<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/NCT02235298</url>
  </required_header>
  <id_info>
    <org_study_id>20140671</org_study_id>
    <nct_id>NCT02235298</nct_id>
  </id_info>
  <brief_title>Dapagliflozin Effects on Epicardial Fat</brief_title>
  <official_title>Effects of Dapagliflozin on Epicardial Fat in Subjects With Type 2 Diabetes</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Miami</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>AstraZeneca</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Miami</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this research study is to learn about the effect of Dapagliflozin (Farxiga) on&#xD;
      the fat of the heart.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 2015</start_date>
  <completion_date type="Actual">September 10, 2020</completion_date>
  <primary_completion_date type="Actual">September 10, 2020</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>Triple (Participant, Care Provider, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Epicardial Fat Thickness</measure>
    <time_frame>At Baseline, 12 weeks, 24 weeks</time_frame>
    <description>Epicardial fat thickness will be measured in millimeters by treating physician using echocardiography at Baseline, 12 weeks, 24 weeks</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Left Ventricular Mass (LVM)</measure>
    <time_frame>At Baseline, Week 12 and Week 24</time_frame>
    <description>LVM will be measured in g/m^2 by treating physician using echocardiography at baseline, Week 12 and Week 24</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">100</enrollment>
  <condition>Type 2 Diabetes</condition>
  <arm_group>
    <arm_group_label>Dapagliflozin and Metformin Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants in this group will receive Dapagliflozin in addition to Metformin for 6 months.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Metformin and Placebo Group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants in this group will receive Metformin and Placebo for 6 months.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Dapagliflozin</intervention_name>
    <description>5 mg taken orally once daily. After 2 weeks, if there are no safety issues as per treating physician discretion, the dose can be titrated up to 10 mg orally taken once daily.</description>
    <arm_group_label>Dapagliflozin and Metformin Group</arm_group_label>
    <other_name>Farxiga</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Metformin</intervention_name>
    <description>500 mg taken orally twice daily to a maximum of 1000 mg twice daily to achieve a fasting glucose between 80-140 md/dL</description>
    <arm_group_label>Dapagliflozin and Metformin Group</arm_group_label>
    <arm_group_label>Metformin and Placebo Group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Placebo pill taken once daily to mimic Dapagliflozin</description>
    <arm_group_label>Metformin and Placebo Group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Type 2 diabetes, as defined by ADA criteria&#xD;
&#xD;
          -  HbA1c &lt; 8% measured at least 1 week prior to the study&#xD;
&#xD;
          -  BMI ≥27 kg/m2&#xD;
&#xD;
          -  Pre-treatment with Metformin as monotherapy&#xD;
&#xD;
          -  Age &gt; 18 and &lt; 65 years old&#xD;
&#xD;
          -  Normal and stable hemodynamic status&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Known contra-indications to Farxiga, in accordance with risks and safety information&#xD;
             included in the latest updated Prescribing Information&#xD;
&#xD;
          -  Type 1 diabetes, as defined by American Diabetes Association (ADA) criteria&#xD;
&#xD;
          -  Insulin dependent or treated type 2 diabetes&#xD;
&#xD;
          -  Current use of other SGLT2 inhibitors, Glucagon Like Peptide -1 (GLP- 1) analogs or&#xD;
             Dipeptidyl Peptidase 4 (DPP4) inhibitors&#xD;
&#xD;
          -  Glomerular Filtration Rate (GFR) &lt; 60 mL/min/1.73 m2&#xD;
&#xD;
          -  Signs or symptoms of hypovolemia&#xD;
&#xD;
          -  Patients with poor glycemic control (HbA1c ≥ 8%) will be excluded to maximize&#xD;
             long-term patient retention without need&#xD;
&#xD;
          -  History of diabetes ketoacidosis&#xD;
&#xD;
          -  Patients with active bladder cancer or with a prior history of bladder cancer&#xD;
&#xD;
          -  Acute or chronic infective, including genital mycotic infections&#xD;
&#xD;
          -  Clinical signs or symptoms of New York Heart Association (NYHA) class III-IV heart&#xD;
             failure&#xD;
&#xD;
          -  Clinical or laboratory evidences of chronic active liver diseases&#xD;
&#xD;
          -  Acute or chronic infective diseases&#xD;
&#xD;
          -  Cancer or chemotherapy&#xD;
&#xD;
          -  Current use of systemic corticosteroids or in the 3 months prior this study&#xD;
&#xD;
          -  Known or suspected allergy to Dapagliflozin, excipients, or related products&#xD;
&#xD;
          -  Pregnant, breast-feeding or the intention of becoming pregnant&#xD;
&#xD;
          -  Females of childbearing potential who are not using adequate contraceptive methods&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>64 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Gianluca Iacobellis, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Miami</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Miami</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33136</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2021</verification_date>
  <study_first_submitted>September 4, 2014</study_first_submitted>
  <study_first_submitted_qc>September 8, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 9, 2014</study_first_posted>
  <results_first_submitted>January 27, 2021</results_first_submitted>
  <results_first_submitted_qc>January 27, 2021</results_first_submitted_qc>
  <results_first_posted type="Actual">February 16, 2021</results_first_posted>
  <last_update_submitted>January 27, 2021</last_update_submitted>
  <last_update_submitted_qc>January 27, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">February 16, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Miami</investigator_affiliation>
    <investigator_full_name>Gianluca Iacobellis</investigator_full_name>
    <investigator_title>Professor of Clinical Medicine</investigator_title>
  </responsible_party>
  <keyword>epicardial fat</keyword>
  <keyword>diabetes</keyword>
  <keyword>dapagliflozin</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <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>Metformin</mesh_term>
    <mesh_term>Dapagliflozin</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>September 24, 2014</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/98/NCT02235298/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Dapagliflozin and Metformin Group</title>
          <description>Participants in this group will receive Dapagliflozin in addition to Metformin for 6 months.&#xD;
Dapagliflozin: 5 mg taken orally once daily. After 2 weeks, if there are no safety issues as per treating physician discretion, the dose can be titrated up to 10 mg orally taken once daily.&#xD;
Metformin: 500 mg taken orally twice daily to a maximum of 1000 mg twice daily to achieve a fasting glucose between 80-140 md/dL</description>
        </group>
        <group group_id="P2">
          <title>Metformin and Placebo Group</title>
          <description>Participants in this group will receive Metformin and Placebo for 6 months.&#xD;
Metformin: 500 mg taken orally twice daily to a maximum of 1000 mg twice daily to achieve a fasting glucose between 80-140 md/dL&#xD;
Placebo: Placebo pill taken once daily to mimic Dapagliflozin</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="50"/>
                <participants group_id="P2" count="50"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="42"/>
                <participants group_id="P2" count="42"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="8"/>
                <participants group_id="P2" count="8"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="6"/>
                <participants group_id="P2" count="5"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Dapagliflozin and Metformin Group</title>
          <description>Participants in this group will receive Dapagliflozin in addition to Metformin for 6 months.&#xD;
Dapagliflozin: 5 mg taken orally once daily. After 2 weeks, if there are no safety issues as per treating physician discretion, the dose can be titrated up to 10 mg orally taken once daily.&#xD;
Metformin: 500 mg taken orally twice daily to a maximum of 1000 mg twice daily to achieve a fasting glucose between 80-140 md/dL</description>
        </group>
        <group group_id="B2">
          <title>Metformin and Placebo Group</title>
          <description>Participants in this group will receive Metformin and Placebo for 6 months.&#xD;
Metformin: 500 mg taken orally twice daily to a maximum of 1000 mg twice daily to achieve a fasting glucose between 80-140 md/dL&#xD;
Placebo: Placebo pill taken once daily to mimic Dapagliflozin</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="50"/>
            <count group_id="B2" value="50"/>
            <count group_id="B3" value="100"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="52" spread="9"/>
                    <measurement group_id="B2" value="51" spread="11"/>
                    <measurement group_id="B3" value="51.5" spread="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="29"/>
                    <measurement group_id="B2" value="30"/>
                    <measurement group_id="B3" value="59"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="21"/>
                    <measurement group_id="B2" value="20"/>
                    <measurement group_id="B3" value="41"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="25"/>
                    <measurement group_id="B2" value="22"/>
                    <measurement group_id="B3" value="47"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="25"/>
                    <measurement group_id="B2" value="28"/>
                    <measurement group_id="B3" value="53"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Epicardial Fat Thickness</title>
        <description>Epicardial fat thickness will be measured in millimeters by treating physician using echocardiography at Baseline, 12 weeks, 24 weeks</description>
        <time_frame>At Baseline, 12 weeks, 24 weeks</time_frame>
        <population>Data is reported only for the participants that completed the study intervention.</population>
        <group_list>
          <group group_id="O1">
            <title>Dapagliflozin and Metformin Group</title>
            <description>Participants in this group will receive Dapagliflozin in addition to Metformin for 6 months.&#xD;
Dapagliflozin: 5 mg taken orally once daily. After 2 weeks, if there are no safety issues as per treating physician discretion, the dose can be titrated up to 10 mg orally taken once daily.&#xD;
Metformin: 500 mg taken orally twice daily to a maximum of 1000 mg twice daily to achieve a fasting glucose between 80-140 md/dL</description>
          </group>
          <group group_id="O2">
            <title>Metformin and Placebo Group</title>
            <description>Participants in this group will receive Metformin and Placebo for 6 months.&#xD;
Metformin: 500 mg taken orally twice daily to a maximum of 1000 mg twice daily to achieve a fasting glucose between 80-140 md/dL&#xD;
Placebo: Placebo pill taken once daily to mimic Dapagliflozin</description>
          </group>
        </group_list>
        <measure>
          <title>Epicardial Fat Thickness</title>
          <description>Epicardial fat thickness will be measured in millimeters by treating physician using echocardiography at Baseline, 12 weeks, 24 weeks</description>
          <population>Data is reported only for the participants that completed the study intervention.</population>
          <units>mm</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="42"/>
                <count group_id="O2" value="42"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.6" spread="2.2"/>
                    <measurement group_id="O2" value="8.0" spread="2.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>12 Weeks</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.2" spread="2.3"/>
                    <measurement group_id="O2" value="7.4" spread="2.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>24 Weeks</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.7" spread="2.1"/>
                    <measurement group_id="O2" value="7.5" spread="2.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Left Ventricular Mass (LVM)</title>
        <description>LVM will be measured in g/m^2 by treating physician using echocardiography at baseline, Week 12 and Week 24</description>
        <time_frame>At Baseline, Week 12 and Week 24</time_frame>
        <population>Due to time and technical limitations, LVM data were not collected for all participants that completed the study intervention.</population>
        <group_list>
          <group group_id="O1">
            <title>Dapagliflozin and Metformin Group</title>
            <description>Participants in this group will receive Dapagliflozin in addition to Metformin for 6 months.&#xD;
Dapagliflozin: 5 mg taken orally once daily. After 2 weeks, if there are no safety issues as per treating physician discretion, the dose can be titrated up to 10 mg orally taken once daily.&#xD;
Metformin: 500 mg taken orally twice daily to a maximum of 1000 mg twice daily to achieve a fasting glucose between 80-140 md/dL</description>
          </group>
          <group group_id="O2">
            <title>Metformin and Placebo Group</title>
            <description>Participants in this group will receive Metformin and Placebo for 6 months.&#xD;
Metformin: 500 mg taken orally twice daily to a maximum of 1000 mg twice daily to achieve a fasting glucose between 80-140 md/dL&#xD;
Placebo: Placebo pill taken once daily to mimic Dapagliflozin</description>
          </group>
        </group_list>
        <measure>
          <title>Left Ventricular Mass (LVM)</title>
          <description>LVM will be measured in g/m^2 by treating physician using echocardiography at baseline, Week 12 and Week 24</description>
          <population>Due to time and technical limitations, LVM data were not collected for all participants that completed the study intervention.</population>
          <units>g/m^2</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="33"/>
                <count group_id="O2" value="24"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="129" spread="13"/>
                    <measurement group_id="O2" value="130" spread="19"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 12</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="127" spread="18"/>
                    <measurement group_id="O2" value="128" spread="20"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 24</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="122" spread="19"/>
                    <measurement group_id="O2" value="122" spread="20"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>24 Weeks</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Dapagliflozin and Metformin Group</title>
          <description>Participants in this group will receive Dapagliflozin in addition to Metformin for 6 months.&#xD;
Dapagliflozin: 5 mg taken orally once daily. After 2 weeks, if there are no safety issues as per treating physician discretion, the dose can be titrated up to 10 mg orally taken once daily.&#xD;
Metformin: 500 mg taken orally twice daily to a maximum of 1000 mg twice daily to achieve a fasting glucose between 80-140 md/dL</description>
        </group>
        <group group_id="E2">
          <title>Metformin and Placebo Group</title>
          <description>Participants in this group will receive Metformin and Placebo for 6 months.&#xD;
Metformin: 500 mg taken orally twice daily to a maximum of 1000 mg twice daily to achieve a fasting glucose between 80-140 md/dL&#xD;
Placebo: Placebo pill taken once daily to mimic Dapagliflozin</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="50"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="8" subjects_at_risk="50"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="50"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Diarrhea</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Abdominal Distention</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="50"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Urinary Tract Infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Balanitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Frequency of Urination</sub_title>
                <counts group_id="E1" events="6" subjects_affected="6" subjects_at_risk="50"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Dysuria</sub_title>
                <counts group_id="E1" events="6" subjects_affected="6" subjects_at_risk="50"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="50"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Gianluca Iacobellis, MD</name_or_title>
      <organization>University of Miami</organization>
      <phone>305-243-3636</phone>
      <email>giacobellis@miami.edu</email>
    </point_of_contact>
  </clinical_results>
</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/NCT02235298
org study id: 20140671
nct id: NCT02235298
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
is us export: No
The purpose of this research study is to learn about the effect of Dapagliflozin (Farxiga) on
      the fat of the heart.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Care Provider, Investigator)
measure: Epicardial Fat Thickness
time frame: At Baseline, 12 weeks, 24 weeks
description: Epicardial fat thickness will be measured in millimeters by treating physician using echocardiography at Baseline, 12 weeks, 24 weeks
measure: Left Ventricular Mass (LVM)
time frame: At Baseline, Week 12 and Week 24
description: LVM will be measured in g/m^2 by treating physician using echocardiography at baseline, Week 12 and Week 24
arm group label: Dapagliflozin and Metformin Group
arm group type: Experimental
description: Participants in this group will receive Dapagliflozin in addition to Metformin for 6 months.
arm group label: Metformin and Placebo Group
arm group type: Active Comparator
description: Participants in this group will receive Metformin and Placebo for 6 months.
intervention type: Drug
intervention name: Dapagliflozin
description: 5 mg taken orally once daily. After 2 weeks, if there are no safety issues as per treating physician discretion, the dose can be titrated up to 10 mg orally taken once daily.
arm group label: Dapagliflozin and Metformin Group
other name: Farxiga
intervention type: Drug
intervention name: Metformin
description: 500 mg taken orally twice daily to a maximum of 1000 mg twice daily to achieve a fasting glucose between 80-140 md/dL
arm group label: Dapagliflozin and Metformin Group
arm group label: Metformin and Placebo Group
intervention type: Drug
intervention name: Placebo
description: Placebo pill taken once daily to mimic Dapagliflozin
arm group label: Metformin and Placebo Group
criteria: 
gender: All
minimum age: 18 Years
maximum age: 64 Years
healthy volunteers: No
last name: Gianluca Iacobellis, MD, PhD
role: Principal Investigator
affiliation: University of Miami
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Miami
investigator full name: Gianluca Iacobellis
investigator title: Professor of Clinical Medicine
mesh term: Diabetes Mellitus, Type 2
mesh term: Metformin
mesh term: Dapagliflozin
sharing ipd: No
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 