A Study of Tirzepatide (LY3298176) in Adult Participants With Type 2 Diabetes Switching From Dulaglutide (SURPASS-SWITCH)
- Conditions
- Type 2 DiabetesTherapeutic area: Diseases [C] - Hormonal diseases [C19]
- Registration Number
- CTIS2022-500101-41-00
- Lead Sponsor
- Eli Lilly Cork Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 250
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, SGLT-2i, and/or sulfonylurea, for at least 3 months before screening, Have stable body weight (±5%) during the 90 days preceding screening, Have BMI =25 kilogram/square meter (kg/m²)
Have type 1 diabetes, 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 chronic or acute pancreatitis, Have a history of proliferative diabetic retinopathy, diabetic maculopathy, or Nonproliferative diabetic retinopathy requiring acute treatment, Have 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 a history of reduction of dose of dulaglutide, due to intolerability, without successful reescalation, Have any of these cardiovascular conditions within 60 days prior to screening: acute myocardial infarction, cerebrovascular accident (stroke), or hospitalization due to congestive heart failure (CHF)
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To demonstrate that switching from once weekly dulaglutide to once weekly tirzepatide is superior to continuing and escalating dulaglutide for HbA1c change from baseline to Week 40;Secondary Objective: To demonstrate that switching from once weekly dulaglutide to once weekly tirzepatide is superior to continuing and escalating dulaglutide for weight change from baseline to Week 40.;Primary end point(s): Change from baseline in Hemoglobin A1c (HbA1c)
- Secondary Outcome Measures
Name Time Method