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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Type 2 Diabetes

Intervention / Treatment
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* Drug: Tirzepatide
* Drug: Dulaglutide


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tirzepatide<br>Participants will receive tirzepatide subcutaneously (SC) | Drug: Tirzepatide<br>* Administered SC<br>* Other names: LY3298176;|
| Active Comparator: Dulaglutide<br>Participants will escalate their dulaglutide dose SC. | Drug: Dulaglutide<br>* Administered SC<br>* Other names: LY2189265;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline in Hemoglobin A1c (HbA1c) |  | Baseline, Week 40 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline in Weight |  | Baseline, Week 40 | 
| Percentage of Participants Who Achieve HbA1c <7% |  | Baseline to Week 40 | 
| Percentage of Participants Who Achieve HbA1c ≤6.5% |  | Baseline to Week 40 | 
| Percentage of Participants Who Achieve HbA1c <5.7% |  | Baseline to Week 40 | 
| Percentage of Participants Who Achieve Weight loss from Baseline of ≥5% |  | Baseline to Week 40 | 
| Percentage of Participants Who Achieve Weight loss from baseline of ≥10% |  | Baseline to Week 40 | 
| Percentage of Participants Who Achieve Weight loss from baseline of ≥15% |  | Baseline to Week 40 | 
| A Composite Endpoint of HbA1c, Weight loss and Hypoglycemia | 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 | Week 40 | 
| Change from Baseline in Fasting Serum Glucose (FSG) |  | Baseline, Week 40 | 
| Change from Baseline in Waist Circumference |  | Baseline, Week 40 | 
| Change from Baseline in Body Mass Index (BMI) |  | Baseline, Week 40 | 
| Change from Baseline in Impact of Weight on Quality of Life Clinical Trials Version (IWQOL-Lite CT) - Physical Functioning Score |  | Baseline, Week 40 |