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

• Status: Not yet recruiting
• Trial end date: 2023-10-09
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Eli Lilly and Company
• Treatments: Tirzepatide

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 screening

• Have been on a stable treatment dose of 1 of the listed GLP-1 RAs for ≥3 months

• No treatment with oral antidabetic medicine (OAM) or on stable doses (for at least 3 months before screening) of up to 3 OAM. The OAM may include metformin, 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 sugical 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.