Status:

COMPLETED

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

Lead Sponsor:

Annesofie Faurschou

Collaborating Sponsors:

University of Copenhagen

Conditions:

Psoriasis

Eligibility:

All Genders

18+ years

Phase:

NA

Brief Summary

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.

Eligibility Criteria

Inclusion

  • 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

  • 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

Key Trial Info

Start Date :

October 1 2011

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

May 1 2013

Estimated Enrollment :

20 Patients enrolled

Trial Details

Trial ID

NCT01460069

Start Date

October 1 2011

End Date

May 1 2013

Last Update

June 21 2013

Active Locations (1)

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1

Gentofte Hospital

Hellerup, Denmark, 2900