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CompletedNCT00652379Updated Jan 26, 2012

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

An interventional study of Pegvisomant and Somatostatin analog (lanreotide or octreotide) in Acromegaly, Insulin Resistance and Impaired Glucose Tolerance, sponsored by University of Aarhus. Completed at 1 site in Denmark. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2012-01-26.

Sponsored by University of Aarhus · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
18
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Acromegaly
  • Insulin Resistance
  • Impaired Glucose Tolerance

Keywords

  • Acromegaly
  • Insulin sensitivity
  • Glucose tolerance
  • Body composition
  • Growth Hormone
03

In context

Acromegaly

196 studies on the registry are indexed under Acromegaly; 18 are open to participants now.

This study's enrollment of 18 is below the median of 43 across 115 interventional studies indexed under Acromegaly.

Browse Acromegaly studies →

Lead sponsor

University of Aarhus is the lead sponsor of 1,274 studies on the registry; 183 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
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

Exclusion Criteria:

  • Pregnancy
  • Liver disease
  • Diabetes mellitus type I
  • Magnetic or electronic implants
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
18 participants (actual)

Study arms

  • Experimental
    1

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

    Drug: Pegvisomant · Drug: Somatostatin analog (lanreotide or octreotide)

  • Active comparator
    2

    Somatostatin analog, unaltered dosage

    Drug: Somatostatin analog (lanreotide or octreotide)

Interventions

  • DrugPegvisomant

    Pegvisomant s.c 15-30 mg 2 times a week

    Also known as: Somavert

  • DrugSomatostatin analog (lanreotide or octreotide)

    Study arm 2: usual dosage of a somatostatin analog Study arm 1: half dosage of somatostatin analog

06

What researchers measure

Primary outcomes

  1. Insulin sensitivity

    Time frame: 0 and after 24 weeks

Secondary outcomes

  1. Glucose tolerance

    Time frame: 0 and after 24 weeks

  2. Symptoms, QoL questionaire

    Time frame: 0, 12 and 24 weeks

  3. Intrahepatic and intramyocellular fat

    Time frame: 0 and 24 weeks

  4. Substrate metabolism

    Time frame: 0 and 24 weeks

07

Study locations

1 site
  • Department of Endocrinology, Aarhus University Hospital
    Aarhus C, Aarhus 8000, Denmark
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 26, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00652379
Lead sponsor
University of Aarhus
Collaborators
Aarhus University Hospital Skejby, Aarhus University Hospital, The Research Council for Health and Disease, Denmark
Responsible party
Sponsor
First posted
Apr 3, 2008
Start date
Jun 2008
Primary completion
Nov 2009
Completion
May 2011
Last update
Jan 26, 2012

Study contacts

Jens Otto L. Jørgensen, MD Professor
principal investigator · Aarhus University Hospital

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2012. You cannot join it, but the record below documents what was studied.

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