Shiga Microalbuminuria Reduction Trial-2

• Aliskiren (Drug): The patient will start taking one a daily 150 mg/day of aliskiren. In case blood pressure doesn't reach the target (SBP/DBP < 130/80 mmHg), higher dose of aliskiren will be given.In case the blood pressure doesn't achieve the target, another anti-hypertensive drug other than RAS inhibitors (ARB or ACE-inhibitor) or potassium-retaining diuretics will be added from the minimum effective dose.
• any angiotensin receptor blockers (Drug): The patient will start taking one a standard dose of an ARB in Japan. In case blood pressure doesn't reach the target (SBP/DBP < 130/80 mmHg), higher dose of the ARB will be given. In case the blood pressure doesn't achieve the target, another anti-hypertensive drug other than RAS inhibitors (DRI, another ARB or ACE-inhibitor) or potassium-retaining diuretics will be added from the minimum effective dose.

Primary outcomes

• Reduction in Albuminuria [baseline and 24 weeks]: Change in the urinary albumin to creatinine ratio (UACR) from the baseline

Secondary outcomes

• Change in the Urinary Angiotensinogen Level [baseline and 24 weeks]: Change in the urinaryurinary angiotensinogen level from the baseline
• Change in the Plasma Renin Activity [baseline and 24 weeks]
• Change in the Serum Insulin Level [baseline and 24 weeks]

Sex: All, ages: 20 Years to 75 Years

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

Participant flow

Outcome results

• Reduction in Albuminuria (Primary), Mean, percentage of UACR change: Direct Renin Inhibitor -5.5 (-13.5 to 2.5); Angiotensin Receptor Blockers -6.7 (-20.3 to 0.6)
• Change in the Urinary Angiotensinogen Level (Secondary), Mean, percentage of change UATGCR: Direct Renin Inhibitor -1.7 (-10.4 to 7.9); Angiotensin Receptor Blockers -5.4 (-22.1 to 1.6)
• Change in the Plasma Renin Activity (Secondary)
• Change in the Serum Insulin Level (Secondary)

Adverse events

Other adverse events by term

• Hiroshi Maegawa, M.D., Study chair, Shiga University of Medical Science