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

• Status: Not yet recruiting
• Trial end date: 2024-09-05
• Target enrollment: 0
• Participant gender: All

Summary

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.

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

Details

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

Criteria

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