Type 2 Diabetes (T2D) Clinical Trials

• Informed consent obtained before any study-related activities. Study-related activities are any procedures that are carried out as part of the study, including activities to determine suitability for the study.

• Male or female (sex assigned at birth, inclusive of all gender identities).

• Age 45 years or above at the time of signing the informed consent.

• Diagnosed with type 2 diabetes (T2D) greater than or equal to (≥) 180 days before screening.

• Treatment with 1-3 marketed oral glucose-lowering medications (metformin, glinide, thiazolidinedione, sodium-glucose cotransporter-2 inhibitors (SGLT2i), α-glucosidase inhibitors (AGI), or sulfonylureas (SU) as a single agent or in combination) according to local label. Treatment with oral glucose-lowering medications must be stable (same drug(s), stable daily dose(s)) before screening.

• Have HbA1c as determined by central laboratory at screening, if background glucose-lowering medications does not include a SU, or if background glucose-lowering medications includes a SU.

• Increased risk of cardiovascular events as evidenced by at least one of the following (a-e):

• Prior myocardial infarction (MI)

• Documented coronary artery disease defined by at least one of the following:

⁃ ≥ 50% stenosis of coronary artery on angiography or other imaging modality.

• Ischaemia documented by stress test with any imaging modality.

• Prior unstable angina with electrocardiogram (ECG) changes.

• Prior coronary artery bypass graft or prior percutaneous coronary intervention.

• Prior stroke (ischemic or haemorrhagic stroke).

• History of chronic kidney disease based on medical records or as judged by the investigator as determined by central laboratory at screening.

• Symptomatic peripheral arterial disease (PAD) defined as at least one of the following:

• Intermittent claudication with an ankle-brachial index (ABI) \< 0.85 at rest.

• Intermittent claudication with a ≥ 50% stenosis in a lower extremity peripheral artery documented by X-ray angiography, magnetic resonance (MR) angiography, computer tomography (CT) angiography or Doppler ultrasound.

• Prior revascularisation procedure of a lower extremity peripheral artery.

• Lower extremity amputation at or above ankle due to atherosclerotic disease (excluding e.g., trauma or osteomyelitis)