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

Phase 2

Completed

• Conditions: Type 2 Diabetes Mellitus
• Interventions: Drug: Bosentan; Drug: Placebo

• Registration Number: NCT01357109
• Lead Sponsor: Karolinska Institutet

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2007-10
• Study Start: 2007-11
• Primary Completion: 2010-04
• Study Completion: 2011-01
• Study First Submitted: 2011-05-18
• Study First Submitted QC: 2011-05-18
• Last Update Submitted: 2011-05-18
• Study First Posted: 2011-05-20
• Last Update Posted: 2011-05-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 56

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Bosentan	Bosentan	-
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
Peripheral endothelial function	4 weeks

Secondary Outcome Measures

Name	Time	Method
Inflammatory markers	4 weeks
Renal protein excretion	4 weeks
Myocardial perfusion	4 weeks

Trial Locations

Locations (1)

Karolinska Institutet, Karolinska University Hospital; 🇸🇪 Stockholm, Sweden