ORIENT: Olmesartan Reducing Incidence of End Stage Renal Disease in Diabetic Nephropathy Trial

CS-866DM Phase 3 Clinical Study: A Double-Blind Controlled Trial in Patients With Diabetic Nephropathy and Overt Proteinuria Secondary to Type 2 Diabetes Mellitus

The purpose of the study is to evaluate the effectiveness and safety of olmesartan versus placebo on the progression of diabetic renal disease.

Inclusion Criteria:

• clinical diagnosis of diabetic nephropathy in patients with type 2 diabetes
• albumin-to-creatinine ratio >= 300 mg/g creatinine in first morning urinalysis
• serum creatinine between 1.0 and 2.5 mg/dL in women and between 1.2 and 2.5 mg/dL in men

Exclusion Criteria:

• type 1 diabetes
• non-diabetic nephropathy
• history of myocardial infarction
• history of cardiac bypass grafting within 3 months
• history of percutaneous coronary intervention (PCI) within 6 months
• history of carotid artery or peripheral artery revascularization within 6 months
• stroke or transient ischemic attack (TIA) within 1 year
• unstable angina pectoris
• heart failure of NYHA functional classes III or IV
• rapid progression of kidney disease within 3 months
• severe orthostatic hypotension
• serum potassium level =<3.5 mEq(mmol)/L or =>5.5 mEq(mmol)L
• history of rapid elevation of the serum creatinine level after starting treatment with AII receptor antagonists or ACE inhibitors
• poor glycemic control: HbA1c level =>11%
• history of myocardial infarction (MI) or coronary artery bypass grafting (CABG) within 3 months