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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01357109
First Posted: May 20, 2011
Last Update Posted: May 20, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Swedish Heart Lung Foundation
The Swedish Research Council
Actelion
Information provided by:
Karolinska Institutet
  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
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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 ]

Secondary Outcome Measures:
  • Inflammatory markers [ Time Frame: 4 weeks ]
  • Renal protein excretion [ Time Frame: 4 weeks ]
  • Myocardial perfusion [ Time Frame: 4 weeks ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 80 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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 ( EudraCT Number )
First Submitted: May 18, 2011
First Posted: May 20, 2011
Last Update Posted: May 20, 2011
Last Verified: October 2007

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Bosentan
Antihypertensive Agents
Endothelin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action