**2.2.1 Diabetes Atherosclerosis Intervention Study (DAIS)**

The DAIS is a placebo-controlled, double-blind, comparative study to verify whether the deterioration of coronary arteriosclerosis can be prevented by restoring abnormal lipid metabolism with fenofibrate in type II diabetics employing quantitative coronary angiography (DAIS investigators, 2001). This international, interventional study was conducted based on the World Health Organization (WHO)'s request and cooperation. This study is the first interventional study in which it was prospectively evaluated whether the correction of disturbance of lipid metabolism in type II DM prevents the deterioration of arteriosclerosis. It was carried out in Canada, Finland, Sweden, and France. Four-hundred and eighteen patients with type II diabetes in whom blood sugar control was favourable were randomly divided into fenofibrate (micronized fenofibrate, 200 mg/day, n=207) and placebo (n=211) groups to evaluate the deterioration of coronary arteriosclerosis using quantitative coronary angiography after 38-month (mean duration) administration.

In the fenofibrate group, a decrease in the minimum lumen diameter and an increase in the percent stenosiswere significantly suppressed in comparison with the placebo group (by 40%), confirming the inhibitory effects of fenofibrate on the deterioration of coronary arteriosclerosis in type II DM.

In the continuing study of DAIS, fenofibrate reduced the small dense LDL level, leading to the inhibition of the deterioration of diabetic nephropathy (DAIS investigators, 2003, 2005), confirming that fenofibrate inhibited the deterioration of macro- and micro-angiopathy in type II DM.
