Efficacy and Safety of LY3298176 Once Weekly Versus Insulin Glargine in Patients With Type 2 Diabetes and Increased Cardiovascular Risk (SURPASS-4)
Who is this study for? Adult patients with type 2 diabetes
What treatments are being studied? Tirzepatide
Status: Completed
Location: See all (216) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY
The purpose of the trial is to assess the efficacy and safety of tirzepatide taken once a week to insulin glargine taken once daily in participants with type 2 diabetes and increased cardiovascular risk. The study will last about 108 weeks and may include up to 30 visits.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
⁃ Participants must:
• 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
Locations
United States
California
Advanced Research Center
Anaheim
Valley Clinical Trials, Inc.
Covina
Marin Endocrine Associates
Greenbrae
National Research Institute
Huntington Park
Scripps Whittier Diabetes Institute
La Jolla
First Valley Medical Group
Lancaster
National Research Institute
Los Angeles
Catalina Research Institute, LLC
Montclair
Monterey Endocrine & Diabetes Institute, Inc.
Monterey
Valley Clinical Trials, Inc.
Northridge
Desert Medical Group Inc
Palm Springs
Havana Research Institute
Pasadena
Western University of Health Sciences
Pomona
LCGK Research
San Carlos
Olive View Medical Center
Sylmar
University Clinical Investigators, Inc.
Tustin
Touro University
Vallejo
Coastal Metabolic Research Centre
Ventura
Diablo Clinical Research
Walnut Creek
Connecticut
Chase Medical Research, LLC
Waterbury
Florida
ALL Medical Research, LLC
Cooper City
Advanced Pharma Research
Cutler Bay
South Florida Wellness & Clinical Research Institute
Margate
New Horizon Research Center
Miami
Suncoast Research Group, LLC
Miami
Clinical Neuroscience Solutions Inc
Orlando
Progressive Medical Research
Port Orange
Georgia
Primary Care Specialists, LLC
Atlanta
Iowa
University of Iowa Hospital & Clinic
Iowa City
Iowa Diabetes Research
West Des Moines
Idaho
Rocky Mountain Diabetes and Osteoporosis Center
Idaho Falls
Solaris Clinical Research
Meridian
Saltzer Medical Group. P.A.
Nampa
Illinois
Northwestern Feinberg School of Medicine
Chicago
NorthShore University HealthSystem
Skokie
Kansas
Cotton O'Neil Diabetes and Endocrinology Center
Topeka
Kentucky
Robley Rex VAMC
Louisville
Massachusetts
NECCR PrimaCare Research, LLC
Fall River
Michigan
AA Medical Research Center
Flint
Troy Internal Medicine, PC
Troy
Missouri
Clinical Research Professionals
Chesterfield
Montana
Glacier View Research Institute
Kalispell
Montana Medical Research, Inc
Missoula
North Carolina
PharmQuest
Greensboro
North Dakota
Lillestol Research LLC
Fargo
New Hampshire
Southern New Hampshire Diabetes and Endocrinology
Nashua
Nevada
Palm Research Center
Las Vegas
Palm Research Center
Las Vegas
Ohio
Rapid Medical Research Inc
Cleveland
Aventiv Research
Columbus
Ohio State Univ College Of Medicine
Columbus
Oklahoma
Intend Research
Norman
Oregon
The Corvallis Clinic P.C.
Corvallis
Oregon Health and Science University
Portland
Pennsylvania
Heritage Valley Medical Group, Inc.
Beaver
Capital Area Research
Camp Hill
Detweiler Family Medicine
Lansdale
Capital Area Research
Newport
Parkside Family Medical
Philadelphia
Preferred Primary Care Physicians- Bower Hill
Pittsburgh
South Carolina
Mountain View Clinical Research, Inc.
Greer
The Research Center of the Upstate
Mauldin
Tennessee
Holston Medical Group Clinical Research
Kingsport
New Phase Research & Development
Knoxville
Texas
Dallas Diabetes Endocrine Center
Dallas
PCP for Life
Houston
BFHC Research
San Antonio
Consano Clinical Research
Shavano Park
Martin Diagnostic Clinic
Tomball
Utah
Alpine Research Organization
Farmington
Virginia
Burke Internal Medicine & Research
Burke
Washington
Private: Dr. Larry Stonesifer
Federal Way
Capital Clinical Research Center
Olympia
Walla Walla Clinic
Walla Walla
Other Locations
Argentina
AXISMED SRL - Bioclinica Research Network
Buenos Aires
CEDIC-Centro de Investigaciones Clinicas
Caba
CEMEDIC
Caba
Centro de Investigaciones Metabólicas (CINME)
Caba
Investigaciones Medicas IMOBA S.R.L.
Caba
Mautalen Salud e Investigación - Servicio de Endocrinología
Caba
Centro de Investigacion y Prevencion Cardiovascular (CIPREC)
Ciudad Autonoma De
Cemediab - Centro Médico Diabetológico Dr. Alejandro Chertkoff
Ciudad Autonoma De Buenos Aire
Centro Medico Dr Laura Maffei Investigacion Clinica Aplicada
Ciudad Autonoma De Buenos Aire
Centro Médico Viamonte
Ciudad Autonoma De Buenos Aire
Instituto Centenario
Ciudad Autonoma De Buenos Aire
Cent Priva Especiali Médicas Ambulatorias Inve Clin CEMAIC
Cordoba
Centro Diabetologico Dr Waitman
Cordoba
Centro Medico Privado San Vicente Diabetes
Cordoba
CIPADI
Godoy Cruz
Australia
Paratus Clinical Blacktown Clinic
Blacktown
Eastern Clinical Research Unit
Box Hill
CORE Research Group Pty Ltd
Brisbane
Campbelltown Medical & Dental Centre
Campbelltown
Forest Hill Medical and Dental Centre
Forest Hill
Fremantle Hospital
Fremantle
Barwon Health - The Geelong Hospital
Geelong
Paratus Clinical Kanwal Clinic
Kanwal
The AIM Centre
Merewether
Morayfield Medical and Dental Centre
Morayfield
GP Plus Marion
Oaklands Park
Royal Melbourne Hospital
Parkville
AusTrials Pty Ltd
Sherwood
Royal North Shore Hospital
St. Leonards
Victoria Point Medical and Dental Centre
Victoria Point
Brazil
Centro de Pesquisa Clinica do Brasil
Brasilia
Centro de Diabetes Curitiba
Curitiba
Centro de Pesq. em Diabetes e Doencas Endocrino Metabol.
Fortaleza
Instituto de Ensino e Pesquisa Clinica do Ceara
Fortaleza
CCBR Brasil Centro de Analises e Pesquisas Clínicas LTDA
Rio De Janeiro
Cpclin Centro de Pesquisas Clinicas
São Paulo
CPQuali Pesquisa Clínica Ltda.
São Paulo
Dr. Consulta Clínica Médica LTDA
São Paulo
Cedoes Centro Diagnostico Pequisa Osteoporose E Santo Ltd
Vitoria
Canada
LMC Endocrinology Centres Ltd.
Barrie
Aggarwal and Associates Ltd
Brampton
LMC Endocrinology Centers Brampton
Brampton
C-Health Diabetes and Endocrinology Clinic Calgary
Calgary
LMC Manna Research
Calgary
LMC Endocrinology Centres Ltd.
Concord
Q & T Research Outaouais
Gatineau
Centre De Recherche Clinique De Laval
Laval
Manna Research (Quebec)
Levis
Milestone Research Inc.
London
LMC Endocrinology Centres Ltd.
Nepean
Bluewater Clinical Research Group Inc
Sarnia
Synergy Medical Research
Sherwood Park
Canadian Centre for Research on Diabetes
Smiths Falls
Manna Research, Inc.
Stoney Creek
Medicor Research Inc
Sudbury
LMC Endocrinology Centres Ltd.
Toronto
LMC Endocrinology Centres Ltd.
Ville St-laurent
Sameh Fikry Medicine Professional Corporation
Waterloo
Greece
University General Hospital of Larissa
Larissa
Iatriko Palaiou Falirou, Medical Center
Palaio Faliro
Thermi Clinic
Thermi
AHEPA Hospital
Thessaloniki
Euromedica - General Clinic of Thessaloniki
Thessaloniki
Israel
Ha'Emek Medical Center
Afula
Soroka Medical Center
Beer Sheva
Rambam Medical Center
Haifa
Wolfson Medical Center
Holon
Hadassah Medical Center
Jerusalem
Rabin Medical Center
Petach Tikva
Sheba Medical Center
Ramat Gan
Sakhnin Community Clinic, Clalit Health Services
Sakhnin
Tel Aviv Sourasky Medical Center
Tel Aviv Jaffa
Mexico
Investigacion en Salud y Metabolismo S.C
Chihuahua
Diseno y Planeacion en Investigacion Medica S.C.
Guadalajara
Instituto Jalisciense de Investigacion en Diabetes y Obesida
Guadalajara
St. Lucas Clinical Research Center
Merida
Unidad Medica para la Salud Integral (UMSI)
Monterrey
Centro de Estudios de Investigacion Metabolicos y Cardiovasc
Tampico
Poland
Poradnia Diabetologiczna SN ZOZ Lege Artis
Bialystok
NZOZ Diab-Endo-Met
Krakow
Centrum Terapii Wspolczesnej J.M. Jasnorzewska S.K.A.
Lodz
Gabinety Terpa
Lublin
NZOZ CenterMed Lublin
Lublin
NZOZ Przychodnia Specjalistyczna MEDICA
Lublin
Nzoz Neuro - Kard
Poznan
Praktyka Lekarska
Poznan
NZOZ Przychodnia Specjalistyczna Henryk RudzkiAndrzej Wittek
Ruda Slaska
Centralny Szpital Kliniczny MSWiA Klinika Dermatologiczna
Warszawa
Woj. Zesp. Spec. Opieki Zdrowotnej
Wroclaw
Puerto Rico
Emanuelli Research & Development Center, LLC
Arecibo
Manati Center for Clinical Research Inc
Manati
Ponce School of Medicine CAIMED Center
Ponce
Research and Cardiovascular Corp.
Ponce
University Of Puerto Rico
Rio Pedras
Consultorio Medico
San Juan
GCM Medical Group PSC
San Juan
Romania
CMI DNBM Dr. Pop Lavinia
Baia Mare
Centrul Medical de Diagnostic si Tratament Ambulatoriu Neomed SRL
Brasov
Cabinetul Medical Nicodiab SRL
Bucharest
SC Nutrilife SRL
Bucuresti
Milena Sante SRL
Galati
SC Gama Diamed SRL
Mangalia
Spitalul Judetean de Urgenta Satu Mare
Satu-mare
Cosamext SRL
Targu Mures
Centrul Medical Dr. Negrisanu
Timisoara
Russian Federation
Arkhangelsk the first city clinical hospital
Arkhangelsk
FSBI Endocrinological Research Center of the MOH of the ROF
Moscow
Novosibirsk Regional Clinical Hospital
Novosibirsk
Ryazan Regional Clinincal Cardiology Dispensary
Ryazan
City Hospital of Saint Martyr Elizabeth
Saint Petersburg
Medical Military Academy
Saint Petersburg
SPb GUZ Diagnostic Center #85
Saint Petersburg
City Consultative and Diagnostic Center
Saint-petersburg
Regional Clinical Hospital
Saratov
Research & Practice Ltd
Yaroslavl
Slovakia
Human care s.r.o.
Kosice
MediVet s.r.o.
Malacky
DIA-MED CENTRUM s.r.o.
Puchov
Tatratrial s.r.o.
Roznava
MEDI-DIA s.r.o.
Sabinov
Areteus s.r.o.
Trebisov
Spain
Hospital de la Ribera
Alcira
Instituto de Ciencias medicas
Alicante
Centro Periférico de Especialidades Bola Azul
Almeria
Hospital Quironsalud Barcelona- END
Barcelona
Hospital Clinico Universitario San Cecilio
Granada
Complexo Hospitalario Universitario A Coruña, CHUAC
La Coruña
Centro Especialidades San Jose Obrero (Barbarela)
Malaga
Clinica Juaneda
Palma De Mallorca
Hospital Universitario Quiron Madrid
Pozuelo De Alarcon
Hospital Universitario Marques De Valdecilla
Santander
Hospital Universitario Virgen Macarena
Sevilla
Clinica Nuevas Tecnologias en Diabetes y Endocrinologia
Seville
Taiwan
Chang Gung Memorial Hospital - Kaohsiung
Kaohsiung City
Cardinal Tien Hospital
Sindian City
China Medical University Hospital
Taichung
Chung Shan Medical University Hospital
Taichung City
Kuang Tien General Hospital
Taichung County
National Cheng Kung University Hospital
Tainan
Chi-Mei Medical Center
Tainan City
Taipei Veterans General Hospital
Taipei
National Taiwan University Hospital
Taipei City
Time Frame
Start Date: 2018-11-20
Completion Date: 2021-04-22
Participants
Target number of participants: 2002
Treatments
Experimental: 5 mg Tirzepatide
5 milligrams (mg) tirzepatide administered subcutaneously (SC) once a week.
Experimental: 10 mg Tirzepatide
10 mg tirzepatide administered SC once a week.
Experimental: 15 mg Tirzepatide
15 mg tirzepatide administered SC once a week.
Active_comparator: 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.
Authors
Iosif Szilagyi, Albert B Knouse, Daniel J Humiston, Stanley Stringam, Clancy L Cone, Betsy M Palal, Ronald K Mayfield, Juan P Loy, Miguel Mujica-Baella, Ronald H Chochinov, Linda M Gaudiani, Lisa Connery, Paul Rosenblit, Courtney Shelton, Ahmed Arif, Gregorio A. Cortes-Maisonet, Eric J. Klein, Stanley Hsia, Alexander J White, Earl E Martin, Timothy W. Jennings, Toby J Briskin, Helen L. Stacey, Juan P Frias, Alan G Wynne, Francisco G Miranda, Raman Purighalla, Vahid Mahabadi, Eric M. Ball, Michael J Oliver, Andrew J Ahmann, Samer Nakhle, Sudip Datta, Amir Tirosh, Fahed Georgeos Bitar, Rizwana H. Mohseni, Anne Tuggle, Evelyne Davidson, Carl D Vance, Mark E. Kutner, Joseph Soufer, James W Chu, Judson K Menefee, Ramon Ortiz-Carrasquillo, Jacqueline Milam, Timothy Davis, Ehab Sorial, Kathleen Dungan, Venkatesh Nadar, Athena Philis-Tsimikas, Kanagaratnam Sivalingam, Michael C Chen, Sathya S Krishnasamy, David Butuk, Julio Rosenstock, Lazaro Nunez, Lee Edward Herman, Najmuddin Karimjee, Michael E Dever, Airani Sathananthan, Harpreet Bajaj, Liana Billings, Alexander V. Murray, Ronald M Goldenberg, Larry Stonesifer, Luis Hernandez-Vazquez, Robert J Silver, Grazia Aleppo, Leila Chaychi, Curtis Jantzi, Anuj Bhargava, Richard Walter Simpson, Jay Shubrook, Nashwa Gabra, Glenn Rosen, Neil Fraser, Michael Lillestol, Jose B Vazquez-Tanus, Joao L C Borges, Claire Morbey, Naresh Kumar Aggarwal, Shih-Ting Tseng, Te-Lin Hsia, Lee-Ming Chuang, Idit Liberty, Luis Vazquez, Ferdinandus de Looze, Kai-Jen Tien, Viera Donicova, Ofri Mosenzon, Avraham Ishay, Natalia V. Vorokhobina, Cristobal Morales, Javier Escalada, Greg Fulcher, GAGIK GALSTYAN, Denise R Franco, Peter G Colman, Naim Shehadeh, Yael Sofer, Julio Wainstein, David Martin Colquhoun, Sue Pedersen, Alexandra Bargiota, Stephen Stranks, Kalliopi Kotsa, Naftali Stern, Horng-Yih Ou, Edward Franek, Chii-Min Hwu, Ilan Shimon, Oren Steen, Chien-Ning Huang
Related Therapeutic Areas
Sponsors
Leads: Eli Lilly and Company