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

Prior treatment

• Have a history of chronic or acute pancreatitis any time prior to study entry
• 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 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 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

Other illness

• Have type 1 diabetes mellitus
• Have a history of proliferative diabetic retinopathy, diabetic macular edema, or no proliferative diabetic retinopathy requiring immediate or urgent treatment
• Have family or personal history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN2).

Lab values

• 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, 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.