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NCT05706506
A Study of Tirzepatide (LY3298176) in Adults With Type 2 Diabetes Switching From a GLP-1 RA (SURPASS-SWITCH-2)
Conditions: Type 2 Diabetes, Diabetes Mellitus, Type 2
Sex: All
Ages: 18 Years – N/A
Phase: PHASE4
Enrollment: 150
Sponsor: Eli Lilly and Company
Summary
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).
Eligibility Criteria
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 screeningHave been on a stable treatment dose of 1 of the listed GLP-1 RAs for ≥3 monthsNo 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 ofproliferative diabetic retinopathydiabetic maculopathy, ornonproliferative diabetic retinopathy that requires acute treatmentAre at high risk for cardiovascular disease or have a history ofmyocardial infarctionpercutaneous coronary revascularization procedurecarotid stenting or surgical revascularizationnontraumatic amputationperipheral vascular procedurecerebrovascular accidentor hospitalization for congestive heart failureHave New York Heart Association (NYHA) Functional Classification Class IV congestive heart failureHave a history of ketoacidosis or hyperosmolar state or comaHave a history of severe hypoglycemia or hypoglycemia unawareness within the 6 months.
Source: ClinicalTrials.gov (NCT05706506). StuddyBuddy aggregates publicly available trial information.