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

This study has been completed.
University of Copenhagen
Information provided by (Responsible Party):
Annesofie Faurschou, University Hospital, Gentofte, Copenhagen Identifier:
First received: October 18, 2011
Last updated: June 19, 2013
Last verified: June 2013
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
Drug: liraglutide
Drug: Placebo

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

Resource links provided by NLM:

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

Primary Outcome Measures:
  • PASI (psoriasis area and severity index) [ Time Frame: Baseline and after 2 months ]
  • DLQI (dermatology life quality index) [ Time Frame: Baseline and after 2 months ]

Secondary Outcome Measures:
  • Body mass index [ Time Frame: Baseline and after 2 months ]
  • CRP [ Time Frame: Baseline and after 2 months ]
  • Skin biopsies [ Time Frame: Baseline and after 2 months ]

Estimated Enrollment: 20
Study Start Date: October 2011
Study Completion Date: May 2013
Primary Completion Date: May 2013 (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.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01460069

Gentofte Hospital
Hellerup, Denmark, 2900
Sponsors and Collaborators
Annesofie Faurschou
University of Copenhagen
Principal Investigator: AnneSofie Faurschou, MD PhD Gentofte Hospital
  More Information

Responsible Party: Annesofie Faurschou, MD PhD - Resident in dermatology, University Hospital, Gentofte, Copenhagen Identifier: NCT01460069     History of Changes
Other Study ID Numbers: 2011-000571-13
Study First Received: October 18, 2011
Last Updated: June 19, 2013

Keywords provided by Annesofie Faurschou, University Hospital, Gentofte, Copenhagen:

Additional relevant MeSH terms:
Skin Diseases, Papulosquamous
Skin Diseases
Hypoglycemic Agents
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists processed this record on May 25, 2017