A Study of Tirzepatide Compared With Intensified Conventional Care in Adult Participants With Type 2 Diabetes
NCT ID: NCT05433584
Last Updated: 2025-12-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE4
780 participants
INTERVENTIONAL
2022-08-01
2027-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Tirzepatide
Participants will receive tirzepatide at the maximum tolerated dose subcutaneously (SC)
Tirzepatide
Administered SC
Intensified Conventional Care Dose
Participants will receive an antihyperglycemic medication
Antihyperglycemic medication
As prescribed
Interventions
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Tirzepatide
Administered SC
Antihyperglycemic medication
As prescribed
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 preceding baseline
* with the minimum effective dose of ≥1500 mg/day, but not higher than the maximum approved dose per country-specific label, or
* \<1500 mg/day in case of intolerance of full therapeutic dose.
Exclusion Criteria
* 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 or have 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 multiple endocrine neoplasia syndrome type 2 (MEN2)
* Have within 90 days prior to screening received treatment with medications intended to promote weight loss. This includes prescribed, over the counter, or alternative remedies
* Have an estimated glomerular filtration rate (eGFR) \<30 mL/minute/1.73 m2 (or lower than the country-specific threshold for discontinuing metformin therapy per local label), calculated by chronic kidney disease-epidemiology equation as determined by central laboratory at screening.
* Have been treated with any injectable glucagon-like peptide-1 (GLP-1) receptor agonists 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 elective surgery.
18 Years
ALL
No
Sponsors
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Eli Lilly and Company
INDUSTRY
Responsible Party
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Principal Investigators
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Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
Role: STUDY_DIRECTOR
Eli Lilly and Company
Locations
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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
Napoli, 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
Countries
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Related Links
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A Study of Tirzepatide Compared With Intensified Conventional Care in Adult Participants With Type 2 Diabetes (SURPASS-EARLY)
Other Identifiers
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I8F-MC-GPHE
Identifier Type: OTHER
Identifier Source: secondary_id
2022-000130-42
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
2022-5010733-40-00
Identifier Type: OTHER
Identifier Source: secondary_id
U1111-1282-0263
Identifier Type: REGISTRY
Identifier Source: secondary_id
17205
Identifier Type: -
Identifier Source: org_study_id
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