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

Last updated: August 15, 2024
Sponsor: Eli Lilly and Company
Overall Status: Completed

Phase

4

Condition

Diabetes Prevention

Diabetes Mellitus Types I And Ii

Diabetes And Hypertension

Treatment

Tirzepatide

Dulaglutide

Clinical Study ID

NCT05564039
18395
I8F-MC-GPIH
2022-500101-41-00
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • 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 atleast 6 months prior to screening.

  • No treatment with oral antihyperglycemic medication (OAM), or on a stable dose of upto 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

Exclusion Criteria:

  • 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 multipleendocrine neoplasia syndrome type 2 (MEN2).

  • Have within 90 days prior to screening received treatment with medications intendedto promote weight loss. This includes prescribed, over-the-counter, or alternativeremedies

  • Have an estimated glomerular filtration rate (eGFR) <30 mL/minute/1.73 m2 (or lowerthan the country-specific threshold for discontinuing metformin therapy per locallabel)

  • 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 electivesurgery.

  • Have a history of reduction of dose of dulaglutide, due to intolerability, withoutsuccessful reescalation

Study Design

Total Participants: 282
Treatment Group(s): 2
Primary Treatment: Tirzepatide
Phase: 4
Study Start date:
November 30, 2022
Estimated Completion Date:
August 12, 2024

Connect with a study center

  • Imelda General Hospital

    Bonheiden, Antwerpen 2820
    Belgium

    Site Not Available

  • Antwerp University Hospital

    Edegem, Antwerpen 2650
    Belgium

    Site Not Available

  • AZ Nikolaas

    Sint-Niklaas, Oost-Vlaanderen B-9100
    Belgium

    Site Not Available

  • VITAZ

    Sint-Niklaas, Oost-Vlaanderen B-9100
    Belgium

    Active - Recruiting

  • ZNA Jan Palfijn

    Merksem, Vlaams Gewest 2170
    Belgium

    Site Not Available

  • UZ Leuven

    Leuven, Vlaams-Brabant 3000
    Belgium

    Site Not Available

  • Az Damiaan vzw

    Oostende, West-Vlaanderen 8400
    Belgium

    Site Not Available

  • Hôpital de la Conception

    Marseille, Bouches-du-Rhône 13005
    France

    Site Not Available

  • CHU Rangueil

    Toulouse, Haute-Garonne 31059 toul
    France

    Site Not Available

  • CHU Rangueil

    Toulouse cedex 9, Haute-Garonne 31059
    France

    Site Not Available

  • CHU Montpellier Lapeyronie Hospital

    Montpellier, Hérault 34295
    France

    Site Not Available

  • Groupe Hospitalier Mutualiste Les Portes du Sud

    Vénissieux, Rhône-Alpes 69200
    France

    Site Not Available

  • Centre Hospitalier Sud Francilien

    Corbeil-Essonnes, Île-de-France 91106
    France

    Site Not Available

  • Groupe hospitalier Paris saint Joseph

    Paris, Île-de-France 75014
    France

    Site Not Available

  • Medizinisches Versorgungszentrum am Bahnhof Spandau

    Spandau, Berlin 13597
    Germany

    Site Not Available

  • InnoDiab Forschung Gmbh

    Essen, Nordrhein-Westfalen 45136
    Germany

    Site Not Available

  • Institut für Diabetesforschung GmbH Münster

    Münster, Nordrhein-Westfalen 48145
    Germany

    Site Not Available

  • MVZ Riesa am Klinikum Döbeln GmbH

    Riesa, Sachsen 01589
    Germany

    Site Not Available

  • Studienzentrum Dr. Tasso Bieler

    Riesa, Sachsen 01589
    Germany

    Site Not Available

  • RED-Institut GmbH

    Oldenburg, Schleswig-Holstein 23758
    Germany

    Site Not Available

  • Diabeteszentrum Hamburg West

    Hamburg, 22607
    Germany

    Site Not Available

  • Centro Especializado En Diabetes, Obesidad Y Prevencion De Enfermedades Cardiovasculares

    Mexico City, Distrito Federal 11650
    Mexico

    Site Not Available

  • Diseno y Planeacion en Investigacion Medica

    Guadalajara, Jalisco 44130
    Mexico

    Site Not Available

  • Unidad de Investigación Clínica y Atención Médica HEPA

    Guadalajara, Jalisco 44670
    Mexico

    Site Not Available

  • Instituto de Diabetes, Obesidad y Nutricion

    Cuernavaca, Morelos 62250
    Mexico

    Site Not Available

  • Hospital Universitario "Dr. Jose Eleuterio Gonzalez"

    Monterrey, Nuevo León 66460
    Mexico

    Site Not Available

  • Unidad biomedica avanzada monterrey

    Monterrey, Nuevo León 64460
    Mexico

    Site Not Available

  • Centro de Estudios de Investigacion Metabolicos y Cardiovasculares

    Ciudad Madero, Tamaulipas 89440
    Mexico

    Site Not Available

  • Centro de Estudios de Investigacion Metabolicos y Cardiovasculares, S.C.

    Ciudad Madero, Tamaulipas 89440
    Mexico

    Active - Recruiting

  • Investigacion En Salud Y Metabolismo Sc

    Chihuahua, 31217
    Mexico

    Site Not Available

  • Diabdana

    Oradea, Bihor 410147
    Romania

    Site Not Available

  • Endodigest Clinica Medicala

    Oradea, Bihor 410151
    Romania

    Site Not Available

  • Mariodiab Clinic

    Brasov, Brașov 500097
    Romania

    Site Not Available

  • Geea Medical Easy Diet

    Bucharest, București 010627
    Romania

    Site Not Available

  • Gama Diamed

    Mangalia, Constanța 905500
    Romania

    Site Not Available

  • CMI DNBM Dr. Pop Lavinia

    Baia Mare, Maramureș 430222
    Romania

    Site Not Available

  • Clinica Korall

    Satu Mare, 440055
    Romania

    Site Not Available

  • ALL Medical Research, LLC

    Cooper City, Florida 33024
    United States

    Site Not Available

  • Metabolic Research Institute, Inc.

    West Palm Beach, Florida 33401
    United States

    Site Not Available

  • NorthShore University Health System

    Skokie, Illinois 60077
    United States

    Site Not Available

  • Iowa Diabetes and Endocrinology Research Center

    West Des Moines, Iowa 50265
    United States

    Site Not Available

  • Clinvest Research LLC

    Springfield, Missouri 65807
    United States

    Site Not Available

  • Alliance for Multispecialty Research, LLC

    Norman, Oklahoma 73069
    United States

    Site Not Available

  • Intend Research, LLC

    Norman, Oklahoma 73069
    United States

    Site Not Available

  • Biopharma Informatic, LLC

    Houston, Texas 77043
    United States

    Site Not Available

  • Juno Research

    Houston, Texas 77040
    United States

    Site Not Available

  • Southern Endocrinology Associates

    Mesquite, Texas 75149
    United States

    Site Not Available

  • North Hills Family Medicine/North Hills Medical Research

    North Richland Hills, Texas 76180
    United States

    Site Not Available

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