<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/NCT03269058</url>
  </required_header>
  <id_info>
    <org_study_id>VERGES AZ 2015</org_study_id>
    <nct_id>NCT03269058</nct_id>
  </id_info>
  <brief_title>Evaluate the Effects of Dapagliflozin in Patients With Type 2 Diabetes</brief_title>
  <acronym>Cinétique DAPA</acronym>
  <official_title>Effects of Dapagliflozin on Lipoprotein Kinetics in Patients With Type 2 Diabetes</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Centre Hospitalier Universitaire Dijon</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Centre Hospitalier Universitaire Dijon</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study will make it possible to better understand the mechanisms responsible for the&#xD;
      increase in bad cholesterol levels observed in patients with type 2 diabetes treated with&#xD;
      Dapagliflozin, an antidiabetic treatment made by Astrazeneca.&#xD;
&#xD;
      The information will:&#xD;
&#xD;
        -  reveal what is not working properly&#xD;
&#xD;
        -  make it possible to choose the most appropriate treatments against cholesterol to&#xD;
           compensate for this impaired functioning&#xD;
&#xD;
      This biomedical research will take place at the University Hospitals of DIJON and NANTES.&#xD;
&#xD;
        -  28 patients will take part: 20 patients will be given Dapagliflozin and 8 patients will&#xD;
           be given the placebo.&#xD;
&#xD;
        -  The study treatment will be randomised: patients will be given either Dapagliflozin or&#xD;
           the placebo. The treatment duration is 6 months.&#xD;
&#xD;
        -  Moreover, during the inclusion visit and at the end of the study (6 months after the&#xD;
           start of treatment), a kinetics study, to follow the production and elimination of&#xD;
           cholesterol, will be conducted. This will involve administering amino acids that have&#xD;
           been specifically synthesised for this purpose.&#xD;
&#xD;
        -  Participation in the study will last 6 months and include 4 protocol visits.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">December 20, 2017</start_date>
  <completion_date type="Anticipated">June 2021</completion_date>
  <primary_completion_date type="Anticipated">June 2021</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change from baseline the rate of production of VLDL Apo B</measure>
    <time_frame>15 days before treatment initiation, Day 0, Day 90 and Day 180</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Change from baseline the rate of production of IDL Apo B</measure>
    <time_frame>15 days before treatment initiation, Day 0, Day 90 and Day 180</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Change from baseline the rate of production of LDL Apo B</measure>
    <time_frame>15 days before treatment initiation, Day 0, Day 90 and Day 180</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Change from baseline the rate of production of HDL Apo A1</measure>
    <time_frame>15 days before treatment initiation, Day 0, Day 90 and Day 180</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Change from baseline the Fractional Catabolic Rate of VLDL1 Apo B</measure>
    <time_frame>15 days before treatment initiation, Day 0, Day 90 and Day 180</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Change from baseline the Fractional Catabolic Rate of VLDL2 Apo B</measure>
    <time_frame>15 days before treatment initiation, Day 0, Day 90 and Day 180</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Change from baseline the Fractional Catabolic Rate of IDL Apo B</measure>
    <time_frame>15 days before treatment initiation, Day 0, Day 90 and Day 180</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Change from baseline the Fractional Catabolic Rate of LDL Apo B</measure>
    <time_frame>15 days before treatment initiation, Day 0, Day 90 and Day 180</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Change from baseline the Fractional Catabolic Rate of HDL 'Apo A1</measure>
    <time_frame>15 days before treatment initiation, Day 0, Day 90 and Day 180</time_frame>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">28</enrollment>
  <condition>Type-2 Diabetes</condition>
  <condition>Oral Antidiabetics</condition>
  <arm_group>
    <arm_group_label>Patients not treated with statins</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Patients treated with statins</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Dapagliflozin</intervention_name>
    <description>Dapagliflozin 10 mg daily per os</description>
    <arm_group_label>Patients not treated with statins</arm_group_label>
    <arm_group_label>Patients treated with statins</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebos</intervention_name>
    <description>Placebo of Dapagliflozin per day per os</description>
    <arm_group_label>Patients not treated with statins</arm_group_label>
    <arm_group_label>Patients treated with statins</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  persons who have provided written consent&#xD;
&#xD;
          -  type 2 diabetes treated with OAD (metformin and/or sulfonylurea and/or glinides and/or&#xD;
             acarbose and/or DPPIV inhibitors)&#xD;
&#xD;
          -  Stable treatment for 3 months&#xD;
&#xD;
          -  HbA1c between 7.5% and 10%&#xD;
&#xD;
          -  Age between 30 and 65 years&#xD;
&#xD;
          -  BMI between 25 and 35 kg/m²&#xD;
&#xD;
          -  Triglycerides &lt; 300 mg/dl&#xD;
&#xD;
          -  Half of the patients being treated with statins&#xD;
&#xD;
          -  eGFR &gt; 75 ml/min/1.73 m² at inclusion&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  persons without national health insurance cover&#xD;
&#xD;
          -  patients treated with Insulin or a GLP-1 agonist&#xD;
&#xD;
          -  Patients under guardianship&#xD;
&#xD;
          -  patients treated with lipid-lowering drugs (except statins for 50% of patients)&#xD;
&#xD;
          -  kidney failure&#xD;
&#xD;
          -  liver failure or abnormal liver function ASAT or ALAT &gt;3 x upper limit of normal&#xD;
&#xD;
          -  total bilirubin &gt;2mg/dl&#xD;
&#xD;
          -  intestinal disease&#xD;
&#xD;
          -  serological evidence of an active liver infection (surface antigen of hepatitis B,&#xD;
             hepatitis C antibodies, hepatitis B IgM antibodies)&#xD;
&#xD;
          -  Pregnancy, breastfeeding&#xD;
&#xD;
          -  hypersensitivity to the active substance or to excipients&#xD;
&#xD;
          -  patients with volume depletion, for example due to an acute disease (gastro-intestinal&#xD;
             disease)&#xD;
&#xD;
          -  patients treated with loop diuretics or thiazides&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>30 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Bruno VERGES</last_name>
    <phone>03.80.29.38.54</phone>
    <phone_ext>+33</phone_ext>
    <email>bruno.verges@chu-dijon.fr</email>
  </overall_contact>
  <location>
    <facility>
      <name>CHU Dijon Bourgogne</name>
      <address>
        <city>Dijon</city>
        <zip>21079</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Bruno VERGES, MD</last_name>
      <phone>03 80 29 38 54</phone>
      <phone_ext>+33</phone_ext>
      <email>bruno.verges@chu-dijon.fr</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>CHU de Nantes</name>
      <address>
        <city>Nantes</city>
        <zip>44093</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Michel KREMPF, MD</last_name>
      <phone>02 53 48 27 07</phone>
      <phone_ext>+33</phone_ext>
      <email>michel.krempf@univ-nantes.fr</email>
    </contact>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>November 2019</verification_date>
  <study_first_submitted>August 25, 2017</study_first_submitted>
  <study_first_submitted_qc>August 30, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 31, 2017</study_first_posted>
  <last_update_submitted>November 19, 2019</last_update_submitted>
  <last_update_submitted_qc>November 19, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">November 20, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Diabetes Mellitus</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>Dapagliflozin</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/NCT03269058
org study id: VERGES AZ 2015
nct id: NCT03269058
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
This study will make it possible to better understand the mechanisms responsible for the
      increase in bad cholesterol levels observed in patients with type 2 diabetes treated with
      Dapagliflozin, an antidiabetic treatment made by Astrazeneca.

      The information will:

        -  reveal what is not working properly

        -  make it possible to choose the most appropriate treatments against cholesterol to
           compensate for this impaired functioning

      This biomedical research will take place at the University Hospitals of DIJON and NANTES.

        -  28 patients will take part: 20 patients will be given Dapagliflozin and 8 patients will
           be given the placebo.

        -  The study treatment will be randomised: patients will be given either Dapagliflozin or
           the placebo. The treatment duration is 6 months.

        -  Moreover, during the inclusion visit and at the end of the study (6 months after the
           start of treatment), a kinetics study, to follow the production and elimination of
           cholesterol, will be conducted. This will involve administering amino acids that have
           been specifically synthesised for this purpose.

        -  Participation in the study will last 6 months and include 4 protocol visits.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Change from baseline the rate of production of VLDL Apo B
time frame: 15 days before treatment initiation, Day 0, Day 90 and Day 180
measure: Change from baseline the rate of production of IDL Apo B
time frame: 15 days before treatment initiation, Day 0, Day 90 and Day 180
measure: Change from baseline the rate of production of LDL Apo B
time frame: 15 days before treatment initiation, Day 0, Day 90 and Day 180
measure: Change from baseline the rate of production of HDL Apo A1
time frame: 15 days before treatment initiation, Day 0, Day 90 and Day 180
measure: Change from baseline the Fractional Catabolic Rate of VLDL1 Apo B
time frame: 15 days before treatment initiation, Day 0, Day 90 and Day 180
measure: Change from baseline the Fractional Catabolic Rate of VLDL2 Apo B
time frame: 15 days before treatment initiation, Day 0, Day 90 and Day 180
measure: Change from baseline the Fractional Catabolic Rate of IDL Apo B
time frame: 15 days before treatment initiation, Day 0, Day 90 and Day 180
measure: Change from baseline the Fractional Catabolic Rate of LDL Apo B
time frame: 15 days before treatment initiation, Day 0, Day 90 and Day 180
measure: Change from baseline the Fractional Catabolic Rate of HDL 'Apo A1
time frame: 15 days before treatment initiation, Day 0, Day 90 and Day 180
arm group label: Patients not treated with statins
arm group type: Experimental
arm group label: Patients treated with statins
arm group type: Experimental
intervention type: Drug
intervention name: Dapagliflozin
description: Dapagliflozin 10 mg daily per os
arm group label: Patients not treated with statins
arm group label: Patients treated with statins
intervention type: Drug
intervention name: Placebos
description: Placebo of Dapagliflozin per day per os
arm group label: Patients not treated with statins
arm group label: Patients treated with statins
criteria: 
gender: All
minimum age: 30 Years
maximum age: 65 Years
healthy volunteers: No
last name: Bruno VERGES
phone: 03.80.29.38.54
phone ext: +33
email: bruno.verges@chu-dijon.fr
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
country: France
responsible party type: Sponsor
mesh term: Diabetes Mellitus
mesh term: Diabetes Mellitus, Type 2
mesh term: Dapagliflozin