Ignite Creation Date:
2025-12-25 @ 12:17 AM
Ignite Modification Date:
2025-12-31 @ 5:56 PM
Study NCT ID:
NCT04927858
Status:
COMPLETED
Last Update Posted:
2021-07-22
First Post:
2021-06-10
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study Using Swedish Registries to Find Out How Many People With Type 2 Diabetes Had Cardiovascular Disease and Started Treatment With Empagliflozin Between 2015 and 2017
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': 'C570240', 'term': 'empagliflozin'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clinicaltriage.rdg@boehringer-ingelheim.com', 'phone': '1-800-243-0217', 'title': 'Boehringer Ingelheim, Call Center', 'organization': 'Boehringer Ingelheim'}, 'certainAgreement': {'otherDetails': "Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI's intellectual property rights.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Adverse event information was not applicable for this study.', 'description': 'As this is a non-interventional study with secondary use of data retrieved from Swedish Databases safety monitoring and safety reporting on an individual case level is not applicable. All-Cause Mortality, Serious Adverse Events and Other Adverse Events are not collected in the database. "0" total Number of Participants at Risk means "All-Cause Mortality, Serious, and Other (Not Including Serious) Adverse Events were not monitored/assessed".', 'eventGroups': [{'id': 'EG000', 'title': 'Overall Type 2 Diabetes Mellitus Population', 'description': 'This arm included all patients ≥ 18 years old on 31st of December 2017 with Type 2 Diabetes Mellitus (T2DM) who were alive on 31st of December 2017 and had at least one registration in the Swedish National Diabetes Registry (NDR) between 1996 - 2017.', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Prevalence of a History of Cardiovascular Disease (CVD) Among Swedish Patients With Type 2 Diabetes Mellitus (T2DM) Who Were Alive on 31st of December 2017', 'denoms': [{'units': 'Participants', 'counts': [{'value': '460558', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Overall Type 2 Diabetes Mellitus Population', 'description': 'This arm included all patients ≥ 18 years old on 31st of December 2017 with Type 2 Diabetes Mellitus (T2DM) who were alive on 31st of December 2017 and had at least one registration in the Swedish National Diabetes Registry (NDR) between 1996 - 2017.'}], 'classes': [{'categories': [{'title': 'With history of CVD', 'measurements': [{'value': '130508', 'groupId': 'OG000'}]}, {'title': 'Without history of CVD', 'measurements': [{'value': '330050', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Data collected at the index date 31st of December 2017, data covering a time period from 1996 until 2017, up to 21 years.', 'description': 'The number of participants with a history of CVD and without a history of CVD among patients who had Type 2 Diabetes Mellitus (T2DM) and were ≥ 18 years old on 31st of December 2017, and were alive on 31st of December 2017, and had at least one registration in the Swedish National Diabetes Registry (NDR) between 1996 - 2017 is reported. History of CVD was defined as a history of either coronary heart disease, stroke, amputation, percutaneous coronary intervention, coronary artery bypass surgery, peripheral vascular disease, or carotid or femoral angioplasty.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All patients ≥ 18 years old on 31st of December 2017 with Type 2 Diabetes Mellitus (T2DM) who were alive on 31st of December 2017 and had at least one registration in the Swedish National Diabetes Registry (NDR) between 1996 - 2017.'}, {'type': 'PRIMARY', 'title': 'Prevalence of a History of CVD Among Swedish Patients With T2DM Who Started Empagliflozin Treatment Between 1st of January 2015 and 31st of December 2017', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16985', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Empagliflozin Type 2 Diabetes Mellitus Population', 'description': 'Patients with Type 2 Diabetes Mellitus (T2DM) who were initiated on Empagliflozin between 1st of January 2015 and 31st of December 2017, who had at least one registration in the Swedish National Diabetes Register (NDR).'}], 'classes': [{'categories': [{'title': 'With history of CVD', 'measurements': [{'value': '1952', 'groupId': 'OG000'}]}, {'title': 'Without history of CVD', 'measurements': [{'value': '15033', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Data collected at the index date 31st of December 2017, data covering a time period from 1996 until 2017, up to 21 years.', 'description': 'The number of participants with a history of CVD and without a history of CVD among patients with Type 2 Diabetes Mellitus (T2DM) who were initiated on Empagliflozin between 1st of January 2015 and 31st of December 2017, who had at least one registration in the Swedish National Diabetes Register (NDR). History of CVD was defined as a history of either coronary heart disease, stroke, amputation, percutaneous coronary intervention, coronary artery bypass surgery, peripheral vascular disease, or carotid or femoral angioplasty.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All patients with Type 2 Diabetes Mellitus (T2DM) who were initiated on Empagliflozin between 1st of January 2015 to 31st of December 2017, who had at least one registration in the Swedish National Diabetes Register (NDR).'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Overall Type 2 Diabetes Mellitus Population', 'description': 'This arm included all patients ≥ 18 years old on 31st of December 2017 with Type 2 Diabetes Mellitus (T2DM) who were alive on 31st of December 2017 and had at least one registration in the Swedish National Diabetes Registry (NDR) between 1996 - 2017.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '460558'}]}, {'type': 'Treated With Empagliflozin', 'comment': 'Patients with Type 2 Diabetes Mellitus (T2DM) who were initiated on Empagliflozin between 1st of January 2015 and 31st of December 2017, who had at least one registration in the Swedish National Diabetes Register (NDR).', 'achievements': [{'groupId': 'FG000', 'numSubjects': '16985'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '460558'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'This retrospective study assessed the prevalence of cardiovascular disease in Swedish patients with type 2 diabetes mellitus (T2DM) and in Swedish patients with T2DM initiating on empagliflozin.', 'preAssignmentDetails': 'This study was conducted using data collected from the Swedish National Diabetes Register (NDR) as well as the Swedish Prescribed Drug Register (SPDR) and the Swedish National Patient Register (NPR) (National Board of Health and Welfare). The observation period was from 1996 to end of December 2017.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '460558', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Overall Type 2 Diabetes Mellitus Population', 'description': 'This arm included all patients ≥ 18 years old on 31st of December 2017 with Type 2 Diabetes Mellitus (T2DM) who were alive on 31st of December 2017 and had at least one registration in the Swedish National Diabetes Registry (NDR) between 1996 - 2017.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '460558', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '68.4', 'spread': '12.3', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '460558', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '197459', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '263099', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}], 'populationDescription': 'All patients ≥ 18 years old on 31st of December 2017 with Type 2 Diabetes Mellitus (T2DM) who were alive on 31st of December 2017 and had at least one registration in the Swedish National Diabetes Registry (NDR) between 1996 - 2017.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-02-22', 'size': 261397, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_001.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2021-07-21T03:26', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 460558}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-04-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-07', 'completionDateStruct': {'date': '2018-11-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-07-21', 'studyFirstSubmitDate': '2021-06-10', 'resultsFirstSubmitDate': '2021-06-16', 'studyFirstSubmitQcDate': '2021-06-10', 'lastUpdatePostDateStruct': {'date': '2021-07-22', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-06-16', 'studyFirstPostDateStruct': {'date': '2021-06-16', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2021-07-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-11-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Prevalence of a History of Cardiovascular Disease (CVD) Among Swedish Patients With Type 2 Diabetes Mellitus (T2DM) Who Were Alive on 31st of December 2017', 'timeFrame': 'Data collected at the index date 31st of December 2017, data covering a time period from 1996 until 2017, up to 21 years.', 'description': 'The number of participants with a history of CVD and without a history of CVD among patients who had Type 2 Diabetes Mellitus (T2DM) and were ≥ 18 years old on 31st of December 2017, and were alive on 31st of December 2017, and had at least one registration in the Swedish National Diabetes Registry (NDR) between 1996 - 2017 is reported. History of CVD was defined as a history of either coronary heart disease, stroke, amputation, percutaneous coronary intervention, coronary artery bypass surgery, peripheral vascular disease, or carotid or femoral angioplasty.'}, {'measure': 'Prevalence of a History of CVD Among Swedish Patients With T2DM Who Started Empagliflozin Treatment Between 1st of January 2015 and 31st of December 2017', 'timeFrame': 'Data collected at the index date 31st of December 2017, data covering a time period from 1996 until 2017, up to 21 years.', 'description': 'The number of participants with a history of CVD and without a history of CVD among patients with Type 2 Diabetes Mellitus (T2DM) who were initiated on Empagliflozin between 1st of January 2015 and 31st of December 2017, who had at least one registration in the Swedish National Diabetes Register (NDR). History of CVD was defined as a history of either coronary heart disease, stroke, amputation, percutaneous coronary intervention, coronary artery bypass surgery, peripheral vascular disease, or carotid or femoral angioplasty.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Type 2 Diabetes Mellitus']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.mystudywindow.com', 'label': 'Related info'}]}, 'descriptionModule': {'briefSummary': 'This study aims to describe the prevalence of type 2 diabetes mellitus (T2DM) patients with established cardiovascular disease (CVD) according to the (Empagliflozin) Cardiovascular Outcome Event Trial in Type 2 Diabetes Mellitus Patients (EMPA-REG OUTCOME (ERO)) study definition in a Swedish population.\n\nThe aim was also to describe the prevalence of established CVD according to ERO study definition in patients with T2DM who initiates treatment with empagliflozin'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The study population includes patients with T2DM and age ≥18 years on 2017-12-31 and who had at least one registration in the Swedish National Diabetes Register (NDR) between 1996 - 2017.', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion criteria\n\nPopulation 1: 'Prevalence of a history of cardiovascular disease (CVD) among persons with type 2 diabetes mellitus (T2DM) who were alive on 31 December 2017' :\n\n* Diagnosed with T2DM in Sweden\n* Alive on 31 December 2017\n* At least one registration in the Swedish National Diabetes Register (NDR)\n* Each patient provides informed consent for inclusion in the register\n\nPopulation 2: 'Prevalence of a history of CVD among persons with type 2 diabetes who started empagliflozin treatment between 1 January 2015 and 31 December 2017':\n\n* Diagnosed with T2DM in Sweden\n* Alive on 31 December 2017\n* Initiated on empagliflozin between 1 January 2015 and 31 December 2017\n* At least one registration in the NDR\n* Each patient provides informed consent for inclusion in the register\n\nExclusion criteria:\n\nnone"}, 'identificationModule': {'nctId': 'NCT04927858', 'briefTitle': 'A Study Using Swedish Registries to Find Out How Many People With Type 2 Diabetes Had Cardiovascular Disease and Started Treatment With Empagliflozin Between 2015 and 2017', 'organization': {'class': 'INDUSTRY', 'fullName': 'Boehringer Ingelheim'}, 'officialTitle': 'Prevalence of Cardiovascular Disease in Swedish Patients With Type 2 Diabetes and in Patients Initiating on Empagliflozin', 'orgStudyIdInfo': {'id': '1245-0190'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Population 1', 'description': 'Patients ≥ 18 years old on 31st of December 2017 with Type 2 Diabetes Mellitus (T2DM) who were alive on 31st of December 2017 and had at least one registration in the Swedish National Diabetes Registry (NDR) between 1996 - 2017.'}, {'label': 'Population 2', 'description': 'Population 2 is a sub-population of population 1. Patients with Type 2 Diabetes Mellitus (T2DM) who were initiated on Empagliflozin between 1st of January 2015 and 31st of December 2017, who had at least one registration in the Swedish National Diabetes Register (NDR).', 'interventionNames': ['Drug: Empagliflozin']}], 'interventions': [{'name': 'Empagliflozin', 'type': 'DRUG', 'description': 'Empagliflozin', 'armGroupLabels': ['Population 2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '120 06', 'city': 'Stockholm', 'country': 'Sweden', 'facility': 'Boehringer Ingelheim AB', 'geoPoint': {'lat': 59.32938, 'lon': 18.06871}}]}, 'ipdSharingStatementModule': {'url': 'https://www.mystudywindow.com/msw/datasharing', 'infoTypes': ['SAP', 'CSR'], 'timeFrame': 'After all regulatory activities are completed in the US and European Union (EU) for the product and indication, and after the primary manuscript has been accepted for publication.', 'ipdSharing': 'YES', 'description': 'After the study is completed and the primary manuscript is accepted for publishing, researchers can use this following link https://www.mystudywindow.com/msw/datasharing to request access to the clinical study documents regarding this study, and upon a signed "Document Sharing Agreement".\n\nAlso, Researchers can use the following link https://www.mystudywindow.com/msw/datasharing to find information in order to request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined in the website.\n\nThe data shared are the raw clinical study data sets', 'accessCriteria': "For study documents - upon signing of a 'Document Sharing Agreement'. For study data - 1. after the submission and approval of the research proposal (checks will be performed by both the independent review panel and the sponsor, including checking that the planned analysis does not compete with sponsor's publication plan); 2. and upon signing of a 'Data Sharing Agreement'."}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Boehringer Ingelheim', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}