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Completed

NCT Number: NCT01461499

Shiga Microalbuminuria Reduction Trial-2

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).

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Key information

Conditions

Type 2 Diabetes Mellitus Albuminuria Cardiovascular Diseases Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Glucose Metabolism Disorders Hypertension Male Urogenital Diseases Metabolic Diseases Nutritional and Metabolic Diseases Pathological Conditions, Signs and Symptoms Proteinuria Signs and Symptoms Urination Disorders Urogenital Diseases Urologic Diseases Urological Manifestations Vascular Diseases

Age range

20 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Shiga University of Medical Science

Ōtsu, Shiga, 520-2192, Japan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Aliskiren

Drug

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.

any angiotensin receptor blockers

Drug

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 outcomes

  1. Reduction in Albuminuria

    Time frame: baseline and 24 weeks

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

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Shiga University

Other

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2014
Study completion
2014
First posted
Oct 28, 2011
Registry last updated
Feb 19, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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