 1. Systemic exclusion criteria 1. Renal failure requiring hemodialysis or peritoneal dialysis within 6 months prior to baseline or anticipated need for hemodialysis, peritoneal dialysis at any time during the study 2. Acute cardiovascular events acute myocardiac infarction andor cerebral infarction within 1 year before Visit 1 3. Blood HbA1c level greater than 12 at Visit 0 