The Effect of Glucagon Like Peptide (GLP)-1 in Psoriasis
NCT ID: NCT01460069
Last Updated: 2013-06-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
20 participants
INTERVENTIONAL
2011-10-31
2013-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Victoza treatment
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 Victoza. The placebo pens are specially prepared for this study and will be used in the study only.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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University of Copenhagen
OTHER
Annesofie Faurschou
OTHER
Responsible Party
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Annesofie Faurschou
MD PhD - Resident in dermatology
Principal Investigators
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AnneSofie Faurschou, MD PhD
Role: PRINCIPAL_INVESTIGATOR
Gentofte Hospital
Locations
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Gentofte Hospital
Hellerup, , Denmark
Countries
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Other Identifiers
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2011-000571-13
Identifier Type: -
Identifier Source: org_study_id
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