[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100275411":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":26,"centralContacts":10,"locations":29,"responsibleParty":35,"collaborators":37,"id":40,"slug":41,"hasResults":42,"nctId":43,"briefTitle":44,"officialTitle":45,"acronym":10,"eligibilityCriteria":46,"healthyVolunteers":47,"sex":48,"minAge":49,"maxAge":10,"enrollmentInfo":50,"targetDuration":10,"studyType":53,"phases":10,"briefSummary":54,"conditions":55,"keywords":10,"overallStatus":57,"whyStopped":10,"lastUpdateSubmitDate":58,"lastUpdatePostDateStruct":59,"startDateStruct":61,"completionDateStruct":63,"leadSponsor":65,"locationsCount":66},{"fullName":5,"class":6},"Boehringer Ingelheim","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Empagliflozin",null,"All eligible patients type 2 diabetes mellitus initiating Empagliflozin treatment within the study period, from existing data of routine medical care in the Clinical Practice Research Datalink (CPRD) in the United Kingdom (UK), HealthCore Integrated Research Database (HIRD) in the United States (US), and Danish Population Registries (Danish Registries) in Denmark.\n\nThe study period started on 01 August 2014, the date of empagliflozin launch in the UK, US, and Denmark. The study end date was 01 August 2019 in CPRD and Danish Registries and 31 July 2019 in HIRD.",[13],"Drug: Empagliflozin",{"label":15,"type":10,"description":16,"interventionNames":17},"DPP-4 inhibitors","All eligible patients with type 2 diabetes mellitus initiating Dipeptidyl peptidase-4 (DPP-4) inhibitors treatment within the study period, existing data of routine medical care in the Clinical Practice Research Datalink (CPRD) in the United Kingdom (UK), HealthCore Integrated Research Database (HIRD) in the United States (US), and Danish Population Registries (Danish Registries) in Denmark.\n\nThe study period started on 01 August 2014, the date of empagliflozin launch in the UK, US, and Denmark. The study end date was 01 August 2019 in CPRD and Danish Registries and 31 July 2019 in HIRD.",[18],"Drug: DPP-4 inhibitors",[20,24],{"type":21,"name":9,"description":22,"armGroupLabels":23,"otherNames":10},"DRUG","drug",[9],{"type":21,"name":15,"description":22,"armGroupLabels":25,"otherNames":10},[15],[27],{"name":5,"affiliation":5,"role":28},"STUDY_CHAIR",[30],{"facility":31,"status":10,"city":32,"state":10,"zip":10,"country":33,"countryCode":34,"cosmosGeoPoint":10,"geoPoint":10,"contacts":10},"RTI health solutions","One Or Multiple Sites","United Kingdom","UK",{"type":36,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR",[38],{"name":39,"class":6},"Eli Lilly and Company","100275411","post-authorisation-safety-study-in-patients-with-type-2-diabetes-to-assess-the-risk-of-liver-injury-kidney-injury-urinary-tract-and-genital-infections-and-diabetic-ketoacidosis-in-patients-treated-with-empagliflozin-compared-to-dpp-4-inhibitors-100275411",true,"NCT02864914","Post-authorisation Safety Study in Patients With Type 2 Diabetes to Assess the Risk of Liver Injury, Kidney Injury, Urinary Tract and Genital Infections, and Diabetic Ketoacidosis in Patients Treated With Empagliflozin, Compared to DPP-4 Inhibitors","Post-authorisation Safety Study in Patients With Type 2 Diabetes Mellitus to Assess the Risk of Acute Liver Injury, Acute Kidney Injury and Chronic Kidney Disease, Severe Complications of Urinary Tract Infection, Genital Infections, and Diabetic Ketoacidosis Among Patients Treated With Empagliflozin Compared to Patients Treated With DPP-4 Inhibitors","Inclusion criteria:\n\n* Patients will have T2DM, be initiating treatment with a study medication, and have at least 12 months of continuous registration in CPRD.\n* Further inclusion criteria apply\n\nExclusion criteria:\n\n* Patients will not have T1DM, will have no prior use of an SGLT2 inhibitor or DPP4 inhibitor, and will not be initiating a SGLT2-DPP4 fixed-dose combination.\n* Additional different exclusion criteria will be applied according to each outcomes of interest.",false,"ALL","18 Years",{"count":51,"type":52},333580,"ACTUAL","OBSERVATIONAL","Empagliflozin (Jardiance), a highly potent and selective inhibitor of the sodium-glucose cotransporter 2 (SGLT2), was approved in Europe in May 2014 for the treatment of type 2 diabetes mellitus (T2DM) to improve glycaemic control in adults. As part of the risk management plan, Boehringer Ingelheim International GmbH (BI) has committed to conduct a post-authorisation safety study (PASS) to evaluate the liver and renal safety of empagliflozin. The study will also evaluate the risks of severe complications of urinary tract infections (UTIs) and genital infections. To evaluate the association between empagliflozin use and mentioned outcomes routinely collected health information from the Clinical Practice Research Datalink (CPRD), the Hospital Episodes Statistics, and Office of National Statistic will be used. This PASS will be conducted through an observational cohort study among adult patients with T2DM and at least 12 months of continuous enrolment in the CPRD where new users of empagliflozin will be compared to new users of dipeptidyl peptidase-4 (DPP4) inhibitors. Estimations will be made on the crude and adjusted incidence rates and adjusted incidence rate ratios of the primary and secondary outcomes.",[56],"Diabetes Mellitus, Type 2","COMPLETED","2024-09-17",{"date":60,"type":52},"2024-11-15",{"date":62,"type":52},"2016-03-15",{"date":64,"type":52},"2022-07-29",{"name":5,"class":6},1]