Effect of bosentan on macro- and microvascular function in patients with type 2 diabetes - BANDY
- Conditions
- Type 2 diabetes and albuminuria.
- Registration Number
- EUCTR2007-000221-22-SE
- Lead Sponsor
- John Pernow
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- Not specified
1. Diabetes mellitus type 2 of >2 years duration
2. Albuminuria
Patients are classified as having diabetes mellitus if fasting blood glucose exceeded 6.0 mmol/l (on at least on two occasions) or blood glucose concentration is >11.0 mmol/l two h after an oral glucose loading (75 g). Albuminuria is defined as urine albumin concentration >20 microg/l or >30 microg/12h
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
1. Age >80 years
2. Myocardial infarction/unstable angina within three months prior to randomisation
3. Decompensated congestive heart failure
4. Changes in dosage of any vasodilator drugs during the preceding six weeks
5. Childbearing potential
6. Impaired hepatic function (2 times upper normal limit of ASAT and ALAT)
7. Ongoing treatment with glibenklamide, cyklosporin 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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Primary end point(s): Improvement in microvascular endothelial function at 4 weeks using the Endo-PAT2000 (Itamar Medical).;Main Objective: To investigate the effect of bosentan (Tracleer) on vascular function in patients with type 2 diabetes and microangiopathy.<br>;Secondary Objective: To investigate the effect of bosentan (Tracleer) on insulin sensitivity, haemostatic function, inflammation, renal function and myocardial perfusion in patients with type 2 diabetes and microangiopathy.<br>
- Secondary Outcome Measures
Name Time Method