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

Primary Purpose

Psoriasis

Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
liraglutide
Placebo
Sponsored by
Annesofie Faurschou
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Psoriasis focused on measuring psoriasis, liraglutide, morbidity, PASI, DLQI

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Gentofte Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Victoza treatment

Placebo

Arm Description

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.

Outcomes

Primary Outcome Measures

PASI (psoriasis area and severity index)
DLQI (dermatology life quality index)

Secondary Outcome Measures

Body mass index
CRP
Skin biopsies

Full Information

First Posted
October 18, 2011
Last Updated
June 19, 2013
Sponsor
Annesofie Faurschou
Collaborators
University of Copenhagen
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1. Study Identification

Unique Protocol Identification Number
NCT01460069
Brief Title
The Effect of Glucagon Like Peptide (GLP)-1 in Psoriasis
Official Title
The Effect of GLP-1 in Psoriasis
Study Type
Interventional

2. Study Status

Record Verification Date
June 2013
Overall Recruitment Status
Completed
Study Start Date
October 2011 (undefined)
Primary Completion Date
May 2013 (Actual)
Study Completion Date
May 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Annesofie Faurschou
Collaborators
University of Copenhagen

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psoriasis
Keywords
psoriasis, liraglutide, morbidity, PASI, DLQI

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Victoza treatment
Arm Type
Active Comparator
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
liraglutide
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
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.
Primary Outcome Measure Information:
Title
PASI (psoriasis area and severity index)
Time Frame
Baseline and after 2 months
Title
DLQI (dermatology life quality index)
Time Frame
Baseline and after 2 months
Secondary Outcome Measure Information:
Title
Body mass index
Time Frame
Baseline and after 2 months
Title
CRP
Time Frame
Baseline and after 2 months
Title
Skin biopsies
Time Frame
Baseline and after 2 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
AnneSofie Faurschou, MD PhD
Organizational Affiliation
Gentofte Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Gentofte Hospital
City
Hellerup
ZIP/Postal Code
2900
Country
Denmark

12. IPD Sharing Statement

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

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