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The Effect of Glucagon Like Peptide (GLP)-1 in Psoriasis

This study is currently recruiting participants.
Verified June 2012 by University Hospital, Gentofte, Copenhagen
Sponsor:
Collaborator:
University of Copenhagen
Information provided by (Responsible Party):
Annesofie Faurschou, University Hospital, Gentofte, Copenhagen
ClinicalTrials.gov Identifier:
NCT01460069
First received: October 18, 2011
Last updated: June 14, 2012
Last verified: June 2012
History of Changes
  Purpose

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.


Condition Intervention
Psoriasis
 Drug: liraglutide
Drug: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effect of GLP-1 in Psoriasis

Resource links provided by NLM:

MedlinePlus related topics: Psoriasis
Drug Information available for: Liraglutide
U.S. FDA Resources

Further study details as provided by University Hospital, Gentofte, Copenhagen:

Primary Outcome Measures:
  • PASI (psoriasis area and severity index) [ Time Frame: Baseline and after 2 months ] [ Designated as safety issue: No ]
  • DLQI (dermatology life quality index) [ Time Frame: Baseline and after 2 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Body mass index [ Time Frame: Baseline and after 2 months ] [ Designated as safety issue: No ]
  • CRP [ Time Frame: Baseline and after 2 months ] [ Designated as safety issue: No ]
  • Skin biopsies [ Time Frame: Baseline and after 2 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 20
Study Start Date: October 2011
Estimated Study Completion Date: November 2012
Estimated Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Victoza treatment Drug: liraglutide
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.
 Drug: Placebo
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01460069

Contacts
Contact: Annesofie Faurschou, MD PhD afau16@gmail.com
Contact: Lone Skov, Prof +45 3977 3977 losk@geh.regionh.dk

Locations
Denmark
Gentofte Hospital Recruiting
Hellerup, Denmark, 2900
Contact: Lone Skov, Prof     +45 3977 3977     losk@geh.regionh.dk    
Sponsors and Collaborators
Annesofie Faurschou
University of Copenhagen
Investigators
Principal Investigator: AnneSofie Faurschou, MD PhD Gentofte Hospital
  More Information

No publications provided

Responsible Party: Annesofie Faurschou, MD PhD - Resident in dermatology, University Hospital, Gentofte, Copenhagen
ClinicalTrials.gov Identifier: NCT01460069     History of Changes
Other Study ID Numbers: 2011-000571-13
Study First Received: October 18, 2011
Last Updated: June 14, 2012
Health Authority: Denmark: The Danish National Committee on Biomedical Research Ethics
Denmark: Danish Medicines Agency
Denmark: The Regional Committee on Biomedical Research Ethics

Keywords provided by University Hospital, Gentofte, Copenhagen:
psoriasis
liraglutide
morbidity
PASI
DLQI

Additional relevant MeSH terms:
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases

ClinicalTrials.gov processed this record on May 21, 2013