Type 2 Diabetes Mellitus
Conditions
Brief 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.
Interventions
DRUGBosentan
62.5 mg bid for two weeks and 125 mg bid for two weeks
DRUGPlacebo
Matched placebo bid
Sponsors
Swedish Heart Lung Foundation
The Swedish Research Council
Actelion
Karolinska Institutet
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
No minimum to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Peripheral endothelial function | 4 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Inflammatory markers | 4 weeks |
| Renal protein excretion | 4 weeks |
| Myocardial perfusion | 4 weeks |
Countries
Sweden
Outcome results
None listed