A Study of Tirzepatide (LY3298176) in Adult Participants With Type 2 Diabetes Switching From Dulaglutide (SURPASS-SWITCH)

NCT05564039 | Completed Phase 4 Results DMC FDA Drug

• 3 other identifiers: 18395I8F-MC-GPIH2022-500101-41-00
• Study Type: interventional
• Target: 282
• Locations: 5 countries
• Sites: 38

Brief Summary

The main purpose of this study is to investigate the efficacy and safety of switching from weekly dulaglutide to weekly tirzepatide compared to increasing the dulaglutide dose in adults with type 2 diabetes.

Conditions

Type 2 Diabetes

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in HbA1c

  HbA1c is the glycated fraction of hemoglobin A. HbA1c is measured primarily to identify average plasma glucose concentration over prolonged periods of time. Least squares (LS) mean was calculated using mixed model repeated measures (MMRM) for post-baseline measures: Variable = Baseline + Number of Background OAMs Group 1 + Dulaglutide Dose at Screening + Geographic Region 1 + Treatment + Time + Treatment\*Time (Type III sum of squares). Variance-Covariance structure (Actual Value) = Unstructured. Variance-Covariance structure (Change from Baseline) = Unstructured.

  Baseline, Week 40

Secondary Outcomes (12)

• Change From Baseline in Body Weight

  Baseline, Week 40

• Percentage of Participants Who Achieved HbA1c <7%

  Week 40

• Percentage of Participants Who Achieved HbA1c <=6.5%

  Week 40

• Percentage of Participants Who Achieved HbA1c <5.7%

  Week 40

• Percentage of Participants Who Achieve Weight Loss From Baseline of ≥5%

  Week 40

Study Arms (2)

15 Milligram (mg) Tirzepatide or Maximum Tolerated Dose (MTD)

EXPERIMENTAL

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.

Drug: Tirzepatide

4.5 mg Dulaglutide or MTD

ACTIVE COMPARATOR

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.

Drug: Dulaglutide

Interventions

Tirzepatide DRUG

Administered SC

Also known as: LY3298176

15 Milligram (mg) Tirzepatide or Maximum Tolerated Dose (MTD)

Dulaglutide DRUG

Administered SC

Also known as: LY2189265

4.5 mg Dulaglutide or MTD

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Have type 2 diabetes
• 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)

You may not qualify if:

• Have type 1 diabetes
• 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

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (38)

ALL Medical Research, LLC

Cooper City, Florida, 33024, United States

Location

Metabolic Research Institute, Inc.

West Palm Beach, Florida, 33401, United States

Location

NorthShore University Health System

Skokie, Illinois, 60077, United States

Location

Iowa Diabetes and Endocrinology Research Center

West Des Moines, Iowa, 50265, United States

Location

Clinvest Research LLC

Springfield, Missouri, 65807, United States

Location

Alliance for Multispecialty Research, LLC

Norman, Oklahoma, 73069, United States

Location

Juno Research

Houston, Texas, 77040, United States

Location

Biopharma Informatic, LLC

Houston, Texas, 77043, United States

Location

Juno Research

Houston, Texas, 77054, United States

Location

Southern Endocrinology Associates

Mesquite, Texas, 75149, United States

Location

North Hills Family Medicine/North Hills Medical Research

North Richland Hills, Texas, 76180, United States

Location

Imelda General Hospital

Bonheiden, Antwerpen, 2820, Belgium

Location

Antwerp University Hospital

Edegem, Antwerpen, 2650, Belgium

Location

ZNA Jan Palfijn

Merksem, Flanders, 2170, Belgium

Location

AZ Nikolaas

Sint-Niklaas, Oost-Vlaanderen, B-9100, Belgium

Location

UZ Leuven

Leuven, Vlaams-Brabant, 3000, Belgium

Location

Az Damiaan vzw

Ostend, West-Vlaanderen, 8400, Belgium

Location

InnoDiab Forschung Gmbh

Essen, North Rhine-Westphalia, 45136, Germany

Location

Institut für Diabetesforschung GmbH Münster

Münster, North Rhine-Westphalia, 48145, Germany

Location

Studienzentrum Dr. Tasso Bieler

Riesa, Saxony, 01589, Germany

Location

RED-Institut GmbH

Oldenburg in Holstein, Schleswig-Holstein, 23758, Germany

Location

Medizinisches Versorgungszentrum am Bahnhof Spandau

Spandau, State of Berlin, 13597, Germany

Location

Diabeteszentrum Hamburg West

Hamburg, 22607, Germany

Location

Diseno y Planeacion en Investigacion Medica

Guadalajara, Jalisco, 44130, Mexico

Location

Unidad de Investigación Clínica y Atención Médica HEPA

Guadalajara, Jalisco, 44670, Mexico

Location

Centro Especializado En Diabetes, Obesidad Y Prevencion De Enfermedades Cardiovasculares

Mexico City, Mexico City, 11650, Mexico

Location

Instituto de Diabetes, Obesidad y Nutricion

Cuernavaca, Morelos, 62250, Mexico

Location

Hospital Universitario "Dr. Jose Eleuterio Gonzalez"

Monterrey, Nuevo León, 64460, Mexico

Location

Unidad biomedica avanzada monterrey

Monterrey, Nuevo León, 64460, Mexico

Location

Hospital Universitario "Dr. Jose Eleuterio Gonzalez"

Monterrey, Nuevo León, 66460, Mexico

Location

Centro de Estudios de Investigacion Metabolicos y Cardiovasculares

Ciudad Madero, Tamaulipas, 89440, Mexico

Location

Investigacion En Salud Y Metabolismo Sc

Chihuahua City, 31217, Mexico

Location

Diabdana

Oradea, Bihor County, 410147, Romania

Location

Mariodiab Clinic

Brasov, Brașov County, 500097, Romania

Location

Geea Medical Easy Diet

Bucharest, București, 010627, Romania

Location

Gama Diamed

Mangalia, Constanța County, 905500, Romania

Location

CMI DNBM Dr. Pop Lavinia

Baia Mare, Maramureş, 430222, Romania

Location

Clinica Korall

Satu Mare, 440055, Romania

Location

Related Publications (1)

• 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.

  PMID: 40183678 DERIVED

Related Links

• A Study of Tirzepatide (LY3298176) in Adult Participants With Type 2 Diabetes Switching From Dulaglutide (SURPASS-SWITCH)

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Tirzepatide; dulaglutide

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Glucagon-Like Peptide-1 Receptor; Glucagon-Like Peptide Receptors; Receptors, G-Protein-Coupled; Receptors, Cell Surface; Membrane Proteins; Proteins; Amino Acids, Peptides, and Proteins; Receptors, Gastrointestinal Hormone; Receptors, Peptide

Results Point of Contact

• Title: Chief Medical Officer
• Organization: Eli Lilly and Company

ClinicalTrials.gov@lilly.com

08004595979

Study Officials

• 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)

  Eli Lilly and Company

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 30, 2022
• First Posted: October 3, 2022
• Study Start: November 30, 2022
• Primary Completion: July 15, 2024
• Study Completion: August 12, 2024
• Last Updated: August 3, 2025
• Results First Posted: August 3, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: Data are available 6 months after the primary publication and approval of the indication studied in the US and European Union (EU), whichever is later. Data will be indefinitely available for requesting.
• Access Criteria: A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.

Locations

ME (9); RO (6); US (11); DE (6); BE (6)