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

Last updated: April 17, 2025
Sponsor: Eli Lilly and Company
Overall Status: Active - Not Recruiting

Phase

4

Condition

Diabetes Prevention

Diabetes Mellitus, Type 2

Diabetes And Hypertension

Treatment

Tirzepatide

Antihyperglycemic medication

Clinical Study ID

NCT05433584
17205
2022-000130-42
I8F-MC-GPHE
2022-5010733-40-00
U1111-1282-0263
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Have, within the last 4 years, been diagnosed with T2D based on the World HealthOrganization classification or other locally applicable diagnostic standards.

  • Have HbA1c ≥7% to ≤9.5% as determined by the central laboratory.

  • Have been on a stable treatment of metformin only at least 90 days precedingbaseline

  • with the minimum effective dose of ≥1500 mg/day, but not higher than themaximum approved dose per country-specific label, or

  • <1500 mg/day in case of intolerance of full therapeutic dose.

Exclusion

Exclusion Criteria:

  • Have type 1 diabetes mellitus

  • Have a history of chronic or acute pancreatitis any time prior to study entry

  • Have a history of

  • proliferative diabetic retinopathy

  • diabetic macular edema, or

  • no proliferative diabetic retinopathy requiring immediate or urgent treatment

  • Are at high risk for cardiovascular disease (CVD) in the investigator's opinion orhave a history of any of these CV conditions prior to study entry

  • myocardial infarction

  • percutaneous coronary revascularization procedure

  • carotid stenting or surgical revascularization

  • nontraumatic amputation

  • peripheral vascular procedure (e.g., stenting or surgical revascularization)

  • cerebrovascular accident (stroke), or congestive heart failure

  • Have family or personal history of medullary thyroid carcinoma (MTC) or multipleendocrine neoplasia syndrome type 2 (MEN2)

  • Have within 90 days prior to screening received treatment with medications intendedto promote weight loss. This includes prescribed, over the counter, or alternativeremedies

  • Have an estimated glomerular filtration rate (eGFR) <30 mL/minute/1.73 m2 (or lowerthan the country-specific threshold for discontinuing metformin therapy per locallabel), calculated by chronic kidney disease-epidemiology equation as determined bycentral laboratory at screening.

  • Have been treated with any injectable glucagon-like peptide-1 (GLP-1) receptoragonists and insulin prior to screening.

  • Exception: use of insulin for gestational diabetes or short-term use (<14 days)for acute conditions such as acute illness, hospitalization, or electivesurgery.

Study Design

Total Participants: 780
Treatment Group(s): 2
Primary Treatment: Tirzepatide
Phase: 4
Study Start date:
August 01, 2022
Estimated Completion Date:
November 30, 2027

Connect with a study center

  • CIAD Moron

    Moron, Buenos Air B1708EPE
    Argentina

    Site Not Available

  • Centro de Investigaciones Metabólicas (CINME)

    Ciudad Autónoma de Buenos Aire, Buenos Aires 1056
    Argentina

    Site Not Available

  • Instituto de Investigaciones Clínicas Mar del Plata

    Mar del Plata, Buenos Aires 7600
    Argentina

    Site Not Available

  • Go Centro Medico San Nicolás

    San Nicolas, Buenos Aires 2900
    Argentina

    Site Not Available

  • Centro Médico Viamonte

    Buenos Aires, Ciudad Aut C1120AAC
    Argentina

    Site Not Available

  • Dr. M.B. Jones Inc.

    Victoria, British Columbia V8V 4A1
    Canada

    Site Not Available

  • Bluewater Clinical Research Group Inc.

    Sarnia, Ontario N7T 4X3
    Canada

    Site Not Available

  • Stouffville Medical Centre

    Stouffville, Ontario L4A 1H2
    Canada

    Site Not Available

  • 9109-0126 Quebec Inc.

    Montreal, Quebec H4N 2W2
    Canada

    Site Not Available

  • MUDr. Tomas Edelsberger

    Krnov, Moravskosl 79401
    Czechia

    Site Not Available

  • Diabet2 s.r.o., diabetologicka a interni ambulance

    Praha, Praha 1 11000
    Czechia

    Site Not Available

  • Milan Kvapil s.r.o., Diabetologicka ambulance

    Praha, Praha 4 14900
    Czechia

    Active - Recruiting

  • ResTrial s.r.o.

    Praha, Praha 8 18100
    Czechia

    Active - Recruiting

  • Milan Kvapil s.r.o., Diabetologicka ambulance Pribram

    Pribram, Středočeský Kraj 26201
    Czechia

    Site Not Available

  • ClinPhenomics CVC GmbH

    Frankfurt, Hessen 60596
    Germany

    Site Not Available

  • ClinPhenomics GmbH & Co KG

    Frankfurt, Hessen 60596
    Germany

    Site Not Available

  • Diabetes- und Stoffwechselpraxis Bochum

    Bochum, Nordrhein-Westfalen 44869
    Germany

    Site Not Available

  • InnoDiab Forschung Gmbh

    Essen, Nordrhein-Westfalen 45136
    Germany

    Site Not Available

  • Zentrum für klinische Studien

    Saint Ingbert, Saarland 66386
    Germany

    Site Not Available

  • Zentrum für klinische Studien

    Sankt Ingbert, Saarland 66386
    Germany

    Site Not Available

  • Arztpraxis Christine Kosch Pirna

    Pirna, Sachsen 01796
    Germany

    Site Not Available

  • Private Practice - Dr. Christine Kosch

    Pirna, Sachsen 01796
    Germany

    Site Not Available

  • RED-Institut GmbH

    Oldenburg, Schleswig-Holstein 23758
    Germany

    Site Not Available

  • Diabetespraxis Mergentheim

    Bad Mergentheim, 97980
    Germany

    Site Not Available

  • Diabetes Zentrum Dr. Tews

    Gelnhausen, 63571
    Germany

    Site Not Available

  • Praxis Dr. med. Ilka Simon-Wagner

    Lichtenfels, 96215
    Germany

    Site Not Available

  • Clalit Health Services - Atlit

    Atlit, HaDarom
    Israel

    Site Not Available

  • Edith Wolfson Medical Center

    Holon, HaMerkaz 5810001
    Israel

    Site Not Available

  • Rabin Medical Center

    Petah-Tikva, HaMerkaz 4941492
    Israel

    Site Not Available

  • Sheba Medical Center

    Ramat Gan, HaMerkaz 5262100
    Israel

    Site Not Available

  • Kaplan Medical Center

    Rehovot, HaMerkaz 7610001
    Israel

    Site Not Available

  • Bnai Zion Medical Center

    Haifa, HaTsafon 3339419
    Israel

    Site Not Available

  • Clalit Health Services - Sakhnin Community Clinic

    Sakhnin, HaTsafon 3081000
    Israel

    Site Not Available

  • Hadassah Medical Center

    Jerusalem, Yerushalayim 9112001
    Israel

    Site Not Available

  • Linn Medical Center

    Haifa, Ḥeifā 3515209
    Israel

    Site Not Available

  • University of Naples Federico II

    Napoli, Campania 80131
    Italy

    Site Not Available

  • Centro Cardiologico Monzino

    Milan, Milano 20138
    Italy

    Site Not Available

  • Ospedale Civile Santa Croce Pronto Soccorso

    Moncalieri, Piemonte 10024
    Italy

    Site Not Available

  • A.O.U.C. Policlinico di Bari

    Bari, Puglia 70124
    Italy

    Site Not Available

  • Ospedale san Giovanni di Dio-Diabetologia

    Olbia, Sardegna 07026
    Italy

    Site Not Available

  • A.O.U. Policlinico Paolo Giaccone

    Palermo, Sicilia 90129
    Italy

    Site Not Available

  • Azienda Ospedaliera Universitaria Pisana

    Pisa, Toscana 56124
    Italy

    Site Not Available

  • AOU Renato Dulbecco

    Catanzaro, 88100
    Italy

    Site Not Available

  • Azienda Ospedaliera Mater Domini

    Catanzaro, 88100
    Italy

    Site Not Available

  • Private Practice - Dr. Arechavaleta Granell Maria del Rosario

    Guadalajara, Jalisco 44670
    Mexico

    Site Not Available

  • Hospital Universitario "Dr. Jose Eleuterio Gonzalez"

    Monterrey, Nuevo León 66460
    Mexico

    Site Not Available

  • Investigacion En Salud Y Metabolismo Sc

    Chihuahua, 31217
    Mexico

    Site Not Available

  • San Juan Bautista School of Medicine - Clinical Research Unit

    Caguas, 00725
    Puerto Rico

    Site Not Available

  • Dorado Medical Complex

    Dorado, 00646
    Puerto Rico

    Site Not Available

  • GCM Medical Group, PSC - Hato Rey Site

    San Juan, 00917
    Puerto Rico

    Site Not Available

  • Diabdana

    Oradea, Bihor 410147
    Romania

    Site Not Available

  • Endodigest Clinica Medicala

    Oradea, Bihor 410151
    Romania

    Active - Recruiting

  • C.M.D.T.A. Neomed

    Brasov, Brașov 500283
    Romania

    Site Not Available

  • Centrul Medical NutriLife

    Bucharest, București 013764
    Romania

    Site Not Available

  • Gama Diamed

    Mangalia, Constanța 905500
    Romania

    Site Not Available

  • Diabmed Dr. Popescu Alexandrina

    Ploiești, Prahova 100179
    Romania

    Site Not Available

  • Milena Sante

    Galați, 800001
    Romania

    Site Not Available

  • Clinica Korall

    Satu Mare, 440055
    Romania

    Site Not Available

  • ENDIANT s.r.o.

    Sered, Trnavský Kraj 926 01
    Slovakia

    Site Not Available

  • IRIDIA

    Vrutky, Žilinský Kraj 038 61
    Slovakia

    Site Not Available

  • MEDIKALS

    Piešťany, 921 01
    Slovakia

    Site Not Available

  • ProDia s.r.o.

    Povazska Bystrica, 017 01
    Slovakia

    Site Not Available

  • JAL

    Trnava, 917 01
    Slovakia

    Site Not Available

  • Aberdeen Royal Infirmary

    Aberdeen, Aberdeen City AB25 2ZN
    United Kingdom

    Site Not Available

  • Ninewells Hospital and Medical School

    Dundee, Angus DD1 9SY
    United Kingdom

    Site Not Available

  • Staploe Medical Centre

    Ely, Cambridgeshire CB7 5JD
    United Kingdom

    Site Not Available

  • Knowle House Surgery

    Plymouth, Devon PL5 3JB
    United Kingdom

    Site Not Available

  • Hull Royal Infirmary

    Hull, Kingston Upon Hull HU3 2JZ
    United Kingdom

    Site Not Available

  • Hull and East Yorkshire Hospitals NHS Trust

    Hull, Kingston Upon Hull HU3 2JZ
    United Kingdom

    Site Not Available

  • Leicester General Hospital

    Leicester, Leicestershire LE5 4PW
    United Kingdom

    Site Not Available

  • Wickersley Health Centre - Clifton Medical Centre

    Rotherham, S65 1DA
    United Kingdom

    Site Not Available

  • Cahaba Research - Trussville

    Birmingham, Alabama 35235
    United States

    Site Not Available

  • Phoenician Centers for Research & Innovation

    Phoenix, Arizona 85021
    United States

    Site Not Available

  • San Fernando Valley Health Institute

    Canoga Park, California 91304
    United States

    Site Not Available

  • National Research Institute - Huntington Park

    Huntington Park, California 90255
    United States

    Site Not Available

  • Velocity Clinical Research, Huntington Park

    Huntington Park, California 90255
    United States

    Site Not Available

  • Velocity Clinical Research, San Diego

    La Mesa, California 91942
    United States

    Site Not Available

  • Clinical Trials Research

    Lincoln, California 95648
    United States

    Site Not Available

  • National Research Institute - Wilshire

    Los Angeles, California 90057
    United States

    Site Not Available

  • Velocity Clinical Research, Westlake

    Los Angeles, California 90057
    United States

    Site Not Available

  • Catalina Research Institute, LLC

    Montclair, California 91763
    United States

    Site Not Available

  • Velocity Clinical Research, North Hollywood

    North Hollywood, California 91606
    United States

    Site Not Available

  • Velocity Clinical Research, Panorama City

    Panorama City, California 91402
    United States

    Site Not Available

  • Western University of Health Sciences

    Pomona, California 91766
    United States

    Site Not Available

  • Velocity Clinical Research, Santa Ana

    Santa Ana, California 92704
    United States

    Site Not Available

  • New England Research Associates, LLC

    Bridgeport, Connecticut 06606
    United States

    Site Not Available

  • Excel Medical Clinical Trials

    Boca Raton, Florida 33434
    United States

    Site Not Available

  • Alliance for Multispecialty Research, LLC

    Coral Gables, Florida 33134
    United States

    Site Not Available

  • South Florida Clinical Research Institute

    Margate, Florida 33063
    United States

    Site Not Available

  • Emory University School of Medicine- Grady Campus

    Atlanta, Georgia 30303
    United States

    Site Not Available

  • Center for Advanced Research & Education

    Gainesville, Georgia 30501
    United States

    Site Not Available

  • Qualmedica Research, LLC

    Evansville, Indiana 47715
    United States

    Site Not Available

  • Iowa Diabetes and Endocrinology Research Center

    West Des Moines, Iowa 50265
    United States

    Site Not Available

  • Qualmedica Research

    Bowling Green, Kentucky 42101
    United States

    Site Not Available

  • Qualmedica Research, LLC

    Owensboro, Kentucky 42301
    United States

    Site Not Available

  • NECCR PrimaCare Research

    Fall River, Massachusetts 02721
    United States

    Site Not Available

  • SKY Clinical Research Network Group-Quinn

    Ridgeland, Mississippi 39157
    United States

    Site Not Available

  • SKY Integrative Medical Center/SKYCRNG

    Ridgeland, Mississippi 39157
    United States

    Site Not Available

  • StudyMetrix Research

    Saint Peters, Missouri 63303
    United States

    Site Not Available

  • Clinvest Research LLC

    Springfield, Missouri 65807
    United States

    Site Not Available

  • Research Foundation of SUNY - University of Buffalo

    Buffalo, New York 14221
    United States

    Site Not Available

  • Lucas Research, Inc

    Morehead City, North Carolina 28557
    United States

    Site Not Available

  • The Corvallis Clinic, P.C.

    Corvallis, Oregon 97330
    United States

    Site Not Available

  • Clinical Research of Philadelphia

    Philadelphia, Pennsylvania 19114
    United States

    Site Not Available

  • Preferred Primary Care Physicians

    Uniontown, Pennsylvania 15401
    United States

    Site Not Available

  • Tribe Clinical Research, LLC

    Greenville, South Carolina 29607
    United States

    Site Not Available

  • Velocity Clinical Research, Spartanburg

    Spartanburg, South Carolina 29303
    United States

    Site Not Available

  • VitaLink Research - Spartanburg

    Spartanburg, South Carolina 29303
    United States

    Site Not Available

  • Dallas Diabetes Research Center

    Dallas, Texas 75230
    United States

    Site Not Available

  • Velocity Clinical Research, Dallas

    Dallas, Texas 75230
    United States

    Active - Recruiting

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