Co-treatment With Pegvisomant and a Somatostatin Analogue (SA) in SA-responsive Acromegalic Patients: Impact on Insulin Sensitivity, Glucose Tolerance, and Pharmacoeconomics
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Aarhus
- Enrollment
- 18
- Locations
- 1
- Primary Endpoint
- Insulin sensitivity
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
2
Somatostatin analog, unaltered dosage
Intervention: Somatostatin analog (lanreotide or octreotide) (Drug)
1
Co-treatment with Pegvisomant (15-30 mg twice a week) and a 50 percent reduced somatostatin-analog dose
Intervention: Somatostatin analog (lanreotide or octreotide) (Drug)
1
Co-treatment with Pegvisomant (15-30 mg twice a week) and a 50 percent reduced somatostatin-analog dose
Intervention: Pegvisomant (Drug)
Outcomes
Primary Outcomes
Insulin sensitivity
Time Frame: 0 and after 24 weeks
Secondary Outcomes
- Glucose tolerance(0 and after 24 weeks)
- Symptoms, QoL questionaire(0, 12 and 24 weeks)
- Intrahepatic and intramyocellular fat(0 and 24 weeks)
- Substrate metabolism(0 and 24 weeks)