GLP-1 Receptors in Normal Skin and Skin From Patients With Psoriasis

To examine GLP-1 receptors in skin of psoriasis patients compared with the skin of humans with no skin disease

Study Overview

• Status: Unknown
• Conditions: Reduction of Psoriasis Following Liraglutide Therapy in Terms of PASI and DLQI
• Intervention / Treatment: Drug: Liraglutide; Drug: Placebo

• Study Type: Interventional
• Enrollment (Anticipated): 12
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Annesofie Faurschou, MD PhD; Phone Number: +45 39773977

Study Locations

• Denmark
  • Hellerup, Denmark, 2900
    • Recruiting
    • Gentofte Hospital
    • Contact: Lone Skov, Prof; Phone Number: +45 39773977; Email: losk@geh.regionh.dk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

4.3 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) 4.4 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

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: 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
Active Comparator: Psoriasis	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 propylene glycol, 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Changes in PASI and DLQI	2 months

Collaborators and Investigators

• Sponsor: University Hospital, Gentofte, Copenhagen

Study record dates

Study Major Dates

• Study Start: August 1, 2011
• Primary Completion (Anticipated): December 1, 2012
• Study Completion (Anticipated): December 1, 2012

Study Registration Dates

• First Submitted: October 11, 2011
• First Submitted That Met QC Criteria: October 11, 2011
• First Posted (Estimate): October 14, 2011

Study Record Updates

• Last Update Posted (Estimate): June 21, 2012
• Last Update Submitted That Met QC Criteria: June 20, 2012
• Last Verified: June 1, 2012

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Skin Diseases, Papulosquamous; Psoriasis; Hypoglycemic Agents; Physiological Effects of Drugs; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Incretins; Liraglutide
• Other Study ID Numbers: GLP1-PSO