Effect of Bosentan on Endothelial Function in Patients Wi... | NCT01357109

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

NCT01357109

Sponsor

Karolinska Institutet

Status

Completed

Last Update Posted

May 20, 2011Estimated

Enrollment

56Actual

Phase

Phase 2

Conditions

Type 2 Diabetes Mellitus

Interventions

Bosentan
Placebo

Countries

Sweden

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
2007-000221-22	EudraCT Number

Status Module

Record Verification Date

Oct 2007

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2007

Primary Completion Date

Apr 2010Actual

Completion Date

Jan 2011Actual

First Submitted Date

May 18, 2011

First Submission Date that Met QC Criteria

May 18, 2011

First Posted Date

May 20, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 18, 2011

Last Update Posted Date

May 20, 2011Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Not provided

Lead Sponsor

Karolinska InstitutetOTHER

Collaborators

Name	Class
Swedish Heart Lung Foundation	OTHER
The Swedish Research Council	OTHER_GOV
Actelion	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

56Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Bosentan	Experimental		Drug: Bosentan
Placebo	Placebo Comparator		Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Bosentan	Drug	62.5 mg bid for two weeks and 125 mg bid for two weeks	Bosentan

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Peripheral endothelial function		4 weeks

Secondary Outcomes

Measure	Description	Time Frame
Inflammatory markers		4 weeks
Renal protein excretion		4 weeks
Myocardial perfusion

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Diabetes mellitus type 2 of >2 years duration
Albuminuria

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

80 Years

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
John Pernow, Dr	Karolinska Institutet	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Karolinska Institutet, Karolinska University Hospital		Stockholm		17176	Sweden

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
22200728	Derived	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.

ID	Term
D003920	Diabetes Mellitus
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases

ID	Term
D000096926	Benzenesulfonamides
D013449	Sulfonamides
D000577	Amides
D009930	Organic Chemicals