Viewing Study NCT02981966


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Ignite Modification Date: 2026-03-08 @ 3:19 AM
Study NCT ID: NCT02981966
Status: COMPLETED
Last Update Posted: 2024-03-04
First Post: 2016-11-30
Is Gene Therapy: True
Has Adverse Events: True

Brief Title: Effect of Dapagliflozin on Hepatic and Renal Glucose Metabolism Subjects
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': 'C529054', 'term': 'dapagliflozin'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'defronzo@uthscsa.edu', 'phone': '210-567-6691', 'title': 'Ralph DeFronzo, MD', 'organization': 'UTexas_SanAntonio'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '4 years', 'eventGroups': [{'id': 'EG000', 'title': 'T2DM Individuals on Dapagliflozin', 'description': 'Individuals with type 2 diabetes mellitus - dapagliflozin\n\nDapagliflozin: dapagliflozin, 10mg tablet', 'otherNumAtRisk': 13, 'deathsNumAtRisk': 13, 'otherNumAffected': 0, 'seriousNumAtRisk': 13, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'T2DM Individuals on Placebo', 'description': 'Individuals with type 2 diabetes mellitus on placebo\n\nPlacebo: Placebo for dapagliflozin', 'otherNumAtRisk': 7, 'deathsNumAtRisk': 7, 'otherNumAffected': 1, 'seriousNumAtRisk': 7, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Normal Glucose Tolerance (NGT) on Dapagliflozin', 'description': 'Individuals with normal glucose tolerance - dapagliflozin\n\nDapagliflozin: dapagliflozin, 10mg tablet', 'otherNumAtRisk': 8, 'deathsNumAtRisk': 8, 'otherNumAffected': 1, 'seriousNumAtRisk': 8, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Normal Glucose Tolerance (NGT) Placebo', 'description': 'Individuals with normal glucose tolerance - on placebo\n\nPlacebo: Placebo for dapagliflozin', 'otherNumAtRisk': 4, 'deathsNumAtRisk': 4, 'otherNumAffected': 0, 'seriousNumAtRisk': 4, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Transcient Syncope', 'notes': 'Participants had been lying in bed and got up too soon from the bed and felt dizzy.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Endogenous Glucose Production Measurement', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'T2DM Individuals on Dapagliflozin', 'description': 'Individuals with type 2 diabetes mellitus - dapagliflozin\n\nDapagliflozin: dapagliflozin, 10mg tablet'}, {'id': 'OG001', 'title': 'T2DM Individuals on Placebo', 'description': 'Individuals with type 2 diabetes mellitus on placebo\n\nPlacebo: Placebo for dapagliflozin'}, {'id': 'OG002', 'title': 'Normal Glucose Tolerance (NGT) on Dapagliflozin', 'description': 'Individuals with normal glucose tolerance - dapagliflozin\n\nDapagliflozin: dapagliflozin, 10mg tablet'}, {'id': 'OG003', 'title': 'Normal Glucose Tolerance (NGT) Placebo', 'description': 'Individuals with normal glucose tolerance - on placebo\n\nPlacebo: Placebo for dapagliflozin'}], 'classes': [{'categories': [{'measurements': [{'value': '155', 'spread': '6.4', 'groupId': 'OG000'}, {'value': '121', 'spread': '6.2', 'groupId': 'OG001'}, {'value': '104', 'spread': '4.2', 'groupId': 'OG002'}, {'value': '98', 'spread': '2', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': '3 weeks', 'description': 'Endogenous Glucose Production in NGT/T2DM subjects before and after dapagliflozin/Placebo administration from baseline to 240 minutes.', 'unitOfMeasure': 'mg/dl', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Renal Glucose Production Measurement of Change', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'T2DM Individuals on Dapagliflozin', 'description': 'Individuals with type 2 diabetes mellitus - dapagliflozin\n\nDapagliflozin: dapagliflozin, 10mg tablet'}, {'id': 'OG001', 'title': 'T2DM Individuals on Placebo', 'description': 'Individuals with type 2 diabetes mellitus on placebo\n\nPlacebo: Placebo for dapagliflozin'}, {'id': 'OG002', 'title': 'Normal Glucose Tolerance (NGT) on Dapagliflozin', 'description': 'Individuals with normal glucose tolerance - dapagliflozin\n\nDapagliflozin: dapagliflozin, 10mg tablet'}, {'id': 'OG003', 'title': 'Normal Glucose Tolerance (NGT) Placebo', 'description': 'Individuals with normal glucose tolerance - on placebo\n\nPlacebo: Placebo for dapagliflozin'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '0.09', 'spread': '0.04', 'groupId': 'OG000'}, {'value': '0.01', 'spread': '0.03', 'groupId': 'OG001'}, {'value': '0.03', 'spread': '0.09', 'groupId': 'OG002'}, {'value': '0.03', 'spread': '0.09', 'groupId': 'OG003'}]}]}, {'title': '3 weeks', 'categories': [{'measurements': [{'value': '0.17', 'spread': '0.05', 'groupId': 'OG000'}, {'value': '0.03', 'spread': '0.05', 'groupId': 'OG001'}, {'value': '0.09', 'spread': '0.1', 'groupId': 'OG002'}, {'value': '0.14', 'spread': '0.12', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to 3 weeks', 'description': 'Renal Glucose Production in T2DM and NGT subjects before and after dapagliflozin/placebo administration from baseline to 240 minutes.', 'unitOfMeasure': 'mg/kg.min', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'T2DM Individuals on Dapagliflozin', 'description': 'Individuals with type 2 diabetes mellitus - dapagliflozin\n\nDapagliflozin: dapagliflozin, 10mg tablet'}, {'id': 'FG001', 'title': 'T2DM Individuals on Placebo', 'description': 'Individuals with type 2 diabetes mellitus on placebo\n\nPlacebo: Placebo for dapagliflozin'}, {'id': 'FG002', 'title': 'Normal Glucose Tolerance (NGT) on Dapagliflozin', 'description': 'Individuals with normal glucose tolerance - dapagliflozin\n\nDapagliflozin: dapagliflozin, 10mg tablet'}, {'id': 'FG003', 'title': 'Normal Glucose Tolerance (NGT) Placebo', 'description': 'Individuals with normal glucose tolerance - on placebo\n\nPlacebo: Placebo for dapagliflozin'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '13'}, {'groupId': 'FG001', 'numSubjects': '7'}, {'groupId': 'FG002', 'numSubjects': '8'}, {'groupId': 'FG003', 'numSubjects': '4'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '13'}, {'groupId': 'FG001', 'numSubjects': '7'}, {'groupId': 'FG002', 'numSubjects': '8'}, {'groupId': 'FG003', 'numSubjects': '4'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '32', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'T2DM Individuals on Dapagliflozin', 'description': 'Individuals with type 2 diabetes mellitus - dapagliflozin\n\nDapagliflozin: dapagliflozin, 10mg tablet'}, {'id': 'BG001', 'title': 'T2DM Individuals on Placebo', 'description': 'Individuals with type 2 diabetes mellitus on placebo\n\nPlacebo: Placebo for dapagliflozin'}, {'id': 'BG002', 'title': 'Normal Glucose Tolerance (NGT) on Dapagliflozin', 'description': 'Individuals with normal glucose tolerance - dapagliflozin\n\nDapagliflozin: dapagliflozin, 10mg tablet'}, {'id': 'BG003', 'title': 'Normal Glucose Tolerance (NGT) Placebo', 'description': 'Individuals with normal glucose tolerance - on placebo\n\nPlacebo: Placebo for dapagliflozin'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '57', 'spread': '3', 'groupId': 'BG000'}, {'value': '58', 'spread': '1.7', 'groupId': 'BG001'}, {'value': '44', 'spread': '2.2', 'groupId': 'BG002'}, {'value': '47', 'spread': '4.9', 'groupId': 'BG003'}, {'value': '51.5', 'spread': '2.95', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '32', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '14', 'groupId': 'BG004'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '18', 'groupId': 'BG004'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}]}], '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'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Black or African American', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}]}, {'title': 'White', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '30', 'groupId': 'BG004'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '32', 'groupId': 'BG004'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2019-10-18', 'size': 451935, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2023-03-16T13:50', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 32}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-05-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2023-05-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-02-28', 'studyFirstSubmitDate': '2016-11-30', 'resultsFirstSubmitDate': '2023-05-10', 'studyFirstSubmitQcDate': '2016-12-02', 'lastUpdatePostDateStruct': {'date': '2024-03-04', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-05-10', 'studyFirstPostDateStruct': {'date': '2016-12-05', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2023-06-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-04-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Endogenous Glucose Production Measurement', 'timeFrame': '3 weeks', 'description': 'Endogenous Glucose Production in NGT/T2DM subjects before and after dapagliflozin/Placebo administration from baseline to 240 minutes.'}], 'secondaryOutcomes': [{'measure': 'Renal Glucose Production Measurement of Change', 'timeFrame': 'Baseline to 3 weeks', 'description': 'Renal Glucose Production in T2DM and NGT subjects before and after dapagliflozin/placebo administration from baseline to 240 minutes.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Diabetes Mellitus, Type 2']}, 'descriptionModule': {'briefSummary': 'Researchers hope to determine the organ (liver and/or kidney) responsible for the increase in endogenous glucose production (EGP) following the induction of glucosuria (when glucose is excreted in detectable amounts in the urine) with an SGLT2 inhibitor, dapagliflozin.', 'detailedDescription': 'Researchers will measure the rate of hepatic and renal glucose production following dapagliflozin administration to determine the site of increase in EGP, liver versus kidney. Researchers will measure the rate of whole body glucose production with 3-3H-glucose (a form of radioactive glucose) and renal glucose production by renal vein catheterization in T2DM (type 2 diabetes mellitus) and in lean healthy NGT (normal glucose tolerance) individuals. Because the increase in EGP is associated with an increase in plasma glucagon concentration and renal glucose production is stated to be unresponsive to glucagon, the investigators anticipate that the liver will be responsible, in part, for the increase in EGP.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 25-35 kg/m\\^2\n* Normal Glucose Tolerance subjects (24)\n* Type 2 Diabetic Subjects (24)\n* Diabetic subjects must be on a stable dose (more than 3 months) of monotherapy or combination therapy with metformin and/or a sulfonylurea\n* Diabetic subjects must have HbA1c \\<8.0%\n* Other than diabetes, subjects must be in good general health as determined by physical exam, medical history, blood chemistries, CBC (complete blood count), TSH (thyroid-stimulating hormone), T4 (thyroxine), EKG (electrocardiogram) and urinanalysis.\n* Only subjects whose body weight has been stable (± 3 lbs) over the preceding three months and who do not participate in an excessively heavy exercise program will be included.\n\nExclusion Criteria:\n\n* Subjects taking drugs known to affect glucose metabolism (other than metformin and sulfonylurea) will be excluded.\n* Individuals with evidence of proliferative diabetic retinopathy, plasma creatinine \\>1.4 females or \\>1.5 males, or 24-hour urine albumin excretion \\> 300 mg will be excluded.'}, 'identificationModule': {'nctId': 'NCT02981966', 'briefTitle': 'Effect of Dapagliflozin on Hepatic and Renal Glucose Metabolism Subjects', 'organization': {'class': 'OTHER', 'fullName': 'The University of Texas Health Science Center at San Antonio'}, 'officialTitle': 'Effect of Dapagliflozin on Hepatic and Renal Glucose Metabolism Subjects (11038)', 'orgStudyIdInfo': {'id': 'HSC20160596H'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'T2DM individuals on Dapagliflozin', 'description': 'Individuals with type 2 diabetes mellitus - dapagliflozin', 'interventionNames': ['Drug: Dapagliflozin']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'T2DM individuals on Placebo', 'description': 'Individuals with type 2 diabetes mellitus on placebo', 'interventionNames': ['Drug: Placebo']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Normal Glucose Tolerance (NGT) on Dapagliflozin', 'description': 'Individuals with normal glucose tolerance - dapagliflozin', 'interventionNames': ['Drug: Dapagliflozin']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Normal Glucose Tolerance (NGT) Placebo', 'description': 'Individuals with normal glucose tolerance - on placebo', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Dapagliflozin', 'type': 'DRUG', 'otherNames': ['Farxiga'], 'description': 'dapagliflozin, 10mg tablet', 'armGroupLabels': ['Normal Glucose Tolerance (NGT) on Dapagliflozin', 'T2DM individuals on Dapagliflozin']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo for dapagliflozin', 'armGroupLabels': ['Normal Glucose Tolerance (NGT) Placebo', 'T2DM individuals on Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '78229', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'University of Texas Health Science Center', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}], 'overallOfficials': [{'name': 'Eugenio Cersosimo, MD,PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The University of Texas Health Science Center at San Antonio'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The University of Texas Health Science Center at San Antonio', 'class': 'OTHER'}, 'collaborators': [{'name': 'AstraZeneca', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}