Diabetes MellitusPhase 4NCT00843388
A Crossover Study With Hexalacton in Patients With Type 1 Diabetes and Microalbuminuria
A Phase 4 study testing Spironolacton (hexalacton(R)) in people with Diabetes Mellitus and Nephropathy, run by Steno Diabetes Center Copenhagen.
Trial summary
A double blind, randomized, cross over study in type 1 diabetic patients. 20 patients, age 18-65 years is treated with spironolacton (Hexalacton (R)) for 60 days followed by 60 days treatment with placebo(or opposite). Primary aim: albuminuria, an expected decrease during hexalacton treatment. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Diabetes Mellitus, Nephropathy, Blood Pressure
- What is being tested?
- Spironolacton (hexalacton(R))
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- Mar 2009to Mar 2010
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- type 1 diabetes
- age 18-80 years
- microalbuminuria
Who cannot join
- blood pressure> 160/100 mmHg
- persistent macroalbuminuria
- pregnancy or in risc of this
- P-Potassium>5.7 mmol/l
- Eplerone treatment
About this study
Official title: A Randomized Doubleblind Placebo Controlled Crossover Study With Hexalacton in Patients With Type 1 Diabetes and Microalbuminuria
A double blind, randomized, cross over study in type 1 diabetic patients. 20 patients, age 18-65 years is treated with spironolacton (Hexalacton (R)) for 60 days followed by 60 days treatment with placebo(or opposite). Primary aim: albuminuria, an expected decrease during hexalacton treatment. Secondary aim: ambulatory blood pressure, GFR, plasma-renin, angiotensin, aldosteron.
- Conditions
- Diabetes Mellitus, Nephropathy, Blood Pressure
- Being tested
- Spironolacton (hexalacton(R)), placebo tablet
- Medical subject headings
- Diabetes Mellitus, Kidney Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spironolacton (hexalacton(R))Drug
Tablet Spironolacton 25 mg OD
placebo tabletDrug
placebo tablet 25 mg OD
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | 60 days treatment with tablet hexalacton 25 mg OD. Receives: Drug: Spironolacton (hexalacton(R)) |
| 2 | Placebo comparator | Inactive drug of 25 mg OD Receives: Drug: placebo tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
albuminuria, expected decrease
Measured: 60 days
Secondary outcomes (3)
GFR
Measured: 60 days
ambulatory blood pressure
Measured: 60 days
plasma renin, angiotensin, aldosteron
Measured: 60 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2009 (estimated)
- Study startMar 2009
- Primary completionMar 2010 (estimated)
- Study completionMar 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Steno Diabetes Center Copenhagen
- Sponsor type
- University, hospital or other
- Investigators
- stine e nielsen, MD, Principal investigator, Steno Diabetes Center Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00843388
- Sponsor's protocol ID
- 2306
- Other IDs
- Eudra CT: 2008-004839-38
- Status last verified
- Jan 2009
- First submitted
- 12 Feb 2009
- Last updated
- 13 Feb 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Doubleblind Placebo Controlled Crossover Study With Hexalacton in Patients With Type 1 Diabetes and Microalbuminuria
- ClinicalTrials.gov ID
- NCT00843388
- Acronym / sponsor ID
- 2306
- Conditions
- Diabetes Mellitus, Nephropathy, Blood Pressure
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Steno Diabetes Center CopenhagenUniversity, hospital or other
- Study start
- Mar 2009
- Primary completion
- Mar 2010 (estimated)
- Study completion
- Mar 2010 (estimated)
- First posted
- 13 Feb 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A double blind, randomized, cross over study in type 1 diabetic patients. 20 patients, age 18-65 years is treated with spironolacton (Hexalacton (R)) for 60 days followed by 60 days treatment with placebo(or opposite). Primary aim: albuminuria, an expected decrease during hexalacton treatment. Secondary aim: ambulatory blood pressure, GFR, plasma-renin, angiotensin, aldosteron.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: Spironolacton (hexalacton(R))60 days treatment with tablet hexalacton 25 mg OD. |
| 2 | Placebo comparator | Drug: placebo tabletInactive drug of 25 mg OD |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- type 1 diabetes
- age 18-80 years
- microalbuminuria
Key exclusion criteria (5 listed)
- blood pressure> 160/100 mmHg
- persistent macroalbuminuria
- pregnancy or in risc of this
- P-Potassium>5.7 mmol/l
- Eplerone treatment
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 |
|---|---|---|
| Spironolacton (hexalacton(R))Tablet Spironolacton 25 mg OD | Drug | 1 |
| placebo tabletplacebo tablet 25 mg OD | Drug | 2 |
Primary outcome
albuminuria, expected decrease
Time frame: 60 days
3 secondary outcomes
GFR
Time frame: 60 days
ambulatory blood pressure
Time frame: 60 days
plasma renin, angiotensin, aldosteron
Time frame: 60 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2009.
Related trials for Diabetes Mellitus
RecruitingObservational study
Diabetes and Heart Disease Risk in Blacks
Cardiovascular Diseases, Diabetes
RecruitingObservational study
Genetic Studies of Insulin and Diabetes
Diabetes Mellitus, Severe Insulin Resistance
RecruitingObservational study
Urinary Vitamin C Loss in Diabetic Subjects
Diabetes
Active, not recruitingObservational study
Healthy Aging in Neighborhoods of Diversity Across the Life Span (HANDLS)
Diabetes, Cerebrovascular Disease
Active, not recruiting
Dietary Behavior Intervention in African Americans at Risk for Cardiovascular Disease
Diet, Cooking
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.
stine e nielsen, MD principal investigator
Steno Diabetes Center Copenhagen
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Spironolacton (hexalacton(R)) in people with Diabetes Mellitus and Nephropathy, run by Steno Diabetes Center Copenhagen.
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 3 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 13 Feb 2009. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
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?
albuminuria, expected decrease (time frame: 60 days). 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 13 Feb 2009; AzTrials last refreshed its copy on 30 Oct 2026.