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

Lilly

Status and phase: Completed; Phase 4

Conditions: Type 2 Diabetes; Diabetes Mellitus, Type 2

Treatments: Drug: Tirzepatide

Study type: Interventional

Funder types: Industry

Identifiers

NCT05706506

I8F-MC-GPIL (Other Identifier)

2022-002708-18 (EudraCT Number)

18520

Details and patient eligibility

About

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).

Enrollment: 152 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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
  • non-proliferative 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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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152 participants in 1 patient group

5 milligrams (mg) Tirzepatide

Experimental group

Description:

Participants received 5 mg tirzepatide subcutaneously administered once weekly for 12 weeks.

Treatment:

Drug: Tirzepatide