Phase 4
N=237
Shiga Microalbuminuria Reduction Trial-2
Type 2 Diabetes Mellitus · Hypertension
Bottom Line
View on ClinicalTrials.gov: NCT01461499 ↗Enrolled (actual)
237
Serious AEs
0.0%
Results posted
Feb 2018
Primary outcome: Primary: Reduction in Albuminuria — -5.5; -6.7 percentage of UACR change
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Aliskiren (Drug); any angiotensin receptor blockers (Drug)
- Age
- Adult, Older Adult · 20+ yrs
- Sex
- All
- Sponsor
- Shiga University
- Primary completion
- Aug 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Reduction in Albuminuria |
-5.5; -6.7 | — |
| SECONDARY Change in the Urinary Angiotensinogen Level |
-1.7; -5.4 | — |
| SECONDARY Change in the Plasma Renin Activity |
— | — |
| SECONDARY Change in the Serum Insulin Level |
— | — |
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).
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 5.6 mEq/L (hyperkalemia)
- Urinary microalbumin 300 mg/gCr
- Patients who participated in another clinical study within three months
Data sourced from ClinicalTrials.gov (NCT01461499). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.