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

University of Aarhus

Status: Completed

Conditions: Impaired Glucose Tolerance; Insulin Resistance; Acromegaly

Treatments: Drug: Somatostatin analog (lanreotide or octreotide); Drug: Pegvisomant

Study type: Interventional

Funder types: Other

Identifiers

NCT00652379

GH-2007-228

2007-005244-25 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 18 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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18 participants in 2 patient groups

1

Experimental group

Description:

Co-treatment with Pegvisomant (15-30 mg twice a week) and a 50 percent reduced somatostatin-analog dose

Treatment:

Drug: Pegvisomant

Drug: Somatostatin analog (lanreotide or octreotide)

2

Active Comparator group

Description:

Somatostatin analog, unaltered dosage

Treatment:

Drug: Somatostatin analog (lanreotide or octreotide)