Co-Treatment With Pegvisomant and a Somatostatin Analogue (SA) in SA-Responsive Acromegalic Patients - Full Text View

Sponsors and Collaborators:	University of Aarhus Skejby Hospital Aarhus University Hospital Forskningsrådet for Sundhed og Sygdom
Information provided by:	University of Aarhus
ClinicalTrials.gov Identifier:	NCT00652379

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 (Lanreotid or Octreotid)

Drug Information available for: Insulin Dextrose Somatotropin Somatropin Somatostatin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title:	Co-Treatment With Pegvisomant and a Somatostatin Analogue (SA) in SA-Responsive Acromegalic Patients: Impact on Insulin Sensitivity, Glucose Tolerance, and Pharmacoeconomics

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 ]

Estimated Enrollment:	30
Study Start Date:	June 2008
Estimated Study Completion Date:	August 2009
Estimated Primary Completion Date:	August 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Co-treatment with Pegvisomant and a somatostatin-analog	Drug: Pegvisomant Pegvisomant s.c 15 mg 2 times a week Drug: Somatostatin analog (Lanreotid or Octreotid) Study arm 2: usual dosage of a somatostatin analog Study arm 1: half dosage of somatostatin analog
2: Active Comparator Somatostatin analog	Drug: Somatostatin analog (Lanreotid or Octreotid) 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

Contacts

Contact: Jens Otto L. Jørgensen, MD Professor	89492505 ext +45	joj@ki.au.dk
Contact: Michael Madsen, MD	89492171 ext +45	michael.madsen@ki.au.dk

Locations

Denmark, Aarhus
Department of Endocrinology, Aarhus University Hospital	Recruiting
Aarhus C, Aarhus, Denmark, 8000
Principal Investigator: Jens Otto L. Jørgensen, MD Professor
Sub-Investigator: Michael Madsen, MD

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

Department of Endocrinology, Aarhus University Hospital

More Information

Responsible Party:	Department of endocrinology, Aarhus University Hospital ( Jens Otto L. Jørgensen, MD., Professor )
Study ID Numbers:	GH-2007-228, M-20070193, 2612-3602, 2008-38/22246-2, 2007-41-1082, 2007-005244-25
Study First Received:	March 26, 2008
Last Updated:	December 12, 2008
ClinicalTrials.gov Identifier:	NCT00652379
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

Study placed in the following topic categories:

Bone Diseases, Endocrine
Hypothalamic Diseases
Metabolic Diseases
Pituitary Diseases
Glucose Intolerance
Central Nervous System Diseases
Endocrine System Diseases
Brain Diseases
Bone Diseases
Somatostatin

Insulin
Hyperinsulinism
Hyperglycemia
Musculoskeletal Diseases
Endocrinopathy
Insulin Resistance
Metabolic disorder
Glucose Metabolism Disorders
Acromegaly

Additional relevant MeSH terms:

Hyperpituitarism
Physiological Effects of Drugs
Nervous System Diseases

Hormones, Hormone Substitutes, and Hormone Antagonists
Hormones
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009