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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00652379
First Posted: April 3, 2008
Last Update Posted: January 26, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Aarhus University Hospital Skejby
Aarhus University Hospital
Forskningsrådet for Sundhed og Sygdom
Information provided by (Responsible Party):
University of Aarhus
  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
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

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 ]

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

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
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
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
Forskningsrådet for Sundhed og Sygdom
Investigators
Principal Investigator: Jens Otto L. Jørgensen, MD Professor Aarhus University Hospital
  More Information

Responsible Party: University of Aarhus
ClinicalTrials.gov Identifier: NCT00652379     History of Changes
Other Study ID Numbers: GH-2007-228
2007-005244-25 ( EudraCT Number )
First Submitted: March 26, 2008
First Posted: April 3, 2008
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:
Insulin Resistance
Acromegaly
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
Insulin
Octreotide
Lanreotide
Somatostatin
Hypoglycemic Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists