<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT01687582</url>
  </required_header>
  <id_info>
    <org_study_id>UCL-DIAB-02</org_study_id>
    <nct_id>NCT01687582</nct_id>
  </id_info>
  <brief_title>Effect of GLP-1 Analogs on Psoriasis in Type 2 Diabetic Patients</brief_title>
  <official_title>Clinical and Histopathological Effect of GLP-1 Analogs on Psoriasis in Type 2 Diabetic Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Cliniques universitaires Saint-Luc- Université Catholique de Louvain</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Cliniques universitaires Saint-Luc- Université Catholique de Louvain</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of the study is to evaluate after 4 to 6 months the effects of a GLP-1 analog&#xD;
      treatment on psoriatic skin lesions in patients with type 2 diabetes.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The objective of this study is to analyse short and medium-term efficacy on clinical,&#xD;
      immunological and histopathological parameters of a GLP-1 receptor agonist on moderate to&#xD;
      severe psoriasis plaques in a group of patients with type 2 diabetes.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>January 2012</start_date>
  <completion_date type="Actual">March 2013</completion_date>
  <primary_completion_date type="Actual">December 2012</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Improvement of PASI score</measure>
    <time_frame>4 to 6 months</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Evolution of BMI (body mass index)</measure>
    <time_frame>4 to 6 months</time_frame>
    <description>number of patients with weight loss</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evolution of immunological data</measure>
    <time_frame>4 to 6 months</time_frame>
    <description>cytokines and T cells</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evolution of histopathological data</measure>
    <time_frame>4 to 6 months</time_frame>
    <description>thickness, dermis infiltrate in skin plaques and in control areas</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evolution of glycaemic control</measure>
    <time_frame>4 to 6 months</time_frame>
    <description>HbA1c</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evolution of routine laboratory measures</measure>
    <time_frame>4 to 6 months</time_frame>
    <description>number of participants with biological adverse effects (pancreatitis enzymes)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evolution of BMI</measure>
    <time_frame>4 to 6 months</time_frame>
    <description>weight</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">10</enrollment>
  <condition>Type 2 Diabetes</condition>
  <condition>Psoriasis</condition>
  <arm_group>
    <arm_group_label>GLP-1 analog</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Liraglutide, 0.6 to 1.8 mg per day or Exenatide, 5 to 10 µg twice a day.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>GLP-1 analog</intervention_name>
    <description>GLP-1 analog treatment</description>
    <arm_group_label>GLP-1 analog</arm_group_label>
    <other_name>Liraglutide, Victoza or Exenatide, Byetta.</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Type 2 diabetic patients treated with oral anti-hyperglycaemic agents and/or insulin&#xD;
             and presenting stable psoriasis plaques for at least one year, which failed to respond&#xD;
             to previous systemic and/or topical treatments.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Type 1 diabetes&#xD;
&#xD;
          -  Secondary diabetes&#xD;
&#xD;
          -  Liver, renal or pancreatic disease&#xD;
&#xD;
          -  Previous treatment with GLP-1 agonist or DPP-4 inhibitors agents&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Martin Buysschaert, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Cliniques universitaires Saint-Luc</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Cliniques universitaires Saint-Luc</name>
      <address>
        <city>Brussels</city>
        <zip>1200</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Belgium</country>
  </location_countries>
  <reference>
    <citation>Buysschaert M, Tennstedt D, Preumont V. Improvement of psoriasis during exenatide treatment in a patient with diabetes. Diabetes Metab. 2012 Feb;38(1):86-8. doi: 10.1016/j.diabet.2011.11.004. Epub 2012 Jan 9.</citation>
    <PMID>22227407</PMID>
  </reference>
  <reference>
    <citation>Hogan AE, Tobin AM, Ahern T, Corrigan MA, Gaoatswe G, Jackson R, O'Reilly V, Lynch L, Doherty DG, Moynagh PN, Kirby B, O'Connell J, O'Shea D. Glucagon-like peptide-1 (GLP-1) and the regulation of human invariant natural killer T cells: lessons from obesity, diabetes and psoriasis. Diabetologia. 2011 Nov;54(11):2745-54. doi: 10.1007/s00125-011-2232-3. Epub 2011 Jul 9.</citation>
    <PMID>21744074</PMID>
  </reference>
  <verification_date>March 2019</verification_date>
  <study_first_submitted>September 11, 2012</study_first_submitted>
  <study_first_submitted_qc>September 13, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 19, 2012</study_first_posted>
  <last_update_submitted>March 8, 2019</last_update_submitted>
  <last_update_submitted_qc>March 8, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">March 12, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>type 2 diabetes</keyword>
  <keyword>psoriasis</keyword>
  <keyword>exenatide</keyword>
  <keyword>liraglutide</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Psoriasis</mesh_term>
    <mesh_term>Diabetes Mellitus, Type 2</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Liraglutide</mesh_term>
    <mesh_term>Exenatide</mesh_term>
  </intervention_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01687582
org study id: UCL-DIAB-02
nct id: NCT01687582
lead sponsor: 
has dmc: No
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.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Improvement of PASI score
time frame: 4 to 6 months
measure: Evolution of BMI (body mass index)
time frame: 4 to 6 months
description: number of patients with weight loss
measure: Evolution of immunological data
time frame: 4 to 6 months
description: cytokines and T cells
measure: Evolution of histopathological data
time frame: 4 to 6 months
description: thickness, dermis infiltrate in skin plaques and in control areas
measure: Evolution of glycaemic control
time frame: 4 to 6 months
description: HbA1c
measure: Evolution of routine laboratory measures
time frame: 4 to 6 months
description: number of participants with biological adverse effects (pancreatitis enzymes)
measure: Evolution of BMI
time frame: 4 to 6 months
description: weight
arm group label: GLP-1 analog
arm group type: Experimental
description: Liraglutide, 0.6 to 1.8 mg per day or Exenatide, 5 to 10 µg twice a day.
intervention type: Drug
intervention name: GLP-1 analog
description: GLP-1 analog treatment
arm group label: GLP-1 analog
other name: Liraglutide, Victoza or Exenatide, Byetta.
criteria: 
gender: All
minimum age: 20 Years
maximum age: 75 Years
healthy volunteers: No
last name: Martin Buysschaert, PhD
role: Principal Investigator
affiliation: Cliniques universitaires Saint-Luc
facility: 
country: Belgium
citation: Buysschaert M, Tennstedt D, Preumont V. Improvement of psoriasis during exenatide treatment in a patient with diabetes. Diabetes Metab. 2012 Feb;38(1):86-8. doi: 10.1016/j.diabet.2011.11.004. Epub 2012 Jan 9.
PMID: 22227407
citation: Hogan AE, Tobin AM, Ahern T, Corrigan MA, Gaoatswe G, Jackson R, O'Reilly V, Lynch L, Doherty DG, Moynagh PN, Kirby B, O'Connell J, O'Shea D. Glucagon-like peptide-1 (GLP-1) and the regulation of human invariant natural killer T cells: lessons from obesity, diabetes and psoriasis. Diabetologia. 2011 Nov;54(11):2745-54. doi: 10.1007/s00125-011-2232-3. Epub 2011 Jul 9.
PMID: 21744074
responsible party type: Sponsor
mesh term: Psoriasis
mesh term: Diabetes Mellitus, Type 2
mesh term: Liraglutide
mesh term: Exenatide