Type 2 Diabetes MellitusPhase 2BANDYNCT01357109
Effect of Bosentan on Endothelial Function in Patients With Type 2 Diabetes
A Phase 2 study testing Bosentan in people with Type 2 Diabetes Mellitus, run by Karolinska Institutet at 1 site in Sweden.
Trial summary
The purpose of the study is to investigate if oral treatment with bosentan improves endothelium-dependent vasodilatation in patients with type 2 diabetes and microangiopathy. Read more about this study
- Who is it for?
- Ages Up to 80 years
- Conditions the study is for
- Type 2 Diabetes Mellitus
- What is being tested?
- Bosentan
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 56 participants
- Where
- 1 siteSweden
- Study dates
- Nov 2007to Jan 2011
- Phase
- Phase 2
- 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 Up to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Diabetes mellitus type 2 of >2 years duration
- Albuminuria
Who cannot join
- Age >80 years
- Myocardial infarction/unstable angina within three months prior to randomisation
- Decompensated congestive heart failure or functional class 3 and 4.
- Changes in dosage of any vasodilator drugs during the preceding six weeks
- Women of fertile age.
- Impaired hepatic function (2 times upper normal limit of aminotransferases ASAT and ALAT)
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- Ongoing treatment with glibenclamide, cyclosporin or warfarin
- Any concomitant disease or condition that may interfere with the possibility for the patient to comply with or complete the study protocol
- Participant in an ongoing study
- Unwillingness to participate following oral and written information
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Karolinska Institutet, Karolinska University Hospital
Stockholm, 17176
About this study
Official title: Effect of Bosentan on Macro- and Microvascular Function in Patients With Type 2 Diabetes
The purpose of the study is to investigate if oral treatment with bosentan improves endothelium-dependent vasodilatation in patients with type 2 diabetes and microangiopathy.
- Conditions
- Type 2 Diabetes Mellitus
- Being tested
- Bosentan, Placebo
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BosentanDrug
62.5 mg bid for two weeks and 125 mg bid for two weeks
PlaceboDrug
Matched placebo bid
| Study group | Role | What they receive |
|---|---|---|
| Bosentan | Experimental | Not described Receives: Drug: Bosentan |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peripheral endothelial function
Measured: 4 weeks
Secondary outcomes (3)
Inflammatory markers
Measured: 4 weeks
Renal protein excretion
Measured: 4 weeks
Myocardial perfusion
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2011 (estimated)
- Study startNov 2007
- Primary completionApr 2010
- Study completionJan 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Type 2 Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Collaborators
- Swedish Heart Lung Foundation, The Swedish Research Council, Actelion
- Investigators
- John Pernow, Dr, Principal investigator, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01357109
- Sponsor's protocol ID
- BANDY 070112
- Other IDs
- 2007-000221-22
- Acronym
- BANDY
- Status last verified
- Oct 2007
- First submitted
- 18 May 2011
- Last updated
- 20 May 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Rafnsson A, Bohm F, Settergren M, Gonon A, Brismar K, Pernow J. The endothelin receptor antagonist bosentan improves peripheral endothelial function in patients with type 2 diabetes mellitus and microalbuminuria: a randomised trial. Diabetologia. 2012 Mar;55(3):600-7. doi: 10.1007/s00125-011-2415-y. Epub 2011 Dec 27.
PubMed 22200728
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Bosentan on Macro- and Microvascular Function in Patients With Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT01357109
- Acronym / sponsor ID
- BANDY / BANDY 070112
- Conditions
- Type 2 Diabetes Mellitus
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Collaborators
- Swedish Heart Lung Foundation, The Swedish Research Council, Actelion
- Study start
- Nov 2007
- Primary completion
- Apr 2010 (actual)
- Study completion
- Jan 2011 (actual)
- First posted
- 20 May 2011 (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.
The purpose of the study is to investigate if oral treatment with bosentan improves endothelium-dependent vasodilatation in patients with type 2 diabetes and microangiopathy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bosentan | Experimental | Drug: Bosentan |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- Up to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Diabetes mellitus type 2 of >2 years duration
- Albuminuria
Key exclusion criteria (10 listed)
- Age >80 years
- Myocardial infarction/unstable angina within three months prior to randomisation
- Decompensated congestive heart failure or functional class 3 and 4.
- Changes in dosage of any vasodilator drugs during the preceding six weeks
- Women of fertile age.
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 |
|---|---|---|
| Bosentan62.5 mg bid for two weeks and 125 mg bid for two weeks | Drug | Bosentan |
| PlaceboMatched placebo bid | Drug | Placebo |
Primary outcome
Peripheral endothelial function
Time frame: 4 weeks
3 secondary outcomes
Inflammatory markers
Time frame: 4 weeks
Renal protein excretion
Time frame: 4 weeks
Myocardial perfusion
Time frame: 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2011.
- Derived from this study: PubMed 22200728Rafnsson A, Bohm F, Settergren M, Gonon A, Brismar K, Pernow J. The endothelin receptor antagonist bosentan improves peripheral endothelial function in patients with type 2 diabetes mellitus and microalbuminuria: a randomised trial. Diabetologia. 2012 Mar;55(3):600-7. doi: 10.1007/s00125-011-2415-y. Epub 2011 Dec 27.
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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.
John Pernow, Dr principal investigator
Karolinska Institutet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Bosentan in people with Type 2 Diabetes Mellitus, run by Karolinska Institutet at 1 site in Sweden.
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 2 inclusion and 10 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 20 May 2011. 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 Sweden. 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. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Peripheral endothelial function (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01357109, which also lists 1 linked publication.
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 20 May 2011.