- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01460069
The Effect of Glucagon Like Peptide (GLP)-1 in Psoriasis
June 19, 2013 updated by: Annesofie Faurschou
The Effect of GLP-1 in Psoriasis
The objective of this study is to investigate the effect of the GLP-1 analogue Victoza® on psoriasis in a double-blinded, randomized placebo-controlled clinical trial.
Study Overview
Study Type
Interventional
Enrollment (Anticipated)
20
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Hellerup, Denmark, 2900
- Gentofte Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Caucasians above 18 years of age
- Plaque psoriasis
- PASI score >10
- No treatment or stable treatment of psoriasis during at least 3 months before inclusion
- Steady weight through 3 months with a body mass index (BMI) above 27 kg/m2
- Normal blood pressure
- Spiral or hormonal birth control for fertile women during the entire treatment period and at least 3 days after the end of the treatment period (~5 times the plasma half-life)
Exclusion Criteria:
- Psoriasis arthritis
- Fasting plasma glucose > 7.5 mmol/L or HbA1c > 7.5%
- Type 1 diabetes
- Treatment for type 2 diabetes with GLP-1-based medicine (DDP-4-inhibitors or GLP-1-receptor-agonists)
- Heart failure, NYHA class III-IV
- Uraemia, end-stage renal disease, or any other cause of impaired renal function with s-creatinine >150 µM and/or albuminuria
- Liver disease (alanine amino transferase (ALAT) and/or aspartate amino transferase (ASAT) >2 x upper normal serum levels)
- Anaemia
- Acute or chronic pancreatitis
- Struma or thyroid cancer
- Pregnancy or breast feeding
- Inability to complete the study
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Victoza treatment
|
Victoza® is supplied in pens for injection containing 18 mg of the GLP-1 agonist liraglutide in 3 mL sterile water with disodiumphosphate and propylenglycol, and phenol for conservation (pH 8.15).
Commercial pens will be used and the information given in the packaging will be applicable.
The initial daily dose will be 0.6 mg for one week, 1.2 mg the following week and then 1.8 mg for the remaining treatment period.
The injection is administered once daily in the morning.
The maximal plasma concentration is reached 8-12 hours after subcutaneous injection.
The half-life in plasma is approximately 13 hours.
The duration of effect is 24 hours.
|
Placebo Comparator: Placebo
The placebo pens contain saline and are administered in the same way and volume as Victoza.
The placebo pens are specially prepared for this study and will be used in the study only.
|
The placebo pens contain saline and are administered in the same way and volume as (liraglutide) Victoza.
The placebo pens are specially prepared for this study and will be used in the study only.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
PASI (psoriasis area and severity index)
Time Frame: Baseline and after 2 months
|
Baseline and after 2 months
|
DLQI (dermatology life quality index)
Time Frame: Baseline and after 2 months
|
Baseline and after 2 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Body mass index
Time Frame: Baseline and after 2 months
|
Baseline and after 2 months
|
CRP
Time Frame: Baseline and after 2 months
|
Baseline and after 2 months
|
Skin biopsies
Time Frame: Baseline and after 2 months
|
Baseline and after 2 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: AnneSofie Faurschou, MD PhD, Gentofte Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2011
Primary Completion (Actual)
May 1, 2013
Study Completion (Actual)
May 1, 2013
Study Registration Dates
First Submitted
October 18, 2011
First Submitted That Met QC Criteria
October 24, 2011
First Posted (Estimate)
October 26, 2011
Study Record Updates
Last Update Posted (Estimate)
June 21, 2013
Last Update Submitted That Met QC Criteria
June 19, 2013
Last Verified
June 1, 2013
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2011-000571-13
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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