': '154', 'groupId': 'OG001'}, {'value': '157', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'In the Main Study, each patient received matching placebo once daily for 26 weeks and were then switched from placebo to 100 mg of sitagliptin once daily until Week 52.'}, {'id': 'OG001', 'title': 'Canagliflozin 100 mg', 'description': 'In the Main Study, each patient received 100 mg of canagliflozin once daily for 52 weeks.'}, {'id': 'OG002', 'title': 'Canagliflozin 300 mg', 'description': 'In the Main Study, each pateint received 300 mg of canagliflozin once daily for 52 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '5.19', 'spread': '4.204', 'groupId': 'OG000'}, {'value': '-42.9', 'spread': '3.763', 'groupId': 'OG001'}, {'value': '-58.8', 'spread': '3.741', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least-Squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-49.1', 'ciLowerLimit': '-59.12', 'ciUpperLimit': '-36.99', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '5.629', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Least-Squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-64.0', 'ciLowerLimit': '-75.02', 'ciUpperLimit': '-52.94', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '5.616', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Day 1 (Baseline) and Week 26', 'description': 'The table below shows the least-squares (LS) mean change in 2-hour post-prandial glucose 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 (Main Study)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '190', 'groupId': 'OG000'}, {'value': '192', 'groupId': 'OG001'}, {'value': '194', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'In the Main Study, each patient received matching placebo once daily for 26 weeks and were then switched from placebo to 100 mg of sitagliptin once daily until Week 52.'}, {'id': 'OG001', 'title': 'Canagliflozin 100 mg', 'description': 'In the Main Study, each patient received 100 mg of canagliflozin once daily for 52 weeks.'}, {'id': 'OG002', 'title': 'Canagliflozin 300 mg', 'description': 'In the Main Study, each pateint received 300 mg of canagliflozin once daily for 52 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.6', 'spread': '0.2', 'groupId': 'OG000'}, {'value': '-2.8', 'spread': '0.2', 'groupId': 'OG001'}, {'value': '-3.9', 'spread': '0.2', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least-Squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.2', 'ciLowerLimit': '-2.9', 'ciUpperLimit': '-1.6', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.3', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Least-Squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-3.3', 'ciLowerLimit': '-4.0', 'ciUpperLimit': '-2.6', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.3', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], '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 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': 'Change in Systolic Blood Pressure (SBP) From Baseline to Week 26 (Main Study)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '190', 'groupId': 'OG000'}, {'value': '192', 'groupId': 'OG001'}, {'value': '195', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'In the Main Study, each patient received matching placebo once daily for 26 weeks and were then switched from placebo to 100 mg of sitagliptin once daily until Week 52.'}, {'id': 'OG001', 'title': 'Canagliflozin 100 mg', 'description': 'In the Main Study, each patient received 100 mg of canagliflozin once daily for 52 weeks.'}, {'id': 'OG002', 'title': 'Canagliflozin 300 mg', 'description': 'In the Main Study, each pateint received 300 mg of canagliflozin once daily for 52 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.38', 'spread': '0.780', 'groupId': 'OG000'}, {'value': '-3.34', 'spread': '0.775', 'groupId': 'OG001'}, {'value': '-5.04', 'spread': '0.769', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least-Squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-3.71', 'ciLowerLimit': '-5.860', 'ciUpperLimit': '-1.568', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.093', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Least-Squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-5.42', 'ciLowerLimit': '-7.556', 'ciUpperLimit': '-3.280', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.088', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], '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 (Main Study)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '171', 'groupId': 'OG000'}, {'value': '183', 'groupId': 'OG001'}, {'value': '183', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'In the Main study, each patient received matching placebo once daily for 26 weeks and were then switched from placebo to 100 mg of sitagliptin once daily until Week 52.'}, {'id': 'OG001', 'title': 'Canagliflozin 100 mg', 'description': 'In the Main Study, each patient received 100 mg of canagliflozin once daily for 52 weeks.'}, {'id': 'OG002', 'title': 'Canagliflozin 300 mg', 'description': 'In the Main Study, each pateint received 300 mg of canagliflozin once daily for 52 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '7.8', 'spread': '3.5', 'groupId': 'OG000'}, {'value': '2.5', 'spread': '3.3', 'groupId': 'OG001'}, {'value': '-2.4', 'spread': '3.3', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.267', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least-Squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-5.3', 'ciLowerLimit': '-14.8', 'ciUpperLimit': '4.1', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '4.8', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.034', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Least-Squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-10.2', 'ciLowerLimit': '-19.6', 'ciUpperLimit': '-0.8', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '4.8', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], '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 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 High-density Lipoprotein Cholesterol (HDL-C) From Baseline to Week 26 (Main Study)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '170', 'groupId': 'OG000'}, {'value': '182', 'groupId': 'OG001'}, {'value': '183', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'In the Main Study, each patient received matching placebo once daily for 26 weeks and were then switched from placebo to 100 mg of sitagliptin once daily until Week 52.'}, {'id': 'OG001', 'title': 'Canagliflozin 100 mg', 'description': 'In the Main Study, each patient received 100 mg of canagliflozin once daily for 52 weeks.'}, {'id': 'OG002', 'title': 'Canagliflozin 300 mg', 'description': 'In the Main Study, each pateint received 300 mg of canagliflozin once daily for 52 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '4.4', 'spread': '1.4', 'groupId': 'OG000'}, {'value': '11.2', 'spread': '1.4', 'groupId': 'OG001'}, {'value': '10.5', 'spread': '1.4', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least-Squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '6.7', 'ciLowerLimit': '2.9', 'ciUpperLimit': '10.6', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.9', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.002', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Least-Squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '6.0', 'ciLowerLimit': '2.2', 'ciUpperLimit': '9.9', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.9', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], '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 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the 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': 'Percentage of Patients With HbA1c <7% at Week 26 (High Glycemic Substudy)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}, {'value': '43', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'In the High Glycemic Substudy, no patients received placebo.'}, {'id': 'OG001', 'title': 'Canagliflozin 100 mg', 'description': 'In the High Glycemic Substudy, each patient received 100 mg of canagliflozin once daily for 26 weeks.'}, {'id': 'OG002', 'title': 'Canagliflozin 300 mg', 'description': 'In the High Glycemic Substudy, each pateint received 300 mg of canagliflozin once daily for 26 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '17.4', 'groupId': 'OG001'}, {'value': '11.6', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 26', 'description': 'The table below shows the percentage of patients with HbA1c \\<7% at Week 26 for each treatment group in patients randomized to the High Glycemic Substudy.', '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 (High Glycemic Substudy)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}, {'value': '43', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'In the High Glycemic Substudy, no patients received placebo.'}, {'id': 'OG001', 'title': 'Canagliflozin 100 mg', 'description': 'In the High Glycemic Substudy, each patient received 100 mg of canagliflozin once daily for 26 weeks.'}, {'id': 'OG002', 'title': 'Canagliflozin 300 mg', 'description': 'In the High Glycemic Substudy, each pateint received 300 mg of canagliflozin once daily for 26 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-81.7', 'spread': '6.459', 'groupId': 'OG001'}, {'value': '-86.3', 'spread': '6.553', 'groupId': 'OG002'}]}]}], '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 in patients randomized to the High Glycemic Substudy.', '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': 'Change in 2-hour Post-prandial Glucose From Baseline to Week 26 (High Glycemic Substudy)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}, {'value': '34', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'In the High Glycemic Substudy, no patients received placebo.'}, {'id': 'OG001', 'title': 'Canagliflozin 100 mg', 'description': 'In the High Glycemic Substudy, each patient received 100 mg of canagliflozin once daily for 26 weeks.'}, {'id': 'OG002', 'title': 'Canagliflozin 300 mg', 'description': 'In the High Glycemic Substudy, each pateint received 300 mg of canagliflozin once daily for 26 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-118', 'spread': '10.179', 'groupId': 'OG001'}, {'value': '-126', 'spread': '9.437', 'groupId': 'OG002'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Day 1 (Baseline) and Week 26', 'description': 'The table below shows the least-squares (LS) mean change in 2-hour post-prandial glucose from Baseline to Week 26 for each treatment group in patients randomized to the High Glycemic Substudy.', '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 (High Glycemic Substudy)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}, {'value': '43', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'In the High Glycemic Substudy, no patients received placebo.'}, {'id': 'OG001', 'title': 'Canagliflozin 100 mg', 'description': 'In the High Glycemic Substudy, each patient received 100 mg of canagliflozin once daily for 26 weeks.'}, {'id': 'OG002', 'title': 'Canagliflozin 300 mg', 'description': 'In the High Glycemic Substudy, each pateint received 300 mg of canagliflozin once daily for 26 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-3.0', 'spread': '0.6', 'groupId': 'OG001'}, {'value': '-3.8', 'spread': '0.6', 'groupId': 'OG002'}]}]}], '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 in patients randomized to the High Glycemic Substudy.', '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 Systolic Blood Pressure (SBP) From Baseline to Week 26 (High Glycemic Substudy)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}, {'value': '43', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'In the High Glycemic Substudy, no patients received placebo.'}, {'id': 'OG001', 'title': 'Canagliflozin 100 mg', 'description': 'In the High Glycemic Substudy, each patient received 100 mg of canagliflozin once daily for 26 weeks.'}, {'id': 'OG002', 'title': 'Canagliflozin 300 mg', 'description': 'In the High Glycemic Substudy, each pateint received 300 mg of canagliflozin once daily for 26 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-4.47', 'spread': '1.754', 'groupId': 'OG001'}, {'value': '-4.97', 'spread': '1.800', 'groupId': 'OG002'}]}]}], '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 in patients randomized to the High Glycemic Substudy.', '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 (High Glycemic Substudy)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}, {'value': '43', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'In the High Glycemic Substudy, no patients received placebo.'}, {'id': 'OG001', 'title': 'Canagliflozin 100 mg', 'description': 'In the High Glycemic Substudy, each patient received 100 mg of canagliflozin once daily for 26 weeks.'}, {'id': 'OG002', 'title': 'Canagliflozin 300 mg', 'description': 'In the High Glycemic Substudy, each pateint received 300 mg of canagliflozin once daily for 26 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.6', 'spread': '7.4', 'groupId': 'OG001'}, {'value': '-12.7', 'spread': '7.5', 'groupId': 'OG002'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Day 1 (Baseline) and Week 26', 'description': 'The table below shows the least-squares mean percent change in triglycerides from Baseline to Week 26 for each treatment group in patients randomized to the High Glycemic Substudy.', '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 (High Glycemic Substudy)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}, {'value': '43', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'In the High Glycemic Substudy, no patients received placebo.'}, {'id': 'OG001', 'title': 'Canagliflozin 100 mg', 'description': 'In the High Glycemic Substudy, each patient received 100 mg of canagliflozin once daily for 26 weeks.'}, {'id': 'OG002', 'title': 'Canagliflozin 300 mg', 'description': 'In the High Glycemic substudy, each pateint received 300 mg of canagliflozin once daily for 26 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.4', 'spread': '2.9', 'groupId': 'OG001'}, {'value': '10.8', 'spread': '2.9', 'groupId': 'OG002'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Day 1 (Baseline) and Week 26', 'description': 'The table below shows the least-squares mean percent change in HDL-C from Baseline to Week 26 for each treatment group in patients randomized to the High Glycemic Substudy.', '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': 'Main Study: Placebo/Sitagliptin', 'description': 'In the Main Study, each patient received matching placebo once daily for 26 weeks and were then switched from placebo to 100 mg of sitagliptin once daily until Week 52.'}, {'id': 'FG001', 'title': 'Main Study: Canagliflozin 100 mg', 'description': 'In the Main Study, each patient received 100 mg of canagliflozin once daily for 52 weeks.'}, {'id': 'FG002', 'title': 'Main Study: Canagliflozin 300 mg', 'description': 'In the Main Study, each patient received 300 mg of canagliflozin once daily for 52 weeks.'}, {'id': 'FG003', 'title': 'High Glycemic Substudy: Canagliflozin 100 mg', 'description': 'In the High Glycemic Substudy, each patient received 100 mg of canagliflozin once daily for 26 weeks only. No patients received treatment during the period Week 26 to Week 52.'}, {'id': 'FG004', 'title': 'High Glycemic Substudy: Canagliflozin 300 mg', 'description': 'In the High Glycemic Substudy, each patient received 300 mg of canagliflozin once daily for 26 weeks only. No patients received treatment during the period Week 26 to Week 52.'}], 'periods': [{'title': 'Core Period: Baseline to Week 26', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '192'}, {'groupId': 'FG001', 'numSubjects': '195'}, {'groupId': 'FG002', 'numSubjects': '197'}, {'groupId': 'FG003', 'numSubjects': '47'}, {'groupId': 'FG004', 'numSubjects': '44'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '160'}, {'groupId': 'FG001', 'numSubjects': '172'}, {'groupId': 'FG002', 'numSubjects': '175'}, {'groupId': 'FG003', 'numSubjects': '40'}, {'groupId': 'FG004', 'numSubjects': '40'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '32'}, {'groupId': 'FG001', 'numSubjects': '23'}, {'groupId': 'FG002', 'numSubjects': '22'}, {'groupId': 'FG003', 'numSubjects': '7'}, {'groupId': 'FG004', 'numSubjects': '4'}]}], 'dropWithdraws': [{'type': 'Pregnancy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '1'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '5'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '2'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '15'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '9'}, {'groupId': 'FG003', 'numSubjects': '3'}, {'groupId': 'FG004', 'numSubjects': '1'}]}, {'type': 'Noncompliance with study drug', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '2'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Unable to take rescue therapy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Lack of efficacy on rescue therapy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}]}, {'title': 'Extension Period: Week 26 to Week 52', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': '5 pts discontinued on last day of core: lack of efficacy on rescue (2), not specified (NS) (3).', 'groupId': 'FG000', 'numSubjects': '155'}, {'comment': '2 pts discontinued on last day of core: adverse event (AE) (1), protocol violation (PV) (1).', 'groupId': 'FG001', 'numSubjects': '170'}, {'comment': '5 pts discontinued last day of core: AE (1), lost f/u (1), PV (1), NS (1), physician decision (1).', 'groupId': 'FG002', 'numSubjects': '170'}, {'comment': 'The treatment duration for the High Glycemic Substudy was 26 weeks only.', 'groupId': 'FG003', 'numSubjects': '0'}, {'comment': 'The treatment duration for the High Glycemic Substudy was 26 weeks only.', 'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '135'}, {'groupId': 'FG001', 'numSubjects': '152'}, {'groupId': 'FG002', 'numSubjects': '165'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}, {'groupId': 'FG001', 'numSubjects': '18'}, {'groupId': 'FG002', 'numSubjects': '5'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Unable to take rescue therapy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Creatinine or eGFR withdrawal criteria', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '4'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Lack of efficacy on rescue therapy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'This study evaluated the efficacy and safety of canagliflozin in patients with type 2 diabetes mellitus inadequately controlled with diet and exercise. The study was conducted between 08 February 2010 and 18 August 2011 and recruited patients from 90 study centers in 17 countries worldwide.', 'preAssignmentDetails': '678 patients were enrolled into the study; 587 patients in the main study and 91 patients in the high glycemic substudy. 584 patients in the main study and all 91 patients in the high glycemic substudy received at least one dose of study drug and were included in the modified intent-to-treat (mITT) analyses sets and the safety analyses sets.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '192', 'groupId': 'BG000'}, {'value': '195', 'groupId': 'BG001'}, {'value': '197', 'groupId': 'BG002'}, {'value': '47', 'groupId': 'BG003'}, {'value': '44', 'groupId': 'BG004'}, {'value': '675', 'groupId': 'BG005'}]}], 'groups': [{'id': 'BG000', 'title': 'Main Study: Placebo/Sitagliptin', 'description': 'In the Main Study, each patient received matching placebo once daily for 26 weeks and were then switched from placebo to 100 mg of sitagliptin once daily until Week 52.'}, {'id': 'BG001', 'title': 'Main Study: Canagliflozin 100 mg', 'description': 'In the Main Study, each patient received 100 mg of canagliflozin once daily for 52 weeks.'}, {'id': 'BG002', 'title': 'Main Study: Canagliflozin 300 mg', 'description': 'In the Main Study, each patient received 300 mg of canagliflozin once daily for 52 weeks.'}, {'id': 'BG003', 'title': 'High Glycemic Substudy: Canagliflozin 100 mg', 'description': 'In the High Glycemic Substudy, each patient received 100 mg of canagliflozin once daily for 26 weeks.'}, {'id': 'BG004', 'title': 'High Glycemic Substudy: Canagliflozin 300 mg', 'description': 'In the High Glycemic Substudy, each patient received 300 mg of canagliflozin once daily for 26 weeks.'}, {'id': 'BG005', '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'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '150', 'groupId': 'BG000'}, {'value': '156', 'groupId': 'BG001'}, {'value': '160', 'groupId': 'BG002'}, {'value': '42', 'groupId': 'BG003'}, {'value': '41', 'groupId': 'BG004'}, {'value': '549', 'groupId': 'BG005'}]}, {'title': '>=65 years', 'measurements': [{'value': '42', 'groupId': 'BG000'}, {'value': '39', 'groupId': 'BG001'}, {'value': '37', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}, {'value': '126', 'groupId': 'BG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '55.7', 'spread': '10.88', 'groupId': 'BG000'}, {'value': '55.1', 'spread': '10.83', 'groupId': 'BG001'}, {'value': '55.3', 'spread': '10.17', 'groupId': 'BG002'}, {'value': '49.7', 'spread': '11.12', 'groupId': 'BG003'}, {'value': '48.8', 'spread': '10.92', 'groupId': 'BG004'}, {'value': '54.5', 'spread': '10.85', 'groupId': 'BG005'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '104', 'groupId': 'BG000'}, {'value': '114', 'groupId': 'BG001'}, {'value': '108', 'groupId': 'BG002'}, {'value': '24', 'groupId': 'BG003'}, {'value': '25', 'groupId': 'BG004'}, {'value': '375', 'groupId': 'BG005'}]}, {'title': 'Male', 'measurements': [{'value': '88', 'groupId': 'BG000'}, {'value': '81', 'groupId': 'BG001'}, {'value': '89', 'groupId': 'BG002'}, {'value': '23', 'groupId': 'BG003'}, {'value': '19', 'groupId': 'BG004'}, {'value': '300', 'groupId': 'BG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'AUSTRIA', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '4', 'groupId': 'BG005'}]}]}, {'title': 'COLOMBIA', 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '25', 'groupId': 'BG005'}]}]}, {'title': 'ESTONIA', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '16', 'groupId': 'BG005'}]}]}, {'title': 'GUATEMALA', 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}, {'value': '9', 'groupId': 'BG003'}, {'value': '10', 'groupId': 'BG004'}, {'value': '52', 'groupId': 'BG005'}]}]}, {'title': 'ICELAND', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}, {'value': '20', 'groupId': 'BG005'}]}]}, {'title': 'INDIA', 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}, {'value': '34', 'groupId': 'BG005'}]}]}, {'title': 'LITHUANIA', 'categories': [{'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '42', 'groupId': 'BG005'}]}]}, {'title': 'MALAYSIA', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '16', 'groupId': 'BG005'}]}]}, {'title': 'MEXICO', 'categories': [{'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}, {'value': '65', 'groupId': 'BG005'}]}]}, {'title': 'PHILIPPINES', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '4', 'groupId': 'BG004'}, {'value': '21', 'groupId': 'BG005'}]}]}, {'title': 'POLAND', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '8', 'groupId': 'BG005'}]}]}, {'title': 'ROMANIA', 'categories': [{'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '4', 'groupId': 'BG004'}, {'value': '60', 'groupId': 'BG005'}]}]}, {'title': 'SOUTH AFRICA', 'categories': [{'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}, {'value': '29', 'groupId': 'BG005'}]}]}, {'title': 'SOUTH KOREA', 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '27', 'groupId': 'BG005'}]}]}, {'title': 'SPAIN', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '8', 'groupId': 'BG005'}]}]}, {'title': 'SWEDEN', 'categories': [{'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '48', 'groupId': 'BG005'}]}]}, {'title': 'UNITED STATES', 'categories': [{'measurements': [{'value': '56', 'groupId': 'BG000'}, {'value': '62', 'groupId': 'BG001'}, {'value': '52', 'groupId': 'BG002'}, {'value': '15', 'groupId': 'BG003'}, {'value': '15', 'groupId': 'BG004'}, {'value': '200', 'groupId': 'BG005'}]}]}], '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': 678}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-06', 'dispFirstSubmitDate': '2012-04-24', 'completionDateStruct': {'date': '2012-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-02-15', 'studyFirstSubmitDate': '2010-03-04', 'dispFirstSubmitQcDate': '2012-04-24', 'resultsFirstSubmitDate': '2013-04-15', 'studyFirstSubmitQcDate': '2010-03-04', 'dispFirstPostDateStruct': {'date': '2012-04-26', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2017-02-23', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2013-04-15', 'studyFirstPostDateStruct': {'date': '2010-03-05', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2013-06-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in HbA1c From Baseline to Week 26 (Main Study)', '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.'}, {'measure': 'Change in HbA1c From Baseline to Week 26 (High Glycemic Substudy)', '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 in patients randomized to the High Glycemic Substudy.'}], 'secondaryOutcomes': [{'measure': 'Percentage of Patients With HbA1c <7% at Week 26 (Main Study)', 'timeFrame': 'Week 26', 'description': 'The table below shows the percentage of patients with HbA1c \\<7% at Week 26. 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 (Main Study)', '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': 'Change in 2-hour Post-prandial Glucose From Baseline to Week 26 (Main Study)', 'timeFrame': 'Day 1 (Baseline) and Week 26', 'description': 'The table below shows the least-squares (LS) mean change in 2-hour post-prandial glucose 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 (Main Study)', '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 percent change.'}, {'measure': 'Change in Systolic Blood Pressure (SBP) From Baseline to Week 26 (Main Study)', '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 (Main Study)', '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 percent change.'}, {'measure': 'Percent Change in High-density Lipoprotein Cholesterol (HDL-C) From Baseline to Week 26 (Main Study)', '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 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the LS mean percent change.'}, {'measure': 'Percentage of Patients With HbA1c <7% at Week 26 (High Glycemic Substudy)', 'timeFrame': 'Week 26', 'description': 'The table below shows the percentage of patients with HbA1c \\<7% at Week 26 for each treatment group in patients randomized to the High Glycemic Substudy.'}, {'measure': 'Change in Fasting Plasma Glucose (FPG) From Baseline to Week 26 (High Glycemic Substudy)', '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 in patients randomized to the High Glycemic Substudy.'}, {'measure': 'Change in 2-hour Post-prandial Glucose From Baseline to Week 26 (High Glycemic Substudy)', 'timeFrame': 'Day 1 (Baseline) and Week 26', 'description': 'The table below shows the least-squares (LS) mean change in 2-hour post-prandial glucose from Baseline to Week 26 for each treatment group in patients randomized to the High Glycemic Substudy.'}, {'measure': 'Percent Change in Body Weight From Baseline to Week 26 (High Glycemic Substudy)', '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 in patients randomized to the High Glycemic Substudy.'}, {'measure': 'Change in Systolic Blood Pressure (SBP) From Baseline to Week 26 (High Glycemic Substudy)', '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 in patients randomized to the High Glycemic Substudy.'}, {'measure': 'Percent Change in Triglycerides From Baseline to Week 26 (High Glycemic Substudy)', 'timeFrame': 'Day 1 (Baseline) and Week 26', 'description': 'The table below shows the least-squares mean percent change in triglycerides from Baseline to Week 26 for each treatment group in patients randomized to the High Glycemic Substudy.'}, {'measure': 'Percent Change in High-density Lipoprotein Cholesterol (HDL-C) From Baseline to Week 26 (High Glycemic Substudy)', 'timeFrame': 'Day 1 (Baseline) and Week 26', 'description': 'The table below shows the least-squares mean percent change in HDL-C from Baseline to Week 26 for each treatment group in patients randomized to the High Glycemic Substudy.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Diabetes Mellitus, Type 2', 'Canagliflozin', 'Placebo', 'Hemoglobin A1c', 'Type 2 diabetes mellitus'], 'conditions': ['Diabetes Mellitus, Type 2']}, 'referencesModule': {'references': [{'pmid': '28327140', 'type': 'DERIVED', 'citation': 'Davies MJ, Merton K, Vijapurkar U, Yee J, Qiu R. Efficacy and safety of canagliflozin in patients with type 2 diabetes based on history of cardiovascular disease or cardiovascular risk factors: a post hoc analysis of pooled data. Cardiovasc Diabetol. 2017 Mar 21;16(1):40. doi: 10.1186/s12933-017-0517-7.'}, {'pmid': '28241822', 'type': 'DERIVED', 'citation': 'Pfeifer M, Townsend RR, Davies MJ, Vijapurkar U, Ren J. Effects of canagliflozin, a sodium glucose co-transporter 2 inhibitor, on blood pressure and markers of arterial stiffness in patients with type 2 diabetes mellitus: a post hoc analysis. Cardiovasc Diabetol. 2017 Feb 27;16(1):29. doi: 10.1186/s12933-017-0511-0.'}, {'pmid': '28197834', 'type': 'DERIVED', 'citation': 'Gilbert RE, Mende C, Vijapurkar U, Sha S, Davies MJ, Desai M. Effects of Canagliflozin on Serum Magnesium in Patients With Type 2 Diabetes Mellitus: A Post Hoc Analysis of Randomized Controlled Trials. Diabetes Ther. 2017 Apr;8(2):451-458. doi: 10.1007/s13300-017-0232-0. Epub 2017 Feb 14.'}, {'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': '27600862', 'type': 'DERIVED', 'citation': 'John M, Cerdas S, Violante R, Deerochanawong C, Hassanein M, Slee A, Canovatchel W, Hamilton G. Efficacy and safety of canagliflozin in patients with type 2 diabetes mellitus living in hot climates. Int J Clin Pract. 2016 Sep;70(9):775-85. doi: 10.1111/ijcp.12868.'}, {'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': '26579834', 'type': 'DERIVED', 'citation': 'Lavalle-Gonzalez FJ, Eliaschewitz FG, Cerdas S, Chacon Mdel P, Tong C, Alba M. Efficacy and safety of canagliflozin in patients with type 2 diabetes mellitus from Latin America. Curr Med Res Opin. 2016;32(3):427-39. doi: 10.1185/03007995.2015.1121865. Epub 2016 Jan 14.'}, {'pmid': '26373629', 'type': 'DERIVED', 'citation': 'Blonde L, Woo V, Mathieu C, Yee J, Vijapurkar U, Canovatchel W, Meininger G. Achievement of treatment goals with canagliflozin in patients with type 2 diabetes mellitus: a pooled analysis of randomized controlled trials. Curr Med Res Opin. 2015 Nov;31(11):1993-2000. doi: 10.1185/03007995.2015.1082991. Epub 2015 Sep 28.'}, {'pmid': '26121561', 'type': 'DERIVED', 'citation': 'Gavin JR 3rd, Davies MJ, Davies M, Vijapurkar U, Alba M, Meininger G. The efficacy and safety of canagliflozin across racial groups in patients with type 2 diabetes mellitus. Curr Med Res Opin. 2015;31(9):1693-702. doi: 10.1185/03007995.2015.1067192. Epub 2015 Sep 4.'}, {'pmid': '25813214', 'type': 'DERIVED', 'citation': 'Cefalu WT, Stenlof K, Leiter LA, Wilding JP, Blonde L, Polidori D, Xie J, Sullivan D, Usiskin K, Canovatchel W, Meininger G. Effects of canagliflozin on body weight and relationship to HbA1c and blood pressure changes in patients with type 2 diabetes. Diabetologia. 2015 Jun;58(6):1183-7. doi: 10.1007/s00125-015-3547-2. Epub 2015 Mar 27.'}, {'pmid': '25329038', 'type': 'DERIVED', 'citation': 'Weir MR, Januszewicz A, Gilbert RE, Vijapurkar U, Kline I, Fung A, Meininger G. Effect of canagliflozin on blood pressure and adverse events related to osmotic diuresis and reduced intravascular volume in patients with type 2 diabetes mellitus. J Clin Hypertens (Greenwich). 2014 Dec;16(12):875-82. doi: 10.1111/jch.12425. Epub 2014 Oct 20.'}, {'pmid': '24918789', 'type': 'DERIVED', 'citation': 'Usiskin K, Kline I, Fung A, Mayer C, Meininger G. Safety and tolerability of canagliflozin in patients with type 2 diabetes mellitus: pooled analysis of phase 3 study results. Postgrad Med. 2014 May;126(3):16-34. doi: 10.3810/pgm.2014.05.2753.'}, {'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': '24742013', 'type': 'DERIVED', 'citation': 'Sinclair A, Bode B, Harris S, Vijapurkar U, Mayer C, Fung A, Shaw W, Usiskin K, Desai M, Meininger G. Efficacy and safety of canagliflozin compared with placebo in older patients with type 2 diabetes mellitus: a pooled analysis of clinical studies. BMC Endocr Disord. 2014 Apr 18;14:37. doi: 10.1186/1472-6823-14-37.'}, {'pmid': '24585202', 'type': 'DERIVED', 'citation': 'Polidori D, Mari A, Ferrannini E. Canagliflozin, a sodium glucose co-transporter 2 inhibitor, improves model-based indices of beta cell function in patients with type 2 diabetes. Diabetologia. 2014 May;57(5):891-901. doi: 10.1007/s00125-014-3196-x. Epub 2014 Mar 1.'}, {'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': '24073995', 'type': 'DERIVED', 'citation': 'Stenlof K, Cefalu WT, Kim KA, Jodar E, Alba M, Edwards R, Tong C, Canovatchel W, Meininger G. Long-term efficacy and safety of canagliflozin monotherapy in patients with type 2 diabetes inadequately controlled with diet and exercise: findings from the 52-week CANTATA-M study. Curr Med Res Opin. 2014 Feb;30(2):163-75. doi: 10.1185/03007995.2013.850066. Epub 2013 Oct 28.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the efficacy, safety, and tolerability of 2 different doses of canagliflozin administered as monotherapy compared with placebo in patients with type 2 diabetes mellitus (T2DM) inadequately controlled with diet and exercise.', '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), parallel-group, 3 arm (patients will be assigned to 1 of 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 diagnosed with T2DM who are not achieving an adequate response from diet and exercise to control their diabetes. Approximately 450 patients with inadequate glycemic control with diet and exercise will receive once-daily treatment with canagliflozin 100 mg or 300 mg once daily for 52 weeks or 26 weeks of double-blind treatment with placebo followed by 26 weeks of sitagliptin 100 mg (sitagliptin is an antihyperglycemic agent that will allow patients randomized to the placebo group to improve glycemic control and remain in the study). Patients will participate in the study for approximately 60 to 68 weeks (referred to as the Main Study). The study will also include a High Glycemic Substudy in 50 to 100 patients with T2DM who have poorer glycemic control with diet and exercise. Patients in the substudy will be assigned to receive double-blind canagliflozin 100 mg or 300 mg for 26 weeks and the total duration of patient participatation in the substudy will be approximately 34 to 42 weeks. During treatment, if a patient's fasting blood sugar remains high despite treatment with study drug and reinforcement with diet and exercise, the patient will receive treatment with metformin (rescue therapy) consistent with local prescribing information. Study drug will be taken orally (by mouth) once daily before the first meal each day unless otherwise specified. Patients will take single blind placebo for 1 or 2 weeks (wks) before randomization to the Main Study or the High Glycemic Substudy."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All patients must have a diagnosis of T2DM\n* Patients in the main study must have a Hemoglobin A1c (HbA1c) between \\>=7% and \\<=10% and a fasting plasma glucose (FPG) \\<270 mg/dL (15 mmol/L)\n* Patients in the High Glycemic Cohort Substudy must have an HbA1c between \\>10% and \\<=12% and a FPG \\<=350 mg/dL (19.44 mmol/L)\n\nExclusion Criteria:\n\n* History of diabetic ketoacidosis, type 1 diabetes mellitus (T1DM), pancreas or beta cell transplantation, diabetes secondary to pancreatitis or pancreatectomy, or a severe hypoglycemic episode within 6 months before screening'}, 'identificationModule': {'nctId': 'NCT01081834', 'briefTitle': 'The CANTATA-M (CANagliflozin Treatment and Trial Analysis - Monotherapy) Trial', '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 as Monotherapy in the Treatment of Subjects With Type 2 Diabetes Mellitus Inadequately Controlled With Diet and Exercise', 'orgStudyIdInfo': {'id': 'CR017011'}, 'secondaryIdInfos': [{'id': '28431754DIA3005', '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 52 weeks (Main Study) or 26 weeks only (High Glycemic Substudy).', 'interventionNames': ['Drug: Canagliflozin']}, {'type': 'EXPERIMENTAL', 'label': 'Canagliflozin 300 mg', 'description': 'Each patient will receive 300 mg of canagliflozin once daily for 52 weeks (Main Study) or 26 weeks only (High Glycemic Substudy).', 'interventionNames': ['Drug: Canagliflozin']}, {'type': 'EXPERIMENTAL', 'label': 'Placebo/Sitagliptin', 'description': 'In the Main Study, each patient will receive matching placebo once daily for 26 weeks and will then switch from placebo to 100 mg of sitagliptin once daily until Week 52.', 'interventionNames': ['Drug: Placebo', 'Drug: Sitagliptin']}], 'interventions': [{'name': 'Canagliflozin', 'type': 'DRUG', 'description': 'One 100 mg or 300 mg over-encapsulated tablet orally (by mouth) once daily for 52 weeks (Main Study) or 26 weeks (High Glycemic Substudy)', 'armGroupLabels': ['Canagliflozin 100 mg', 'Canagliflozin 300 mg']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'One matching placebo capsule orally once daily for 26 weeks (Main Study)', 'armGroupLabels': ['Placebo/Sitagliptin']}, {'name': 'Sitagliptin', 'type': 'DRUG', 'description': 'One 100 mg over-encapsulated tablet orally once daily beginning at Week 26 until Week 52 (Main Study)', 'armGroupLabels': ['Placebo/Sitagliptin']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'city': 'Concord', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 37.97798, 'lon': -122.03107}}, {'city': 'Greenbrae', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 37.94854, 'lon': -122.5247}}, {'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'city': 'Spring Valley', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 32.74477, 'lon': -116.99892}}, {'city': 'Colorado Springs', 'state': 'Colorado', 'country': 'United States', 'geoPoint': {'lat': 38.83388, 'lon': -104.82136}}, {'city': 'Denver', 'state': 'Colorado', 'country': 'United States', 'geoPoint': {'lat': 39.73915, 'lon': -104.9847}}, {'city': 'Northglenn', 'state': 'Colorado', 'country': 'United States', 'geoPoint': {'lat': 39.88554, 'lon': -104.9872}}, {'city': 'Springfield', 'state': 'Illinois', 'country': 'United States', 'geoPoint': {'lat': 39.80172, 'lon': -89.64371}}, {'city': 'Evansville', 'state': 'Indiana', 'country': 'United States', 'geoPoint': {'lat': 37.97476, 'lon': -87.55585}}, {'city': 'Baton Rouge', 'state': 'Louisiana', 'country': 'United States', 'geoPoint': {'lat': 30.44332, 'lon': -91.18747}}, {'city': 'Metairie', 'state': 'Louisiana', 'country': 'United States', 'geoPoint': {'lat': 29.98409, 'lon': -90.15285}}, {'city': 'Meridian', 'state': 'New Jersey', 'country': 'United States'}, {'city': 'Albuquerque', 'state': 'New Mexico', 'country': 'United States', 'geoPoint': {'lat': 35.08449, 'lon': -106.65114}}, {'city': 'New York', 'state': 'New York', 'country': 'United States', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'city': 'West Seneca', 'state': 'New York', 'country': 'United States', 'geoPoint': {'lat': 42.85006, 'lon': -78.79975}}, {'city': 'Mooresville', 'state': 'North Carolina', 'country': 'United States', 'geoPoint': {'lat': 35.58486, 'lon': -80.81007}}, {'city': 'Perryopolis', 'state': 'Pennsylvania', 'country': 'United States', 'geoPoint': {'lat': 40.08702, 'lon': -79.7506}}, {'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}, {'city': 'Taylors', 'state': 'South Carolina', 'country': 'United States', 'geoPoint': {'lat': 34.92039, 'lon': -82.29623}}, {'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'city': 'Norfolk', 'state': 'Virginia', 'country': 'United States', 'geoPoint': {'lat': 36.84681, 'lon': -76.28522}}, {'city': 'Horn', 'country': 'Austria', 'geoPoint': {'lat': 48.66274, 'lon': 15.65663}}, {'city': 'Salzburg', 'country': 'Austria', 'geoPoint': {'lat': 47.79941, 'lon': 13.04399}}, {'city': 'Vienna', 'country': 'Austria', 'geoPoint': {'lat': 48.20849, 'lon': 16.37208}}, {'city': 'Barranquilla', 'country': 'Colombia', 'geoPoint': {'lat': 10.96854, 'lon': -74.78132}}, {'city': 'Bogotá', 'country': 'Colombia', 'geoPoint': {'lat': 4.60971, 'lon': -74.08175}}, {'city': 'Pärnu', 'country': 'Estonia', 'geoPoint': {'lat': 58.38588, 'lon': 24.49711}}, {'city': 'Tartu', 'country': 'Estonia', 'geoPoint': {'lat': 58.38062, 'lon': 26.72509}}, {'city': 'Viljandi', 'country': 'Estonia', 'geoPoint': {'lat': 58.36319, 'lon': 25.59159}}, {'city': 'Guatemala City', 'country': 'Guatemala', 'geoPoint': {'lat': 14.64072, 'lon': -90.51327}}, {'city': 'Reykjavik', 'country': 'Iceland', 'geoPoint': {'lat': 64.13548, 'lon': -21.89541}}, {'city': 'Bangalore', 'country': 'India', 'geoPoint': {'lat': 12.97194, 'lon': 77.59369}}, {'city': 'Hyderabad', 'country': 'India', 'geoPoint': {'lat': 17.38405, 'lon': 78.45636}}, {'city': 'Nagpur', 'country': 'India', 'geoPoint': {'lat': 21.14631, 'lon': 79.08491}}, {'city': 'Kaunas', 'country': 'Lithuania', 'geoPoint': {'lat': 54.90156, 'lon': 23.90909}}, {'city': 'Klaipėda', 'country': 'Lithuania', 'geoPoint': {'lat': 55.7068, 'lon': 21.13912}}, {'city': 'Šiauliai', 'country': 'Lithuania', 'geoPoint': {'lat': 55.93333, 'lon': 23.31667}}, {'city': 'Vilnius', 'country': 'Lithuania', 'geoPoint': {'lat': 54.68916, 'lon': 25.2798}}, {'city': 'Vilnius Lt', 'country': 'Lithuania'}, {'city': 'Kelantan', 'country': 'Malaysia'}, {'city': 'Kuala Lumpur', 'country': 'Malaysia', 'geoPoint': {'lat': 3.1412, 'lon': 101.68653}}, {'city': 'Aguascalientes', 'country': 'Mexico', 'geoPoint': {'lat': 21.88262, 'lon': -102.2843}}, {'city': 'Guadalajara', 'country': 'Mexico', 'geoPoint': {'lat': 20.67738, 'lon': -103.34749}}, {'city': 'Mexico City', 'country': 'Mexico', 'geoPoint': {'lat': 19.42847, 'lon': -99.12766}}, {'city': 'Monterrey', 'country': 'Mexico', 'geoPoint': {'lat': 25.68435, 'lon': -100.31721}}, {'city': 'Zapopan', 'country': 'Mexico', 'geoPoint': {'lat': 20.72111, 'lon': -103.38742}}, {'city': 'Makati', 'country': 'Philippines', 'geoPoint': {'lat': 16.412, 'lon': 121.1226}}, {'city': 'Manila', 'country': 'Philippines', 'geoPoint': {'lat': 14.6042, 'lon': 120.9822}}, {'city': 'Marikina City', 'country': 'Philippines', 'geoPoint': {'lat': 14.6481, 'lon': 121.1133}}, {'city': 'Pasay', 'country': 'Philippines', 'geoPoint': {'lat': 14.53748, 'lon': 121.00144}}, {'city': 'Katowice', 'country': 'Poland', 'geoPoint': {'lat': 50.2597, 'lon': 19.02173}}, {'city': 'Torun', 'country': 'Poland', 'geoPoint': {'lat': 53.01375, 'lon': 18.59814}}, {'city': 'Warsaw', 'country': 'Poland', 'geoPoint': {'lat': 52.22977, 'lon': 21.01178}}, {'city': 'Fajardo', 'country': 'Puerto Rico', 'geoPoint': {'lat': 18.32579, 'lon': -65.65238}}, {'city': 'Ponce', 'country': 'Puerto Rico', 'geoPoint': {'lat': 18.01031, 'lon': -66.62398}}, {'city': 'San Juan', 'country': 'Puerto Rico', 'geoPoint': {'lat': 18.46633, 'lon': -66.10572}}, {'city': 'Baia Mare', 'country': 'Romania', 'geoPoint': {'lat': 47.65729, 'lon': 23.56808}}, {'city': 'Brasov', 'country': 'Romania', 'geoPoint': {'lat': 45.64861, 'lon': 25.60613}}, {'city': 'Bucharest', 'country': 'Romania', 'geoPoint': {'lat': 44.43225, 'lon': 26.10626}}, {'city': 'Târgu Mureş', 'country': 'Romania', 'geoPoint': {'lat': 46.54245, 'lon': 24.55747}}, {'city': 'Halfway', 'country': 'South Africa'}, {'city': 'Pretoria', 'country': 'South Africa', 'geoPoint': {'lat': -25.74486, 'lon': 28.18783}}, {'city': 'Busan', 'country': 'South Korea', 'geoPoint': {'lat': 35.10168, 'lon': 129.03004}}, {'city': 'Goyang-si', 'country': 'South Korea', 'geoPoint': {'lat': 37.65639, 'lon': 126.835}}, {'city': 'Jeonju', 'country': 'South Korea', 'geoPoint': {'lat': 35.82194, 'lon': 127.14889}}, {'city': 'Seoul', 'country': 'South Korea', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Wŏnju', 'country': 'South Korea', 'geoPoint': {'lat': 37.35139, 'lon': 127.94528}}, {'city': 'Alcalá de Henares', 'country': 'Spain', 'geoPoint': {'lat': 40.48205, 'lon': -3.35996}}, {'city': 'Elche', 'country': 'Spain', 'geoPoint': {'lat': 38.26218, 'lon': -0.70107}}, {'city': 'Girona', 'country': 'Spain', 'geoPoint': {'lat': 41.98311, 'lon': 2.82493}}, {'city': 'Pozuelo de Alarcón', 'country': 'Spain', 'geoPoint': {'lat': 40.43293, 'lon': -3.81338}}, {'city': 'Gothenburg', 'country': 'Sweden', 'geoPoint': {'lat': 57.70716, 'lon': 11.96679}}, {'city': 'Lund', 'country': 'Sweden', 'geoPoint': {'lat': 55.70584, 'lon': 13.19321}}, {'city': 'Malmo', 'country': 'Sweden', 'geoPoint': {'lat': 55.60587, 'lon': 13.00073}}, {'city': 'Skene', 'country': 'Sweden', 'geoPoint': {'lat': 57.48995, 'lon': 12.64196}}], 'overallOfficials': [{'name': 'Janssen Research & Development, LLC Clinical Trial', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Janssen Research & Development, LLC'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Janssen Research & Development, LLC', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}