NCT01357109

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
56

participants targeted

Target at P25-P50 for phase_2 type-2-diabetes-mellitus

Timeline
Completed

Started Nov 2007

Longer than P75 for phase_2 type-2-diabetes-mellitus

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2007

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2010

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2011

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

May 18, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 20, 2011

Completed
Last Updated

May 20, 2011

Status Verified

October 1, 2007

Enrollment Period

2.4 years

First QC Date

May 18, 2011

Last Update Submit

May 18, 2011

Conditions

Type 2 Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

  • Peripheral endothelial function

    4 weeks

Secondary Outcomes (3)

  • Inflammatory markers

    4 weeks

  • Renal protein excretion

    4 weeks

  • Myocardial perfusion

    4 weeks

Study Arms (2)

Bosentan

EXPERIMENTAL
Drug: Bosentan

Placebo

PLACEBO COMPARATOR
Drug: Placebo

Interventions

BosentanDRUG

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

Bosentan
PlaceboDRUG

Matched placebo bid

Placebo

Eligibility Criteria

AgeUp to 80 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Diabetes mellitus type 2 of \>2 years duration
  • Albuminuria

You may not qualify if:

  • Age \>80 years
  • Myocardial infarction/unstable angina within three months prior to randomisation
  • Decompensated congestive heart failure or functional class 3 and 4.
  • Changes in dosage of any vasodilator drugs during the preceding six weeks
  • Women of fertile age.
  • Impaired hepatic function (2 times upper normal limit of aminotransferases ASAT and ALAT)
  • Ongoing treatment with glibenclamide, cyclosporin or warfarin
  • Any concomitant disease or condition that may interfere with the possibility for the patient to comply with or complete the study protocol
  • Participant in an ongoing study
  • Unwillingness to participate following oral and written information

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Karolinska Institutet, Karolinska University Hospital

Stockholm, 17176, Sweden

Location

Related Publications (1)

  • Rafnsson A, Bohm F, Settergren M, Gonon A, Brismar K, Pernow J. The endothelin receptor antagonist bosentan improves peripheral endothelial function in patients with type 2 diabetes mellitus and microalbuminuria: a randomised trial. Diabetologia. 2012 Mar;55(3):600-7. doi: 10.1007/s00125-011-2415-y. Epub 2011 Dec 27.

    PMID: 22200728DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Bosentan

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

BenzenesulfonamidesSulfonamidesAmidesOrganic ChemicalsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsSulfonesSulfur CompoundsPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • John Pernow, Dr

    Karolinska Institutet

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 18, 2011

First Posted

May 20, 2011

Study Start

November 1, 2007

Primary Completion

April 1, 2010

Study Completion

January 1, 2011

Last Updated

May 20, 2011

Record last verified: 2007-10

Locations

SE(1)