We evaluated whether high doses of valsartan (V), an angiotensin receptor blocker (ARB), are superior to conventional doses to reduce urinary albumin excretion rates (UAER) in type 2 diabetes mellitus (T2DM). In a multicenter, double-blind study, 391 hypertensive patients with T2DM and UAER 20 –700 g/min were randomized to V160 mg (V160), 320 mg (V320) or 640 mg (V640). All patients received V160 for the first 4 wks, then treatment was maintained in one group and increased in the other two groups to V320 or V640 for a total of 30 wks. Comparable UAER reductions from baseline were seen in all groups at wk 4 (P