A Study of Tirzepatide (LY3298176) in Adults With Type 2 Diabetes Switching From a GLP-1 RA (SURPASS-SWITCH-2)

Study Overview
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Brief Summary
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The main purpose of this study is to investigate the effects of switching from glucagon-like peptide-1 receptor agonist (GLP-1 RA) therapy to tirzepatide glucose-dependent insulinotropic polypeptide (GIP) GLP-1 RA agonist in participants with type 2 diabetes (T2D).

Official Title
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An Open-Label, Single-Arm, Phase 4 Study to Assess Glycemic Control When Adults With Type 2 Diabetes Switch From a GLP-1 RA to Tirzepatide (SURPASS-SWITCH-2)

Conditions
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Type 2 Diabetes, Diabetes Mellitus, Type 2

Intervention / Treatment
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* Drug: Tirzepatide


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Have Type 2 diabetes (T2D) Have an HbA1c c ≥6.5% (≥48 mmol/mol) to ≤9.0% (≤75 mmol/mol) Have a body mass index (BMI) ≥25 kilogram per square meter (kg/m²) at screening Have been on a stable treatment dose of 1 of the listed GLP-1 RAs for ≥3 months No treatment with oral antidiabetic medicine (OAM) or on stable doses (for at least 3 months before screening) of up to 3 OAM. The OAM may include metformin, sodium-glucose linked transporter-2 inhibitor (SGLT-2i), thiazolidinediones, or α-glucosidase inhibitors. Exclusion Criteria: Have Type 1 Diabetes (T1D) Have a clinical history of proliferative diabetic retinopathy diabetic maculopathy, or nonproliferative diabetic retinopathy that requires acute treatment Are at high risk for cardiovascular disease or have a history of myocardial infarction percutaneous coronary revascularization procedure carotid stenting or surgical revascularization nontraumatic amputation peripheral vascular procedure cerebrovascular accident or hospitalization for congestive heart failure Have New York Heart Association (NYHA) Functional Classification Class IV congestive heart failure Have a history of ketoacidosis or hyperosmolar state or coma Have a history of severe hypoglycemia or hypoglycemia unawareness within the 6 months.

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
Intervention Model: Single Group 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;|

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 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline in Percentage of Time per Day that Continuous Glucose Monitoring (CGM)-derived Values are >180 milligram/deciliter (mg/dl) 10 millimole/liter (mmol/L) |  | Baseline, Week 4 | 
| Change from Baseline in Percentage of Time per Day that Continuous Glucose Monitoring (CGM)-derived Values are >180 mg/dl (10 mmol/L) |  | Baseline, Week 12 | 
| Change from Baseline in Duration of Time in Minutes per Day that CGM derived Values are >180 mg/dl (10 mmol/L) |  | Baseline, Week 4 | 
| Change from Baseline in Duration of Time in Minutes per Day that CGM derived Values are >180 mg/dl (10 mmol/L) |  | Baseline, Week 12 | 
| Change from Baseline in Fasting Serum Glucose (FSG) |  | Baseline, Week 12 | 
| Change from Baseline in Weight |  | Baseline, Week 12 |