Type 2 Diabetes MellitusPhase 4NCT01461499
Shiga Microalbuminuria Reduction Trial-2
A Phase 4 study testing Aliskiren and any angiotensin receptor blockers in people with Type 2 Diabetes Mellitus and Hypertension, run by Shiga University at 1 site in Japan.
Trial 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). Read more about this study
- Who is it for?
- Ages 20 to 75 years
- Conditions the study is for
- Type 2 Diabetes Mellitus, Hypertension
- What is being tested?
- Aliskiren and any angiotensin receptor blockers
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 237 participants
- Where
- 1 siteJapan
- Study dates
- Oct 2011to Dec 2014
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Investigation on the Effects of Reducing Microalbuminuria in Hypertensive Patients With Type 2 Diabetes - SMART2
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).
- Conditions
- Type 2 Diabetes Mellitus, Hypertension
- Being tested
- Aliskiren, any angiotensin receptor blockers
- Keywords
- Hypertension, Albuminuria, Direct renin inhibitor, Angiotensin receptor blocker, Type 2 diabetes
- Medical subject headings
- Diabetes Mellitus, Type 2, Hypertension, Albuminuria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AliskirenDrug
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 blockersDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Direct renin inhibitor | Active comparator | Not described Receives: Drug: Aliskiren |
| Angiotensin receptor blockers | Active comparator | Not described Receives: Drug: any angiotensin receptor blockers |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction in Albuminuria
Change in the urinary albumin to creatinine ratio (UACR) from the baseline
Measured: baseline and 24 weeks
Secondary outcomes (3)
Change in the Urinary Angiotensinogen Level
Change in the urinaryurinary angiotensinogen level from the baseline
Measured: baseline and 24 weeks
Change in the Plasma Renin Activity
Measured: baseline and 24 weeks
Change in the Serum Insulin Level
Measured: baseline and 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2011 (estimated)
- Study startOct 2011
- Primary completionAug 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Type 2 Diabetes MellitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 237 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shiga University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hiroshi Maegawa, Shiga University
- Investigators
- Hiroshi Maegawa, M.D., Study chair, Shiga University of Medical Science
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01461499
- Sponsor's protocol ID
- SMART-2
- Status last verified
- Aug 2017
- First submitted
- 19 Oct 2011
- Last updated
- 19 Feb 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Investigation on the Effects of Reducing Microalbuminuria in Hypertensive Patients With Type 2 Diabetes - SMART2
- ClinicalTrials.gov ID
- NCT01461499
- Acronym / sponsor ID
- SMART-2
- Conditions
- Type 2 Diabetes Mellitus, Hypertension
- Keywords
- Hypertension, Albuminuria, Direct renin inhibitor, Angiotensin receptor blocker, Type 2 diabetes
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 237 participants (actual)
- Lead sponsor
- Shiga UniversityUniversity, hospital or other
- Study start
- Oct 2011
- Primary completion
- Aug 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 28 Oct 2011 (estimated)
- Results
- Posted 19 Feb 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Direct renin inhibitor | Active comparator | Drug: Aliskiren |
| Angiotensin receptor blockers | Active comparator | Drug: any angiotensin receptor blockers |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AliskirenThe 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. | Drug | Direct renin inhibitor |
| any angiotensin receptor blockersThe 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. | Drug | Angiotensin receptor blockers |
Primary outcome
Reduction in Albuminuria
Time frame: baseline and 24 weeks
Change in the urinary albumin to creatinine ratio (UACR) from the baseline
3 secondary outcomes
Change in the Urinary Angiotensinogen Level
Time frame: baseline and 24 weeks
Change in the Plasma Renin Activity
Time frame: baseline and 24 weeks
Change in the Serum Insulin Level
Time frame: baseline and 24 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hiroshi Maegawa, M.D. study chair
Shiga University of Medical Science
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Aliskiren and any angiotensin receptor blockers in people with Type 2 Diabetes Mellitus and Hypertension, run by Shiga University at 1 site in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Feb 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction in Albuminuria (time frame: baseline and 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Feb 2018.