Shiga Microalbuminuria Reduction Trial-2

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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).

Condition or disease	Intervention/treatment	Phase
Type 2 Diabetes Mellitus; Hypertension	Drug: Aliskiren; Drug: any angiotensin receptor blockers	Phase 4

Study Design

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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

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.

Outcome Measures

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Primary Outcome Measures :

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

Secondary Outcome Measures :

1. Change in the Urinary Angiotensinogen Level [ Time Frame: baseline and 24 weeks ]
   Change in the urinaryurinary angiotensinogen level from the baseline
2. Change in the Plasma Renin Activity [ Time Frame: baseline and 24 weeks ]
3. Change in the Serum Insulin Level [ Time Frame: baseline and 24 weeks ]

Eligibility Criteria

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

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

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

Japan
Shiga University of Medical Science
Otsu, Shiga, Japan, 520-2192

Sponsors and Collaborators

Shiga University

Investigators

Study Chair:	Hiroshi Maegawa, M.D.	Shiga University of Medical Science

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Hiroshi Maegawa, Professor of Medicine, Shiga University
ClinicalTrials.gov Identifier:	NCT01461499 History of Changes
Other Study ID Numbers:	SMART-2
First Posted:	October 28, 2011
Results First Posted:	February 19, 2018
Last Update Posted:	February 19, 2018
Last Verified:	August 2017

Keywords provided by Hiroshi Maegawa, Shiga University:

Hypertension; Albuminuria; Direct renin inhibitor; Angiotensin receptor blocker; Type 2 diabetes

Additional relevant MeSH terms:

Diabetes Mellitus; Hypertension; Diabetes Mellitus, Type 2; Glucose Metabolism Disorders; Metabolic Diseases	Endocrine System Diseases; Vascular Diseases; Cardiovascular Diseases; Angiotensin Receptor Antagonists; Molecular Mechanisms of Pharmacological Action