A Study of Tirzepatide (LY3298176) Versus Insulin Degludec in Participants With Type 2 Diabetes
NCT ID: NCT03882970
Last Updated: 2022-01-19
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
1444 participants
INTERVENTIONAL
2019-04-01
2021-01-04
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 Degludec
Insulin degludec administered SC once a day.
Insulin Degludec
Administered SC
Interventions
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Tirzepatide
Administered SC
Insulin Degludec
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 ≥7.0% and ≤10.5%
* Be on stable treatment with unchanged dose of metformin or metformin plus an SGLT-2 inhibitor for at least 3 months before screening
* Be of stable weight (± 5%) for at least 3 months before screening
* 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 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 their ALT level is ≤3.0 the ULN for the reference range
* Have an estimated glomerular filtration rate \<45 mL/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, or metformin plus an SGLT-2 inhibitor 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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Arkansas Clinical Research
Little Rock, Arkansas, United States
Valley Research
Fresno, California, United States
National Research Institute
Huntington Park, California, United States
National Research Institute
Los Angeles, California, United States
Catalina Research Institute, LLC
Montclair, California, United States
Valley Clinical Trials, Inc.
Northridge, California, United States
National Research Institute
Panorama City, California, United States
Encompass Clinical Research
Spring Valley, California, United States
University Clinical Investigators, Inc.
Tustin, California, United States
Chase Medical Research, LLC
Waterbury, Connecticut, United States
Indago Research & Health Center, Inc.
Hialeah, Florida, United States
East Coast Clinical Research
Jacksonville, Florida, United States
East Coast Institute For Research
Jacksonville, Florida, United States
Bayside Clinical Research, LLC
New Port Richey, Florida, United States
East Coast Institute For Research
Macon, Georgia, United States
Sky Clinical Research Network
Union City, Georgia, United States
Elite Clinical Trials LLLP
Blackfoot, Idaho, United States
Humphreys Diabetes Center
Boise, Idaho, United States
Rocky Mountain Diabetes and Osteoporosis Center
Idaho Falls, Idaho, United States
Springfield Diabetes & Endocrine Center
Springfield, Illinois, United States
Crescent City Clinical Research
Metairie, Louisiana, United States
Endocrine and Metabolic Consultants
Rockville, Maryland, United States
Troy Internal Medicine, PC
Troy, Michigan, United States
International Diabetes Center
Minneapolis, Minnesota, United States
Clinical Research Professionals
Chesterfield, Missouri, United States
Palm Research Center
Las Vegas, Nevada, United States
Palm Research Center
Las Vegas, Nevada, United States
Aventiv Research
Columbus, Ohio, United States
The Corvallis Clinic P.C.
Corvallis, Oregon, United States
Heritage Valley Medical Group, Inc.
Beaver, Pennsylvania, United States
Detweiler Family Medicine
Lansdale, Pennsylvania, United States
Office of Dr. Osvaldo Brusco
Corpus Christi, Texas, United States
Consano Clinical Research
Shavano Park, Texas, United States
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
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
CENUDIAB
Ciudad Autonoma de Buenos Aire, , Argentina
Landesklinikum Korneuburg-Stockerau, Standort Stockerau
Stockerau, Lower Austria, Austria
Universitätsklinikum Graz
Graz, Styria, Austria
Universitätsklinikum Salzburg
Salzburg, , Austria
KA Rudolfstiftung
Vienna, , Austria
Iatriko Palaiou Falirou, Medical Center
Palaió Fáliro, Athens, Greece
Laiko General Hospital of Athens
Ampelokipoi, Attica, Greece
Gen Hospital of Athens G Gennimatas
Athens, Attica, Greece
General Hospital of Thessaloniki Papageorgiou
N. Efkarpia, Thessaloniki, Greece
Thermi Clinic
Thermi, Thessaloniki, Greece
Athens Euroclinic
Athens, , Greece
University General Hospital of Larissa
Larissa, , Greece
AHEPA Hospital
Thessaloniki, , Greece
Ippokrateio General Hospital of Thessaloniki
Thessaloniki, , Greece
Euromedica - General Clinic of Thessaloniki
Thessaloniki, , Greece
Kenezy Gyula Korhaz es Rendelointezet
Debrecen, Hajdú-Bihar, Hungary
Szent Margit Rendelointezet
Budapest, , Hungary
ClinDiab Kft.
Budapest, , Hungary
XIII.ker Onkormanyzat Egeszsegugyi Szolgalat
Budapest, , Hungary
Strazsahegy Medicina Bt.
Budapest, , Hungary
TRANTOR 99 Bt.
Budapest, , Hungary
Kanizsai Dorottya Korhaz
Nagykanizsa, , Hungary
Zala Megyei Szent Rafael Korhaz
Zalaegerszeg, , Hungary
Azienda ospedaliero-universitaria Mater Domini
Germaneto, Catanzaro, Italy
Policlinico Univ. Agostino Gemelli
Rome, Lazio, Italy
Centro Cardiologico Monzino, IRCCS
Milan, MI, Italy
Azienda Ospedaliera Policlinico Consorziale
Bari, , Italy
Azienda Ospedaliera Papa Giovanni XXIII
Bergamo, , Italy
Ospedale Santa Maria Goretti
Latina, , Italy
Ambulatorium Barbara Bazela
Elblag, Warminsko-Mazurki, Poland
NZOZ ZDROWIE Osteo-Medic
Bialystok, , Poland
Poradnia Diabetologiczna SN ZOZ Lege Artis
Bialystok, , Poland
NZOZ Diab-Endo-Met
Krakow, , Poland
Gabinet Lekarski Malgorzata Saryusz-Wolska
Lodz, , Poland
Centrum Terapii Wspolczesnej J.M. Jasnorzewska S.K.A.
Lodz, , Poland
NZOZ Przychodnia Specjalistyczna MEDICA
Lublin, , Poland
NZOZ Przychodnia Specjalistyczna Henryk RudzkiAndrzej Wittek
Ruda Śląska, , Poland
Latin Clinical Trial Center
San Juan, PR, Puerto Rico
GCM Medical Group PSC
San Juan, PR, Puerto Rico
San Miguel Medical
Trujillo Alto, PR, Puerto Rico
S. C. Grandmed S.R.L., Str.
Oradea, Bihor County, Romania
SC Diamed Obesity SRL
Galati, Galați 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
Societatea Civila Medicala "Dr. Paveliu"
Bucharest, Sect.5, Romania
Centrul Medical de Diagnostic si Tratament Ambulatoriu Neomed SRL
Brasov, , Romania
Cabinetul Medical Nicodiab SRL
Bucharest, , Romania
SC Nutrilife SRL
Bucharest, , Romania
Consultmed SRL
Iași, , Romania
Bucheon St. Mary's Hospital
Bucheon-si, Gyeonggi-do, South Korea
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, South Korea
Hanyang University Guri Hospital
Guri-si, Gyeonggido, South Korea
Seoul St. Mary's Hospital
Seoul, Korea, South Korea
Korea University Ansan Hospital
Ansan-si, , South Korea
Korea University Anam Hospital
Seoul, , South Korea
Seoul National University Hospital
Seoul, , South Korea
Severance Hospital Yonsei University Health System
Seoul, , South Korea
Kyunghee University Hospital at Gangdong
Seoul, , South Korea
Samsung Medical Center
Seoul, , South Korea
Hospital Infanta Luisa
Seville, Andalusia, Spain
Hospital Universitario Marques De Valdecilla
Santander, Cantabria, Spain
Hospital Universitario Quiron Madrid
Pozuelo de Alarcón, Madrid, Spain
Instituto de Ciencias médicas
Alicante, , Spain
Hospital Clinico Universitario San Cecilio
Granada, , Spain
Clinica Juaneda
Palma de Mallorca, , Spain
Clinica Nuevas Tecnologias en Diabetes y Endocrinologia
Seville, , Spain
Policlinica Galileo
Teruel, , Spain
Changhua Christian Hospital
Changhua, , Taiwan
Chang Gung Memorial Hospital - Kaohsiung
Kaohsiung City, , Taiwan
Taipei Medical University- Shuang Ho Hospital
New Taipei City, , Taiwan
Chung Shan Medical University Hospital
Taichung, , Taiwan
Taichung Veterans General 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
Taipei Veterans General Hospital
Taipei, , Taiwan
Dnipro City Clinical Hospital #9
Dnipro, , Ukraine
V.P. Komisarenko Institute of Endocrinology and Metabolism of NAMS of Ukraine
Kyiv, , Ukraine
Communal Institution "Poltava Reg.Cl.H. n.a.M.V.Sklifosovskogo"
Poltava, , Ukraine
Vinnytsia Regional Clinical Highly Specialized Endocrinology Center
Vinnytsia, , Ukraine
Countries
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References
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Sattar N, Neeland IJ, Dahlqvist Leinhard O, Fernandez Lando L, Bray R, Linge J, Rodriguez A. Tirzepatide and muscle composition changes in people with type 2 diabetes (SURPASS-3 MRI): a post-hoc analysis of a randomised, open-label, parallel-group, phase 3 trial. Lancet Diabetes Endocrinol. 2025 Jun;13(6):482-493. doi: 10.1016/S2213-8587(25)00027-0. Epub 2025 Apr 30.
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.
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.
Gastaldelli A, Cusi K, Fernandez Lando L, Bray R, Brouwers B, Rodriguez A. Effect of tirzepatide versus insulin degludec on liver fat content and abdominal adipose tissue in people with type 2 diabetes (SURPASS-3 MRI): a substudy of the randomised, open-label, parallel-group, phase 3 SURPASS-3 trial. Lancet Diabetes Endocrinol. 2022 Jun;10(6):393-406. doi: 10.1016/S2213-8587(22)00070-5. Epub 2022 Apr 22.
Battelino T, Bergenstal RM, Rodriguez A, Fernandez Lando L, Bray R, Tong Z, Brown K. Efficacy of once-weekly tirzepatide versus once-daily insulin degludec on glycaemic control measured by continuous glucose monitoring in adults with type 2 diabetes (SURPASS-3 CGM): a substudy of the randomised, open-label, parallel-group, phase 3 SURPASS-3 trial. Lancet Diabetes Endocrinol. 2022 Jun;10(6):407-417. doi: 10.1016/S2213-8587(22)00077-8. Epub 2022 Apr 22.
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.
Ludvik B, Giorgino F, Jodar E, Frias JP, Fernandez Lando L, Brown K, Bray R, Rodriguez A. Once-weekly tirzepatide versus once-daily insulin degludec as add-on to metformin with or without SGLT2 inhibitors in patients with type 2 diabetes (SURPASS-3): a randomised, open-label, parallel-group, phase 3 trial. Lancet. 2021 Aug 14;398(10300):583-598. doi: 10.1016/S0140-6736(21)01443-4. Epub 2021 Aug 6.
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 Insulin Degludec in Participants With Type 2 Diabetes
Other Identifiers
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I8F-MC-GPGH
Identifier Type: OTHER
Identifier Source: secondary_id
2018-003422-84
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
16997
Identifier Type: -
Identifier Source: org_study_id
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