A Study of Tirzepatide (LY3298176) Versus Semaglutide Once Weekly as Add-on Therapy to Metformin in Participants With Type 2 Diabetes
NCT ID: NCT03987919
Last Updated: 2022-02-14
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
1879 participants
INTERVENTIONAL
2019-07-30
2021-02-15
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
1 mg Semaglutide
1 mg semaglutide administered SC once a week.
Semaglutide
Administered SC
Interventions
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Tirzepatide
Administered SC
Semaglutide
Administered SC
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Have HbA1c between ≥7.0% and ≤10.5%
* Be on stable treatment with unchanged dose of metformin \>1500 mg/day for at least 3 months prior to screening
* Be of stable weight (±5%) for at least 3 months before screening
* Have a body mass index (BMI) ≥25 kilograms per meter squared (kg/m²) at screening
Exclusion Criteria
* Have had chronic or acute pancreatitis any time prior to study entry
* Have proliferative diabetic retinopathy or diabetic maculopathy or nonproliferative diabetic retinopathy requiring acute 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 an estimated glomerular filtration rate \<45 milliliters/minute/1.73 m² (or lower than the country specific threshold for using the protocol required dose of metformin per local label)
* 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 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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Cahaba Research
Birmingham, Alabama, United States
Syed Research Consultants Llc
Sheffield, Alabama, United States
National Research Institute - Huntington Park
Huntington Park, California, United States
Catalina Research Institute, LLC
Montclair, California, United States
Valley Clinical Trials, Inc.
Northridge, California, United States
National Research Institute - Huntington Park
Panorama City, California, United States
Artemis Institute for Clinical Research
Riverside, California, United States
Artemis Institute for Clinical Research
San Diego, California, United States
Artemis Institute for Clinical Research
San Marcos, California, United States
University Clinical Investigators, Inc.
Tustin, California, United States
CMR of Greater New Haven
Hamden, Connecticut, United States
Clinical Research of South Florida
Coral Gables, Florida, United States
East Coast Institute for Research at The Jones Center
Lake City, Florida, United States
South Florida Clinical Research Institute
Margate, Florida, United States
Suncoast Research Group
Miami, Florida, United States
New Horizon Research Center
Miami, Florida, United States
Oviedo Medical Research
Oviedo, Florida, United States
South Broward Research
Pembroke Pines, Florida, United States
United Osteoporosis Center
Gainesville, Georgia, United States
Sky Clinical Research Network
Union City, Georgia, United States
Elite Clinical Trials
Blackfoot, Idaho, United States
University of Iowa Hospital & Clinic
Iowa City, Iowa, United States
Cotton O'Neil Clinic
Topeka, Kansas, United States
Cotton O'Neil Diabetes and Endocrinology Center
Topeka, Kansas, United States
NECCR PrimaCare Research
Fall River, Massachusetts, United States
ActivMed Practices and Research
Methuen, Massachusetts, United States
Olive Branch Family Medical Center
Olive Branch, Mississippi, United States
Clinvest Research LLC
Springfield, Missouri, United States
Premier Research
Trenton, New Jersey, United States
Albany Medical College, Division of Community Endocrinology
Albany, New York, United States
PharmQuest
Greensboro, North Carolina, United States
Diabetes & Endocrinology Consultants, PC
Morehead City, North Carolina, United States
PMG Research of Wilmington
Wilmington, North Carolina, United States
Lillestol Research LLC
Fargo, North Dakota, United States
Aventiv Research Inc
Columbus, Ohio, United States
Intend Research, LLC
Norman, Oklahoma, United States
Heritage Valley Medical Group, Inc.
Beaver, Pennsylvania, United States
Capital Area Research, LLC
Camp Hill, Pennsylvania, United States
Detweiler Family Medicine & Associates
Lansdale, Pennsylvania, United States
Green & Seidner Family Practice Associates
Lansdale, Pennsylvania, United States
Thomas Jefferson University
Philadelphia, Pennsylvania, United States
Preferred Primary Care Physicians, Preferred Clinical Research-St. Clair
Pittsburgh, Pennsylvania, United States
Holston Medical Group
Bristol, Tennessee, United States
Dallas Diabetes Research Center
Dallas, Texas, United States
Biopharma Informatic, Inc.
Houston, Texas, United States
Consano Clinical Research, LLC
Shavano Park, Texas, United States
Carl R. Meisner Medical Clinic, PLLC
Sugar Land, Texas, United States
Martin Diagnostic Clinic
Tomball, Texas, United States
Burke Internal Medicine and Research
Burke, Virginia, United States
Capital Clinical Research Center
Olympia, Washington, United States
The Vancouver Clinic
Vancouver, Washington, United States
CEDIC
CABA, AR-B, Argentina
CIPREC
Ciudad Autonoma de Buenos Aire, AR-B, Argentina
Investigaciones Medicas Imoba Srl
Buenos Aires, AR-C, Argentina
CEMEDIAB
C.a.b.a., AR-C, Argentina
Sanatorio Norte
Santiago del Estero, AR-G, Argentina
Centro de Investigaciones Metabólicas (CINME)
CABA, Buenos Aires, Argentina
Centro Médico Viamonte
CABA, Buenos Aires, Argentina
Centro Medico Dr Laura Maffei Investigacion Clinica Aplicada
CABA, Buenos Aires, Argentina
Mautalen Salud e Investigacion-Centro de Osteopatías Médicas
Ciudad Autonoma de Buenos Air, Buenos Aires, Argentina
Instituto de Investigaciones Clínicas Mar del Plata
Mar del Plata, Buenos Aires, Argentina
CIPADI
Godoy Cruz, Mendoza Province, Argentina
Instituto Centenario
Ciudad Autonoma de Buenos Aire, , Argentina
Cent Priva Especiali Médicas Ambulatorias Inve Clin CEMAIC
Córdoba, , Argentina
Paratus Clinical Research Western Sydney
Blacktown, Au-nsw, Australia
Campbelltown Medical & Dental Centre
Campbelltown, Au-nsw, Australia
Paratus Clinical Research Central Coast
Kanwal, Au-nsw, Australia
Holdsworth House Medical Practice
Sydney, New South Wales, Australia
GenesisCare - Bundaberg
Bundaberg, Queensland, Australia
Royal Brisbane and Womens Hospital
Herston, Queensland, Australia
Core Research Group
Milton, Queensland, Australia
AusTrials
Taringa, Queensland, Australia
Eastern Clinical Research Unit
Box Hill, Victoria, Australia
Barwon Health - The Geelong Hospital
Geelong, Victoria, Australia
GenesisCare - Wexford Medical Centre WA
Joondalup, Western Australia, Australia
GenesisCare - Wexford Medical Centre WA
Murdoch, Western Australia, Australia
Adelaide Medical Solutions
Woodville South, , Australia
CEDOES
Vitória, Br-es, Brazil
ISPEM - Instituto São José dos Campos em Pesquisas Médicas
São José dos Campos, Br-sp, Brazil
CPQuali Pesquisa Clínica
São Paulo, Br-sp, Brazil
CEPIC - Centro Paulista de Investigação Clínica
São Paulo, Br-sp, Brazil
Centro de Pesquisas em Diabetes
Porto Alegre, Rio Grande do Sul, Brazil
CPCLIN
São Paulo, São Paulo, Brazil
Dr. Consulta Clínica Médica LTDA
São Paulo, , Brazil
Milestone Research Inc.
London, Ca-on, Canada
Bluewater Clinical Research Group Inc.
Sarnia, Ca-on, Canada
Dr. Anil K. Gupta Medicine Professional Corporation
Toronto, Ca-on, Canada
Manna Research
Lévis, Ca-qc, Canada
Manna Research - Burlington North
Burlington, Ontario, Canada
Manna Research - Burlington North
Nepean, Ontario, Canada
Manna Research - Burlington North
Stoney Creek, Ontario, Canada
Manna Research - Burlington North
Toronto, Ontario, Canada
Meir Medical Center
Kfar Saba, Central District, Israel
Clalit Health Services - Shuali Clinic
Raanana, Central District, Israel
Sheba Medical Center
Ramat Gan, Central District, Israel
Diabetes Medical Center
Tel Aviv, Il-ta, Israel
Hadassah Medical Center
Jerusalem, Jerusalem, Israel
Clalit Health Services - Sakhnin Community Clinic
Sakhnin, , Israel
Tel Aviv Sourasky Medical Center
Tel Aviv, , Israel
Rambam Health Care Campus
Haifa, Ḥeifā, Israel
Linn Medical Center
Haifa, Ḥeifā, Israel
Centro Especializado en Diabetes Obesidad y Enfermedades
México, D.F., Mexico
Diseno y Planeacion en Investigacion Medica
Guadalajara, Jalisco, Mexico
Instituto Jalisciense de Investigacion en Diabetes y Obesida
Guadalajara, Jalisco, Mexico
Unidad de Investigaci�n Cl�nica Cardiometabolica de Occidente
Guadalajara, Mx-jal, Mexico
Hospital Universitario Dr. Jose Eleuterio Gonzalez
Monterrey, N.L., Mexico
Unidad Médica para la Salud Integral
San Nicolás de los Garza, Nuevo León, Mexico
Centro de Estudios de Investigacion Metabolicos y Cardiovasculares
Ciudad Madero, Tamaulipas, Mexico
Investigacion en Salud y Metabolismo S.C
Chihuahua City, , Mexico
Paola Mansilla-Letelier, MD
Guaynabo, PR, Puerto Rico
Research and Cardiovascular Corp.
Ponce, PR, Puerto Rico
Martha Gomez Cuellar M.D.
San Juan, PR, Puerto Rico
Clinical Research Puerto Rico
San Juan, , Puerto Rico
Oldfield Surgery
Bath, Avon, United Kingdom
Staploe Medical Centre
Ely, Gb-cam, United Kingdom
Fowey River Practice
Fowey, Gb-con, United Kingdom
Oak Tree Surgery
Liskeard, Gb-con, United Kingdom
Rame Medical Ltd
Torpoint, Gb-con, United Kingdom
Royal Primary Care Chesterfield North west
Chesterfield, Gb-dby, United Kingdom
Knowle House Surgery
Plymouth, Gb-dev, United Kingdom
Queen Alexandra Hospital
Portsmouth, Gb-ham, United Kingdom
Lister Hospital
Stevenage, Gb-hrt, United Kingdom
Oakenhurst Medical Practice
Blackburn, Gb-lan, United Kingdom
Rowden Surgery
Chippenham, Gb-wil, United Kingdom
Leicester General Hospital
Leicester, Leicestershire, United Kingdom
University Hospital Coventry & Warwickshire
Coventry, Warwickshire, United Kingdom
Wickersley Health Centre - Clifton Medical Centre
Rotherham, , United Kingdom
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.
Osumili B, Fan L, Paik JS, Pantalone KM, Ranta K, Sapin H, Tofe S. Tirzepatide 5, 10 and 15 mg versus injectable semaglutide 0.5 mg for the treatment of type 2 diabetes: An adjusted indirect treatment comparison. Diabetes Res Clin Pract. 2024 Jun;212:111717. doi: 10.1016/j.diabres.2024.111717. Epub 2024 May 21.
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.
Reitzel SB, Bogelund M, Basse A, Barszczewska O, Ren H. Semaglutide versus tirzepatide for people with type 2 diabetes: cost of glycemic control in Austria, the Netherlands, Lithuania, and the United Arab Emirates. Curr Med Res Opin. 2023 Aug;39(8):1055-1060. doi: 10.1080/03007995.2023.2231275. Epub 2023 Jul 10.
Viljoen A, Pantalone KM, Galindo RJ, Cui X, Huh R, Hemmingway A, Fernandez Lando L, Patel H. Time to Reach Glycaemic and Body Weight Loss Thresholds with Tirzepatide in Patients with Type 2 Diabetes: A Pre-planned Exploratory Analysis of SURPASS-2 and SURPASS-3. Diabetes Ther. 2023 May;14(5):925-936. doi: 10.1007/s13300-023-01398-1. Epub 2023 Mar 31.
Ten Doesschate T, van der Vaart TW, Debisarun PA, Taks E, Moorlag SJCFM, Paternotte N, Boersma WG, Kuiper VP, Roukens AHE, Rijnders BJA, Voss A, Veerman KM, Kerckhoffs APM, Oever JT, van Crevel R, van Nieuwkoop C, Lalmohamed A, van de Wijgert JHHM, Netea MG, Bonten MJM, van Werkhoven CH. Bacillus Calmette-Guerin vaccine to reduce healthcare worker absenteeism in COVID-19 pandemic, a randomized controlled trial. Clin Microbiol Infect. 2022 Sep;28(9):1278-1285. doi: 10.1016/j.cmi.2022.04.009. Epub 2022 Apr 28.
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.
Frias JP, Davies MJ, Rosenstock J, Perez Manghi FC, Fernandez Lando L, Bergman BK, Liu B, Cui X, Brown K; SURPASS-2 Investigators. Tirzepatide versus Semaglutide Once Weekly in Patients with Type 2 Diabetes. N Engl J Med. 2021 Aug 5;385(6):503-515. doi: 10.1056/NEJMoa2107519. Epub 2021 Jun 25.
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) Versus Semaglutide Once Weekly as Add-on Therapy to Metformin in Participants With Type 2 Diabetes
Other Identifiers
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I8F-MC-GPGL
Identifier Type: OTHER
Identifier Source: secondary_id
2018-004422-29
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
17001
Identifier Type: -
Identifier Source: org_study_id
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