There were few clinically signi®cant changes inlaboratory parameters throughout the trial. Only threepatients showed elevation of transaminases, two in theplacebo group and one patient in the miglitol group. Inthese cases the elevation may have been due toconcomitant medication being taken rather than tostudy drug or background therapy. No cases of hypoglycaemia were reported in either treatment group. Noclinically relevant changes in vital signs occurred, andpatients did not report weight gain.