A Study of Tirzepatide (LY3298176) Once a Week Versus Insulin Glargine Once a Day in Participants With Type 2 Diabetes and Increased Cardiovascular Risk
NCT ID: NCT03730662
Last Updated: 2022-02-14
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
2002 participants
INTERVENTIONAL
2018-11-20
2021-04-22
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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5 mg Tirzepatide
5 milligrams (mg) tirzepatide administered subcutaneously (SC) once a week.
Tirzepatide
Administered SC.
10 mg Tirzepatide
10 mg tirzepatide administered SC once a week.
Tirzepatide
Administered SC.
15 mg Tirzepatide
15 mg tirzepatide administered SC once a week.
Tirzepatide
Administered SC.
Insulin Glargine
Insulin glargine administered SC once a day. Doses were individualized and titrated according to protocol-defined targets.
The starting dose of insulin glargine was 10 IU/day at bedtime, titrated to a FBG \<100 mg/dL, following a treat-to-target (TTT) algorithm.
Insulin Glargine
Administered SC
Interventions
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Tirzepatide
Administered SC.
Insulin Glargine
Administered SC
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Have been diagnosed with type 2 diabetes mellitus (T2DM)
* Have HbA1c between ≥7.5% and ≤10.5%
* Be on stable treatment with unchanged dose of at least 1 and no more than 3 types of oral antihyperglycemic drugs, which may only include metformin, SGLT-2 inhibitors, and/or sulfonylureas for at least 3 months before screening
* Have increased risk for cardiovascular (CV) events
* Be of stable weight (± 5%)
* Have a BMI ≥25 kilograms per meter squared (kg/m2) at screening
Exclusion Criteria
* Have type 1 diabetes mellitus
* Have had chronic or acute pancreatitis any time prior to study entry
* Have proliferative diabetic retinopathy or diabetic maculopathy or nonproliferative diabetic retinopathy requiring immediate or urgent treatment
* Have disorders associated with slowed emptying of the stomach, or have had any stomach surgeries for the purpose of weight loss
* Have acute or chronic hepatitis, signs and symptoms of any other liver disease, or blood alanine transaminase (ALT) enzyme level \>3.0 times the upper limit of normal (ULN) for the reference range, as determined by the central laboratory. Participants with nonalcoholic fatty liver disease (NAFLD) are eligible for participation in this trial only if there ALT level is ≤3.0 the ULN for the reference range
* Have had a heart attack, stroke, or hospitalization for congestive heart failure in the past 2 months
* Have a personal or family history of medullary thyroid carcinoma or personal history of multiple endocrine neoplasia syndrome type 2
* Have been taking any other diabetes medicines other than metformin, SGLT-2 inhibitors, and/or sulfonylureas during the last 3 months
* Have been taking weight loss drugs, including over-the-counter medications during the last 3 months
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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Advanced Research Center
Anaheim, California, United States
Valley Clinical Trials, Inc.
Covina, California, United States
Marin Endocrine Associates
Greenbrae, California, United States
National Research Institute
Huntington Park, California, United States
Scripps Whittier Diabetes Institute
La Jolla, California, United States
First Valley Medical Group
Lancaster, California, United States
National Research Institute
Los Angeles, California, United States
Catalina Research Institute, LLC
Montclair, California, United States
Monterey Endocrine & Diabetes Institute, Inc.
Monterey, California, United States
Valley Clinical Trials, Inc.
Northridge, California, United States
Desert Medical Group Inc
Palm Springs, California, United States
Havana Research Institute
Pasadena, California, United States
Western University of Health Sciences
Pomona, California, United States
LCGK Research
San Carlos, California, United States
Olive View Medical Center
Sylmar, California, United States
University Clinical Investigators, Inc.
Tustin, California, United States
Touro University
Vallejo, California, United States
Coastal Metabolic Research Centre
Ventura, California, United States
Diablo Clinical Research
Walnut Creek, California, United States
Chase Medical Research, LLC
Waterbury, Connecticut, United States
ALL Medical Research, LLC
Cooper City, Florida, United States
Advanced Pharma Research
Cutler Bay, Florida, United States
South Florida Wellness & Clinical Research Institute
Margate, Florida, United States
Suncoast Research Group, LLC
Miami, Florida, United States
New Horizon Research Center
Miami, Florida, United States
Clinical Neuroscience Solutions Inc
Orlando, Florida, United States
Progressive Medical Research
Port Orange, Florida, United States
Primary Care Specialists, LLC
Atlanta, Georgia, United States
Rocky Mountain Diabetes and Osteoporosis Center
Idaho Falls, Idaho, United States
Solaris Clinical Research
Meridian, Idaho, United States
Saltzer Medical Group. P.A.
Nampa, Idaho, United States
Northwestern Feinberg School of Medicine
Chicago, Illinois, United States
NorthShore University HealthSystem
Skokie, Illinois, United States
University of Iowa Hospital & Clinic
Iowa City, Iowa, United States
Iowa Diabetes Research
West Des Moines, Iowa, United States
Cotton O'Neil Diabetes and Endocrinology Center
Topeka, Kansas, United States
Robley Rex VAMC
Louisville, Kentucky, United States
NECCR PrimaCare Research, LLC
Fall River, Massachusetts, United States
AA Medical Research Center
Flint, Michigan, United States
Troy Internal Medicine, PC
Troy, Michigan, United States
Clinical Research Professionals
Chesterfield, Missouri, United States
Glacier View Research Institute
Kalispell, Montana, United States
Montana Medical Research, Inc
Missoula, Montana, United States
Palm Research Center
Las Vegas, Nevada, United States
Palm Research Center
Las Vegas, Nevada, United States
Southern New Hampshire Diabetes and Endocrinology
Nashua, New Hampshire, United States
PharmQuest
Greensboro, North Carolina, United States
Lillestol Research LLC
Fargo, North Dakota, United States
Rapid Medical Research Inc
Cleveland, Ohio, United States
Ohio State Univ College Of Medicine
Columbus, Ohio, United States
Aventiv Research
Columbus, Ohio, United States
Intend Research
Norman, Oklahoma, United States
The Corvallis Clinic P.C.
Corvallis, Oregon, United States
Oregon Health and Science University
Portland, Oregon, United States
Heritage Valley Medical Group, Inc.
Beaver, Pennsylvania, United States
Capital Area Research
Camp Hill, Pennsylvania, United States
Detweiler Family Medicine
Lansdale, Pennsylvania, United States
Capital Area Research
Newport, Pennsylvania, United States
Parkside Family Medical
Philadelphia, Pennsylvania, United States
Preferred Primary Care Physicians- Bower Hill
Pittsburgh, Pennsylvania, United States
Mountain View Clinical Research, Inc.
Greer, South Carolina, United States
The Research Center of the Upstate
Mauldin, South Carolina, United States
Holston Medical Group Clinical Research
Kingsport, Tennessee, United States
New Phase Research & Development
Knoxville, Tennessee, United States
Dallas Diabetes Endocrine Center
Dallas, Texas, United States
PCP for Life
Houston, Texas, United States
BFHC Research
San Antonio, Texas, United States
Consano Clinical Research
Shavano Park, Texas, United States
Martin Diagnostic Clinic
Tomball, Texas, United States
Alpine Research Organization
Farmington, Utah, United States
Burke Internal Medicine & Research
Burke, Virginia, United States
Private: Dr. Larry Stonesifer
Federal Way, Washington, United States
Capital Clinical Research Center
Olympia, Washington, United States
Walla Walla Clinic
Walla Walla, Washington, United States
Centro de Investigaciones Metabólicas (CINME)
CABA, Buenos Aires, Argentina
Mautalen Salud e Investigación - Servicio de Endocrinología
CABA, Buenos Aires, Argentina
Investigaciones Medicas IMOBA S.R.L.
Caba, Buenos Aires, Argentina
CEDIC-Centro de Investigaciones Clinicas
Caba, Buenos Aires, Argentina
CEMEDIC
CABA, Buenos Aires, Argentina
Centro Medico Dr Laura Maffei Investigacion Clinica Aplicada
Ciudad Autonoma de Buenos Aire, Buenos Aires, Argentina
Centro de Investigacion y Prevencion Cardiovascular (CIPREC)
Ciudad Autonoma de, Buenos Aires, Argentina
CIPADI
Godoy Cruz, Mendoza Province, Argentina
AXISMED SRL - Bioclinica Research Network
Buenos Aires, , Argentina
Centro Médico Viamonte
Ciudad Autonoma de Buenos Aire, , Argentina
Instituto Centenario
Ciudad Autonoma de Buenos Aire, , Argentina
Cemediab - Centro Médico Diabetológico Dr. Alejandro Chertkoff
Ciudad Autonoma de Buenos Aire, , Argentina
Centro Diabetologico Dr Waitman
Córdoba, , Argentina
Centro Medico Privado San Vicente Diabetes
Córdoba, , Argentina
Cent Priva Especiali Médicas Ambulatorias Inve Clin CEMAIC
Córdoba, , Argentina
Paratus Clinical Blacktown Clinic
Blacktown, New South Wales, Australia
Campbelltown Medical & Dental Centre
Campbelltown, New South Wales, Australia
Paratus Clinical Kanwal Clinic
Kanwal, New South Wales, Australia
The AIM Centre
Merewether, New South Wales, Australia
Royal North Shore Hospital
St Leonards, New South Wales, Australia
CORE Research Group Pty Ltd
Brisbane, Queensland, Australia
Morayfield Medical and Dental Centre
Morayfield, Queensland, Australia
AusTrials Pty Ltd
Sherwood, Queensland, Australia
Victoria Point Medical and Dental Centre
Victoria Point, Queensland, Australia
GP Plus Marion
Oaklands Park, South Australia, Australia
Eastern Clinical Research Unit
Box Hill, Victoria, Australia
Forest Hill Medical and Dental Centre
Forest Hill, Victoria, Australia
Barwon Health - The Geelong Hospital
Geelong, Victoria, Australia
Royal Melbourne Hospital
Parkville, Victoria, Australia
Fremantle Hospital
Fremantle, Western Australia, Australia
Instituto de Ensino e Pesquisa Clinica do Ceara
Fortaleza, Ceará, Brazil
Cedoes Centro Diagnostico Pequisa Osteoporose E Santo Ltd
Vitória, Espírito Santo, Brazil
Centro de Pesquisa Clinica do Brasil
Brasília, Federal District, Brazil
Centro de Diabetes Curitiba
Curitiba, Paraná, Brazil
CCBR Brasil Centro de Analises e Pesquisas Clínicas LTDA
Rio de Janeiro, Rio de Janeiro, Brazil
CPQuali Pesquisa Clínica Ltda.
São Paulo, São Paulo, Brazil
Cpclin Centro de Pesquisas Clinicas
São Paulo, São Paulo, Brazil
Centro de Pesq. em Diabetes e Doencas Endocrino Metabol.
Fortaleza, , Brazil
Dr. Consulta Clínica Médica LTDA
São Paulo, , Brazil
LMC Manna Research
Calgary, Alberta, Canada
C-Health Diabetes and Endocrinology Clinic Calgary
Calgary, Alberta, Canada
Synergy Medical Research
Sherwood Park, Alberta, Canada
LMC Endocrinology Centres Ltd.
Barrie, Ontario, Canada
LMC Endocrinology Centers Brampton
Brampton, Ontario, Canada
Aggarwal and Associates Ltd
Brampton, Ontario, Canada
LMC Endocrinology Centres Ltd.
Concord, Ontario, Canada
Medicor Research Inc
Greater Sudbury, Ontario, Canada
Milestone Research Inc.
London, Ontario, Canada
LMC Endocrinology Centres Ltd.
Nepean, Ontario, Canada
Bluewater Clinical Research Group Inc
Sarnia, Ontario, Canada
Canadian Centre for Research on Diabetes
Smiths Falls, Ontario, Canada
Manna Research, Inc.
Stoney Creek, Ontario, Canada
LMC Endocrinology Centres Ltd.
Toronto, Ontario, Canada
Sameh Fikry Medicine Professional Corporation
Waterloo, Ontario, Canada
Q & T Research Outaouais
Gatineau, Quebec, Canada
Centre De Recherche Clinique De Laval
Laval, Quebec, Canada
Manna Research (Quebec)
Lévis, Quebec, Canada
LMC Endocrinology Centres Ltd.
Saint-Laurent, Quebec, Canada
Iatriko Palaiou Falirou, Medical Center
Palaió Fáliro, Athens, Greece
Thermi Clinic
Thermi, Thessaloniki, Greece
University General Hospital of Larissa
Larissa, , Greece
AHEPA Hospital
Thessaloniki, , Greece
Euromedica - General Clinic of Thessaloniki
Thessaloniki, , Greece
Ha'Emek Medical Center
Afula, , Israel
Soroka Medical Center
Beersheba, , Israel
Rambam Medical Center
Haifa, , Israel
Wolfson Medical Center
Holon, , Israel
Hadassah Medical Center
Jerusalem, , Israel
Rabin Medical Center
Petah Tikva, , Israel
Sheba Medical Center
Ramat Gan, , Israel
Sakhnin Community Clinic, Clalit Health Services
Sakhnin, , Israel
Tel Aviv Sourasky Medical Center
Tel Aviv, , Israel
Instituto Jalisciense de Investigacion en Diabetes y Obesida
Guadalajara, Jalisco, Mexico
Diseno y Planeacion en Investigacion Medica S.C.
Guadalajara, Jalisco, Mexico
Unidad Medica para la Salud Integral (UMSI)
Monterrey, Nuevo León, Mexico
St. Lucas Clinical Research Center
Merida, State of Mexico, Mexico
Centro de Estudios de Investigacion Metabolicos y Cardiovasc
Tampico, Tamaulipas, Mexico
Investigacion en Salud y Metabolismo S.C
Chihuahua City, , Mexico
Centralny Szpital Kliniczny MSWiA Klinika Dermatologiczna
Warsaw, Masovian Voivodeship, Poland
Poradnia Diabetologiczna SN ZOZ Lege Artis
Bialystok, , Poland
NZOZ Diab-Endo-Met
Krakow, , Poland
Centrum Terapii Wspolczesnej J.M. Jasnorzewska S.K.A.
Lodz, , Poland
NZOZ CenterMed Lublin
Lublin, , Poland
Gabinety Terpa
Lublin, , Poland
NZOZ Przychodnia Specjalistyczna MEDICA
Lublin, , Poland
Praktyka Lekarska
Poznan, , Poland
Nzoz Neuro - Kard
Poznan, , Poland
NZOZ Przychodnia Specjalistyczna Henryk RudzkiAndrzej Wittek
Ruda Śląska, , Poland
Woj. Zesp. Spec. Opieki Zdrowotnej
Wroclaw, , Poland
Manati Center for Clinical Research Inc
Manatí, PR, Puerto Rico
Ponce School of Medicine CAIMED Center
Ponce, PR, Puerto Rico
Research and Cardiovascular Corp.
Ponce, PR, Puerto Rico
University Of Puerto Rico
Rio Pedras, PR, Puerto Rico
GCM Medical Group PSC
San Juan, PR, Puerto Rico
Consultorio Medico
San Juan, PR, Puerto Rico
Emanuelli Research & Development Center, LLC
Arecibo, , Puerto Rico
SC Gama Diamed SRL
Mangalia, Constanța County, Romania
Spitalul Judetean de Urgenta Satu Mare
Satu Mare, Jud Satu-Mare, Romania
CMI DNBM Dr. Pop Lavinia
Baia Mare, Maramureş, Romania
Cosamext SRL
Târgu Mureş, Mureș County, Romania
Centrul Medical Dr. Negrisanu
Timișoara, Timiș County, Romania
Centrul Medical de Diagnostic si Tratament Ambulatoriu Neomed SRL
Brasov, , Romania
Cabinetul Medical Nicodiab SRL
Bucharest, , Romania
SC Nutrilife SRL
Bucharest, , Romania
Milena Sante SRL
Galati, , Romania
Regional Clinical Hospital
Saratov, Russian Federation, Russia
Arkhangelsk the first city clinical hospital
Arkhangelsk, , Russia
FSBI Endocrinological Research Center of the MOH of the ROF
Moscow, , Russia
Novosibirsk Regional Clinical Hospital
Novosibirsk, , Russia
Ryazan Regional Clinincal Cardiology Dispensary
Ryazan, , Russia
City Hospital of Saint Martyr Elizabeth
Saint Petersburg, , Russia
Medical Military Academy
Saint Petersburg, , Russia
City Consultative and Diagnostic Center
Saint Petersburg, , Russia
SPb GUZ "Diagnostic Center #85"
Saint Petersburg, , Russia
Research & Practice Ltd
Yaroslavl, , Russia
Human care s.r.o.
Košice, Slovak Republic, Slovakia
MediVet s.r.o.
Malacky, Slovak Republic, Slovakia
Areteus s.r.o.
Trebišov, Slovak Republic, Slovakia
DIA-MED CENTRUM s.r.o.
Púchov, , Slovakia
Tatratrial s.r.o.
Rožňava, , Slovakia
MEDI-DIA s.r.o.
Sabinov, , Slovakia
Hospital Universitario Marques De Valdecilla
Santander, Cantabria, Spain
Hospital Universitario Quiron Madrid
Pozuelo de Alarcón, Madrid, Spain
Hospital de la Ribera
Alzira, Valencia, Spain
Complexo Hospitalario Universitario A Coruña, CHUAC
A Coruña, , Spain
Instituto de Ciencias medicas
Alicante, , Spain
Centro Periférico de Especialidades Bola Azul
Almería, , Spain
Hospital Quironsalud Barcelona- END
Barcelona, , Spain
Hospital Clinico Universitario San Cecilio
Granada, , Spain
Centro Especialidades San Jose Obrero (Barbarela)
Málaga, , Spain
Clinica Juaneda
Palma de Mallorca, , Spain
Clinica Nuevas Tecnologias en Diabetes y Endocrinologia
Seville, , Spain
Hospital Universitario Virgen Macarena
Seville, , Spain
Cardinal Tien Hospital
Sindian City, Taipei, Taiwan
Chang Gung Memorial Hospital - Kaohsiung
Kaohsiung City, , Taiwan
Chung Shan Medical University Hospital
Taichung, , Taiwan
China Medical University Hospital
Taichung, , Taiwan
Kuang Tien General Hospital
Taichung County, , Taiwan
National Cheng Kung University Hospital
Tainan City, , Taiwan
Chi-Mei Medical Center
Tainan City, , Taiwan
National Taiwan University Hospital
Taipei, , Taiwan
Taipei Veterans General Hospital
Taipei, , Taiwan
Countries
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References
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De Block C, Peleshok J, Wilding JPH, Kwan AYM, Rasouli N, Maldonado JM, Wysham C, Liu M, Aleppo G, Benneyworth BD. Post Hoc Analysis of SURPASS-1 to -5: Efficacy and Safety of Tirzepatide in Adults with Type 2 Diabetes are Independent of Baseline Characteristics. Diabetes Ther. 2025 Jan;16(1):43-71. doi: 10.1007/s13300-024-01660-0. Epub 2024 Nov 12.
Boye KS, Sapin H, Dong W, Williamson S, Lee CJ, Thieu VT. Improved Glycaemic and Weight Management Are Associated with Better Quality of Life in People with Type 2 Diabetes Treated with Tirzepatide. Diabetes Ther. 2023 Nov;14(11):1867-1887. doi: 10.1007/s13300-023-01457-7. Epub 2023 Sep 5.
Boye KS, Thieu VT, Sapin H, Lee CJ, Lando LF, Brown K, Bray R, Wiese RJ, Patel H, Rodriguez A, Yu M. Patient-Reported Outcomes in People with Type 2 Diabetes Receiving Tirzepatide in the SURPASS Clinical Trial Programme. Diabetes Ther. 2023 Nov;14(11):1833-1852. doi: 10.1007/s13300-023-01451-z. Epub 2023 Aug 1.
Heerspink HJL, Sattar N, Pavo I, Haupt A, Duffin KL, Yang Z, Wiese RJ, Tuttle KR, Cherney DZI. Effects of tirzepatide versus insulin glargine on kidney outcomes in type 2 diabetes in the SURPASS-4 trial: post-hoc analysis of an open-label, randomised, phase 3 trial. Lancet Diabetes Endocrinol. 2022 Nov;10(11):774-785. doi: 10.1016/S2213-8587(22)00243-1. Epub 2022 Sep 21.
Sattar N, McGuire DK, Pavo I, Weerakkody GJ, Nishiyama H, Wiese RJ, Zoungas S. Tirzepatide cardiovascular event risk assessment: a pre-specified meta-analysis. Nat Med. 2022 Mar;28(3):591-598. doi: 10.1038/s41591-022-01707-4. Epub 2022 Feb 24.
Del Prato S, Kahn SE, Pavo I, Weerakkody GJ, Yang Z, Doupis J, Aizenberg D, Wynne AG, Riesmeyer JS, Heine RJ, Wiese RJ; SURPASS-4 Investigators. Tirzepatide versus insulin glargine in type 2 diabetes and increased cardiovascular risk (SURPASS-4): a randomised, open-label, parallel-group, multicentre, phase 3 trial. Lancet. 2021 Nov 13;398(10313):1811-1824. doi: 10.1016/S0140-6736(21)02188-7. Epub 2021 Oct 18.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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A Study of Tirzepatide (LY3298176) Once a Week Versus Insulin Glargine Once a Day in Participants With Type 2 Diabetes and Increased Cardiovascular Risk
Other Identifiers
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I8F-MC-GPGM
Identifier Type: OTHER
Identifier Source: secondary_id
2018-002618-11
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
17072
Identifier Type: -
Identifier Source: org_study_id
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