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

Reduction of Psoriasis Following Liraglutide Therapy in Terms of PASI and DLQI Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01451905
• Other study ID #: GLP1-PSO
• Status: Recruiting
• Phase: N/A
• First received: October 11, 2011
• Last updated: June 20, 2012
• Start date: August 2011
• Est. completion date: December 2012

Study information

• Verified date: June 2012
• Source: University Hospital, Gentofte, Copenhagen
• Contact: Annesofie Faurschou, MD PhD
• Phone: +45 39773977
• Is FDA regulated: No
• Health authority: Denmark: Danish Dataprotection AgencyDenmark: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 12
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)

Related Conditions & MeSH terms

• Psoriasis
• Reduction of Psoriasis Following Liraglutide Therapy in Terms of PASI and DLQI

Intervention

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.
• 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

Locations

Country	Name	City	State
Denmark	Gentofte Hospital	Hellerup

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Gentofte, Copenhagen

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in PASI and DLQI		2 months	No