Type 2 diabetes and albuminuria.
Conditions
Interventions
Trade Name: Traleer (bosentan)
Product Name: Tracleer (bosentan)
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: bosentan monohydrate
CAS Number: 157212-55-0
Concentration unit: mg millig
Sponsors
John Pernow
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. ;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. | — |
Countries
Sweden
Outcome results
None listed