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

Sponsor
Eli Lilly and Company (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05564039
Collaborator
(none)
250
Enrollment
44
Locations
2
Arms
19.1
Anticipated Duration (Months)
5.7
Patients Per Site
0.3
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 4

Study Design

Study Type:
Interventional
Anticipated Enrollment :
250 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
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
Actual Study Start Date :
Nov 30, 2022
Anticipated Primary Completion Date :
Jun 6, 2024
Anticipated Study Completion Date :
Jul 4, 2024

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Change from Baseline in Hemoglobin A1c (HbA1c) [Baseline, Week 40]

    Secondary Outcome Measures

    1. Change from Baseline in Weight [Baseline, Week 40]

    2. Percentage of Participants Who Achieve HbA1c <7% [Baseline to Week 40]

    3. Percentage of Participants Who Achieve HbA1c ≤6.5% [Baseline to Week 40]

    4. Percentage of Participants Who Achieve HbA1c <5.7% [Baseline to Week 40]

    5. Percentage of Participants Who Achieve Weight loss from Baseline of ≥5% [Baseline to Week 40]

    6. Percentage of Participants Who Achieve Weight loss from baseline of ≥10% [Baseline to Week 40]

    7. Percentage of Participants Who Achieve Weight loss from baseline of ≥15% [Baseline to Week 40]

    8. A Composite Endpoint of HbA1c, Weight loss and Hypoglycemia [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

    9. Change from Baseline in Fasting Serum Glucose (FSG) [Baseline, Week 40]

    10. Change from Baseline in Waist Circumference [Baseline, Week 40]

    11. Change from Baseline in Body Mass Index (BMI) [Baseline, Week 40]

    12. Change from Baseline in Impact of Weight on Quality of Life Clinical Trials Version (IWQOL-Lite CT) - Physical Functioning Score [Baseline, Week 40]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 ALL Medical Research, LLC Cooper City Florida United States 33024
    2 Metabolic Research Institute, Inc. West Palm Beach Florida United States 33401
    3 NorthShore University Health System Skokie Illinois United States 60077
    4 Iowa Diabetes and Endocrinology Research Center West Des Moines Iowa United States 50265
    5 Clinvest Research LLC Springfield Missouri United States 65807
    6 Alliance for Multispecialty Research, LLC Norman Oklahoma United States 73069
    7 Juno Research Houston Texas United States 77040
    8 Biopharma Informatic, LLC Houston Texas United States 77043
    9 Juno Research Houston Texas United States 77054
    10 Southern Endocrinology Associates Mesquite Texas United States 75149
    11 North Hills Family Medicine/North Hills Medical Research North Richland Hills Texas United States 76180
    12 Imelda General Hospital Bonheiden Antwerpen Belgium 2820
    13 Antwerp University Hospital Edegem Antwerpen Belgium 2650
    14 VITAZ Sint-Niklaas Oost-Vlaanderen Belgium B-9100
    15 ZNA Jan Palfijn Merksem Vlaams Gewest Belgium 2170
    16 UZ Leuven Leuven Vlaams-Brabant Belgium 3000
    17 Az Damiaan vzw Oostende West-Vlaanderen Belgium 8400
    18 Hôpital de la Conception Marseille Bouches-du-Rhône France 13005
    19 CHU Rangueil Toulouse cedex 9 Haute-Garonne France 31059
    20 CHU Montpellier Lapeyronie Hospital Montpellier Hérault France 34295
    21 Groupe Hospitalier Mutualiste Les Portes du Sud Vénissieux Rhône-Alpes France 69200
    22 Centre Hospitalier Sud Francilien Corbeil-Essonnes Île-de-France France 91106
    23 Groupe hospitalier Paris saint Joseph Paris Île-de-France France 75014
    24 Medizinisches Versorgungszentrum am Bahnhof Spandau Spandau Berlin Germany 13597
    25 InnoDiab Forschung Gmbh Essen Nordrhein-Westfalen Germany 45136
    26 Institut für Diabetesforschung GmbH Münster Münster Nordrhein- Germany 48145
    27 Studienzentrum Dr. Tasso Bieler Riesa Sachsen Germany 01589
    28 RED-Institut GmbH Oldenburg Schleswig-Holstein Germany 23758
    29 Diabeteszentrum Hamburg West Hamburg Germany 22607
    30 Centro Especializado En Diabetes, Obesidad Y Prevencion De Enfermedades Cardiovasculares Mexico City Distrito Federal Mexico 11650
    31 Diseno y Planeacion en Investigacion Medica Guadalajara Jalisco Mexico 44130
    32 Unidad de Investigación Clínica y Atención Médica HEPA Guadalajara Jalisco Mexico 44670
    33 Instituto de Diabetes, Obesidad y Nutricion Cuernavaca Morelos Mexico 62250
    34 Hospital Universitario "Dr. Jose Eleuterio Gonzalez" Monterrey Nuevo León Mexico 64460
    35 Unidad biomedica avanzada monterrey Monterrey Nuevo León Mexico 64460
    36 Hospital Universitario "Dr. Jose Eleuterio Gonzalez" Monterrey Nuevo León Mexico 66460
    37 Centro de Estudios de Investigacion Metabolicos y Cardiovasculares Ciudad Madero Tamaulipas Mexico 89440
    38 Investigacion En Salud Y Metabolismo Sc Chihuahua Mexico 31217
    39 Endodigest Clinica Medicala Oradea Bihor Romania 410151
    40 Mariodiab Clinic Brasov Brașov Romania 500097
    41 Geea Medical Easy Diet Bucharest București Romania 010627
    42 Gama Diamed Mangalia Constanța Romania 905500
    43 CMI DNBM Dr. Pop Lavinia Baia Mare Maramureș Romania 430222
    44 Clinica Korall Satu Mare Romania 440055

    Sponsors and Collaborators

    • 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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Eli Lilly and Company
    ClinicalTrials.gov Identifier:
    NCT05564039
    Other Study ID Numbers:
    • 18395
    • I8F-MC-GPIH
    • 2022-500101-41-00
    First Posted:
    Oct 3, 2022
    Last Update Posted:
    Jan 18, 2023
    Last Verified:
    Jan 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Diabetes Mellitus
    Diabetes Mellitus, Type 2
    Dulaglutide
    Tirzepatide

    Study Results

    No Results Posted as of Jan 18, 2023