Type 2 DiabetesPhase 4SURPASS-SWITCHNCT05564039
A Study of Tirzepatide (LY3298176) in Adult Participants With Type 2 Diabetes Switching From Dulaglutide (SURPASS-SWITCH)
A Phase 4 study testing Tirzepatide and Dulaglutide in people with Type 2 Diabetes, run by Eli Lilly and Company at 38 sites in 5 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- Tirzepatide and Dulaglutide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 282 participants
- Where
- 38 sitesin 5 countries
- Study dates
- 30 Nov 2022to 12 Aug 2024
- Phase
- Phase 4
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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.
Show all 17Show fewer
- 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
Trial locations and contacts
38 sites in 5 countries.
38 sites in 5 countries
United States11 sites
ALL Medical Research, LLC
Cooper City, Florida, 33024
Juno Research
Houston, Texas, 77040
Biopharma Informatic, LLC
Houston, Texas, 77043
Juno Research
Houston, Texas, 77054
Southern Endocrinology Associates
Mesquite, Texas, 75149
Alliance for Multispecialty Research, LLC
Norman, Oklahoma, 73069
North Hills Family Medicine/North Hills Medical Research
North Richland Hills, Texas, 76180
NorthShore University Health System
Skokie, Illinois, 60077
Clinvest Research LLC
Springfield, Missouri, 65807
Iowa Diabetes and Endocrinology Research Center
West Des Moines, Iowa, 50265
Metabolic Research Institute, Inc.
West Palm Beach, Florida, 33401
Mexico9 sites
Investigacion En Salud Y Metabolismo Sc
Chihuahua City, 31217
Centro de Estudios de Investigacion Metabolicos y Cardiovasculares
Ciudad Madero, Tamaulipas, 89440
Instituto de Diabetes, Obesidad y Nutricion
Cuernavaca, Morelos, 62250
Diseno y Planeacion en Investigacion Medica
Guadalajara, Jalisco, 44130
Unidad de Investigación Clínica y Atención Médica HEPA
Guadalajara, Jalisco, 44670
Centro Especializado En Diabetes, Obesidad Y Prevencion De Enfermedades Cardiovasculares
Mexico City, Mexico City, 11650
Hospital Universitario "Dr. Jose Eleuterio Gonzalez"
Monterrey, Nuevo León, 64460
Unidad biomedica avanzada monterrey
Monterrey, Nuevo León, 64460
Hospital Universitario "Dr. Jose Eleuterio Gonzalez"
Monterrey, Nuevo León, 66460
Belgium6 sites
Imelda General Hospital
Bonheiden, Antwerpen, 2820
Antwerp University Hospital
Edegem, Antwerpen, 2650
UZ Leuven
Leuven, Vlaams-Brabant, 3000
ZNA Jan Palfijn
Merksem, Flanders, 2170
Az Damiaan vzw
Ostend, West-Vlaanderen, 8400
AZ Nikolaas
Sint-Niklaas, Oost-Vlaanderen, B-9100
Germany6 sites
InnoDiab Forschung Gmbh
Essen, North Rhine-Westphalia, 45136
Diabeteszentrum Hamburg West
Hamburg, 22607
Institut für Diabetesforschung GmbH Münster
Münster, North Rhine-Westphalia, 48145
RED-Institut GmbH
Oldenburg in Holstein, Schleswig-Holstein, 23758
Studienzentrum Dr. Tasso Bieler
Riesa, Saxony, 01589
Medizinisches Versorgungszentrum am Bahnhof Spandau
Spandau, State of Berlin, 13597
Romania6 sites
CMI DNBM Dr. Pop Lavinia
Baia Mare, Maramureş, 430222
Mariodiab Clinic
Brasov, Brașov County, 500097
Geea Medical Easy Diet
Bucharest, Bucharest, 010627
Gama Diamed
Mangalia, Constanța County, 905500
Diabdana
Oradea, Bihor County, 410147
Clinica Korall
Satu Mare, 440055
About this study
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
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
- Being tested
- Tirzepatide, Dulaglutide
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TirzepatideDrug
Also called LY3298176
Administered SC
DulaglutideDrug
Also called LY2189265
Administered SC
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Dulaglutide |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, Week 40
Secondary outcomes (12)
Change From Baseline in Body Weight
LSMean was calculated using MMRM for post-baseline measures: Variable = Baseline + Number of Background OAMs Group 1 + Dulaglutide Dose at Screening + Geographic Region 1 + Baseline HbA1c Group + Treatment + Time + Treatment*Time (Type III sum of squares). Variance-Covariance structure (Actual Value) = Unstructured. Variance-Covariance structure (Change from Baseline) = Unstructured.
Measured: Baseline, Week 40
Percentage of Participants Who Achieved HbA1c <7%
The percentage of participants was calculated by dividing the number of participants reaching target HbA1c by the total number of participants analyzed, multiplied by 100. Analyses included all participants having non-missing baseline and at least one non-missing post-baseline value of the response variable. Missing endpoint measures are imputed by predictions from an MMRM analysis model using observed data in the efficacy analysis set and adjusted for Baseline HbA1c Value, Baseline SGLT2i use(Yes/No), Treatment, Visit, and Treatment by Visit interaction.
Measured: Week 40
Percentage of Participants Who Achieved HbA1c <=6.5%
The percentage of participants was calculated by dividing the number of participants reaching target HbA1c by the total number of participants analyzed, multiplied by 100. Analyses included all participants having non-missing baseline and at least one non-missing post-baseline value of the response variable. Logistic regression model was used with missing endpoint measures imputed by predictions from an MMRM analysis model using observed data in the efficacy analysis set and adjusted for baseline HbA1c, geographic region 1, number of background OAMs in group 1, dulaglutide dose at screening, and treatment as factors.
Measured: Week 40
Percentage of Participants Who Achieved HbA1c <5.7%
The percentage of participants was calculated by dividing the number of participants reaching target HbA1c by the total number of participants analyzed, multiplied by 100. Analyses included all participants having non-missing baseline and at least one non-missing post-baseline value of the response variable. Logistic regression model was used with missing endpoint measures imputed by predictions from an MMRM analysis model using observed data in the efficacy analysis set and adjusted for baseline HbA1c, geographic region 1, number of background OAMs in group 1, dulaglutide dose at screening, and treatment as factors.
Measured: Week 40
Percentage of Participants Who Achieve Weight Loss From Baseline of ≥5%
Missing endpoint measures are imputed by predictions using observed data in the efficacy analysis set from the same treatment group through an MMRM analysis model for post-baseline measures: Variable = Baseline + Geographic Region 1 + Number of Background OAMs Group 1 + Dulaglutide Dose at Screening + Baseline HBA1C Group + Treatment + Time + Treatment*Time.
Measured: Week 40
Percentage of Participants Who Achieve Weight Loss From Baseline of ≥10%
Missing endpoint measures are imputed by predictions using observed data in the efficacy analysis set from the same treatment group through an MMRM analysis model for post-baseline measures: Variable = Baseline + Geographic Region 1 + Number of Background OAMs Group 1 + Dulaglutide Dose at Screening + Baseline HBA1C Group + Treatment + Time + Treatment*Time.
Measured: Week 40
Percentage of Participants Who Achieve Weight Loss From Baseline of ≥15%
Missing endpoint measures are imputed by predictions using observed data in the efficacy analysis set from the same treatment group through an MMRM analysis model for post-baseline measures: Variable = Baseline + Geographic Region 1 + Number of Background OAMs Group 1 + Dulaglutide Dose at Screening + Baseline HBA1C Group + Treatment + Time + Treatment*Time.
Measured: Week 40
Percentage of Participants Who Achieved Composite Endpoint (HbA1c <=6.5% & Weight Loss >=10% & No-Hypoglycemia)
A composite endpoint is defined as HbA1c ≤ 6.5%, weight loss ≥ 10%, and no hypoglycemia, defined as blood glucose (BG) <3.0 millimole/liter (mmol/L) and/or severe hypoglycemia. Missing endpoint measures are imputed by predictions using observed data in the efficacy analysis set from the same treatment group through an MMRM analysis model for post-baseline measures:
For HbA1c: Variable = Baseline + Geographic Region 1 + Number of Background OAMs Group 1 + Dulaglutide Dose at Screening + Treatment + Time + Treatment*Time.
For Weight: Variable = Baseline + Geographic Region 1 + Number of Background OAMs Group 1 + Dulaglutide Dose at Screening + Baseline HbA1c Group + Treatment + Time + Treatment*Time.
Measured: Week 40
Change From Baseline in Fasting Serum Glucose (FSG)
LSMean was calculated using the ANCOVA model for endpoint measures: Variable = Baseline + A1CGR1 + DULDSCRN + OAMGR1 + REGION1 + Treatment (Type I sum of squares).
Measured: Baseline, Week 40
Change From Baseline in Waist Circumference
LSMean was calculated using MMRM for post-baseline measures: Variable = Baseline + Number of Background OAMs Group 1 + Dulaglutide Dose at Screening + Geographic Region 1 + Baseline HbA1c Group + Treatment + Time + Treatment*Time (Type III sum of squares). Variance-Covariance structure (Actual Value) = Unstructured. Variance-Covariance structure (Change from Baseline) = Unstructured.
Measured: Baseline, Week 40
Change From Baseline in Body Mass Index (BMI)
Change from Baseline in BMI is presented. LSMean was calculated using MMRM for post-baseline measures: Variable = Baseline + Number of Background OAMs Group 1 + Dulaglutide Dose at Screening + Geographic Region 1 + Baseline HbA1c Group + Treatment + Time + Treatment*Time (Type III sum of squares). Variance-Covariance structure (Actual Value) = Unstructured. Variance-Covariance structure (Change from Baseline) = Unstructured.
Measured: Baseline, Week 40
Change From Baseline in Impact of Weight on Quality of Life-Lite Clinical Trials Version (IWQOL-Lite CT) - Physical Functioning Score
The IWQOL-Lite-CT is a 20-item, obesity-specific PRO (patient-reported outcome) instrument developed for use in obesity clinical trials. It assesses 2 primary domains of obesity-related health-related quality of life (HRQoL): physical (7 items, where 5 of the items comprise the physical functioning sub-domain) and psychosocial (13 items). The IWQOL-Lite-CT provides composite scores for each domain, as well as a total score, all ranging from 0 to 100. Higher scores reflect better levels of functioning. This endpoint shows results for 'physical function domain.'
Measured: Baseline, Week 40
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2022
- Study start30 Nov 2022
- Primary completion15 Jul 2024
- Study completion12 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- More trials run by Eli Lilly and CompanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 282 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eli Lilly and Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- 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), Study director, Eli Lilly and Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05564039
- Sponsor's protocol ID
- 18395
- Other IDs
- I8F-MC-GPIH, 2022-500101-41-00
- Acronym
- SURPASS-SWITCH
- Status last verified
- Jul 2025
- First submitted
- 30 Sep 2022
- Last updated
- 3 Aug 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
Violante-Ortiz R, Rose L, Sharma P, Gomez Valderas E, Chivukula KK, Kwan AY. 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 Mar 30;14(2):e005711. doi: 10.1136/bmjdrc-2025-005711.
PubMed 41912265Billings 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.
PubMed 40183678