A Study of Tirzepatide (LY3298176) Once a Week Versus Insulin Glargine Once a Day in Participants With Type 2 Diabetes and Increased Cardiovascular Risk

Inclusion Criteria:

Participants must:

- Have been diagnosed with type 2 diabetes mellitus (T2DM)

- Have HbA1c between ≥7.5% and ≤10.5%

- Be on stable treatment with unchanged dose of at least 1 and no more than 3 types of
oral antihyperglycemic drugs, which may only include metformin, SGLT-2 inhibitors,
and/or sulfonylureas for at least 3 months before screening

- Have increased risk for cardiovascular (CV) events

- Be of stable weight (± 5%)

- Have a BMI ≥25 kilograms per meter squared (kg/m2) at screening

Exclusion Criteria

Participants must not:

- Have type 1 diabetes mellitus

- Have had chronic or acute pancreatitis any time prior to study entry

- Have proliferative diabetic retinopathy or diabetic maculopathy or nonproliferative
diabetic retinopathy requiring immediate or urgent treatment

- Have disorders associated with slowed emptying of the stomach, or have had any stomach
surgeries for the purpose of weight loss

- Have acute or chronic hepatitis, signs and symptoms of any other liver disease, or
blood alanine transaminase (ALT) enzyme level >3.0 times the upper limit of normal
(ULN) for the reference range, as determined by the central laboratory. Participants
with nonalcoholic fatty liver disease (NAFLD) are eligible for participation in this
trial only if there ALT level is ≤3.0 the ULN for the reference range

- Have had a heart attack, stroke, or hospitalization for congestive heart failure in
the past 2 months

- Have a personal or family history of medullary thyroid carcinoma or personal history
of multiple endocrine neoplasia syndrome type 2

- Have been taking any other diabetes medicines other than metformin, SGLT-2 inhibitors,
and/or sulfonylureas during the last 3 months

- Have been taking weight loss drugs, including over-the-counter medications during the
last 3 months