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

Psoriasis Clinical Trial

Official title:

The Effect of GLP-1 in Psoriasis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01460069
• Other study ID #: 2011-000571-13
• Status: Completed
• Phase: N/A
• First received: October 18, 2011
• Last updated: June 19, 2013
• Start date: October 2011
• Est. completion date: May 2013

Study information

• Verified date: June 2013
• Source: University Hospital, Gentofte, Copenhagen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: The Danish National Committee on Biomedical Research EthicsDenmark: Danish Medicines AgencyDenmark: The Regional Committee on Biomedical Research Ethics
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: May 2013
• Est. primary completion date: May 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Psoriasis

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 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
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.

Locations

Country	Name	City	State
Denmark	Gentofte Hospital	Hellerup

Sponsors (2)

Lead Sponsor	Collaborator
Annesofie Faurschou	University of Copenhagen

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PASI (psoriasis area and severity index)		Baseline and after 2 months	No
Primary	DLQI (dermatology life quality index)		Baseline and after 2 months	No
Secondary	Body mass index		Baseline and after 2 months	No
Secondary	CRP		Baseline and after 2 months	No
Secondary	Skin biopsies		Baseline and after 2 months	No