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Trial · Interventional

CompletedPhase 4Results postedRegistry data

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

Short name SURPASS-SWITCH

NCTNCT05564039 (opens ClinicalTrials.gov in a new tab)Other id18395Other idI8F-MC-GPIHOther id2022-500101-41-00
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 4
Enrollment
282 participants (actual)
Sponsor
Eli Lilly and Company · Industry
Design
Randomized · Open label (no masking)
Countries
5 countries

United States, Belgium, Germany, Mexico, Romania

Start
30 Nov 2022
Primary completion
15 Jul 2024
Completion
12 Aug 2024
First posted
3 Oct 2022
Last update posted
3 Aug 2025
Conditions
Type 2 Diabetes

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2022202320242025
  1. Ph 4

    SURPASS-SWITCH

    NCT05564039

    30 Nov 2022 to 12 Aug 2024

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • TirzepatideDrug
  • DulaglutideDrug

Arms2

  • Experimental

    15 Milligram (mg) Tirzepatide or Maximum Tolerated Dose (MTD)

    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.

  • Active comparator

    4.5 mg Dulaglutide or MTD

    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.

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Change From Baseline in HbA1c

    Time frame · Baseline, Week 40

    Registry description

    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.

Secondary outcomes(12)

  1. Change From Baseline in Body Weight

    Time frame · Baseline, Week 40

    Registry description

    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.

  2. Percentage of Participants Who Achieved HbA1c <7%

    Time frame · Week 40

    Registry description

    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.

  3. Percentage of Participants Who Achieved HbA1c <=6.5%

    Time frame · Week 40

    Registry description

    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.

  4. Percentage of Participants Who Achieved HbA1c <5.7%

    Time frame · Week 40

    Registry description

    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.

  5. Percentage of Participants Who Achieve Weight Loss From Baseline of ≥5%

    Time frame · Week 40

    Registry description

    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.

  6. Percentage of Participants Who Achieve Weight Loss From Baseline of ≥10%

    Time frame · Week 40

    Registry description

    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.

  7. Percentage of Participants Who Achieve Weight Loss From Baseline of ≥15%

    Time frame · Week 40

    Registry description

    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.

  8. Percentage of Participants Who Achieved Composite Endpoint (HbA1c <=6.5% & Weight Loss >=10% & No-Hypoglycemia)

    Time frame · Week 40

    Registry description

    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.

  9. Change From Baseline in Fasting Serum Glucose (FSG)

    Time frame · Baseline, Week 40

    Registry description

    LSMean was calculated using the ANCOVA model for endpoint measures: Variable = Baseline + A1CGR1 + DULDSCRN + OAMGR1 + REGION1 + Treatment (Type I sum of squares).

  10. Change From Baseline in Waist Circumference

    Time frame · Baseline, Week 40

    Registry description

    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.

  11. Change From Baseline in Body Mass Index (BMI)

    Time frame · Baseline, Week 40

    Registry description

    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.

  12. Change From Baseline in Impact of Weight on Quality of Life-Lite Clinical Trials Version (IWQOL-Lite CT) - Physical Functioning Score

    Time frame · Baseline, Week 40

    Registry description

    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.'

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeLeast squares mean· Baseline, Week 40

Change From Baseline in HbA1c

GroupValue (percentage of HbA1c)Spread
15 mg Tirzepatide or MTD-1.590.073
4.5 mg Dulaglutide or MTD-0.690.074
Secondary and other outcome results(7)
Secondary outcomeLeast squares mean· Baseline, Week 40

Change From Baseline in Body Weight

GroupValue (kilograms (kg))Spread
15 mg Tirzepatide or MTD-11.00.48
4.5 mg Dulaglutide or MTD-3.60.49
Secondary outcomeNumber· Week 40

Percentage of Participants Who Achieved HbA1c <7%

GroupValue (percentage of participants)
15 mg Tirzepatide or MTD84.21
4.5 mg Dulaglutide or MTD52.38
Secondary outcomeNumber· Week 40

Percentage of Participants Who Achieved HbA1c <=6.5%

GroupValue (percentage of participants)
15 mg Tirzepatide or MTD73.88
4.5 mg Dulaglutide or MTD22.73
Secondary outcomeNumber· Week 40

Percentage of Participants Who Achieved HbA1c <5.7%

GroupValue (percentage of participants)
15 mg Tirzepatide or MTD21.64
4.5 mg Dulaglutide or MTD2.27
Secondary outcomeNumber· Week 40

Percentage of Participants Who Achieve Weight Loss From Baseline of ≥5%

GroupValue (percentage of participants)
15 mg Tirzepatide or MTD84.33
4.5 mg Dulaglutide or MTD37.40
Secondary outcomeNumber· Week 40

Percentage of Participants Who Achieve Weight Loss From Baseline of ≥10%

GroupValue (percentage of participants)
15 mg Tirzepatide or MTD58.21
4.5 mg Dulaglutide or MTD6.87
Secondary outcomeNumber· Week 40

Percentage of Participants Who Achieve Weight Loss From Baseline of ≥15%

GroupValue (percentage of participants)
15 mg Tirzepatide or MTD27.61
4.5 mg Dulaglutide or MTD0.76

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
15 mg Tirzepatide or MTDParticipants received 15 mg of tirzepatide administered as SC injection via a SDP 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 12.5 mg to 15 mg) until 15 mg or MTD was reached.1 / 13910 / 13977 / 139
4.5 mg Dulaglutide or MTDParticipants received 4.5 mg of dulaglutide administered as SC injection via a SDP QW for 40 weeks. The starting dose of dulaglutide was 0.75 mg QW, which increased by 1.5 mg every 4 weeks (0.75 mg to 1.5 mg to 3 mg to 4.5 mg) until 4.5 mg or MTD was reached.1 / 14310 / 14379 / 143

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies2

Studies that cite this trial.

Studies with results

2 studies on this page

Indexing hint: Randomized controlled trial · 2026

10 results

Safety and efficacy of switching from dulaglutide to tirzepatide across clinically relevant baseline characteristics in participants with T2D: subgroup analysis of SURPASS-SWITCH.

Violante-Ortiz et al. 2026BMJ open diabetes research & care

PMID 41912265PMC13052782DOI 10.1136/bmjdrc-2025-005711PUB-41912265

Free to read · publisher termsCC BY-NC10 results
Read at sourceSee results (10)

Indexing hint: Randomized controlled trial · 2025

8 results

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.

Billings et al. 2025Annals of internal medicinecited by 13

PMID 40183678DOI 10.7326/annals-24-03849PUB-40183678

Full text at the publisher8 results
Publisher pageSee results (8)

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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

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