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Clinical Trial Details

Trial ID: L5090
Source ID: NCT03363464
Associated Drug: Empagliflozin
Title: Comparative Effectiveness of Empagliflozin in the US
Acronym:
Status: ACTIVE_NOT_RECRUITING
Study Results: NO
Results:
Conditions: Diabetes Mellitus, Type 2
Interventions: DRUG: Empagliflozin|DRUG: DPP-4 inhibitor|DRUG: GLP-1 receptor agonist
Outcome Measures: Primary: 3-point major adverse cardiovascular events (MACE), i.e., non-fatal myocardial infarction (MI), non-fatal stroke, or cardiovascular (CV) mortality; as well as each individual component: * Hospital admission for MI (for purposes of this individual component, fatal MI is included) * Hospital admission for stroke (for purposes of this individual component, fatal stroke is included) * CV mortality, 60 months|Hospitalization for heart failure (specific, based on primary inpatient diagnosis code), 60 months|Hospitalization for heart failure (broad, based on any inpatient diagnosis code), 60 months|Modified MACE, i.e., composite of MI, stroke or all-cause mortality, 60 months|Composite of MI or stroke hospital admission for heart failure, 60 months|All-cause mortality, 60 months | Secondary: Coronary revascularization procedure, 60 months|Hospitalization for unstable angina, 60 months|Composite of MI, stroke, unstable angina hospitalization or coronary revascularization, 60 months|End-stage renal disease (ESRD), 60 months|Bone fracture, 60 months|Diabetic ketoacidosis (Inpatient, primary position), 60 months|Diabetic ketoacidosis (Inpatient, any position), 60 months|Severe hypoglycemia, 60 months|Urinary tract cancers, 60 months|Lower-limb amputation, 60 months|Acute kidney injury (Inpatient, primary), 60 months|Acute kidney injury (Inpatient, any position), 60 months
Sponsor/Collaborators: Sponsor: Boehringer Ingelheim | Collaborators: Eli Lilly and Company
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases:
Enrollment: 230000
Study Type: OBSERVATIONAL
Study Designs: Observational Model: |Time Perspective: p
Start Date: 2017-10-16
Completion Date: 2025-12-31
Results First Posted:
Last Update Posted: 2025-04-15
Locations: Bringham Women Hospital, Boston, Massachusetts, 02120, United States
URL: https://clinicaltrials.gov/show/NCT03363464