A Study of Tirzepatide (LY3298176) in Adult Participants With Type 2 Diabetes Switching From Dulaglutide (SURPASS-SWITCH)
NCT ID: NCT05564039
Last Updated: 2025-08-03
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
282 participants
INTERVENTIONAL
2022-11-30
2024-08-12
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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15 Milligram (mg) Tirzepatide or Maximum Tolerated Dose (MTD)
Participants received tirzepatide administered as subcutaneous (SC) injection via a single-dose pen (SDP) once weekly (QW) for 40 weeks.
The starting dose of tirzepatide was 2.5 mg QW, which increased by 2.5 mg every 4 weeks (2.5 mg to 5 mg to 7.5 mg to 10 mg to 12.5mg to 15 mg) until 15 mg or MTD was reached.
Tirzepatide
Administered SC
4.5 mg Dulaglutide or MTD
Participants received dulaglutide administered as SC injection via a SDP QW for 40 weeks.
The starting dose of dulaglutide was either 1.5 mg QW, which increased by 1.5 mg every 4 weeks (1.5 mg to 3 mg to 4.5 mg) until 4.5 mg or MTD was reached, or 3.0 mg QW, which increased to 4.5 mg after 4 weeks or until MTD was reached.
Dulaglutide
Administered SC
Interventions
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Tirzepatide
Administered SC
Dulaglutide
Administered SC
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Have HbA1c ≥7.0% (≥53 mmol/mol) to ≤9.5% (≤80 mmol/mol)
* Are currently on a stable dose of dulaglutide weekly (0.75 mg or 1.5 mg) for at least 6 months prior to screening.
* No treatment with oral antihyperglycemic medication (OAM), or on a stable dose of up to 3 OAMs, which may include metformin, sodium glucose cotransporter-2 inhibitors (SGLT-2i), and/or sulfonylurea, for at least 3 months before screening.
* Have had stable body weight (±5%) during the 90 days preceding screening
* Have BMI ≥25 kilogram/square meter (kg/m²)
Exclusion Criteria
* Have a history of chronic or acute pancreatitis
* Have a history of
* proliferative diabetic retinopathy, or
* diabetic maculopathy, or
* nonproliferative diabetic retinopathy that requires acute treatment.
* Have any of these cardiovascular (CV) conditions within 60 days prior to screening:
* acute myocardial infarction,
* cerebrovascular accident (stroke), or
* hospitalization due to congestive heart failure (CHF).
* Have New York Heart Assocation (NYHA) Functional Classification Class IV CHF
* Have family or personal history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN2).
* Have within 90 days prior to screening received treatment with medications intended to promote weight loss. This includes prescribed, over-the-counter, or alternative remedies
* Have an estimated glomerular filtration rate (eGFR) \<30 mL/minute/1.73 m2 (or lower than the country-specific threshold for discontinuing metformin therapy per local label)
* Have been treated with insulin prior to screening
* Exception: use of insulin for gestational diabetes or short-term use (\<14 days) for acute conditions such as acute illness, hospitalization, or elective surgery.
* Have a history of reduction of dose of dulaglutide, due to intolerability, without successful reescalation
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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ALL Medical Research, LLC
Cooper City, Florida, United States
Metabolic Research Institute, Inc.
West Palm Beach, Florida, United States
NorthShore University Health System
Skokie, Illinois, United States
Iowa Diabetes and Endocrinology Research Center
West Des Moines, Iowa, United States
Clinvest Research LLC
Springfield, Missouri, United States
Alliance for Multispecialty Research, LLC
Norman, Oklahoma, United States
Juno Research
Houston, Texas, United States
Biopharma Informatic, LLC
Houston, Texas, United States
Juno Research
Houston, Texas, United States
Southern Endocrinology Associates
Mesquite, Texas, United States
North Hills Family Medicine/North Hills Medical Research
North Richland Hills, Texas, United States
Imelda General Hospital
Bonheiden, Antwerpen, Belgium
Antwerp University Hospital
Edegem, Antwerpen, Belgium
ZNA Jan Palfijn
Merksem, Flanders, Belgium
AZ Nikolaas
Sint-Niklaas, Oost-Vlaanderen, Belgium
UZ Leuven
Leuven, Vlaams-Brabant, Belgium
Az Damiaan vzw
Ostend, West-Vlaanderen, Belgium
InnoDiab Forschung Gmbh
Essen, North Rhine-Westphalia, Germany
Institut für Diabetesforschung GmbH Münster
Münster, North Rhine-Westphalia, Germany
Studienzentrum Dr. Tasso Bieler
Riesa, Saxony, Germany
RED-Institut GmbH
Oldenburg in Holstein, Schleswig-Holstein, Germany
Medizinisches Versorgungszentrum am Bahnhof Spandau
Spandau, State of Berlin, Germany
Diabeteszentrum Hamburg West
Hamburg, , Germany
Diseno y Planeacion en Investigacion Medica
Guadalajara, Jalisco, Mexico
Unidad de Investigación Clínica y Atención Médica HEPA
Guadalajara, Jalisco, Mexico
Centro Especializado En Diabetes, Obesidad Y Prevencion De Enfermedades Cardiovasculares
Mexico City, Mexico City, Mexico
Instituto de Diabetes, Obesidad y Nutricion
Cuernavaca, Morelos, Mexico
Hospital Universitario "Dr. Jose Eleuterio Gonzalez"
Monterrey, Nuevo León, Mexico
Unidad biomedica avanzada monterrey
Monterrey, Nuevo León, Mexico
Hospital Universitario "Dr. Jose Eleuterio Gonzalez"
Monterrey, Nuevo León, Mexico
Centro de Estudios de Investigacion Metabolicos y Cardiovasculares
Ciudad Madero, Tamaulipas, Mexico
Investigacion En Salud Y Metabolismo Sc
Chihuahua City, , Mexico
Diabdana
Oradea, Bihor County, Romania
Mariodiab Clinic
Brasov, Brașov County, Romania
Geea Medical Easy Diet
Bucharest, București, Romania
Gama Diamed
Mangalia, Constanța County, Romania
CMI DNBM Dr. Pop Lavinia
Baia Mare, Maramureş, Romania
Clinica Korall
Satu Mare, , Romania
Countries
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References
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Billings LK, Winne L, Sharma P, Gomez-Valderas E, Chivukula KK, Kwan AYM. Comparison of Dose Escalation Versus Switching to Tirzepatide Among People With Type 2 Diabetes Inadequately Controlled on Lower Doses of Dulaglutide : A Randomized Clinical Trial. Ann Intern Med. 2025 May;178(5):609-619. doi: 10.7326/ANNALS-24-03849. Epub 2025 Apr 4.
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) in Adult Participants With Type 2 Diabetes Switching From Dulaglutide (SURPASS-SWITCH)
Other Identifiers
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I8F-MC-GPIH
Identifier Type: OTHER
Identifier Source: secondary_id
2022-500101-41-00
Identifier Type: OTHER
Identifier Source: secondary_id
18395
Identifier Type: -
Identifier Source: org_study_id
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