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Shiga Microalbuminuria Reduction Trial-2

Primary Purpose

Type 2 Diabetes Mellitus, Hypertension

Status

Completed

Phase

Phase 4

Locations

Japan

Study Type

Interventional

Intervention

Aliskiren

any angiotensin receptor blockers

About this trial

This is an interventional treatment trial for Type 2 Diabetes Mellitus focused on measuring Hypertension, Albuminuria, Direct renin inhibitor, Angiotensin receptor blocker, Type 2 diabetes

Eligibility Criteria

20 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Shiga University of Medical Science

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Direct renin inhibitor

Angiotensin receptor blockers

Arm Description

Outcomes

Primary Outcome Measures

Reduction in Albuminuria

Change in the urinary albumin to creatinine ratio (UACR) from the baseline

Secondary Outcome Measures

Change in the Urinary Angiotensinogen Level

Change in the urinaryurinary angiotensinogen level from the baseline

Change in the Plasma Renin Activity

Change in the Serum Insulin Level

Full Information

NCT ID

NCT01461499

First Posted

October 19, 2011

Last Updated

August 15, 2017

Sponsor

Shiga University

1. Study Identification

Unique Protocol Identification Number

NCT01461499

Brief Title

Shiga Microalbuminuria Reduction Trial-2

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2017

Overall Recruitment Status

Completed

Study Start Date

October 2011 (undefined)

Primary Completion Date

August 2014 (Actual)

Study Completion Date

December 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Shiga University

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Type 2 Diabetes Mellitus, Hypertension

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

237 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Direct renin inhibitor

Arm Type

Active Comparator

Arm Title

Angiotensin receptor blockers

Arm Type

Active Comparator

Intervention Type

Drug

Intervention Name(s)

Aliskiren

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

any angiotensin receptor blockers

Intervention Description

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 Outcome Measure Information:

Title

Reduction in Albuminuria

Description

Change in the urinary albumin to creatinine ratio (UACR) from the baseline

Time Frame

baseline and 24 weeks

Secondary Outcome Measure Information:

Title

Change in the Urinary Angiotensinogen Level

Description

Change in the urinaryurinary angiotensinogen level from the baseline

Time Frame

baseline and 24 weeks

Title

Change in the Plasma Renin Activity

Time Frame

baseline and 24 weeks

Title

Change in the Serum Insulin Level

Time Frame

baseline and 24 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Hiroshi Maegawa, M.D.

Organizational Affiliation

Shiga University of Medical Science

Official's Role

Study Chair

Facility Information:

Facility Name

Shiga University of Medical Science

City

Otsu

State/Province

Shiga

ZIP/Postal Code

520-2192

Country

Japan

12. IPD Sharing Statement

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Shiga Microalbuminuria Reduction Trial-2

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