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Table 1 Key inclusion criteria
| Insufficient glycemic control | High risk of cardiovascular events (≥1 of the following) |
|---|---|
| • Drug-naive subjects: HbA1c ≥7.0% and ≤9.0% at screening | • History of myocardial infarction >2 months prior to informed consent |
| • Evidence of multi-vessel CAD i.e. in ≥ 2 major coronary arteries or the left main coronary artery, documented by any of the following: | |
| • Subjects on background therapy: HbA1c ≥7.0% and ≤10.0% at screening | – Presence of significant stenosis: ≥50% luminal narrowing during angiography (coronary or multi-slice computed tomography) |
| – Previous revascularization (percutaneous transluminal coronary angioplasty ± stent or coronary artery bypass graft >2 months prior to consent | |
| – The combination of revascularization in one major coronary artery and significant stenosis (≥50% luminal narrowing) in another major coronary artery | |
| • Evidence of single-vessel CAD, ≥50% luminal narrowing during angiography (coronary or multi-slice computed tomography) not subsequently successfully revascularized, with at least 1 of the following: | |
| – A positive non-invasive stress test for ischemia | |
| – Hospital discharge for unstable angina ≤12 months prior to consent | |
| • Unstable angina >2 months prior to consent with evidence of single- or multi-vessel CAD | |
| • History of stroke (ischemic or hemorrhagic) >2 months prior to consent | |
| • Occlusive peripheral artery disease documented by any of the following: | |
| – Limb angioplasty, stenting, or bypass surgery | |
| – Limb or foot amputation due to circulatory insufficiency | |
| – Evidence of significant peripheral artery stenosis (>50% on angiography, or >50% or hemodynamically significant via non-invasive methods ) in 1 limb | |
| – Ankle brachial index <0.9 in ≥1 ankle |
