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

NCT01451905 | Unknown

• 1 other identifier: GLP1-PSO
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Reduction of Psoriasis Following Liraglutide Therapy in Terms of PASI and DLQI

Outcome Measures

Primary Outcomes (1)

• Changes in PASI and DLQI

  2 months

Study Arms (2)

Psoriasis

ACTIVE COMPARATOR

Drug: Liraglutide

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Liraglutide DRUG

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.

Psoriasis

Placebo DRUG

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Caucasians above 18 years of age
• Plaque psoriasis
• PASI score \>10
• Steady weight through 3 months with a body mass index (BMI) above 27 kg/m2
• Normal blood pressure

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Gentofte, Copenhagen: lead

Study Sites (1)

Gentofte Hospital

Hellerup, 2900, Denmark

RECRUITING

MeSH Terms

Interventions

Liraglutide

Intervention Hierarchy (Ancestors)

Glucagon-Like Peptide 1; Glucagon-Like Peptides; Proglucagon; Gastrointestinal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Central Study Contacts

Annesofie Faurschou, MD PhD

CONTACT

+45 39773977

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD PhD

Study Record Dates

• First Submitted: October 11, 2011
• First Posted: October 14, 2011
• Study Start: August 1, 2011
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: June 21, 2012

Record last verified: 2012-06

Locations

DK (1)