Ignite Creation Date:
2025-12-25 @ 4:48 AM
Ignite Modification Date:
2026-03-09 @ 10:56 PM
Study NCT ID:
NCT02920918
Status:
COMPLETED
Last Update Posted:
2019-10-29
First Post:
2016-09-22
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Treatment of Diabetes in Patients With Systolic Heart Failure
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D054143', 'term': 'Heart Failure, Systolic'}, {'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}], 'ancestors': [{'id': 'D006333', 'term': 'Heart Failure'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'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': {'email': 'scarbone@vcu.edu', 'phone': '804 628 3980', 'title': 'Salvatore Carbone', 'organization': 'Virginia Commonwealth University'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '12 weeks', 'description': 'An Adverse Event (AE) is any untoward medical occurrence in a clinical study subject administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the treatment. An event that is considered by the investigator(s) to be expected and related to the natural history of the disease is not considered an AE.', 'eventGroups': [{'id': 'EG000', 'title': 'Canagliflozin', 'description': 'Canagliflozin will be administered orally in pill form at 100 mg, daily for 12 weeks.\n\nCanagliflozin', 'otherNumAtRisk': 17, 'deathsNumAtRisk': 17, 'otherNumAffected': 7, 'seriousNumAtRisk': 17, 'deathsNumAffected': 0, 'seriousNumAffected': 3}, {'id': 'EG001', 'title': 'Sitagliptin', 'description': 'Sitagliptin will be administered orally in pill form at 100 mg, daily for 12 weeks.\n\nSitagliptin', 'otherNumAtRisk': 19, 'deathsNumAtRisk': 19, 'otherNumAffected': 6, 'seriousNumAtRisk': 19, 'deathsNumAffected': 0, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Genital infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypotensive event', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Arrhythmic events', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Acute kidney injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 19, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Influenza B', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Occlusion superficial femoral artery', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Heart failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Dizziness and acute kidney injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change From Baseline Aerobic Exercise Capacity at 12 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Canagliflozin', 'description': 'Canagliflozin will be administered orally in pill form at 100 mg, daily for 12 weeks.\n\nCanagliflozin'}, {'id': 'OG001', 'title': 'Sitagliptin', 'description': 'Sitagliptin will be administered orally in pill form at 100 mg, daily for 12 weeks.\n\nSitagliptin'}], 'classes': [{'categories': [{'measurements': [{'value': '0.67', 'spread': '2.10', 'groupId': 'OG000'}, {'value': '-0.53', 'spread': '1.75', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.083', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'We expected a baseline peak oxygen consumption (VO2) of 14.5 mL/kg/min. A sample size of 40 patients per group (total of 80 patients) provided sufficient power to detect a mean difference in the interval change in peak VO2 of 1.50±1.76 mL/kg/min (primary endpoint) expected with Canagliflozin compared to Sitagliptin, which we predict to have no significant effect on peak VO2 (0±1.76 mL/kg/min).', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'baseline and 12 weeks', 'description': 'Peak oxygen consumption (VO2) measured by maximal cardiopulmonary exercise test', 'unitOfMeasure': 'mL/kg/min', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Unadjusted p values were reported throughout, with statistical significance set at the 2-tailed 0.05 level. Only cases with available data used to compute the primary endpoint will be included in the analyses (16 subjects for canagliflozin group and 18 subjects for sitagliptin group).'}, {'type': 'PRIMARY', 'title': 'Change From Baseline Ventilatory Efficiency at 12 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Canagliflozin', 'description': 'Canagliflozin will be administered orally in pill form at 100 mg, daily for 12 weeks.\n\nCanagliflozin'}, {'id': 'OG001', 'title': 'Sitagliptin', 'description': 'Sitagliptin will be administered orally in pill form at 100 mg, daily for 12 weeks.\n\nSitagliptin'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.3', 'spread': '4.1', 'groupId': 'OG000'}, {'value': '-0.3', 'spread': '5.1', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.51', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'baseline and 12 weeks', 'description': 'Minute ventilation (VE) relative to CO2 production (VCO2) slope measured by cardiopulmonary exercise test', 'unitOfMeasure': 'Unitless', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Unadjusted p values were reported throughout, with statistical significance set at the 2-tailed 0.05 level. Only cases with available data used to compute the primary endpoint will be included in the analyses (16 subjects for canagliflozin group and 18 subjects for sitagliptin group).'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Canagliflozin', 'description': 'Canagliflozin will be administered orally in pill form at 100 mg, daily for 12 weeks.\n\nCanagliflozin'}, {'id': 'FG001', 'title': 'Sitagliptin', 'description': 'Sitagliptin will be administered orally in pill form at 100 mg, daily for 12 weeks.\n\nSitagliptin'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '17'}, {'groupId': 'FG001', 'numSubjects': '19'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '17'}, {'groupId': 'FG001', 'numSubjects': '19'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '36', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Canagliflozin', 'description': 'Canagliflozin will be administered orally in pill form at 100 mg, daily for 12 weeks.\n\nCanagliflozin'}, {'id': 'BG001', 'title': 'Sitagliptin', 'description': 'Sitagliptin will be administered orally in pill form at 100 mg, daily for 12 weeks.\n\nSitagliptin'}, {'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': '15', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '34', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '58.0', 'spread': '6.1', 'groupId': 'BG000'}, {'value': '54.3', 'spread': '8.8', 'groupId': 'BG001'}, {'value': '56.0', 'spread': '7.8', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '28', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '36', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Peak Oxygen Consumption', 'classes': [{'categories': [{'measurements': [{'value': '16.2', 'spread': '3.4', 'groupId': 'BG000'}, {'value': '15.3', 'spread': '3.5', 'groupId': 'BG001'}, {'value': '15.7', 'spread': '3.4', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Peak oxygen consumption (VO2) measured with maximal cardiopulmonary exercise test.', 'unitOfMeasure': 'mL/kg/min', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Ventilator Efficiency', 'classes': [{'categories': [{'measurements': [{'value': '34.1', 'spread': '6.1', 'groupId': 'BG000'}, {'value': '32.6', 'spread': '7.2', 'groupId': 'BG001'}, {'value': '33.3', 'spread': '6.7', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Minute ventilation (VE) relative to CO2 production (VCO2) slope measured by cardiopulmonary exercise test', 'unitOfMeasure': 'Unitless', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2016-12-08', 'size': 2555143, 'label': 'Study Protocol, Statistical Analysis Plan, and Informed Consent Form', 'hasIcf': True, 'hasSap': True, 'filename': 'Prot_SAP_ICF_000.pdf', 'typeAbbrev': 'Prot_SAP_ICF', 'uploadDate': '2019-09-22T17:47', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 36}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-10', 'completionDateStruct': {'date': '2018-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-10-28', 'studyFirstSubmitDate': '2016-09-22', 'resultsFirstSubmitDate': '2019-09-23', 'studyFirstSubmitQcDate': '2016-09-28', 'lastUpdatePostDateStruct': {'date': '2019-10-29', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-10-28', 'studyFirstPostDateStruct': {'date': '2016-09-30', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-10-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change From Baseline Aerobic Exercise Capacity at 12 Weeks', 'timeFrame': 'baseline and 12 weeks', 'description': 'Peak oxygen consumption (VO2) measured by maximal cardiopulmonary exercise test'}, {'measure': 'Change From Baseline Ventilatory Efficiency at 12 Weeks', 'timeFrame': 'baseline and 12 weeks', 'description': 'Minute ventilation (VE) relative to CO2 production (VCO2) slope measured by cardiopulmonary exercise test'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Systolic Heart Failure', 'Canagliflozin', 'Sitagliptin Phosphate', 'Type 2 Diabetes', 'SGLT2 inhibitor', 'DPPIV inhibitor'], 'conditions': ['Heart Failure, Systolic', 'Diabetes Mellitus, Type 2']}, 'descriptionModule': {'briefSummary': 'Investigator Initiated Study to study the effects of Canagliflozin 100 milligrams (mg) vs Sitagliptin 100 mg on parameters of aerobic exercise capacity (peak oxygen consumption \\[VO2\\]) and ventilator efficiency (minute ventilation \\[VE\\]/carbon dioxide production \\[VCO2\\] slope) at cardiopulmonary exercise test (CPET) after 12 weeks of active treatment (primary endpoints). Blood pressure (BP), body water content, body composition, cardiac function, and diet will be also measured (secondary endpoints).', 'detailedDescription': 'Investigator Initiated Study: Randomized, double-blinded, active-control clinical trial to determine the safety and efficacy of Canagliflozin and Sitagliptin in patients with type 2 diabetes and systolic heart failure (HF).\n\nThe investigators propose to study the effects of Canagliflozin 100 mg vs Sitagliptin 100 mg (both administered once daily for 12 weeks) on parameters of aerobic exercise capacity and ventilator efficiency by CPET after 12 weeks of active treatment. BP, body water content (Bioelectrical Impedance Analysis \\[BIA\\]), body composition (Dual-energy X-ray absorptiometry \\[DEXA\\]), cardiac function, diet and biomarkers will be also measured. Subjects with evidence of left ventricular hypertrophy will undergo cardiac magnetic resonance (CMR) imaging.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Major Inclusion Criteria:\n\n* Symptomatic stable heart failure (New York Heart Association (NYHA) functional classification II-III) with reduced left ventricular ejection fraction (LVEF) ≤40%\n* Peak exercise limited by shortness of breath and associated with a respiratory exchange ratio (RER) \\>1.00 (reflecting maximal aerobic effort);\n* Poorly controlled Type 2 Diabetes Mellitus (T2DM)(HbA1c levels between 7.0% and 10.0% if on a treatment regimen including insulin, or between 6.5% and 10.0% if not on an insulin regimen);\n* Eighteen years of age or older.\n\nMajor Exclusion Criteria:\n\n* Type I diabetes;\n* Open label treatment with Sodium-GLucose coTransporter (SGLT)-2 inhibitors (within the past 3 months);\n* Current treatment with thiazolidinedione (within the past 3 months);\n* Chronic Renal Disease defined as Glomerular Filtration Rate (GFR) \\<50 ml•min-1/1.73m2 according to local laboratory\n* Pregnancy or of child-bearing potential or lactating;\n* Active or recent (within 2 weeks) genital/urinary infection;\n* Concomitant conditions or treatment which would affect completion or interpretation of the study (i.e, physical inability to walk or run on a treadmill\n* Inability to give informed consent.\n\nExclusion criteria specific to the cardiac magnetic resonance (CMR) substudy.\n\n* Estimated GFR \\<60 ml•min-1/1.73m2\n* Implantable cardioverter defibrillator, pacemaker or other implantable metal device not compatible with CMR scanning;\n* Severe claustrophobia, inability to lay flat for up to 60 minutes, or other contraindication to CMR scanning.'}, 'identificationModule': {'nctId': 'NCT02920918', 'briefTitle': 'Treatment of Diabetes in Patients With Systolic Heart Failure', 'organization': {'class': 'OTHER', 'fullName': 'Virginia Commonwealth University'}, 'officialTitle': 'A Randomized Active-Control Double-Blinded Study to Evaluate the Treatment of Diabetes in Patients With Systolic Heart Failure', 'orgStudyIdInfo': {'id': 'HM20007043'}, 'secondaryIdInfos': [{'id': '28431754DIATBD', 'type': 'OTHER_GRANT', 'domain': 'Janssen Scientific Affairs'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Canagliflozin', 'description': 'Canagliflozin will be administered orally in pill form at 100 mg, daily for 12 weeks.', 'interventionNames': ['Drug: Canagliflozin']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Sitagliptin', 'description': 'Sitagliptin will be administered orally in pill form at 100 mg, daily for 12 weeks.', 'interventionNames': ['Drug: Sitagliptin']}], 'interventions': [{'name': 'Canagliflozin', 'type': 'DRUG', 'otherNames': ['Invokana'], 'armGroupLabels': ['Canagliflozin']}, {'name': 'Sitagliptin', 'type': 'DRUG', 'otherNames': ['Januvia'], 'armGroupLabels': ['Sitagliptin']}]}, 'contactsLocationsModule': {'locations': [{'zip': '23298', 'city': 'Richmond', 'state': 'Virginia', 'country': 'United States', 'facility': 'Virginia Commonwealth University', 'geoPoint': {'lat': 37.55376, 'lon': -77.46026}}], 'overallOfficials': [{'name': 'Antonio Abbate, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Virginia Commonwealth University'}]}, 'ipdSharingStatementModule': {'url': 'https://www.eventscribe.com/2019/HFSA/PosterTitles.asp?pfp=PosterTitles', 'infoTypes': ['CSR'], 'timeFrame': 'Data were presented as late breaking clinical trial at the Heart Failure Society of America (HFSA) 2019 in Philadelphia as poster presentation.', 'ipdSharing': 'YES', 'description': 'The investigators plan to present the data promptly upon analysis as an abstract to a national meeting and/or a manuscript.', 'accessCriteria': 'Data in the form of poster were made available from HFSA.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Virginia Commonwealth University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Janssen Scientific Affairs, LLC', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}