A Study of Tirzepatide Compared With Intensified Conventional Care in Adult Participants With Type 2 Diabetes

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Eli Lilly and Company
Study ID
NCT05433584
Phase
PHASE4
Status
Active Not Recruiting

Conditions

Eligibility Criteria

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

Interventions

  • Tirzepatide — DRUG
    Administered SC
  • Antihyperglycemic medication — DRUG
    As prescribed

Study Details

This study aims to investigate the efficacy and safety of tirzepatide in participants with type 2 diabetes (T2D) compared to other existing treatment options when treatment is initiated early.

Key Dates

Start date
Aug 1, 2022
Status verified
Dec 2025
Primary completion
Oct 21, 2025
Completion
Nov 30, 2027

Study Design

Enrollment
780 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Tirzepatide
    Participants will receive tirzepatide at the maximum tolerated dose subcutaneously (SC)
  • Active Comparator: Intensified Conventional Care Dose
    Participants will receive an antihyperglycemic medication

Primary Outcome Measure

Change from Baseline in Hemoglobin A1c (HbA1c) [ Time Frame: Baseline, Week 104 ]

Locations (32)

FacilityCityStateZIPSite coordinators
Cahaba Research - TrussvilleBirminghamAlabama35235-
San Fernando Valley Health InstituteCanoga ParkCalifornia91304-
Velocity Clinical Research, Huntington ParkHuntington ParkCalifornia90255-
Velocity Clinical Research, San DiegoLa MesaCalifornia91942-
Clinical Trials ResearchLincolnCalifornia95648-
Velocity Clinical Research, WestlakeLos AngelesCalifornia90057-
Catalina Research Institute, LLCMontclairCalifornia91763-
Velocity Clinical Research, North HollywoodNorth HollywoodCalifornia91606-
Velocity Clinical Research, Panorama CityPanorama CityCalifornia91402-
Western University of Health SciencesPomonaCalifornia91766-
Velocity Clinical Research, Santa AnaSanta AnaCalifornia92704-
New England Research Associates, LLCBridgeportConnecticut06606-
Excel Medical Clinical TrialsBoca RatonFlorida33434-
Alliance for Multispecialty Research, LLCCoral GablesFlorida33134-
South Florida Clinical Research InstituteMargateFlorida33063-
Emory University School of Medicine- Grady CampusAtlantaGeorgia30303-
Center for Advanced Research & EducationGainesvilleGeorgia30501-
Qualmedica Research, LLCEvansvilleIndiana47715-
Iowa Diabetes and Endocrinology Research CenterWest Des MoinesIowa50265-
Qualmedica ResearchBowling GreenKentucky42101-
NECCR PrimaCare ResearchFall RiverMassachusetts02721-
SKY Integrative Medical Center/SKYCRNGRidgelandMississippi39157-
StudyMetrix ResearchCity of Saint PetersMissouri63303-
Clinvest Research LLCSpringfieldMissouri65807-
Research Foundation of SUNY - University of BuffaloBuffaloNew York14221-
Lucas Research, IncMorehead CityNorth Carolina28557-
The Corvallis Clinic, P.C.CorvallisOregon97330-
Clinical Research of PhiladelphiaPhiladelphiaPennsylvania19114-
Preferred Primary Care PhysiciansUniontownPennsylvania15401-
Tribe Clinical Research, LLCGreenvilleSouth Carolina29607-
Velocity Clinical Research, SpartanburgSpartanburgSouth Carolina29303-
Dallas Diabetes Research CenterDallasTexas75230-

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