A Study of Tirzepatide (LY3298176) Compared With Dulaglutide on Major Cardiovascular Events in Participants With Type 2 Diabetes

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Eli Lilly and Company
Study ID
NCT04255433
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
40 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

The purpose of the trial is to assess the efficacy and safety of tirzepatide to dulaglutide in participants with type 2 diabetes and increased cardiovascular risk.

Key Dates

Start date
May 29, 2020
Status verified
Aug 2025
Primary completion
Jun 12, 2025
Completion
Jun 12, 2025

Study Design

Enrollment
13,299 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Tirzepatide
    Tirzepatide administered subcutaneously (SC) once a week.
  • Active Comparator: Dulaglutide
    Dulaglutide administered SC once a week.

Primary Outcome Measure

Time to First Occurrence of Death from Cardiovascular (CV) Causes, Myocardial Infarction (MI), or Stroke (MACE-3) [ Time Frame: Randomization up to Study Completion (Approximate Maximum 54 Months) ]

Locations (121)

FacilityCityStateZIPSite coordinators
University of Alabama at Birmingham Medical CenterBirminghamAlabama35294-0012-
John Muir Medical Center - Concord CampusConcordCalifornia94520-
Valley Clinical Trials, Inc.CovinaCalifornia91723-
AMCR InstituteEscondidoCalifornia92025-
Valley ResearchFresnoCalifornia93720-
NorCal Medical Research, IncGreenbraeCalifornia94904-
UCSD - Altman Clinical and Translational Research Institute (ACTRI)La JollaCalifornia92037-
First Valley Medical GroupLancasterCalifornia93534-
Monterey Endocrine & Diabetes Institute, Inc.MontereyCalifornia93940-
Riverside University Health System - Medical CenterMoreno ValleyCalifornia92555-
Diabetes Associates Medical GroupOrangeCalifornia92868-
Pasadena Clinical ResearchPasadenaCalifornia91105-
LCGK ResearchSan CarlosCalifornia94070-
Norcal Endocrinology & Internal MedicineSan RamonCalifornia94583-
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical CenterTorranceCalifornia90502-
University of Colorado Anschutz Medical CampusAuroraColorado80045-
CMR of Greater New Haven, LLCHamdenConnecticut06517-
Chase Medical Research, LLCWaterburyConnecticut06708-
Orlando Heart & Vascular Institute, LLCAltamonte SpringsFlorida32714-
Excel Medical Clinical TrialsBoca RatonFlorida33434-
Encore Medical ResearchHollywoodFlorida33024-
East Coast Institute for Research, LLCJacksonvilleFlorida32204-
Jacksonville Center for Clinical ResearchJacksonvilleFlorida32216-
Accel Research Sites - St. Pete-Largo Clinical Research UnitLargoFlorida33777-
Ocala Caridovascular ResearchOcalaFlorida34474-
Cardiology Partners Clinical Research Institute - Palm Beach GardensPalm Beach GardensFlorida33410-
Peace River Cardiovascular CenterPort CharlotteFlorida33952-
Professional Health Care of PinellasSt. PetersburgFlorida33713-
Cardiology Partners Clinical Research Institute - WellingtonWellingtonFlorida33449-
Clinical Research of Central FloridaWinter HavenFlorida33880-
Atlanta Diabetes AssociatesAtlantaGeorgia30318-
Kaiser Permanente - Dutluth, GADuluthGeorgia30096-
NSC ResearchJohns CreekGeorgia30024-
Physicians Research AssociatesLawrencevilleGeorgia30045-
East Coast Institute for Research at The Jones CenterMaconGeorgia31210-
Atlanta Heart SpecialistsTuckerGeorgia30084-
East-West Medical Research InstituteHonoluluHawaii96814-
VA Pacific Islands Health Care SystemHonoluluHawaii96819-
Elite Clinical TrialsBlackfootIdaho83221-
Rocky Mountain Clinical ResearchIdaho FallsIdaho83404-
Northwest Heart Clinical ResearchArlington HeightsIllinois60005-
Cedar-Crosse Research CenterChicagoIllinois60607-
Clinical Investigation SpecialistsGurneeIllinois60031-
Central Illinois Diabetes and Clinical Research a Division of Prairie Education and Research CooperativeSpringfieldIllinois62711-
University of IowaIowa CityIowa52242-
Iowa Diabetes and Endocrinology Research CenterWest Des MoinesIowa50266-
The University of Kansas - Clinical Research CenterFairwayKansas66205-
Cotton O'Neil Diabetes & EndocrinologyTopekaKansas66606-
Cotton O'Neil MulvaneTopekaKansas66606-
Qualmedica ResearchBowling GreenKentucky42101-
L-MARC Research CenterLouisvilleKentucky40213-
Qualmedica Research, LLCOwensboroKentucky42301-
Ascension Saint Agnes Heart CareBaltimoreMaryland21229-
MedStar Health Research Institute (MedStar Physician Based Research Network)HyattsvilleMaryland20782-
MD Medical ResearchOxon HillMaryland20745-
Endocrine and Metabolic ConsultantsRockvilleMaryland20852-
Brigham and Women's Hospital Diabetes ProgramBostonMassachusetts02115-
Joslin Diabetes CenterBostonMassachusetts02215-
ActivMed Practices and ResearchMethuenMassachusetts01844-
Infinity Medical ResearchNorth DartmouthMassachusetts02747-
Arcturus Healthcare , PLC, Troy Internal Medicine Research DivisionTroyMichigan48098-
St. John's HospitalEdinaMinnesota55435-
M Health Fairview St. John's HospitalMaplewoodMinnesota55109-
CentraCare Heart & Vascular CenterSaint CloudMinnesota56303-
StudyMetrix ResearchCity of Saint PetersMissouri63303-
Clinvest Research LLCSpringfieldMissouri65807-
Mercy Research - Smith Glynn CallawaySpringfieldMissouri65807-
Billings ClinicBillingsMontana59101-
Mercury Street Medical Group, PLLCButteMontana59701-
University Of Nebraska Medical CenterOmahaNebraska68198-4130-
VA Nebraska-Western Iowa Health Care SystemOmahaNebraska68105-
Palm Research Center SunsetLas VegasNevada89148-
Palm Research Center TenayaLas VegasNevada89128-
Southern Nh Diabetes and EndocrinologyNashuaNew Hampshire03060-
Albany Medical College, Division of Community EndocrinologyAlbanyNew York12203-
Great Lakes Medical Research, LLCWestfieldNew York14787-
Atrium Health - Department of Family Medicine ResearchCharlotteNorth Carolina28207-
Duke UniversityDurhamNorth Carolina27710-
PMG Research Inc., d/b/a PMG of Piedmont HealthcareMooresvilleNorth Carolina28117-
Accellacare - WilmingtonWilmingtonNorth Carolina24801-
Lillestol ResearchFargoNorth Dakota58104-
Cleveland Clinic FoundationClevelandOhio44195-
Alliance for Multispecialty Research, LLCNormanOklahoma73069-
Heritage Valley Medical Group, Inc.BeaverPennsylvania15009-
Capital Area Research, LLCCamp HillPennsylvania17011-
Decpa, LlcFeastervillePennsylvania19053-
Northeast Endocrine Metabolic AssociatesPhiladelphiaPennsylvania19114-
Thomas Jefferson University - Clinical Research InstitutePhiladelphiaPennsylvania19107-
Preferred Primary Care Physicians, Preferred Clinical Research (Ofc 18)PittsburghPennsylvania15236-
Cardiology Consultants of Philadelphia YardleyYardleyPennsylvania19067-
Ralph H. Johnson VA Medical CenterCharlestonSouth Carolina29401-
Tribe Clinical Research, LLCGreenvilleSouth Carolina29607-
Accellacare - Mt PleasantMt. PleasantSouth Carolina29464-
Monument Health Rapid City HospitalRapid CitySouth Dakota57701-
Holston Medical GroupBristolTennessee37620-
PMG Research, Inc. d/b/a PMG Research of KnoxvilleKnoxvilleTennessee37938-
Endocrine ClinicMemphisTennessee38119-
Private Practice - Dr. Osvaldo A. BruscoCorpus ChristiTexas78414-
Dallas Diabetes Research CenterDallasTexas75230-
Galenos ResearchDallasTexas75251-
North Texas Endocrine CenterDallasTexas75231-
Research Institute of DallasDallasTexas75231-
Texas Health Physicians GroupDallasTexas75231-
Academy of Diabetes, Thyroid and EndocrineEl PasoTexas79935-
Diabetes and Thyroid Center of Ft. WorthFort WorthTexas76132-
Northwest Houston Cardiology - CypressHoustonTexas77070-
Southern Endocrinology AssociatesMesquiteTexas75149-
North Hills Family Medicine/North Hills Medical ResearchNorth Richland HillsTexas76180-
Audie L Murphy VA HospitalSan AntonioTexas75231-
Consano Clinical Research, LLCShavano ParkTexas78231-
Northwest Houston Heart CenterTomballTexas77375-
Physicians' Research OptionsDraperUtah84020-
Advanced Research InstituteOgdenUtah84405-
Alpine Medical GroupSalt Lake CityUtah84102-
Kalo Clinical ResearchWest Valley CityUtah84120-
Virginia HeartFalls ChurchVirginia22042-
MultiCare Good Samaritan HospitalPuyallupWashington98372-
VA Puget Sound Health Care SystemSeattleWashington98108-
Multicare Institute for Research and InnovationSpokaneWashington99202-
Central Washington Health Services Association d/b/a Confluence HealthWenatcheeWashington98801-
Clinical Investigation SpecialistsKenoshaWisconsin53144-

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