A Study of Tirzepatide (LY3298176) Versus Placebo in Participants With Type 2 Diabetes Inadequately Controlled on Insulin Glargine With or Without Metformin
NCT ID: NCT04039503
Last Updated: 2022-01-12
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
475 participants
INTERVENTIONAL
2019-08-30
2021-01-13
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
DOUBLE
Study Groups
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5 mg Tirzepatide
5 milligrams (mg) tirzepatide administered subcutaneously (SC) once a week.
Tirzepatide
Administered SC as add-on to the pre-trial background medication.
10 mg Tirzepatide
10 mg tirzepatide administered SC once a week.
Tirzepatide
Administered SC as add-on to the pre-trial background medication.
15 mg Tirzepatide
15 mg tirzepatide administered SC once a week.
Tirzepatide
Administered SC as add-on to the pre-trial background medication.
Placebo
Placebo administered SC once a week.
Placebo
Administered SC as add-on to the pre-trial background medication.
Interventions
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Tirzepatide
Administered SC as add-on to the pre-trial background medication.
Placebo
Administered SC as add-on to the pre-trial background medication.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Have HbA1c between ≥7.0% and ≤10.5%.
* Have a stable weight (± 5%) for at least 3 months before screening.
* Have a body mass index (BMI) ≥23 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 an estimated glomerular filtration rate \<30 mL/minute/1.73 m² \[for participants on metformin, estimated glomerular filtration rate \<45 mL/min/1.73 m2 (or lower than the country-specific threshold for using the protocol-required dose of metformin per local label)\]
* 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 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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Valley Endocrine, Fresno
Fresno, California, United States
Sun Coast Clinical Research, Inc
New Port Richey, Florida, United States
Southern New Hampshire Diabetes and Endocrinology
Nashua, New Hampshire, United States
Manhattan Medical Research
New York, New York, United States
Intend Research
Norman, Oklahoma, United States
Milan Kvapil s.r.o.
Příbram, Central Bohemia, Czechia
Diacentrum Brandys n.L. s.r.o.
Brandys Nad Labem-Stara Bolesl, , Czechia
Diabetologicka ordinace pro dospele
Krnov, , Czechia
Diahelp s.r.o., Interni a diabetologicka ambulance
Pardubice, , Czechia
Lekarna Dr. Max
Prague, , Czechia
Milan Kvapil s.r.o.
Prague, , Czechia
RESTRIAL s.r.o.
Prague, , Czechia
Praxis Dr. Jörg Lüdemann
Falkensee, Brandenburg, Germany
Arztpraxis Dr. Cornelia Marck
Pohlheim, Hesse, Germany
InnoDiab Forschung GmbH
Essen, North Rhine-Westphalia, Germany
Institut für Diabetesforschung Münster GmbH
Münster, North Rhine-Westphalia, Germany
Praxis Dr. Kempe - Dr. Stemler
Ludwigshafen am Rhein, Rhineland-Palatinate, Germany
Schwerpunktpraxis Diabetes
Saint Ingbert-Oberwürzbach, Saarland, Germany
SMO.MD GmbH
Magdeburg, Saxony-Anhalt, Germany
RED-Institut GmbH
Oldenburg in Holstein, Schleswig-Holstein, Germany
Diabetologische Schwerpunktpraxis B. Scholz/Dr. B. Paschen
Hamburg, , Germany
Gemeinschaftspraxis für innere Medizin und Diabetologie
Hamburg, , Germany
Kashiwa hospital
Kashiwa, Chiba, Japan
Manda Hospital
Sapporo, Hokkaido, Japan
Takai Naika Clinic
Kamakura, Kanagawa, Japan
Takatsuki Red Cross Hospital
Takatsuki, Osaka, Japan
Tokyo-Eki Center-building Clinic
Chuo-ku, Tokyo, Japan
Tokyo Center Clinic
Chuo-ku, Tokyo, Japan
Tokyo Clinical Trial Centre Fukuwa Clinic
Chuo-ku, Tokyo, Japan
The Institute for Adult Diseases, Asahi Life Foundation
Chuou-ku, Tokyo, Japan
Sato Naika Clinic
Ōta-ku, Tokyo, Japan
Jinnouchi Hospital
Kumamoto, , Japan
Centrum Medyczne AMED
Warsaw, Masovian Voivodeship, Poland
NZOZ ZDROWIE Osteo-Medic
Bialystok, Podlaskie Voivodeship, Poland
Centrum Badan Klinicznych, PI House
Gdansk, Pomeranian Voivodeship, Poland
NZOZ Przychodnia Specjalistyczna MEDICA
Lublin, , Poland
Centro de Endocrinologia y Nutricion del Turabo
Caguas, PR, Puerto Rico
Manati Center for Clinical Research Inc
Manatí, PR, Puerto Rico
Ambulancia vnútorného lekárstva Hnúša (Diabetes care)
Hnúšťa, , Slovakia
Sin Azucar
Malacky, , Slovakia
Dia-Clarus.s.r.o.
Prievidza, , Slovakia
JAL
Trnava, , Slovakia
Medivasa, s.r.o.
Žilina, , Slovakia
Hospital Clinico Universitario Virgen de la Victoria
Málaga, Andalusia, Spain
Hospital de la Ribera
Alzira, Valencia, Spain
Hospital Universitario Virgen Macarena
Seville, , Spain
Hospital Infanta Luisa
Seville, , Spain
Hospital Universitari i Politecnic La Fe-ENDO
Valencia, , Spain
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.
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.
Dahl D, Onishi Y, Norwood P, Huh R, Bray R, Patel H, Rodriguez A. Effect of Subcutaneous Tirzepatide vs Placebo Added to Titrated Insulin Glargine on Glycemic Control in Patients With Type 2 Diabetes: The SURPASS-5 Randomized Clinical Trial. JAMA. 2022 Feb 8;327(6):534-545. doi: 10.1001/jama.2022.0078.
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 Placebo in Participants With Type 2 Diabetes Inadequately Controlled on Insulin Glargine With or Without Metformin
Other Identifiers
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I8F-MC-GPGI
Identifier Type: OTHER
Identifier Source: secondary_id
2019-000860-99
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
16998
Identifier Type: -
Identifier Source: org_study_id
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