Shiga Microalbuminuria Reduction Trial-2

Study Overview
=================
Brief Summary
-----------------
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).

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

Conditions
-----------------
Type 2 Diabetes Mellitus, Hypertension

Intervention / Treatment
-----------------
* Drug: Aliskiren
* Drug: any angiotensin receptor blockers


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Direct renin inhibitor<br> | Drug: Aliskiren<br>* 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.<br>|
| Active Comparator: Angiotensin receptor blockers<br> | Drug: any angiotensin receptor blockers<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction in Albuminuria | Change in the urinary albumin to creatinine ratio (UACR) from the baseline | baseline and 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in the Urinary Angiotensinogen Level | Change in the urinaryurinary angiotensinogen level from the baseline | baseline and 24 weeks | 
| Change in the Plasma Renin Activity |  | baseline and 24 weeks | 
| Change in the Serum Insulin Level |  | baseline and 24 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hypertension, Albuminuria, Direct renin inhibitor, Angiotensin receptor blocker, Type 2 diabetes