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

April 16, 2024 updated by: Eli Lilly and Company

A Phase 4, Randomized, Open-Label, Active-Controlled Study to Investigate the Efficacy and Safety of Switching From Weekly Dulaglutide to Weekly Tirzepatide in Adults With Type 2 Diabetes

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

250

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or
  • Phone Number: 1-317-615-4559
  • Email: ClinicalTrials.gov@lilly.com

Study Locations

  • Belgium
    • Antwerpen
      • Bonheiden, Antwerpen, Belgium, 2820
        • Imelda General Hospital
      • Edegem, Antwerpen, Belgium, 2650
        • Antwerp University Hospital
    • Oost-Vlaanderen
      • Sint-Niklaas, Oost-Vlaanderen, Belgium, B-9100
        • AZ Nikolaas
    • Vlaams Gewest
      • Merksem, Vlaams Gewest, Belgium, 2170
        • ZNA Jan Palfijn
    • Vlaams-Brabant
      • Leuven, Vlaams-Brabant, Belgium, 3000
        • UZ Leuven
    • West-Vlaanderen
      • Oostende, West-Vlaanderen, Belgium, 8400
        • Az Damiaan vzw
  • Germany
      • Hamburg, Germany, 22607
        • Diabeteszentrum Hamburg West
    • Berlin
      • Spandau, Berlin, Germany, 13597
        • Medizinisches Versorgungszentrum am Bahnhof Spandau
    • Nordrhein-
      • Münster, Nordrhein-, Germany, 48145
        • Institut für Diabetesforschung GmbH Münster
    • Nordrhein-Westfalen
      • Essen, Nordrhein-Westfalen, Germany, 45136
        • InnoDiab Forschung GmbH
    • Sachsen
      • Riesa, Sachsen, Germany, 01589
        • MVZ Riesa am Klinikum Döbeln GmbH
    • Schleswig-Holstein
      • Oldenburg, Schleswig-Holstein, Germany, 23758
        • RED-Institut GmbH
  • Mexico
      • Chihuahua, Mexico, 31217
        • Investigacion En Salud Y Metabolismo Sc
    • Distrito Federal
      • Mexico City, Distrito Federal, Mexico, 11650
        • Centro Especializado En Diabetes, Obesidad Y Prevencion De Enfermedades Cardiovasculares
    • Jalisco
      • Guadalajara, Jalisco, Mexico, 44130
        • Diseno y Planeacion en Investigacion Medica
      • Guadalajara, Jalisco, Mexico, 44670
        • Unidad de Investigación Clínica y Atención Médica HEPA
    • Morelos
      • Cuernavaca, Morelos, Mexico, 62250
        • Instituto de Diabetes, Obesidad y Nutricion
    • Nuevo León
      • Monterrey, Nuevo León, Mexico, 64460
        • Unidad biomedica avanzada monterrey
      • Monterrey, Nuevo León, Mexico, 64460
        • Hospital Universitario "Dr. Jose Eleuterio Gonzalez"
    • Tamaulipas
      • Ciudad Madero, Tamaulipas, Mexico, 89440
        • Centro de Estudios de Investigacion Metabolicos y Cardiovasculares
  • Romania
      • Satu Mare, Romania, 440055
        • Clinica Korall
    • Bihor
      • Oradea, Bihor, Romania, 410147
        • Diabdana
    • Brașov
      • Brasov, Brașov, Romania, 500097
        • Mariodiab Clinic
    • București
      • Bucharest, București, Romania, 010627
        • Geea Medical Easy Diet
    • Constanța
      • Mangalia, Constanța, Romania, 905500
        • Gama Diamed
    • Maramureș
      • Baia Mare, Maramureș, Romania, 430222
        • CMI DNBM Dr. Pop Lavinia
  • United States
    • Florida
      • Cooper City, Florida, United States, 33024
        • ALL Medical Research, LLC
      • West Palm Beach, Florida, United States, 33401
        • Metabolic Research Institute, Inc.
    • Illinois
      • Skokie, Illinois, United States, 60077
        • NorthShore University Health System
    • Iowa
      • West Des Moines, Iowa, United States, 50265
        • Iowa Diabetes and Endocrinology Research Center
    • Oklahoma
      • Norman, Oklahoma, United States, 73069
        • Intend Research, LLC
    • Texas
      • Houston, Texas, United States, 77040
        • Juno Research
      • Houston, Texas, United States, 77054
        • Juno Research
      • Mesquite, Texas, United States, 75149
        • Southern Endocrinology Associates
      • North Richland Hills, Texas, United States, 76180
        • North Hills Family Medicine/North Hills Medical Research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 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 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

    • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Tirzepatide
Participants will receive tirzepatide subcutaneously (SC)
Drug: Tirzepatide
Administered SC
Other Names:
  • LY3298176
Active Comparator: Dulaglutide
Participants will escalate their dulaglutide dose SC.
Drug: Dulaglutide
Administered SC
Other Names:
  • LY2189265

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change from Baseline in Hemoglobin A1c (HbA1c)
Time Frame: Baseline, Week 40
Baseline, Week 40

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from Baseline in Weight
Time Frame: Baseline, Week 40
Baseline, Week 40
Percentage of Participants Who Achieve HbA1c <7%
Time Frame: Baseline to Week 40
Baseline to Week 40
Percentage of Participants Who Achieve HbA1c ≤6.5%
Time Frame: Baseline to Week 40
Baseline to Week 40
Percentage of Participants Who Achieve HbA1c <5.7%
Time Frame: Baseline to Week 40
Baseline to Week 40
Percentage of Participants Who Achieve Weight loss from Baseline of ≥5%
Time Frame: Baseline to Week 40
Baseline to Week 40
Percentage of Participants Who Achieve Weight loss from baseline of ≥10%
Time Frame: Baseline to Week 40
Baseline to Week 40
Percentage of Participants Who Achieve Weight loss from baseline of ≥15%
Time Frame: Baseline to Week 40
Baseline to Week 40
A Composite Endpoint of HbA1c, Weight loss and Hypoglycemia
Time Frame: Week 40
A composite endpoint defined as HbA1c ≤ 6.5%, weight loss ≥10%, no hypoglycemia, defined as blood glucose (BG) <54 milligram/deciliter (mg/dL) <3.0 millimole/liter (mmol/L) and/or severe hypoglycemia
Week 40
Change from Baseline in Fasting Serum Glucose (FSG)
Time Frame: Baseline, Week 40
Baseline, Week 40
Change from Baseline in Waist Circumference
Time Frame: Baseline, Week 40
Baseline, Week 40
Change from Baseline in Body Mass Index (BMI)
Time Frame: Baseline, Week 40
Baseline, Week 40
Change from Baseline in Impact of Weight on Quality of Life Clinical Trials Version (IWQOL-Lite CT) - Physical Functioning Score
Time Frame: Baseline, Week 40
Baseline, Week 40

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Eli Lilly and Company

Investigators

  • Study Director: 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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 30, 2022

Primary Completion (Estimated)

August 1, 2024

Study Completion (Estimated)

August 29, 2024

Study Registration Dates

First Submitted

September 30, 2022

First Submitted That Met QC Criteria

September 30, 2022

First Posted (Actual)

October 3, 2022

Study Record Updates

Last Update Posted (Actual)

April 18, 2024

Last Update Submitted That Met QC Criteria

April 16, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 18395
  • I8F-MC-GPIH (Other Identifier: Eli Lilly and Company)
  • 2022-500101-41-00 (Other Identifier: EU Trial Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.

IPD Sharing 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.

IPD Sharing Access Criteria

A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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