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Completed

NCT Number: NCT00652379

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

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.

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Key information

Conditions

Acromegaly Bone Diseases Bone Diseases, Endocrine Brain Diseases Central Nervous System Diseases Endocrine System Diseases Glucose Intolerance Glucose Metabolism Disorders Hyperglycemia Hyperinsulinism Hyperpituitarism Hypothalamic Diseases Impaired Glucose Tolerance Insulin Resistance Metabolic Diseases Musculoskeletal Diseases Nervous System Diseases Nutritional and Metabolic Diseases Pituitary Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Endocrinology, Aarhus University Hospital

Aarhus C, Aarhus, 8000, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Pegvisomant

Drug

Pegvisomant s.c 15-30 mg 2 times a week

Other names: Somavert

Somatostatin analog (lanreotide or octreotide)

Drug

Study arm 2: usual dosage of a somatostatin analog Study arm 1: half dosage of somatostatin analog

Primary outcomes

  1. Insulin sensitivity

    Time frame: 0 and after 24 weeks

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Aarhus

Other

Collaborators

  • Aarhus University Hospital
  • Aarhus University Hospital Skejby
  • The Research Council for Health and Disease, Denmark

Registry information

Official study title

Co-treatment With Pegvisomant and a Somatostatin Analogue (SA) in SA-responsive Acromegalic Patients: Impact on Insulin Sensitivity, Glucose Tolerance, and Pharmacoeconomics

Important dates

Study start
2008
Primary completion
2009
Study completion
2011
First posted
Apr 3, 2008
Registry last updated
Jan 26, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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