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

Insulin Resistance Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00652379
• Other study ID #: GH-2007-228
• Secondary ID: 2007-005244-25
• Status: Completed
• Phase: N/A
• First received: March 26, 2008
• Last updated: January 25, 2012
• Start date: June 2008
• Est. completion date: May 2011

Study information

• Verified date: January 2012
• Source: University of Aarhus
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Dataprotection AgencyDenmark: Danish Medicines AgencyDenmark: The Danish National Committee on Biomedical Research EthicsDenmark: The Regional Committee on Biomedical Research Ethics
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: May 2011
• Est. primary completion date: November 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acromegaly
• Glucose Intolerance
• Impaired Glucose Tolerance
• Insulin Resistance

Intervention

Drug:
• Pegvisomant
Pegvisomant s.c 15-30 mg 2 times a week
• Somatostatin analog (lanreotide or octreotide)
Study arm 2: usual dosage of a somatostatin analog Study arm 1: half dosage of somatostatin analog

Locations

Country	Name	City	State
Denmark	Department of Endocrinology, Aarhus University Hospital	Aarhus C	Aarhus

Sponsors (4)

Lead Sponsor	Collaborator
University of Aarhus	Aarhus University Hospital, Aarhus University Hospital Skejby, Forskningsrådet for Sundhed og Sygdom

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Insulin sensitivity		0 and after 24 weeks	No
Secondary	Glucose tolerance		0 and after 24 weeks	No
Secondary	Symptoms, QoL questionaire		0, 12 and 24 weeks	No
Secondary	Intrahepatic and intramyocellular fat		0 and 24 weeks	No
Secondary	Substrate metabolism		0 and 24 weeks	No