Effect of Bosentan on Endothelial Function in Patients With Type 2 Diabetes (BANDY)

May 18, 2011 updated by: Karolinska Institutet

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

56

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Stockholm, Sweden, 17176
        • Karolinska Institutet, Karolinska University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 80 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Diabetes mellitus type 2 of >2 years duration
  2. Albuminuria

Exclusion Criteria:

  1. Age >80 years
  2. Myocardial infarction/unstable angina within three months prior to randomisation
  3. Decompensated congestive heart failure or functional class 3 and 4.
  4. Changes in dosage of any vasodilator drugs during the preceding six weeks
  5. Women of fertile age.
  6. Impaired hepatic function (2 times upper normal limit of aminotransferases ASAT and ALAT)
  7. Ongoing treatment with glibenclamide, cyclosporin or warfarin
  8. Any concomitant disease or condition that may interfere with the possibility for the patient to comply with or complete the study protocol
  9. Participant in an ongoing study
  10. Unwillingness to participate following oral and written information

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Drug: Placebo
Matched placebo bid
Experimental: Bosentan
Drug: Bosentan
62.5 mg bid for two weeks and 125 mg bid for two weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Peripheral endothelial function
Time Frame: 4 weeks
4 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Inflammatory markers
Time Frame: 4 weeks
4 weeks
Renal protein excretion
Time Frame: 4 weeks
4 weeks
Myocardial perfusion
Time Frame: 4 weeks
4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Karolinska Institutet

Collaborators

The Swedish Research Council
Actelion
Swedish Heart Lung Foundation

Investigators

  • Principal Investigator: John Pernow, Dr, Karolinska Institutet

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2007

Primary Completion (Actual)

April 1, 2010

Study Completion (Actual)

January 1, 2011

Study Registration Dates

First Submitted

May 18, 2011

First Submitted That Met QC Criteria

May 18, 2011

First Posted (Estimate)

May 20, 2011

Study Record Updates

Last Update Posted (Estimate)

May 20, 2011

Last Update Submitted That Met QC Criteria

May 18, 2011

Last Verified

October 1, 2007

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BANDY 070112
  • 2007-000221-22 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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