• Drug-naive subjects: HbA1c ≥7.0% and ≤9.0% at screening
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• History of myocardial infarction >2 months prior to informed consent
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• Evidence of multi-vessel CAD i.e. in ≥ 2 major coronary arteries or the left main coronary artery, documented by any of the following:
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• Subjects on background therapy: HbA1c ≥7.0% and ≤10.0% at screening
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– Presence of significant stenosis: ≥50% luminal narrowing during angiography (coronary or multi-slice computed tomography)
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– Previous revascularization (percutaneous transluminal coronary angioplasty ± stent or coronary artery bypass graft >2 months prior to consent
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– The combination of revascularization in one major coronary artery and significant stenosis (≥50% luminal narrowing) in another major coronary artery
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• 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:
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– A positive non-invasive stress test for ischemia
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– Hospital discharge for unstable angina ≤12 months prior to consent
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• Unstable angina >2 months prior to consent with evidence of single- or multi-vessel CAD
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• History of stroke (ischemic or hemorrhagic) >2 months prior to consent
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• Occlusive peripheral artery disease documented by any of the following:
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– Limb angioplasty, stenting, or bypass surgery
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– Limb or foot amputation due to circulatory insufficiency
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– Evidence of significant peripheral artery stenosis (>50% on angiography, or >50% or hemodynamically significant via non-invasive methods ) in 1 limb
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– Ankle brachial index <0.9 in ≥1 ankle
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