A Study of Tirzepatide (LY3298176) Compared With Dulaglutide on Major Cardiovascular Events in Participants With Type 2 Diabetes

The purpose of the trial is to assess the efficacy and safety of tirzepatide to dulaglutide in participants with type 2 diabetes and increased cardiovascular risk.

Inclusion Criteria: * Men or women at least 40 years old with a diagnosis of type 2 diabetes * Established cardiovascular disease, including at least 1 of the following: * Coronary artery disease (CAD) with any of the following: * Documented history of spontaneous myocardial infarction (MI) * ≥50% stenosis in 1 or more major coronary arteries, determined by invasive angiography * ≥50% stenosis in 2 or more major coronary arteries, determined by computed tomography coronary angiography (CTCA) * History of surgical or percutaneous coronary revascularization procedure * Cerebrovascular disease - any of the following: * Documented history of ischemic stroke * Carotid arterial disease with ≥50% stenosis, documented by carotid ultrasound, magnetic resonance imaging (MRI), or angiography * Carotid stenting or surgical revascularization * Peripheral arterial disease with either of the following: * Intermittent claudication and ankle-brachial index \40 mIU/mL; or ii. A woman 55 or older not on hormone therapy, who has had at least 12 months of spontaneous amenorrhea; or A woman at least 55 years of age with a diagnosis of menopause prior to starting hormone replacement therapy. * In the investigator's opinion, are well motivated, capable, and willing to: * learn how to self-inject treatment (tirzepatide or dulaglutide), as required for this protocol (visually impaired persons who are not able to perform the injections must have the assistance of a sighted individual trained to inject the study drug; persons with physical limitations who are not able to perform the injections must have the assistance of an individual trained to inject the study drug), * inject study drug weekly, * have a sufficient understanding of 1 of the provided languages of the country such that they will be able to complete the patient questionnaires, and * make themselves available for the duration of the study, and who will comply with the required study visits. * Capable of giving signed informed consent Exclusion Criteria: * Have type 1 diabetes mellitus * Have uncontrolled diabetes requiring immediate therapy (such as diabetic ketoacidosis) at screening or randomization, in the judgment of the physician * Have had 1 or more events of severe hypoglycemia and/or 1 or more events of hypoglycemia unawareness within 6 months prior to screening * Are currently planning treatment for diabetic retinopathy and/or macular edema. * Have been hospitalized for congestive heart failure (CHF) within 2 months prior to screening * Have chronic New York Heart Association Functional Classification IV CHF * Are currently planning a coronary, carotid, or peripheral artery revascularization * Had chronic or acute pancreatitis any time prior to screening, irrespective of etiology * Have a known clinically significant gastric emptying abnormality such as severe gastroparesis or gastric outlet obstruction, or have undergone or currently planning any gastric bypass (bariatric) surgery or restrictive bariatric surgery * Have acute or chronic hepatitis, signs or symptoms of any other liver disease, an alanine aminotransferase (ALT) level ≥3 times the upper limit of normal (ULN) for the reference range, as determined by the central laboratory (Note: Patients with nonalcoholic fatty liver disease are eligible to participate if their ALT level is \