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

This study has been completed.
Sponsor:
Collaborators:
Skejby Hospital
Aarhus University Hospital
Forskningsrådet for Sundhed og Sygdom
Information provided by (Responsible Party):
University of Aarhus
ClinicalTrials.gov Identifier:
NCT00652379
First received: March 26, 2008
Last updated: January 25, 2012
Last verified: January 2012

March 26, 2008
January 25, 2012
June 2008
November 2009   (final data collection date for primary outcome measure)
Insulin sensitivity [ Time Frame: 0 and after 24 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00652379 on ClinicalTrials.gov Archive Site
  • Glucose tolerance [ Time Frame: 0 and after 24 weeks ] [ Designated as safety issue: No ]
  • Symptoms, QoL questionaire [ Time Frame: 0, 12 and 24 weeks ] [ Designated as safety issue: No ]
  • Intrahepatic and intramyocellular fat [ Time Frame: 0 and 24 weeks ] [ Designated as safety issue: No ]
  • Substrate metabolism [ Time Frame: 0 and 24 weeks ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Co-treatment With Pegvisomant and a Somatostatin Analogue (SA) in SA-responsive Acromegalic Patients
Co-treatment With Pegvisomant and a Somatostatin Analogue (SA) in SA-responsive Acromegalic Patients: Impact on Insulin Sensitivity, Glucose Tolerance, and Pharmacoeconomics

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Acromegaly
  • Insulin Resistance
  • Impaired Glucose Tolerance
  • Drug: Pegvisomant
    Pegvisomant s.c 15-30 mg 2 times a week
    Other Name: Somavert
  • Drug: Somatostatin analog (lanreotide or octreotide)
    Study arm 2: usual dosage of a somatostatin analog Study arm 1: half dosage of somatostatin analog
  • Experimental: 1
    Co-treatment with Pegvisomant (15-30 mg twice a week) and a 50 percent reduced somatostatin-analog dose
    Interventions:
    • Drug: Pegvisomant
    • Drug: Somatostatin analog (lanreotide or octreotide)
  • Active Comparator: 2
    Somatostatin analog, unaltered dosage
    Intervention: Drug: Somatostatin analog (lanreotide or octreotide)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
18
May 2011
November 2009   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Denmark
 
NCT00652379
GH-2007-228, 2007-005244-25
Yes
University of Aarhus
University of Aarhus
  • Skejby Hospital
  • Aarhus University Hospital
  • Forskningsrådet for Sundhed og Sygdom
Principal Investigator: Jens Otto L. Jørgensen, MD Professor Aarhus University Hospital
University of Aarhus
January 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP