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

• Status: Completed
• Trial end date: 2011-01-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Karolinska Institutet
• Collaborators: Actelion; Swedish Heart Lung Foundation; The Swedish Research Council
• Treatments: Bosentan

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