Table 1.

Inclusion criteria.

Provision of signed and dated, written informed consent prior to any study-specific procedures, and:
1. Females or males ≥40 years up to 75 years of age.
2. Patients with type 2 diabetes on stable dose of metformin for at least 6 weeks prior to screening and HbA1c at screening visit of ≥42 mmol/mol and ≤75 mmol/mol.
3. No significant signs or symptoms of coronary artery disease or, if known coronary artery disease, currently free of symptomsa and (i) all major epicardial vessels with <50% stenosis within 12 months prior to screening, or (ii) if revascularized, with all major epicardial vessels with <50% remaining stenosis after stenting or bypass surgery procedure between 3 and 12 months prior to screening.
4. Normal left ventricular ejection fraction (≥50%) assessed within 1 year prior to informed consent, and, if applicable, after most recent acute episode of coronary artery syndrome, or at screening visit.
5. Subjects with BMI ≥25 kg/m2.
6. Female subjects must be 1 year post-menopausal, surgically sterile, or using an acceptable method of contraception (an acceptable method of contraception is defined as a barrier method in conjunction with a spermicide) for the duration of the study (from the time they sign consent) to prevent pregnancy.b

^aCardiac symptoms include, but are not limited to, angina pectoris, dyspnea, and fatigue on exertion judged by a physician to be of cardiac origin.

^bIn addition, oral contraceptives, approved contraceptive implant, long-term injectable contraception, intrauterine device, or tubal ligation are allowed. Oral contraception alone is not acceptable; additional barrier methods in conjunction with spermicide must be used.