AcromegalyNCT00652379
Co-treatment With Pegvisomant and a Somatostatin Analogue (SA) in SA-responsive Acromegalic Patients
A study testing Pegvisomant and Somatostatin analog (lanreotide or octreotide) in people with Acromegaly and Insulin Resistance, run by University of Aarhus at 1 site in Denmark.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acromegaly, Insulin Resistance, Impaired Glucose Tolerance
- What is being tested?
- Pegvisomant and Somatostatin analog (lanreotide or octreotide)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteDenmark
- Study dates
- Jun 2008to May 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.)
Who cannot join
- Pregnancy
- Liver disease
- Diabetes mellitus type I
- Magnetic or electronic implants
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Department of Endocrinology, Aarhus University Hospital
Aarhus C, Aarhus, 8000
About this study
Official title: Co-treatment With Pegvisomant and a Somatostatin Analogue (SA) in SA-responsive Acromegalic Patients: Impact on Insulin Sensitivity, Glucose Tolerance, and Pharmacoeconomics
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.
- Conditions
- Acromegaly, Insulin Resistance, Impaired Glucose Tolerance
- Being tested
- Pegvisomant, Somatostatin analog (lanreotide or octreotide)
- Keywords
- Acromegaly, Insulin sensitivity, Glucose tolerance, Body composition, Growth Hormone
- Medical subject headings
- Acromegaly, Insulin Resistance, Glucose Intolerance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PegvisomantDrug
Also called Somavert
Pegvisomant s.c 15-30 mg 2 times a week
Somatostatin analog (lanreotide or octreotide)Drug
Study arm 2: usual dosage of a somatostatin analog Study arm 1: half dosage of somatostatin analog
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Co-treatment with Pegvisomant (15-30 mg twice a week) and a 50 percent reduced somatostatin-analog dose Receives: Drug: Pegvisomant; Drug: Somatostatin analog (lanreotide or octreotide) |
| 2 | Active comparator | Somatostatin analog, unaltered dosage Receives: Drug: Somatostatin analog (lanreotide or octreotide) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Insulin sensitivity
Measured: 0 and after 24 weeks
Secondary outcomes (4)
Glucose tolerance
Measured: 0 and after 24 weeks
Symptoms, QoL questionaire
Measured: 0, 12 and 24 weeks
Intrahepatic and intramyocellular fat
Measured: 0 and 24 weeks
Substrate metabolism
Measured: 0 and 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2008 (estimated)
- Study startJun 2008
- Primary completionNov 2009
- Study completionMay 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AcromegalyStudies of the same condition, open and under way.
- More trials run by University of AarhusThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Collaborators
- Aarhus University Hospital Skejby, Aarhus University Hospital, The Research Council for Health and Disease, Denmark
- Responsible party
- Sponsor
- Investigators
- Jens Otto L. Jørgensen, MD Professor, Principal investigator, Aarhus University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00652379
- Sponsor's protocol ID
- GH-2007-228
- Other IDs
- 2007-005244-25
- Status last verified
- Jan 2012
- First submitted
- 26 Mar 2008
- Last updated
- 26 Jan 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Co-treatment With Pegvisomant and a Somatostatin Analogue (SA) in SA-responsive Acromegalic Patients: Impact on Insulin Sensitivity, Glucose Tolerance, and Pharmacoeconomics
- ClinicalTrials.gov ID
- NCT00652379
- Acronym / sponsor ID
- GH-2007-228
- Conditions
- Acromegaly, Insulin Resistance, Impaired Glucose Tolerance
- Keywords
- Acromegaly, Insulin sensitivity, Glucose tolerance, Body composition, Growth Hormone
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Collaborators
- Aarhus University Hospital Skejby, Aarhus University Hospital, The Research Council for Health and Disease, Denmark
- Study start
- Jun 2008
- Primary completion
- Nov 2009 (actual)
- Study completion
- May 2011 (actual)
- First posted
- 3 Apr 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Pegvisomant, Drug: Somatostatin analog (lanreotide or octreotide)Co-treatment with Pegvisomant (15-30 mg twice a week) and a 50 percent reduced somatostatin-analog dose |
| 2 | Active comparator | Drug: Somatostatin analog (lanreotide or octreotide)Somatostatin analog, unaltered dosage |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.)
Key exclusion criteria (4 listed)
- Pregnancy
- Liver disease
- Diabetes mellitus type I
- Magnetic or electronic implants
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PegvisomantAlso: SomavertPegvisomant s.c 15-30 mg 2 times a week | Drug | 1 |
| Somatostatin analog (lanreotide or octreotide)Study arm 2: usual dosage of a somatostatin analog Study arm 1: half dosage of somatostatin analog | Drug | 1, 2 |
Primary outcome
Insulin sensitivity
Time frame: 0 and after 24 weeks
4 secondary outcomes
Glucose tolerance
Time frame: 0 and after 24 weeks
Symptoms, QoL questionaire
Time frame: 0, 12 and 24 weeks
Intrahepatic and intramyocellular fat
Time frame: 0 and 24 weeks
Substrate metabolism
Time frame: 0 and 24 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jens Otto L. Jørgensen, MD Professor principal investigator
Aarhus University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pegvisomant and Somatostatin analog (lanreotide or octreotide) in people with Acromegaly and Insulin Resistance, run by University of Aarhus at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jan 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Insulin sensitivity (time frame: 0 and after 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jan 2012.