- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00652379
Co-treatment With Pegvisomant and a Somatostatin Analogue (SA) in SA-responsive Acromegalic Patients
Co-treatment With Pegvisomant and a Somatostatin Analogue (SA) in SA-responsive Acromegalic Patients: Impact on Insulin Sensitivity, Glucose Tolerance, and Pharmacoeconomics
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.
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Aarhus
-
Aarhus C, Aarhus, Denmark, 8000
- Department of Endocrinology, Aarhus University Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 1
Co-treatment with Pegvisomant (15-30 mg twice a week) and a 50 percent reduced somatostatin-analog dose
|
Pegvisomant s.c 15-30 mg 2 times a week
Other Names:
Study arm 2: usual dosage of a somatostatin analog Study arm 1: half dosage of somatostatin analog
|
Active Comparator: 2
Somatostatin analog, unaltered dosage
|
Study arm 2: usual dosage of a somatostatin analog Study arm 1: half dosage of somatostatin analog
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Insulin sensitivity
Time Frame: 0 and after 24 weeks
|
0 and after 24 weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Glucose tolerance
Time Frame: 0 and after 24 weeks
|
0 and after 24 weeks
|
Symptoms, QoL questionaire
Time Frame: 0, 12 and 24 weeks
|
0, 12 and 24 weeks
|
Intrahepatic and intramyocellular fat
Time Frame: 0 and 24 weeks
|
0 and 24 weeks
|
Substrate metabolism
Time Frame: 0 and 24 weeks
|
0 and 24 weeks
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Jens Otto L. Jørgensen, MD Professor, Aarhus University Hospital
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Glucose Metabolism Disorders
- Metabolic Diseases
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Endocrine System Diseases
- Musculoskeletal Diseases
- Hypothalamic Diseases
- Hyperinsulinism
- Bone Diseases
- Hyperglycemia
- Bone Diseases, Endocrine
- Hyperpituitarism
- Pituitary Diseases
- Glucose Intolerance
- Insulin Resistance
- Acromegaly
- Physiological Effects of Drugs
- Antineoplastic Agents
- Gastrointestinal Agents
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Antineoplastic Agents, Hormonal
- Octreotide
- Lanreotide
- Somatostatin
Other Study ID Numbers
- GH-2007-228
- 2007-005244-25 (EudraCT Number)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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