NCT05564039CompletedPhase 4
A Study of Tirzepatide (LY3298176) in Adult Participants With Type 2 Diabetes Switching From Dulaglutide (SURPASS-SWITCH)
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
Source: ClinicalTrials.gov · Last updated 3 Aug 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 282 (actual)
- First submitted
- 30 Sept 2022
- Start date
- 30 Nov 2022
- Primary completion date
- 15 Jul 2024
- Lead sponsor
- Eli Lilly and Company
- Diseases
- Type 2 diabetes
- NCT number
- NCT05564039
- EU CT number
- 2022-500101-41-00
What you commit to
- Study type: Interventional · Phase 4
- Participants enrolled: 282
- From 30 Nov 2022 to the primary completion date, 15 Jul 2024
- 41 sites in 6 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study design.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior 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 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 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.
Other illness
- 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 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 a history of reduction of dose of dulaglutide, due to intolerability, without successful reescalation
Lab values
- 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)
Who the study is looking for
- 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)
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (41)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Het Ziekenhuisnetwerk Antwerpen Coordinator of this site? Confirm its status | Antwerp | Belgium | Completed |
| Imelda Coordinator of this site? Confirm its status | Bonheiden | Belgium | Completed |
| Antwerp University Hospital Coordinator of this site? Confirm its status | Edegem | Belgium | Completed |
| UZ Leuven Coordinator of this site? Confirm its status | Leuven | Belgium | Completed |
| Algemeen Ziekenhuis Damiaan Oostende Coordinator of this site? Confirm its status | Ostend | Belgium | Completed |
| Verenigde Ziekenhuizen van Waas en Durme Coordinator of this site? Confirm its status | Sint-Niklaas | Belgium | Completed |
| Medizinisches Versorgungszentrum Am Bahnhof Spandau GbR Coordinator of this site? Confirm its status | Berlin | Germany | Completed |
| InnoDiab Forschung Gmbh Coordinator of this site? Confirm its status | Essen | Germany | Completed |
| Praxisinhaber Dr Ulrich Wendisch Dr Dominik Dahl Und Prof Dr Jens Aberle Coordinator of this site? Confirm its status | Hamburg | Germany | Completed |
| Institut fuer Diabetesforschung Muenster GmbH Coordinator of this site? Confirm its status | Muenster | Germany | Completed |
| Red Institut Fur Medizinische Forschung Und Weiterbildung Coordinator of this site? Confirm its status | Oldenburg In Holstein | Germany | Completed |
| Centre Hospitalier Sud Francilien Coordinator of this site? Confirm its status | Corbeil-Essonnes | France | Withdrawn |
| Assistance Publique Hôpitaux de Marseille Coordinator of this site? Confirm its status | Marseille | France | Withdrawn |
| Centre Hospitalier Universitaire De Montpellier Coordinator of this site? Confirm its status | Montpellier Cedex 5 | France | Withdrawn |
| GIE Groupe hospitalier Paris Saint-Joseph Coordinator of this site? Confirm its status | Paris Cedex 14 | France | Withdrawn |
| Centre Hospitalier Universitaire De Toulouse Coordinator of this site? Confirm its status | Toulouse Cedex 9 | France | Withdrawn |
| Centre de Recherche Clinique Portes Du Sud Coordinator of this site? Confirm its status | Vénissieux | France | Withdrawn |
| Investigacion En Salud Y Metabolismo Sc Coordinator of this site? Confirm its status | Chihuahua City | Mexico | Unknown status |
| Centro de Estudios de Investigacion Metabolicos y Cardiovasculares Coordinator of this site? Confirm its status | Ciudad Madero | Mexico | Unknown status |
| Instituto de Diabetes, Obesidad y Nutricion Coordinator of this site? Confirm its status | Cuernavaca | Mexico | Unknown status |
| Diseno y Planeacion en Investigacion Medica Coordinator of this site? Confirm its status | Guadalajara | Mexico | Unknown status |
| Unidad de Investigación Clinica y atencion Medica HEPA Coordinator of this site? Confirm its status | Guadalajara | Mexico | Unknown status |
| Centro Especializado En Diabetes, Obesidad Y Prevencion De Enfermedades Cardiovasculares Coordinator of this site? Confirm its status | Mexico City | Mexico | Unknown status |
| Hospital Universitario Dr. Jose Eleuterio González Coordinator of this site? Confirm its status | Monterrey | Mexico | Unknown status |
| Unidad Biomedica Avanzada Monterrey Coordinator of this site? Confirm its status | Monterrey | Mexico | Unknown status |
| Cabinet Medical Individual Diabet, Nutritie, Boli Metabolice Dr. Pop Lavinia Coordinator of this site? Confirm its status | Baia Mare | Romania | Completed |
| Mariodiab Clinic S.R.L. Coordinator of this site? Confirm its status | Brasov | Romania | Completed |
| Easydiet S.R.L. Coordinator of this site? Confirm its status | Bucharest | Romania | Completed |
| Gama Diamed S.R.L. Coordinator of this site? Confirm its status | Mangalia | Romania | Completed |
| Diabdana S.R.L. Coordinator of this site? Confirm its status | Oradea | Romania | Completed |
| Clinica Korall S.R.L. Coordinator of this site? Confirm its status | Satu Mare | Romania | Completed |
| ALL Medical Research, LLC Coordinator of this site? Confirm its status | Cooper City | United States | Unknown status |
| Biopharma Informatic, LLC Coordinator of this site? Confirm its status | Houston | United States | Unknown status |
| Juno Research Coordinator of this site? Confirm its status | Houston | United States | Unknown status |
| Southern Endocrinology Associates Coordinator of this site? Confirm its status | Mesquite | United States | Unknown status |
| Alliance for Multispecialty Research, LLC Coordinator of this site? Confirm its status | Norman | United States | Unknown status |
| North Hills Family Medicine/North Hills Medical Research Coordinator of this site? Confirm its status | North Richland Hills | United States | Unknown status |
| NorthShore University Health System Coordinator of this site? Confirm its status | Skokie | United States | Unknown status |
| Clinvest Research, LLC Coordinator of this site? Confirm its status | Springfield | United States | Unknown status |
| Iowa Diabetes and Endocrinology Research Center Coordinator of this site? Confirm its status | West Des Moines | United States | Unknown status |
| Metabolic Research Institute, Inc Coordinator of this site? Confirm its status | West Palm Beach | United States | Unknown status |
Related publications
- Safety and efficacy of switching from dulaglutide to tirzepatide across clinically relevant baseline characteristics in participants with T2D: subgroup analysis of SURPASS-SWITCH.BMJ Open Diabetes Res Care · 2026 · PMID 41912265
This page is information, not medical advice. Discuss any trial with your doctor.