Shiga Microalbuminuria Reduction Trial-2
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ClinicalTrials.gov Identifier: NCT01461499 |
Recruitment Status :
Completed
First Posted : October 28, 2011
Results First Posted : February 19, 2018
Last Update Posted : February 19, 2018
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Type 2 Diabetes Mellitus Hypertension | Drug: Aliskiren Drug: any angiotensin receptor blockers | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 237 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Clinical Investigation on the Effects of Reducing Microalbuminuria in Hypertensive Patients With Type 2 Diabetes - SMART2 |
Study Start Date : | October 2011 |
Actual Primary Completion Date : | August 2014 |
Actual Study Completion Date : | December 2014 |

Arm | Intervention/treatment |
---|---|
Active Comparator: Direct renin inhibitor |
Drug: Aliskiren
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. |
Active Comparator: Angiotensin receptor blockers |
Drug: any angiotensin receptor blockers
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. |
- Reduction in Albuminuria [ Time Frame: baseline and 24 weeks ]Change in the urinary albumin to creatinine ratio (UACR) from the baseline
- Change in the Urinary Angiotensinogen Level [ Time Frame: baseline and 24 weeks ]Change in the urinaryurinary angiotensinogen level from the baseline
- Change in the Plasma Renin Activity [ Time Frame: baseline and 24 weeks ]
- Change in the Serum Insulin Level [ Time Frame: baseline and 24 weeks ]

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Ages Eligible for Study: | 20 Years to 75 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01461499
Japan | |
Shiga University of Medical Science | |
Otsu, Shiga, Japan, 520-2192 |
Study Chair: | Hiroshi Maegawa, M.D. | Shiga University of Medical Science |
Responsible Party: | Hiroshi Maegawa, Professor of Medicine, Shiga University |
ClinicalTrials.gov Identifier: | NCT01461499 |
Other Study ID Numbers: |
SMART-2 |
First Posted: | October 28, 2011 Key Record Dates |
Results First Posted: | February 19, 2018 |
Last Update Posted: | February 19, 2018 |
Last Verified: | August 2017 |
Hypertension Albuminuria Direct renin inhibitor Angiotensin receptor blocker Type 2 diabetes |
Hypertension Diabetes Mellitus, Type 2 Diabetes Mellitus Glucose Metabolism Disorders Metabolic Diseases |
Endocrine System Diseases Vascular Diseases Cardiovascular Diseases Angiotensin Receptor Antagonists Molecular Mechanisms of Pharmacological Action |