The addition of miglitol to the treatment regimen wasgenerally well tolerated, with the overall AE pro®le notsigni®cantly different from that associated with miglitoltaken alone or in previous studies combining miglitolwith sulphonylureas [9]. The treatment-associated AEswere generally mild, non-treatment limiting and con-®ned to the gastrointestinal system. Although the overall incidence of active treatment-associated AEsincreased with background metformin therapy abovethat previously reported in comparable studies usingmiglitol alone [10,18], the difference in AE incidencebetween the miglitol/metformin and placebo/metformingroups was still only 8%. The combination of miglitolwith metformin was not associated with a greaternumber of patient withdrawals due to AEs (11 onmiglitol/metformin, eight on placebo/metformin). Noside-effects such as weight gain or hypoglycaemia werereported, and the lack of any hepatotoxicity eliminatesthe need for liver function monitoring during miglitoladministration. While the effects of miglitol on HbA1cand fasting and postprandial glucose in patients withtype 2 diabetes in this study are similar to those of the®rst a-glucosidase inhibitor to be marketed