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ACTIVE NOT RECRUITING
NCT05433584
PHASE4

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

Sponsor: Eli Lilly and Company

View on ClinicalTrials.gov

Summary

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.

Official title: A Randomized, Open-Label, Parallel-Group, Two-Arm, Phase 4 Study to Evaluate the Long-Term Efficacy and Safety of Tirzepatide Compared With Intensified Conventional Care in Adults When Initiating Treatment Early in the Course of Type 2 Diabetes

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

780

Start Date

2022-08-01

Completion Date

2027-11

Last Updated

2025-12-12

Healthy Volunteers

No

Conditions

Interventions

DRUG

Tirzepatide

Administered SC

DRUG

Antihyperglycemic medication

As prescribed

Locations (90)

Cahaba Research - Trussville

Birmingham, Alabama, United States

San Fernando Valley Health Institute

Canoga Park, California, United States

Velocity Clinical Research, Huntington Park

Huntington Park, California, United States

Velocity Clinical Research, San Diego

La Mesa, California, United States

Clinical Trials Research

Lincoln, California, United States

Velocity Clinical Research, Westlake

Los Angeles, California, United States

Catalina Research Institute, LLC

Montclair, California, United States

Velocity Clinical Research, North Hollywood

North Hollywood, California, United States

Velocity Clinical Research, Panorama City

Panorama City, California, United States

Western University of Health Sciences

Pomona, California, United States

Velocity Clinical Research, Santa Ana

Santa Ana, California, United States

New England Research Associates, LLC

Bridgeport, Connecticut, United States

Excel Medical Clinical Trials

Boca Raton, Florida, United States

Alliance for Multispecialty Research, LLC

Coral Gables, Florida, United States

South Florida Clinical Research Institute

Margate, Florida, United States

Emory University School of Medicine- Grady Campus

Atlanta, Georgia, United States

Center for Advanced Research & Education

Gainesville, Georgia, United States

Qualmedica Research, LLC

Evansville, Indiana, United States

Iowa Diabetes and Endocrinology Research Center

West Des Moines, Iowa, United States

Qualmedica Research

Bowling Green, Kentucky, United States

NECCR PrimaCare Research

Fall River, Massachusetts, United States

SKY Integrative Medical Center/SKYCRNG

Ridgeland, Mississippi, United States

StudyMetrix Research

City of Saint Peters, Missouri, United States

Clinvest Research LLC

Springfield, Missouri, United States

Research Foundation of SUNY - University of Buffalo

Buffalo, New York, United States

Lucas Research, Inc

Morehead City, North Carolina, United States

The Corvallis Clinic, P.C.

Corvallis, Oregon, United States

Clinical Research of Philadelphia

Philadelphia, Pennsylvania, United States

Preferred Primary Care Physicians

Uniontown, Pennsylvania, United States

Tribe Clinical Research, LLC

Greenville, South Carolina, United States

Velocity Clinical Research, Spartanburg

Spartanburg, South Carolina, United States

Dallas Diabetes Research Center

Dallas, Texas, United States

Centro de Investigaciones Metabólicas (CINME)

Ciudad Autónoma de Buenos Aire, Buenos Aires, Argentina

Instituto de Investigaciones Clínicas Mar del Plata

Mar del Plata, Buenos Aires, Argentina

Go Centro Medico San Nicolás

San Nicolás de los Arroyos, Buenos Aires, Argentina

CIAD Moron

Morón, Buenos Air, Argentina

Centro Médico Viamonte

Buenos Aires, Ciudad Aut, Argentina

Dr. M.B. Jones Inc.

Victoria, British Columbia, Canada

Bluewater Clinical Research Group Inc.

Sarnia, Ontario, Canada

Stouffville Medical Centre

Stouffville, Ontario, Canada

9109-0126 Quebec Inc.

Montreal, Quebec, Canada

ClinPhenomics CVC GmbH

Frankfurt am Main, Hesse, Germany

Diabetes- und Stoffwechselpraxis Bochum

Bochum, North Rhine-Westphalia, Germany

InnoDiab Forschung Gmbh

Essen, North Rhine-Westphalia, Germany

Zentrum für klinische Studien

Saint Ingbert, Saarland, Germany

Arztpraxis Christine Kosch Pirna

Pirna, Saxony, Germany

RED-Institut GmbH

Oldenburg in Holstein, Schleswig-Holstein, Germany

Diabetespraxis Mergentheim

Bad Mergentheim, Germany

Diabetes Zentrum Dr. Tews

Gelnhausen, Germany

Edith Wolfson Medical Center

Holon, Central District, Israel

Rabin Medical Center

Petah Tikva, Central District, Israel

Sheba Medical Center

Ramat Gan, Central District, Israel

Kaplan Medical Center

Rehovot, Central District, Israel

Hadassah Medical Center

Jerusalem, Jerusalem, Israel

Bnai Zion Medical Center

Haifa, Northern District, Israel

Clalit Health Services - Sakhnin Community Clinic

Sakhnin, Northern District, Israel

Clalit Health Services - Atlit

Atlit, Southern District, Israel

Linn Medical Center

Haifa, Ḥeifā, Israel

A.O.U.C. Policlinico di Bari

Bari, Apulia, Italy

University of Naples Federico II

Naples, Campania, Italy

Centro Cardiologico Monzino

Milan, Milano, Italy

Ospedale Civile Santa Croce Pronto Soccorso

Moncalieri, Piedmont, Italy

Ospedale san Giovanni di Dio-Diabetologia

Olbia, Sardinia, Italy

A.O.U. Policlinico Paolo Giaccone

Palermo, Sicily, Italy

Azienda Ospedaliera Universitaria Pisana

Pisa, Tuscany, Italy

AOU Renato Dulbecco

Catanzaro, Italy

Private Practice - Dr. Arechavaleta Granell Maria del Rosario

Guadalajara, Jalisco, Mexico

Hospital Universitario "Dr. Jose Eleuterio Gonzalez"

Monterrey, Nuevo León, Mexico

Investigacion En Salud Y Metabolismo Sc

Chihuahua City, Mexico

San Juan Bautista School of Medicine - Clinical Research Unit

Caguas, PR, Puerto Rico

GCM Medical Group, PSC - Hato Rey Site

San Juan, PR, Puerto Rico

Dorado Medical Complex

Dorado, Puerto Rico

Diabdana

Oradea, Bihor County, Romania

C.M.D.T.A. Neomed

Brasov, Brașov County, Romania

Centrul Medical NutriLife

Bucharest, București, Romania

Gama Diamed

Mangalia, Constanța County, Romania

Diabmed Dr. Popescu Alexandrina

Ploieşti, Prahova, Romania

Milena Sante

Galați, Romania

Clinica Korall

Satu Mare, Romania

MEDIKALS

Piešťany, Slovakia

ProDia s.r.o.

Považská Bystrica, Slovakia

JAL

Trnava, Slovakia

IRIDIA

Vrútky, Žilina Region, Slovakia

Aberdeen Royal Infirmary

Aberdeen, Aberdeen City, United Kingdom

Ninewells Hospital and Medical School

Dundee, Angus, United Kingdom

Staploe Medical Centre

Ely, Cambridgeshire, United Kingdom

Knowle House Surgery

Plymouth, Devon, United Kingdom

Hull Royal Infirmary

Hull, Kingston Upon Hull, United Kingdom

Leicester General Hospital

Leicester, Leicestershire, United Kingdom

Wickersley Health Centre - Clifton Medical Centre

Rotherham, United Kingdom