Diabetes mellitus is very common, with Type II (noninsulin-dependent) diabetes mellitus accounting for 90 % to 95 % of the diagnosed patients [1]. A frequent complication of diabetes is erectile dysfunction (ED), with an estimated prevalence of 20 % to 85 % (ranging from mild to complete ED) [2], which occurs at an earlier age than in non-diabetic men. In the Massachusetts Male Aging study [3], men with treated diabetes had an age-adjusted prevalence of complete ED (no erections) of 28 %, which was approximately three times higher than the prevalence of complete ED observed in the entire sample of men (10 %).Although ED in patients with diabetes is often complex and can be caused by several mechanisms Diabetologia (2001) Abstract Aims/hypothesis. Ninety percent of all men with diabetes have Type II (non-insulin-dependent) diabetes mellitus, and erectile dysfunction (ED) is common in this patient group. This study evaluated the effects of sildenafil on men with erectile dysfunction and Type II diabetes and compared the results with glycated haemoglobin concentrations and chronic diabetic complications. Methods. Patients (mean age, 59 years) in this double-blind, placebo-controlled trial were randomised to sildenafil (25±100 mg; n = 110) or matching placebo (n = 109) for 12 weeks. Primary criteria for efficacy included questions 3 (achieving an erection) and 4 (maintaining an erection) from the International Index of Erectile Function (IIEF, score range, 0±5). Secondary outcome measures included a global efficacy question (GEQ), patient event logs, a life satisfaction checklist, and the remaining IIEF questions. Results. After 12 weeks, the mean scores for questions 3 and 4 had improved significantly in patients receiving sildenafil (3.42 0.23 and 3.35 0.24) compared with placebo (1.86 0.22 and 1.84 0.23; p < 0.0001). Similarly, the GEQ score was higher in the sildenafil (64.6 %) than the placebo group (10.5 %). Even when correlating efficacy with glycated haemoglobin concentrations ( £ 8.3 % or > 8.3 %, the median concentration found in this study) or the number of diabetic complications (0 or ³ 1), the mean scores for the GEQ and questions 3 and 4 from the IIEF remained higher for all the sildenafil groups compared with the placebo groups (p < 0.0001). Conclusion/interpretation. Sildenafil was well-tolerated and effective in improving erectile dysfunction in men with Type II diabetes, even in patients with poor glycaemic control and chronic complications. [Diabetologia (2001