A Study of Tirzepatide Compared with Intensified Conventional Care in Adult Participants with Type 2 Diabetes (SURPASS-EARLY)

Phase 1

Recruiting

• Conditions: Type 2 Diabetes; Therapeutic area: Diseases [C] - Hormonal diseases [C19]

• Registration Number: CTIS2022-501073-40-00
• Lead Sponsor: Eli Lilly & Co.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2022-08-16
• Last Update Posted: 21 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 781

Inclusion Criteria

Have, within the last 4 years, been diagnosed with T2D based on the World Health Organization classification or other locally applicable diagnostic standards., Have HbA1c =7% to =9.5% as determined by the central laboratory., Have been on a stable treatment of metformin only at least 90 days preceding baseline with the minimum effective dose of =1500 mg/day, but not higher than the maximum approved dose per country-specific label, or <1500 mg/day in case of intolerance of full therapeutic dose.

Exclusion Criteria

Have type 1 diabetes mellitus, Have a history of chronic or acute pancreatitis any time prior to study entry, Have a history of proliferative diabetic retinopathy, diabetic macular edema, or no proliferative diabetic retinopathy requiring immediate or urgent treatment, Are at high risk for cardiovascular disease (CVD) in the investigator’s opinion or have a history of any of these CV conditions prior to Visit 1 myocardial infarction, percutaneous coronary revascularization procedure, carotid stenting or surgical revascularization, nontraumatic amputation, peripheral vascular procedure (e.g., stenting or surgical revascularization), cerebrovascular accident (stroke), or congestive heart failure, 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 eGFR <30 mL/minute/1.73 m2 (or lower than the country-specific threshold for discontinuing metformin therapy per local label), calculated by chronic kidney disease-epidemiology equation as determined by central laboratory at screening., Have been treated with any injectable GLP-1 receptor agonists and 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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified