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

This study is currently recruiting participants.

Verified June 2012 by University Hospital, Gentofte, Copenhagen

Sponsor:

Information provided by (Responsible Party):

Annesofie Faurschou, University Hospital, Gentofte, Copenhagen

ClinicalTrials.gov Identifier:

NCT01451905

First received: October 11, 2011

Last updated: June 20, 2012

Last verified: June 2012

History of Changes

Purpose

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

Condition	Intervention
Reduction of Psoriasis Following Liraglutide Therapy in Terms of PASI and DLQI	Drug: Liraglutide Drug: Placebo

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

Resource links provided by NLM:

MedlinePlus related topics: Psoriasis

Drug Information available for: Liraglutide

U.S. FDA Resources

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

Primary Outcome Measures:

Changes in PASI and DLQI [ Time Frame: 2 months ] [ Designated as safety issue: No ]

Estimated Enrollment:	12
Study Start Date:	August 2011
Estimated Study Completion Date:	December 2012
Estimated Primary Completion Date:	December 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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.
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

Arms

Assigned Interventions

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.

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

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01451905

Contacts

Contact: Annesofie Faurschou, MD PhD

+45 39773977

Locations

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

Sponsors and Collaborators

University Hospital, Gentofte, Copenhagen

More Information

No publications provided

Responsible Party:	Annesofie Faurschou, MD PhD, University Hospital, Gentofte, Copenhagen
ClinicalTrials.gov Identifier:	NCT01451905 History of Changes
Other Study ID Numbers:	GLP1-PSO
Study First Received:	October 11, 2011
Last Updated:	June 20, 2012
Health Authority:	Denmark: Danish Dataprotection Agency Denmark: Ethics Committee

Additional relevant MeSH terms:

Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases

ClinicalTrials.gov processed this record on May 19, 2013

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