Hypertension, Type 2 Diabetes Mellitus
Conditions
Keywords
Hypertension, Albuminuria, Direct renin inhibitor, Angiotensin receptor blocker, Type 2 diabetes
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).
Interventions
DRUGAliskiren
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.
DRUGany 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.
Sponsors
Shiga University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Reduction in Albuminuria | baseline and 24 weeks | Change in the urinary albumin to creatinine ratio (UACR) from the baseline |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in the Urinary Angiotensinogen Level | baseline and 24 weeks | Change in the urinaryurinary angiotensinogen level from the baseline |
| Change in the Plasma Renin Activity | baseline and 24 weeks | — |
| Change in the Serum Insulin Level | baseline and 24 weeks | — |
Countries
Japan
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Direct Renin Inhibitor 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. | 111 |
| Angiotensin Receptor Blockers 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. | 114 |
| Total | 225 |
Baseline characteristics
| Characteristic | Angiotensin Receptor Blockers | Direct Renin Inhibitor | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 57 Participants | 56 Participants | 113 Participants |
| Age, Categorical Between 18 and 65 years | 57 Participants | 55 Participants | 112 Participants |
| Age, Continuous | 63.0 years STANDARD_DEVIATION 8.4 | 62.9 years STANDARD_DEVIATION 9.3 | 63.0 years STANDARD_DEVIATION 8.8 |
| Region of Enrollment Japan | 114 participants | 111 participants | 225 participants |
| Sex: Female, Male Female | 33 Participants | 34 Participants | 67 Participants |
| Sex: Female, Male Male | 81 Participants | 77 Participants | 158 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 119 | 0 / 118 |
| other Total, other adverse events | 2 / 119 | 2 / 118 |
| serious Total, serious adverse events | 0 / 119 | 0 / 118 |
Outcome results
Primary
Reduction in Albuminuria
Change in the urinary albumin to creatinine ratio (UACR) from the baseline
Time frame: baseline and 24 weeks
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Direct Renin Inhibitor | Reduction in Albuminuria | -5.5 percentage of UACR change |
| Angiotensin Receptor Blockers | Reduction in Albuminuria | -6.7 percentage of UACR change |
Secondary
Change in the Plasma Renin Activity
Time frame: baseline and 24 weeks
Secondary
Change in the Serum Insulin Level
Time frame: baseline and 24 weeks
Secondary
Change in the Urinary Angiotensinogen Level
Change in the urinaryurinary angiotensinogen level from the baseline
Time frame: baseline and 24 weeks
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Direct Renin Inhibitor | Change in the Urinary Angiotensinogen Level | -1.7 percentage of change UATGCR |
| Angiotensin Receptor Blockers | Change in the Urinary Angiotensinogen Level | -5.4 percentage of change UATGCR |