Shiga Microalbuminuria Reduction Trial-2

Clinical Investigation on the Effects of Reducing Microalbuminuria in Hypertensive Patients With Type 2 Diabetes - SMART2

The purpose of this study is to compare the effects of a direct renin inhibitor (DRI), aliskiren, on the urinary albumin excretion in hypertensive patients with type 2 diabetes under strict blood pressure control with angiotensin receptor blocker (ARB).

Inclusion Criteria:

• Segment: outpatients
• Hypertension: taking an anti-hypertensive treatment or indicating mean sitting SBP/DBP more than130/80 mmHg
• Type 2 diabetes: diagnosed by ADA criteria or under an anti-diabetic drug treatment
• Microalbuminuria: 10 < and < 300 mg/gCr
• Informed consent: patients who understand well about this study based on own voluntary will and can give a written consent

Exclusion Criteria:

• Sever hypertension (over 180/110 mmHg), malignant hypertension and secondary hypertension
• Type 1 diabetes
• Patients whose investigator regards as difficult to comply with study protocol in reference to the package insert of aliskiren
• Patients who have history of operation in gastrointestinal tract surgery, and anamnestic or concurrent gastrointestinal disorders, which may interfere with drug absorption
• Serum potassium > 5.6 mEq/L (hyperkalemia)
• Urinary microalbumin < 10 or > 300 mg/gCr
• Patients who participated in another clinical study within three months