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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

56 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-11-30

Study Completion Date

2011-01-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Type 2 Diabetes Mellitus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Bosentan

Group Type EXPERIMENTAL

Bosentan

Intervention Type DRUG

62.5 mg bid for two weeks and 125 mg bid for two weeks

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Matched placebo bid

Interventions

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Bosentan

62.5 mg bid for two weeks and 125 mg bid for two weeks

Intervention Type DRUG

Placebo

Matched placebo bid

Intervention Type DRUG

Eligibility Criteria

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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

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No