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

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ClinicalTrials.gov Identifier: NCT01460069
Recruitment Status : Completed
First Posted : October 26, 2011
Last Update Posted : June 21, 2013
Sponsor:
Collaborator:
University of Copenhagen
Information provided by (Responsible Party):
Annesofie Faurschou, University Hospital, Gentofte, Copenhagen

Study Description
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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.

Condition or disease Intervention/treatment Phase
Psoriasis Drug: liraglutide Drug: Placebo Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effect of GLP-1 in Psoriasis
Study Start Date : October 2011
Actual Primary Completion Date : May 2013
Actual Study Completion Date : May 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis
Drug Information available for: Liraglutide

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Victoza treatment 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 Comparator: 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.
 Drug: 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.


Outcome Measures
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Primary Outcome Measures :
  1. PASI (psoriasis area and severity index) [ Time Frame: Baseline and after 2 months ]
  2. DLQI (dermatology life quality index) [ Time Frame: Baseline and after 2 months ]

Secondary Outcome Measures :
  1. Body mass index [ Time Frame: Baseline and after 2 months ]
  2. CRP [ Time Frame: Baseline and after 2 months ]
  3. Skin biopsies [ Time Frame: Baseline and after 2 months ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01460069


Locations
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Denmark
Gentofte Hospital
Hellerup, Denmark, 2900
Sponsors and Collaborators
Annesofie Faurschou
University of Copenhagen
Investigators
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Principal Investigator: AnneSofie Faurschou, MD PhD Gentofte Hospital
More Information
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Responsible Party: Annesofie Faurschou, MD PhD - Resident in dermatology, University Hospital, Gentofte, Copenhagen
ClinicalTrials.gov Identifier: NCT01460069    
Other Study ID Numbers: 2011-000571-13
First Posted: October 26, 2011    Key Record Dates
Last Update Posted: June 21, 2013
Last Verified: June 2013
Keywords provided by Annesofie Faurschou, University Hospital, Gentofte, Copenhagen:
psoriasis
liraglutide
morbidity
PASI
DLQI
Additional relevant MeSH terms:
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Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
Liraglutide
Hypoglycemic Agents
 Physiological Effects of Drugs
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists