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

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ClinicalTrials.gov Identifier: NCT00652379
Recruitment Status : Completed
First Posted : April 3, 2008
Last Update Posted : January 26, 2012
Sponsor:
Collaborators:
Aarhus University Hospital Skejby
Aarhus University Hospital
The Research Council for Health and Disease, Denmark
Information provided by (Responsible Party):
University of Aarhus

Study Description
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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.


Condition or disease Intervention/treatment Phase
Acromegaly Insulin Resistance Impaired Glucose Tolerance Drug: Pegvisomant Drug: Somatostatin analog (lanreotide or octreotide) Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : June 2008
Actual Primary Completion Date : November 2009
Actual Study Completion Date : May 2011

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Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. Insulin sensitivity [ Time Frame: 0 and after 24 weeks ]

Secondary Outcome Measures :
  1. Glucose tolerance [ Time Frame: 0 and after 24 weeks ]
  2. Symptoms, QoL questionaire [ Time Frame: 0, 12 and 24 weeks ]
  3. Intrahepatic and intramyocellular fat [ Time Frame: 0 and 24 weeks ]
  4. Substrate metabolism [ Time Frame: 0 and 24 weeks ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00652379


Locations
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Denmark
Department of Endocrinology, Aarhus University Hospital
Aarhus C, Aarhus, Denmark, 8000
Sponsors and Collaborators
University of Aarhus
Aarhus University Hospital Skejby
Aarhus University Hospital
The Research Council for Health and Disease, Denmark
Investigators
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Principal Investigator: Jens Otto L. Jørgensen, MD Professor Aarhus University Hospital
More Information
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Responsible Party: University of Aarhus
ClinicalTrials.gov Identifier: NCT00652379    
Other Study ID Numbers: GH-2007-228
2007-005244-25 ( EudraCT Number )
First Posted: April 3, 2008    Key Record Dates
Last Update Posted: January 26, 2012
Last Verified: January 2012
Keywords provided by University of Aarhus:
Acromegaly
Insulin sensitivity
Glucose tolerance
Body composition
Growth Hormone
Additional relevant MeSH terms:
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Acromegaly
Insulin Resistance
Glucose Intolerance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Bone Diseases, Endocrine
Bone Diseases
Musculoskeletal Diseases
Hyperpituitarism
Pituitary Diseases
Hypothalamic Diseases
Brain Diseases
Central Nervous System Diseases
 Nervous System Diseases
Endocrine System Diseases
Hyperglycemia
Octreotide
Lanreotide
Angiopeptin
Somatostatin
Gastrointestinal Agents
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs