Co-treatment With Pegvisomant and a Somatostatin Analogue (SA) in SA-responsive Acromegalic Patients

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Brief Title

Co-treatment With Pegvisomant and a Somatostatin Analogue (SA) in SA-responsive Acromegalic Patients

Official Title

Co-treatment With Pegvisomant and a Somatostatin Analogue (SA) in SA-responsive Acromegalic Patients: Impact on Insulin Sensitivity, Glucose Tolerance, and Pharmacoeconomics

Brief Summary

      The purpose of this study is to investigate if co-treatment of acromegalic patients, who
      beforehand are considered well-controlled on SA monotherapy, with pegvisomant and SA will
      improve insulin sensitivity and glucose tolerance, and if these effects of co-treatment can
      be obtained at a neutral cost as compared to SA mono therapy.

      Second to investigate body composition, substrate metabolism, symptoms, intrahepatic and
      intramyocellular fat.

Study Type

Interventional

Primary Outcome

Insulin sensitivity

Secondary Outcome

 Glucose tolerance

Condition

Acromegaly

Intervention

Pegvisomant

Study Arms / Comparison Groups

 1
Description:  Co-treatment with Pegvisomant (15-30 mg twice a week) and a 50 percent reduced somatostatin-analog dose

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status

Drug

Estimated Enrollment

18

Start Date

June 2008

Completion Date

May 2011

Primary Completion Date

November 2009

Eligibility Criteria

        Inclusion Criteria:

          -  Age > 18

          -  Diagnosed with acromegaly

          -  Safe anticonceptive for fertile women

          -  Well controlled on somatostatin analog (a serum IGF-I within normal range a nadir GH <
             0.5 µg/l.)

        Exclusion Criteria:

          -  Pregnancy

          -  Liver disease

          -  Diabetes mellitus type I

          -  Magnetic or electronic implants

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Jens Otto L. Jørgensen, MD Professor, ,

Location Countries

Denmark

Location Countries

Denmark

Administrative Informations

NCT ID

NCT00652379

Organization ID

GH-2007-228

Secondary IDs

2007-005244-25

Responsible Party

Sponsor

Study Sponsor

University of Aarhus

Collaborators

 Aarhus University Hospital Skejby

Study Sponsor

Jens Otto L. Jørgensen, MD Professor, Principal Investigator, Aarhus University Hospital

Verification Date

January 2012