Ignite Creation Date:
2025-12-24 @ 10:22 PM
Ignite Modification Date:
2026-02-20 @ 11:09 AM
Study NCT ID:
NCT02354235
Status:
COMPLETED
Last Update Posted:
2018-11-01
First Post:
2015-01-29
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Confirmatory Study of MT-2412 in Japanese Patients With Type 2 Diabetes (Add-on Study of Canagliflozin)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, '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': 'C579035', 'term': '3-(4-(4-(3-methyl-1-phenyl-1H-pyrazol-5-yl)piperazin-1-yl)pyrrolidin-2-ylcarbonyl)thiazolidine'}, {'id': 'D000068896', 'term': 'Canagliflozin'}], 'ancestors': [{'id': 'D013876', 'term': 'Thiophenes'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D005960', 'term': 'Glucosides'}, {'id': 'D006027', 'term': 'Glycosides'}, {'id': 'D002241', 'term': 'Carbohydrates'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': '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': {'eventGroups': [{'id': 'EG000', 'title': 'Canagliflozin+Teneligliptin', 'description': 'Canagliflozin for 24 weeks in combination with Teneligliptin', 'otherNumAtRisk': 70, 'otherNumAffected': 13, 'seriousNumAtRisk': 70, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'Placebo+Teneligliptin', 'description': 'Placebo for 24 weeks in combination with Teneligliptin', 'otherNumAtRisk': 68, 'otherNumAffected': 11, 'seriousNumAtRisk': 68, 'seriousNumAffected': 2}], 'otherEvents': [{'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 68, 'numAffected': 11}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'MedDRA 18.1'}], 'seriousEvents': [{'term': 'Gastric cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 68, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Cerebral infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 68, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Chondrocalcinosis pyrophosphate', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 68, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'sourceVocabulary': 'MedDRA 18.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change From Baseline in Percentage of Glycated Hemoglobin (HbA1c)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'OG000'}, {'value': '68', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Canagliflozin+Teneligliptin', 'description': 'Canagliflozin for 24 weeks in combination with Teneligliptin'}, {'id': 'OG001', 'title': 'Placebo+Teneligliptin', 'description': 'Placebo for 24 weeks in combination with Teneligliptin'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.97', 'spread': '0.10', 'groupId': 'OG000'}, {'value': '-0.10', 'spread': '0.10', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least Squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.88', 'ciLowerLimit': '-1.15', 'ciUpperLimit': '-0.60', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.14', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, 24 Weeks', 'description': 'The change from baseline in percentage of HbA1c (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at Week 24.', 'unitOfMeasure': 'percentage of HbA1c', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set, last observation carried forward'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Fasting Plasma Glucose Level', 'denoms': [{'units': 'Participants', 'counts': [{'value': '69', 'groupId': 'OG000'}, {'value': '67', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Canagliflozin+Teneligliptin', 'description': 'Canagliflozin for 24 weeks in combination with Teneligliptin'}, {'id': 'OG001', 'title': 'Placebo+Teneligliptin', 'description': 'Placebo for 24 weeks in combination with Teneligliptin'}], 'classes': [{'categories': [{'measurements': [{'value': '-34.9', 'spread': '3.4', 'groupId': 'OG000'}, {'value': '3.9', 'spread': '3.5', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least Squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-38.8', 'ciLowerLimit': '-48.5', 'ciUpperLimit': '-29.2', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '4.9', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, 24 Weeks', 'description': 'The change from baseline in fasting plasma glucose level collected at Week 24.', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set, last observation carried forward. Outcome measure for one patient of each group was not assessed at a certain timepoint due to dropout.'}, {'type': 'SECONDARY', 'title': 'Percentage Change in Body Weight From Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '69', 'groupId': 'OG000'}, {'value': '67', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Canagliflozin+Teneligliptin', 'description': 'Canagliflozin for 24 weeks in combination with Teneligliptin'}, {'id': 'OG001', 'title': 'Placebo+Teneligliptin', 'description': 'Placebo for 24 weeks in combination with Teneligliptin'}], 'classes': [{'categories': [{'measurements': [{'value': '-3.32', 'spread': '0.31', 'groupId': 'OG000'}, {'value': '-0.99', 'spread': '0.31', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least Squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.33', 'ciLowerLimit': '-3.20', 'ciUpperLimit': '-1.45', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.44', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, 24 Weeks', 'description': 'The percentage change from baseline in body weight collected at Week 24.', 'unitOfMeasure': 'percent change', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set, last observation carried forward. Outcome measure for one patient of each group was not assessed at a certain timepoint due to dropout.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in the AUC(0-2h) for Postprandial Plasma Glucose (PPG)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Canagliflozin+Teneligliptin', 'description': 'Canagliflozin for 24 weeks in combination with Teneligliptin'}, {'id': 'OG001', 'title': 'Placebo+Teneligliptin', 'description': 'Placebo for 24 weeks in combination with Teneligliptin'}], 'classes': [{'categories': [{'measurements': [{'value': '-105.9', 'spread': '7.6', 'groupId': 'OG000'}, {'value': '-5.6', 'spread': '8.0', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least Squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-100.3', 'ciLowerLimit': '-122.2', 'ciUpperLimit': '-78.4', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '11.1', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '0, 0.5, 1 and 2 hour postprandial, at Baseline and 24 Weeks', 'description': 'The change from Baseline in AUC(0-2h) for Postprandial Plasma Glucose collected at Week 24.', 'unitOfMeasure': 'hour*mg/dL', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in 2-hour Postprandial Plasma Glucose Level', 'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Canagliflozin+Teneligliptin', 'description': 'Canagliflozin for 24 weeks in combination with Teneligliptin'}, {'id': 'OG001', 'title': 'Placebo+Teneligliptin', 'description': 'Placebo for 24 weeks in combination with Teneligliptin'}], 'classes': [{'categories': [{'measurements': [{'value': '-60.1', 'spread': '4.9', 'groupId': 'OG000'}, {'value': '-9.2', 'spread': '5.1', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least Squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-50.9', 'ciLowerLimit': '-64.9', 'ciUpperLimit': '-36.9', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '7.1', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '2 Hours Postprandial, at Baseline and 24 Weeks', 'description': 'The change from baseline in 2-hour postprandial plasma glucose level collected at Week 24.', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Canagliflozin+Teneligliptin', 'description': 'Canagliflozin for 24 weeks in combination with Teneligliptin'}, {'id': 'FG001', 'title': 'Placebo+Teneligliptin', 'description': 'Placebo for 24 weeks in combination with Teneligliptin'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '70'}, {'groupId': 'FG001', 'numSubjects': '68'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '67'}, {'groupId': 'FG001', 'numSubjects': '61'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '7'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Conflict with the stopping criteria', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'BG000'}, {'value': '68', 'groupId': 'BG001'}, {'value': '138', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Canagliflozin+Teneligliptin', 'description': 'Canagliflozin for 24 weeks in combination with Teneligliptin'}, {'id': 'BG001', 'title': 'Placebo+Teneligliptin', 'description': 'Placebo for 24 weeks in combination with Teneligliptin'}, {'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': '48', 'groupId': 'BG000'}, {'value': '52', 'groupId': 'BG001'}, {'value': '100', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '22', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '38', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '31', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '54', 'groupId': 'BG000'}, {'value': '53', 'groupId': 'BG001'}, {'value': '107', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 138}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-10', 'completionDateStruct': {'date': '2016-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-10-03', 'studyFirstSubmitDate': '2015-01-29', 'resultsFirstSubmitDate': '2017-11-16', 'studyFirstSubmitQcDate': '2015-01-29', 'lastUpdatePostDateStruct': {'date': '2018-11-01', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-11-16', 'studyFirstPostDateStruct': {'date': '2015-02-03', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2018-08-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change From Baseline in Percentage of Glycated Hemoglobin (HbA1c)', 'timeFrame': 'Baseline, 24 Weeks', 'description': 'The change from baseline in percentage of HbA1c (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at Week 24.'}], 'secondaryOutcomes': [{'measure': 'Change From Baseline in Fasting Plasma Glucose Level', 'timeFrame': 'Baseline, 24 Weeks', 'description': 'The change from baseline in fasting plasma glucose level collected at Week 24.'}, {'measure': 'Percentage Change in Body Weight From Baseline', 'timeFrame': 'Baseline, 24 Weeks', 'description': 'The percentage change from baseline in body weight collected at Week 24.'}, {'measure': 'Change From Baseline in the AUC(0-2h) for Postprandial Plasma Glucose (PPG)', 'timeFrame': '0, 0.5, 1 and 2 hour postprandial, at Baseline and 24 Weeks', 'description': 'The change from Baseline in AUC(0-2h) for Postprandial Plasma Glucose collected at Week 24.'}, {'measure': 'Change From Baseline in 2-hour Postprandial Plasma Glucose Level', 'timeFrame': '2 Hours Postprandial, at Baseline and 24 Weeks', 'description': 'The change from baseline in 2-hour postprandial plasma glucose level collected at Week 24.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['MT-2412', 'MP-513', 'TA-7284', 'Teneligliptin', 'Canagliflozin'], 'conditions': ['Type 2 Diabetes Mellitus']}, 'referencesModule': {'references': [{'pmid': '28177187', 'type': 'RESULT', 'citation': 'Kadowaki T, Inagaki N, Kondo K, Nishimura K, Kaneko G, Maruyama N, Nakanishi N, Iijima H, Watanabe Y, Gouda M. Efficacy and safety of canagliflozin as add-on therapy to teneligliptin in Japanese patients with type 2 diabetes mellitus: Results of a 24-week, randomized, double-blind, placebo-controlled trial. Diabetes Obes Metab. 2017 Jun;19(6):874-882. doi: 10.1111/dom.12898. Epub 2017 Mar 31.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the efficacy and safety of co-administration of Teneligliptin (MP-513) and Canagliflozin (TA-7284) once daily for 24 weeks in Japanese patients with Type 2 diabetes mellitus who are receiving treatment with Teneligliptin and have inadequate glycemic control.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Men or women who are 20 - 75 years old\n* HbA1c of ≥7.0% and \\<10.5%\n* FPG of ≤ 270 mg/dL\n* Patients who are under dietary management and taking therapeutic exercise for diabetes over 8 weeks before run-in period\n\nExclusion Criteria:\n\n* Patients with type I diabetes, diabetes mellitus resulting from pancreatic disorder, or secondary diabetes\n* Patients with serious diabetic complications\n* Patients with hereditary glucose-galactose malabsorption or primary renal glucosuria\n* Patients with Class III/IV heart failure symptoms according to New York Heart Association (NYHA) functional classification\n* Patients with severe hepatic disorder or severe renal disorder.'}, 'identificationModule': {'nctId': 'NCT02354235', 'briefTitle': 'Confirmatory Study of MT-2412 in Japanese Patients With Type 2 Diabetes (Add-on Study of Canagliflozin)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Tanabe Pharma Corporation'}, 'officialTitle': 'Confirmatory Study of MT-2412 in Japanese Patients With Type 2 Diabetes (Add-on Study of Canagliflozin in Patients With Inadequate Glycemic Control on Teneligliptin)', 'orgStudyIdInfo': {'id': 'MT-2412-J03'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Canagliflozin + Teneligliptin', 'description': 'Patients receive Canagliflozin for 24 weeks in combination with Teneligliptin.', 'interventionNames': ['Drug: Teneligliptin', 'Drug: Canagliflozin']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo + Teneligliptin', 'description': 'Patients receive placebo for 24 weeks in combination with Teneligliptin.', 'interventionNames': ['Drug: Teneligliptin', 'Drug: Placebo']}], 'interventions': [{'name': 'Teneligliptin', 'type': 'DRUG', 'otherNames': ['Tenelia, MP-513'], 'armGroupLabels': ['Canagliflozin + Teneligliptin', 'Placebo + Teneligliptin']}, {'name': 'Canagliflozin', 'type': 'DRUG', 'otherNames': ['Canaglu, TA-7284'], 'armGroupLabels': ['Canagliflozin + Teneligliptin']}, {'name': 'Placebo', 'type': 'DRUG', 'armGroupLabels': ['Placebo + Teneligliptin']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Kanto', 'country': 'Japan', 'facility': 'Reserch site'}, {'city': 'Kinki', 'country': 'Japan', 'facility': 'Reserch site'}, {'city': 'Tōhoku', 'country': 'Japan', 'facility': 'Reserch site', 'geoPoint': {'lat': 35.81882, 'lon': 139.57138}}], 'overallOfficials': [{'name': 'Takashi Kadowaki, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Tokyo University'}, {'name': 'Kazuoki Kondo, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Tanabe Pharma Corporation'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tanabe Pharma Corporation', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}