Type I diabetes mellitus or type 2 diabetes on insulin treatment.
History of cerebrovascular disorder, myocardial infarction, angina pectoris, coronary angioplasty or coronary artery bypass graft surgery within 6 months prior to enrolment in the study.
Heart failure (New York Heart Association \[NYHA\] functional classification II, III or IV).
Chronic atrial fibrillation or atrial flutter.
Congenital heart disease or a history of rheumatic heart disease.
Severe peripheral arterial disease (Fontaine Class II, III or IV).
Serious liver dysfunction (AST or ALT ≥100 IU / l).