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Completed

NCT Number: NCT01357109

Effect of Bosentan on Endothelial 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.

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Key information

Conditions

Type 2 Diabetes Mellitus Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

Up to 80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Karolinska Institutet, Karolinska University Hospital

Stockholm, 17176, Sweden

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Diabetes mellitus type 2 of >2 years duration
  • Albuminuria

Exclusion criteria

  • 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)
  • 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

Treatment and study plan

Bosentan

Drug

62.5 mg bid for two weeks and 125 mg bid for two weeks

Placebo

Drug

Matched placebo bid

Primary outcomes

  1. Peripheral endothelial function

    Time frame: 4 weeks

Secondary outcomes

  1. Inflammatory markers

    Time frame: 4 weeks

  2. Renal protein excretion

    Time frame: 4 weeks

  3. Myocardial perfusion

    Time frame: 4 weeks

Sponsors and collaborators

Lead sponsor

Karolinska Institutet

Other

Collaborators

  • Actelion
  • Swedish Heart Lung Foundation
  • The Swedish Research Council

Registry information

Official study title

Effect of Bosentan on Macro- and Microvascular Function in Patients With Type 2 Diabetes

Acronym: BANDY

Important dates

Study start
2007
Primary completion
2010
Study completion
2011
First posted
May 20, 2011
Registry last updated
May 20, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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