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

Karolinska Institute

Status and phase: Completed; Phase 2

Conditions: Type 2 Diabetes Mellitus

Treatments: Drug: Placebo; Drug: Bosentan

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01357109

2007-000221-22 (EudraCT Number)

BANDY 070112

Details and patient eligibility

About

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.

Enrollment: 56 patients

Sex: All

Ages: Under 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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56 participants in 2 patient groups, including a placebo group

Bosentan

Experimental group

Treatment:

Drug: Bosentan

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo