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

Primary Purpose

Acromegaly, Insulin Resistance, Impaired Glucose Tolerance

Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Pegvisomant
Somatostatin analog (lanreotide or octreotide)
Sponsored by
University of Aarhus
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acromegaly focused on measuring Acromegaly, Insulin sensitivity, Glucose tolerance, Body composition, Growth Hormone

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Department of Endocrinology, Aarhus University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

1

2

Arm Description

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

Somatostatin analog, unaltered dosage

Outcomes

Primary Outcome Measures

Insulin sensitivity

Secondary Outcome Measures

Glucose tolerance
Symptoms, QoL questionaire
Intrahepatic and intramyocellular fat
Substrate metabolism

Full Information

First Posted
March 26, 2008
Last Updated
January 25, 2012
Sponsor
University of Aarhus
Collaborators
Aarhus University Hospital Skejby, Aarhus University Hospital, The Research Council for Health and Disease, Denmark
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1. Study Identification

Unique Protocol Identification Number
NCT00652379
Brief Title
Co-treatment With Pegvisomant and a Somatostatin Analogue (SA) in SA-responsive Acromegalic Patients
Official Title
Co-treatment With Pegvisomant and a Somatostatin Analogue (SA) in SA-responsive Acromegalic Patients: Impact on Insulin Sensitivity, Glucose Tolerance, and Pharmacoeconomics
Study Type
Interventional

2. Study Status

Record Verification Date
January 2012
Overall Recruitment Status
Completed
Study Start Date
June 2008 (undefined)
Primary Completion Date
November 2009 (Actual)
Study Completion Date
May 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Aarhus
Collaborators
Aarhus University Hospital Skejby, Aarhus University Hospital, The Research Council for Health and Disease, Denmark

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acromegaly, Insulin Resistance, Impaired Glucose Tolerance
Keywords
Acromegaly, Insulin sensitivity, Glucose tolerance, Body composition, Growth Hormone

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
18 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Co-treatment with Pegvisomant (15-30 mg twice a week) and a 50 percent reduced somatostatin-analog dose
Arm Title
2
Arm Type
Active Comparator
Arm Description
Somatostatin analog, unaltered dosage
Intervention Type
Drug
Intervention Name(s)
Pegvisomant
Other Intervention Name(s)
Somavert
Intervention Description
Pegvisomant s.c 15-30 mg 2 times a week
Intervention Type
Drug
Intervention Name(s)
Somatostatin analog (lanreotide or octreotide)
Intervention Description
Study arm 2: usual dosage of a somatostatin analog Study arm 1: half dosage of somatostatin analog
Primary Outcome Measure Information:
Title
Insulin sensitivity
Time Frame
0 and after 24 weeks
Secondary Outcome Measure Information:
Title
Glucose tolerance
Time Frame
0 and after 24 weeks
Title
Symptoms, QoL questionaire
Time Frame
0, 12 and 24 weeks
Title
Intrahepatic and intramyocellular fat
Time Frame
0 and 24 weeks
Title
Substrate metabolism
Time Frame
0 and 24 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jens Otto L. Jørgensen, MD Professor
Organizational Affiliation
Aarhus University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Endocrinology, Aarhus University Hospital
City
Aarhus C
State/Province
Aarhus
ZIP/Postal Code
8000
Country
Denmark

12. IPD Sharing Statement

Learn more about this trial

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

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