A Study of Tirzepatide Compared With Intensified Conventional Care in Adult Participants With Type 2 Diabetes

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 study entry

• 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 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), calculated by chronic kidney disease-epidemiology equation as determined by central laboratory at screening.
• Have been treated with any injectable glucagon-like peptide-1 (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.