Procedures
The randomization of patients was stratified ac-
cording to cardiovascular disease status (estab-
lished cardiovascular or chronic kidney disease or
cardiovascular risk factors only), insulin treatment
(none, basal insulin only, or premixed insulin),
and estimated glomerular filtration rate (≤30 ml
or >30 ml per minute per 1.73 m2
of body-surface
area) at screening. A fixed dose-escalation proce-
dure was used, with a starting dose of 0.25 mg
for 4 weeks that escalated to 0.5 mg for 4 weeks
until the maintenance dose (0.5 mg or 1.0 mg