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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
Sponsor:
Information provided by (Responsible Party):
Hiroshi Maegawa, Shiga University

Study Description
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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

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Arms and Interventions
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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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Ages Eligible for Study:   20 Years to 75 Years   (Adult, Older Adult)
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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Information from the National Library of Medicine

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


Locations
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Japan
Shiga University of Medical Science
Otsu, Shiga, Japan, 520-2192
Sponsors and Collaborators
Shiga University
Investigators
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Study Chair: Hiroshi Maegawa, M.D. Shiga University of Medical Science
More Information
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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
Keywords provided by Hiroshi Maegawa, Shiga University:
Hypertension
Albuminuria
Direct renin inhibitor
Angiotensin receptor blocker
Type 2 diabetes
Additional relevant MeSH terms:
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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