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
  Purpose

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.


Condition Intervention
Acromegaly
Insulin Resistance
Impaired Glucose Tolerance
Drug: Pegvisomant
Drug: Somatostatin analog (lanreotide or octreotide)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Co-treatment With Pegvisomant and a Somatostatin Analogue (SA) in SA-responsive Acromegalic Patients: Impact on Insulin Sensitivity, Glucose Tolerance, and Pharmacoeconomics

Resource links provided by NLM:


Further study details as provided by University of Aarhus:

Primary Outcome Measures:
  • Insulin sensitivity [ Time Frame: 0 and after 24 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 18
Study Start Date: June 2008
Study Completion Date: May 2011
Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Co-treatment with Pegvisomant (15-30 mg twice a week) and a 50 percent reduced somatostatin-analog dose
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
Active Comparator: 2
Somatostatin analog, unaltered dosage
Drug: Somatostatin analog (lanreotide or octreotide)
Study arm 2: usual dosage of a somatostatin analog Study arm 1: half dosage of somatostatin analog

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00652379

Locations
Denmark
Department of Endocrinology, Aarhus University Hospital
Aarhus C, Aarhus, Denmark, 8000
Sponsors and Collaborators
University of Aarhus
Skejby Hospital
Aarhus University Hospital
Forskningsrådet for Sundhed og Sygdom
Investigators
Principal Investigator: Jens Otto L. Jørgensen, MD Professor Aarhus University Hospital
  More Information

No publications provided

Responsible Party: University of Aarhus
ClinicalTrials.gov Identifier: NCT00652379     History of Changes
Other Study ID Numbers: GH-2007-228, 2007-005244-25
Study First Received: March 26, 2008
Last Updated: January 25, 2012
Health Authority: Denmark: Danish Dataprotection Agency
Denmark: Danish Medicines Agency
Denmark: The Danish National Committee on Biomedical Research Ethics
Denmark: The Regional Committee on Biomedical Research Ethics

Keywords provided by University of Aarhus:
Acromegaly
Insulin sensitivity
Glucose tolerance
Body composition
Growth Hormone

Additional relevant MeSH terms:
Acromegaly
Insulin Resistance
Glucose Intolerance
Bone Diseases, Endocrine
Bone Diseases
Musculoskeletal Diseases
Hyperpituitarism
Pituitary Diseases
Hypothalamic Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Endocrine System Diseases
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Hyperglycemia
Octreotide
Lanreotide
Somatostatin
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Gastrointestinal Agents
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on April 14, 2014