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

CAD, coronary artery disease.