Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

Effect of GLP-1 Analogs on Psoriasis in Type 2 Diabetic Patients

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified September 2012 by Cliniques universitaires Saint-Luc- Université Catholique de Louvain.
Recruitment status was:  Recruiting
Sponsor:
Information provided by (Responsible Party):
Buysschaert, Cliniques universitaires Saint-Luc- Université Catholique de Louvain
ClinicalTrials.gov Identifier:
NCT01687582
First received: September 11, 2012
Last updated: September 13, 2012
Last verified: September 2012

September 11, 2012
September 13, 2012
January 2012
December 2012   (final data collection date for primary outcome measure)
Improvement of PASI score [ Time Frame: 4 to 6 months ] [ Designated as safety issue: No ]
Same as current
No Changes Posted
  • Evolution of BMI (body mass index) [ Time Frame: 4 to 6 months ] [ Designated as safety issue: No ]
    number of patients with weight loss
  • Evolution of immunological data [ Time Frame: 4 to 6 months ] [ Designated as safety issue: No ]
    cytokines and T cells
  • Evolution of histopathological data [ Time Frame: 4 to 6 months ] [ Designated as safety issue: No ]
    thickness, dermis infiltrate in skin plaques and in control areas
  • Evolution of glycaemic control [ Time Frame: 4 to 6 months ] [ Designated as safety issue: No ]
    HbA1c
  • Evolution of routine laboratory measures [ Time Frame: 4 to 6 months ] [ Designated as safety issue: Yes ]
    number of participants with biological adverse effects (pancreatitis enzymes)
  • Evolution of BMI [ Time Frame: 4 to 6 months ] [ Designated as safety issue: No ]
    weight
Same as current
Not Provided
Not Provided
 
Effect of GLP-1 Analogs on Psoriasis in Type 2 Diabetic Patients
Clinical and Histopathological Effect of GLP-1 Analogs on Psoriasis in Type 2 Diabetic Patients
The aim of the study is to evaluate after 4 to 6 months the effects of a GLP-1 analog treatment on psoriatic skin lesions in patients with type 2 diabetes.
The objective of this study is to analyse short and medium-term efficacy on clinical, immunological and histopathological parameters of a GLP-1 receptor agonist on moderate to severe psoriasis plaques in a group of patients with type 2 diabetes.
Interventional
Not Provided
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Type 2 Diabetes
  • Psoriasis
Drug: GLP-1 analog
GLP-1 analog treatment
Other Name: Liraglutide, Victoza or Exenatide, Byetta.
Experimental: GLP-1 analog
Liraglutide, 0.6 to 1.8 mg per day or Exenatide, 5 to 10 µg twice a day.
Intervention: Drug: GLP-1 analog

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
10
March 2013
December 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Type 2 diabetic patients treated with oral anti-hyperglycaemic agents and/or insulin and presenting stable psoriasis plaques for at least one year, which failed to respond to previous systemic and/or topical treatments.

Exclusion Criteria:

  • Type 1 diabetes
  • Secondary diabetes
  • Liver, renal or pancreatic disease
  • Previous treatment with GLP-1 agonist or DPP-4 inhibitors agents
Both
20 Years to 75 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Belgium
 
NCT01687582
UCL-DIAB-02
No
Not Provided
Not Provided
Buysschaert, Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Not Provided
Principal Investigator: Martin Buysschaert, PhD Cliniques universitaires Saint-Luc
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
September 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP