Ignite Creation Date:
2025-12-25 @ 4:18 AM
Ignite Modification Date:
2026-03-02 @ 4:09 PM
Study NCT ID:
NCT02220920
Status:
COMPLETED
Last Update Posted:
2016-12-15
First Post:
2014-08-19
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Efficacy and Safety Study of Canagliflozin (TA-7284) in Combination With Insulin in Patients With Type 2 Diabetes Mellitus
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}, {'id': 'D007333', 'term': 'Insulin Resistance'}], 'ancestors': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D006946', 'term': 'Hyperinsulinism'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068896', 'term': 'Canagliflozin'}, {'id': 'D007328', 'term': 'Insulin'}], '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': 'D011384', 'term': 'Proinsulin'}, {'id': 'D061385', 'term': 'Insulins'}, {'id': 'D010187', 'term': 'Pancreatic Hormones'}, {'id': 'D036361', 'term': 'Peptide Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'cti-inq-ml@ml.mt-pharma.co.jp', 'title': 'Clinical Trials, Information Desk', 'organization': 'Mitsubishi Tanabe Pharma Corporation'}, 'certainAgreement': {'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'description': '"Safety Population" reflects the "as treated" population, and one "Canagliflozin(TA-7284) + Insulin" participant actually received "Placebo + Insulin".', 'eventGroups': [{'id': 'EG000', 'title': 'Canagliflozin (TA-7284) ＋Insulin', 'description': 'Canagliflozin, once daily for 16 weeks', 'otherNumAtRisk': 75, 'otherNumAffected': 39, 'seriousNumAtRisk': 75, 'seriousNumAffected': 3}, {'id': 'EG001', 'title': 'Placebo＋Insulin', 'description': 'Placebo, once daily for 16 weeks', 'otherNumAtRisk': 71, 'otherNumAffected': 34, 'seriousNumAtRisk': 71, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 71, 'numAffected': 13}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Hypoglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 71, 'numAffected': 15}], 'organSystem': 'Metabolism and nutrition disorders', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Pollakiuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 71, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Blood glucose decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 71, 'numAffected': 12}], 'organSystem': 'Investigations', 'sourceVocabulary': 'MedDRA 18.0'}], 'seriousEvents': [{'term': 'Cataract', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 71, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Retinal detachment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 71, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Vitreous haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 71, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Alcoholic liver disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 71, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'sourceVocabulary': 'MedDRA 18.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in HbA1c From Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '76', 'groupId': 'OG000'}, {'value': '70', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Canagliflozin (TA-7284) ＋Insulin', 'description': 'Canagliflozin, once daily for 16 weeks'}, {'id': 'OG001', 'title': 'Placebo＋Insulin', 'description': 'Placebo, once daily for 16 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.97', 'spread': '0.08', 'groupId': 'OG000'}, {'value': '0.13', 'spread': '0.08', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least-Squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.10', 'ciLowerLimit': '-1.33', 'ciUpperLimit': '-0.87', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.11', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'baseline and Week 16', 'unitOfMeasure': 'Percent', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set, last observation carried forward'}, {'type': 'SECONDARY', 'title': 'Change in Fasting Plasma Glucose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '75', 'groupId': 'OG000'}, {'value': '70', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Canagliflozin (TA-7284) ＋Insulin', 'description': 'Canagliflozin, once daily for 16 weeks'}, {'id': 'OG001', 'title': 'Placebo＋Insulin', 'description': 'Placebo, once daily for 16 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '-34.1', 'spread': '4.8', 'groupId': 'OG000'}, {'value': '-1.4', 'spread': '5.0', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least-Squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-32.6', 'ciLowerLimit': '-46.3', 'ciUpperLimit': '-18.9', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '6.9', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'baseline and Week 16', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set, last observation carried forward. There was a lack of measurement of fasting plasma glucose at the end of treatment visit(Week 4) in one participant who was randomized to "Canagliflozin(TA-7284) + Insulin" group.'}, {'type': 'SECONDARY', 'title': 'Percent Change in Body Weight', 'denoms': [{'units': 'Participants', 'counts': [{'value': '75', 'groupId': 'OG000'}, {'value': '70', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Canagliflozin (TA-7284) ＋Insulin', 'description': 'Canagliflozin, once daily for 16 weeks'}, {'id': 'OG001', 'title': 'Placebo＋Insulin', 'description': 'Placebo, once daily for 16 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '-2.13', 'spread': '0.25', 'groupId': 'OG000'}, {'value': '0.24', 'spread': '0.26', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least-Squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.37', 'ciLowerLimit': '-3.09', 'ciUpperLimit': '-1.65', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.36', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'baseline and Week 16', 'unitOfMeasure': 'percent change', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set, last observation carried forward. There was a lack of measurement of body weight at the end of treatment visit(Week 4) in one participant who was randomized to "Canagliflozin(TA-7284) + Insulin" group.'}, {'type': 'SECONDARY', 'title': 'Change in Blood Pressure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '76', 'groupId': 'OG000'}, {'value': '70', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Canagliflozin (TA-7284) ＋Insulin', 'description': 'Canagliflozin, once daily for 16 weeks'}, {'id': 'OG001', 'title': 'Placebo＋Insulin', 'description': 'Placebo, once daily for 16 weeks'}], 'classes': [{'title': 'Systolic blood pressure', 'categories': [{'measurements': [{'value': '-3.58', 'spread': '1.14', 'groupId': 'OG000'}, {'value': '-0.40', 'spread': '1.19', 'groupId': 'OG001'}]}]}, {'title': 'Diastolic blood pressure', 'categories': [{'measurements': [{'value': '-1.55', 'spread': '0.71', 'groupId': 'OG000'}, {'value': '-0.31', 'spread': '0.74', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.058', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least-Squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-3.19', 'ciLowerLimit': '-6.49', 'ciUpperLimit': '0.11', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.67', 'estimateComment': 'Estimated P-Value, Least-Squares Mean Difference, Standard Error of the mean, 95% CI are presented for the change from Baseline in systolic blood pressure for week 16.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.232', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least-Squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.24', 'ciLowerLimit': '-3.27', 'ciUpperLimit': '0.80', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.03', 'estimateComment': 'Estimated P-Value, Least-Squares Mean Difference, Standard Error of the mean, 95% CI are presented for the change from Baseline in diastolic blood pressure for week 16.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'baseline and Week 16', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set, last observation carried forward'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With "Adverse Events" and "Hypoglycemia and Blood Glucose Decreased"', 'denoms': [{'units': 'Participants', 'counts': [{'value': '75', 'groupId': 'OG000'}, {'value': '71', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Canagliflozin (TA-7284) ＋Insulin', 'description': 'Canagliflozin, once daily for 16 weeks'}, {'id': 'OG001', 'title': 'Placebo＋Insulin', 'description': 'Placebo, once daily for 16 weeks'}], 'classes': [{'title': 'adverse events', 'categories': [{'measurements': [{'value': '68.0', 'groupId': 'OG000'}, {'value': '64.8', 'groupId': 'OG001'}]}]}, {'title': 'Hypoglycemia and Blood glucose decreased', 'categories': [{'measurements': [{'value': '40.0', 'groupId': 'OG000'}, {'value': '29.6', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 16', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety analysis set. "Safety Population" reflects the "as treated" population, and one "Canagliflozin (TA-7284) + Insulin" participant actually received "Placebo + Insulin".'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Canagliflozin (TA-7284) ＋Insulin', 'description': 'Canagliflozin, once daily for 16 weeks'}, {'id': 'FG001', 'title': 'Placebo＋Insulin', 'description': 'Placebo, once daily for 16 weeks'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '76'}, {'groupId': 'FG001', 'numSubjects': '70'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '73'}, {'groupId': 'FG001', 'numSubjects': '67'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '3'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Conflict with the stopping criteria', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '76', 'groupId': 'BG000'}, {'value': '70', 'groupId': 'BG001'}, {'value': '146', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Canagliflozin (TA-7284) ＋Insulin', 'description': 'Canagliflozin, once daily for 16 weeks'}, {'id': 'BG001', 'title': 'Placebo＋Insulin', 'description': 'Placebo, once daily for 16 weeks'}, {'id': 'BG002', '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'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '47', 'groupId': 'BG000'}, {'value': '48', 'groupId': 'BG001'}, {'value': '95', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '29', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '51', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Gender', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '32', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '53', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '44', 'groupId': 'BG000'}, {'value': '49', 'groupId': 'BG001'}, {'value': '93', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 146}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-08', 'completionDateStruct': {'date': '2015-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-10-24', 'studyFirstSubmitDate': '2014-08-19', 'resultsFirstSubmitDate': '2016-08-03', 'studyFirstSubmitQcDate': '2014-08-19', 'lastUpdatePostDateStruct': {'date': '2016-12-15', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2016-10-24', 'studyFirstPostDateStruct': {'date': '2014-08-20', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-12-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in HbA1c From Baseline', 'timeFrame': 'baseline and Week 16'}], 'secondaryOutcomes': [{'measure': 'Change in Fasting Plasma Glucose', 'timeFrame': 'baseline and Week 16'}, {'measure': 'Percent Change in Body Weight', 'timeFrame': 'baseline and Week 16'}, {'measure': 'Change in Blood Pressure', 'timeFrame': 'baseline and Week 16'}, {'measure': 'Percentage of Participants With "Adverse Events" and "Hypoglycemia and Blood Glucose Decreased"', 'timeFrame': 'Week 16'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['insulin resistance'], 'conditions': ['Type 2 Diabetes Mellitus']}, 'referencesModule': {'references': [{'pmid': '27316668', 'type': 'RESULT', 'citation': 'Inagaki N, Harashima S, Maruyama N, Kawaguchi Y, Goda M, Iijima H. Efficacy and safety of canagliflozin in combination with insulin: a double-blind, randomized, placebo-controlled study in Japanese patients with type 2 diabetes mellitus. Cardiovasc Diabetol. 2016 Jun 18;15:89. doi: 10.1186/s12933-016-0407-4.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the efficacy and safety of Canagliflozin (TA-7284) in combination with Insulin in patients with type 2 Diabetes for 16 weeks administration.', 'detailedDescription': 'This is a randomized, 2-arm, parallel group, double blind study to evaluate the efficacy and safety of Canagliflozin (TA-7284) in Japanese patients with type 2 diabetes mellitus, who are receiving treatment with insulin therapy on diet and exercise and have inadequate glycemic control. The patients will receive either TA-7284 100mg or Placebo orally for 16 weeks.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patients who has been receiving a stable dose and regimen of insulin over 12 weeks before administration of investigational dug\n* Patients who are under dietary management and taking therapeutic exercise for diabetes over 12 weeks before administration of investigational drug\n* Patients with HbA1c of ≥7.5% and \\<10.5%\n* Patients who were not administered diabetes therapeutic drugs prohibited for concomitant use within 12 weeks before administration of investigational drug\n\nExclusion Criteria:\n\n* Patients with type 1 diabetes mellitus, diabetes mellitus resulting from pancreatic disorder, or secondary diabetes mellitus (Cushing's syndrome, acromegaly, etc.)\n* Patients with severe diabetic complications (proliferative diabetic retinopathy, stage 4 nephropathy, or serious diabetic neuropathy)\n* Patients with hereditary glucose-galactose malabsorption or primary renal glucosuria\n* Patients with systolic blood pressure of ≥160 mmHg or diastolic blood pressure of ≥100 mmHg\n* Patients with serious renal or hepatic disease\n* Patients with eGFR of \\<45 mL/min/1.73 m2\n* Patients who are the excessive alcohol addicts\n* Patients who are pregnant, lactating and probably pregnant patients and patients who can not agree to contraception"}, 'identificationModule': {'nctId': 'NCT02220920', 'briefTitle': 'Efficacy and Safety Study of Canagliflozin (TA-7284) in Combination With Insulin in Patients With Type 2 Diabetes Mellitus', 'organization': {'class': 'INDUSTRY', 'fullName': 'Tanabe Pharma Corporation'}, 'officialTitle': 'A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Study to Evaluate the Efficacy, Safety, and Tolerability of Canagliflozin (TA-7284) as add-on to Insulin in Subjects With Type 2 Diabetes Mellitus', 'orgStudyIdInfo': {'id': 'TA-7284-11'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Canagliflozin (TA-7284) ＋insulin', 'interventionNames': ['Drug: Canagliflozin (TA-7284)', 'Drug: Insulin']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo＋insulin', 'interventionNames': ['Drug: Placebo', 'Drug: Insulin']}], 'interventions': [{'name': 'Canagliflozin (TA-7284)', 'type': 'DRUG', 'description': 'The patients will receive Canagliflozin orally for 16 weeks', 'armGroupLabels': ['Canagliflozin (TA-7284) ＋insulin']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'The patients will receive Placebo orally for 16 weeks', 'armGroupLabels': ['Placebo＋insulin']}, {'name': 'Insulin', 'type': 'DRUG', 'armGroupLabels': ['Canagliflozin (TA-7284) ＋insulin', 'Placebo＋insulin']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Chugoku', 'country': 'Japan', 'facility': 'Reserch site'}, {'city': 'Chūbu', 'country': 'Japan', 'facility': 'Reserch site', 'geoPoint': {'lat': 35.43379, 'lon': 140.2797}}, {'city': 'Hokkaido', 'country': 'Japan', 'facility': 'Reserch site'}, {'city': 'Kanto', 'country': 'Japan', 'facility': 'Reserch site'}, {'city': 'Kinki', 'country': 'Japan', 'facility': 'Reserch site'}, {'city': 'Kyushu', 'country': 'Japan', 'facility': 'Reserch site'}, {'city': 'Tōhoku', 'country': 'Japan', 'facility': 'Reserch site', 'geoPoint': {'lat': 35.81882, 'lon': 139.57138}}], 'overallOfficials': [{'name': 'Kazuoki Kondo, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Tanabe Pharma Corporation'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tanabe Pharma Corporation', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}