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

This study has been completed.
Sponsor:
Collaborators:
Swedish Heart Lung Foundation
The Swedish Research Council
Actelion
Information provided by:
Karolinska Institutet
ClinicalTrials.gov Identifier:
NCT01357109
First received: May 18, 2011
Last updated: NA
Last verified: October 2007
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Type 2 Diabetes Mellitus
Drug: Bosentan
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of Bosentan on Macro- and Microvascular Function in Patients With Type 2 Diabetes

Resource links provided by NLM:


Further study details as provided by Karolinska Institutet:

Primary Outcome Measures:
  • Peripheral endothelial function [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Inflammatory markers [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • Renal protein excretion [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • Myocardial perfusion [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

Enrollment: 56
Study Start Date: November 2007
Study Completion Date: January 2011
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Bosentan Drug: Bosentan
62.5 mg bid for two weeks and 125 mg bid for two weeks
Placebo Comparator: Placebo Drug: Placebo
Matched placebo bid

  Eligibility

Ages Eligible for Study:   up to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01357109

Locations
Sweden
Karolinska Institutet, Karolinska University Hospital
Stockholm, Sweden, 17176
Sponsors and Collaborators
Karolinska Institutet
Swedish Heart Lung Foundation
The Swedish Research Council
Actelion
Investigators
Principal Investigator: John Pernow, Dr Karolinska Institutet
  More Information

No publications provided by Karolinska Institutet

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: John Pernow, Karolinska Institutet
ClinicalTrials.gov Identifier: NCT01357109     History of Changes
Other Study ID Numbers: BANDY 070112, 2007-000221-22
Study First Received: May 18, 2011
Last Updated: May 18, 2011
Health Authority: Sweden: Medical Products Agency

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Bosentan
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 26, 2014