Phase 4
N=282
A Study of Tirzepatide (LY3298176) in Adult Participants With Type 2 Diabetes Switching From Dulaglutide (SURPASS-SWITCH)
Type 2 Diabetes
Bottom Line
View on ClinicalTrials.gov: NCT05564039 ↗Enrolled (actual)
282
Serious AEs
7.1%
Results posted
Aug 2025
Primary outcome: Primary: Change From Baseline in HbA1c — -1.59; -0.69 percentage of HbA1c — p=<0.0001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Tirzepatide (Drug); Dulaglutide (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Eli Lilly and Company
- Primary completion
- Jul 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in HbA1c |
-1.59; -0.69 | <0.0001 sig |
| SECONDARY Change From Baseline in Body Weight |
-11.0; -3.6 | <.0001 sig |
| SECONDARY Percentage of Participants Who Achieved HbA1c <7% |
84.21; 52.38 | <0.0001 sig |
| SECONDARY Percentage of Participants Who Achieved HbA1c <=6.5% |
73.88; 22.73 | <0.0001 sig |
| SECONDARY Percentage of Participants Who Achieved HbA1c <5.7% |
21.64; 2.27 | <0.0001 sig |
| SECONDARY Percentage of Participants Who Achieve Weight Loss From Baseline of ≥5% |
84.33; 37.40 | <0.0001 sig |
| SECONDARY Percentage of Participants Who Achieve Weight Loss From Baseline of ≥10% |
58.21; 6.87 | <0.0001 sig |
| SECONDARY Percentage of Participants Who Achieve Weight Loss From Baseline of ≥15% |
27.61; 0.76 | <0.0001 sig |
| SECONDARY Percentage of Participants Who Achieved Composite Endpoint (HbA1c <=6.5% & Weight Loss >=10% & No-Hypoglycemia) |
46.62; 4.58 | <0.0001 sig |
| SECONDARY Change From Baseline in Fasting Serum Glucose (FSG) |
-2.00; -1.10 | <0.001 sig |
| SECONDARY Change From Baseline in Waist Circumference |
-8.2; -3.1 | 0.0002 sig |
| SECONDARY Change From Baseline in Body Mass Index (BMI) |
-3.9; -1.3 | <0.0001 sig |
| SECONDARY Change From Baseline in Impact of Weight on Quality of Life-Lite Clinical Trials Version (IWQOL-Lite CT) - Physical Functioning Score |
11.8; 7.8 | 0.1181 |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT05564039). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.