<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/NCT02981966</url>
  </required_header>
  <id_info>
    <org_study_id>HSC20160596H</org_study_id>
    <nct_id>NCT02981966</nct_id>
  </id_info>
  <brief_title>Effect of Dapagliflozin on Hepatic and Renal Glucose Metabolism Subjects</brief_title>
  <official_title>Effect of Dapagliflozin on Hepatic and Renal Glucose Metabolism Subjects (11038)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>The University of Texas Health Science Center at San Antonio</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>AstraZeneca</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>The University of Texas Health Science Center at San Antonio</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Researchers hope to determine the organ (liver and/or kidney) responsible for the increase in&#xD;
      endogenous glucose production (EGP) following the induction of glucosuria (when glucose is&#xD;
      excreted in detectable amounts in the urine) with an SGLT2 inhibitor, dapagliflozin.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Researchers will measure the rate of hepatic and renal glucose production following&#xD;
      dapagliflozin administration to determine the site of increase in EGP, liver versus kidney.&#xD;
      Researchers will measure the rate of whole body glucose production with 3-3H-glucose (a form&#xD;
      of radioactive glucose) and renal glucose production by renal vein catheterization in T2DM&#xD;
      (type 2 diabetes mellitus) and in lean healthy NGT (normal glucose tolerance) individuals.&#xD;
      Because the increase in EGP is associated with an increase in plasma glucagon concentration&#xD;
      and renal glucose production is stated to be unresponsive to glucagon, the investigators&#xD;
      anticipate that the liver will be responsible, in part, for the increase in EGP.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">May 23, 2019</start_date>
  <completion_date type="Anticipated">December 2023</completion_date>
  <primary_completion_date type="Actual">April 30, 2022</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Endogenous Glucose Production Measurement</measure>
    <time_frame>3 weeks</time_frame>
    <description>Endogenous Glucose Production NGT subjects after dapagliflozin administration. Measured as free plasma glucose</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Renal Glucose Production Measurement of Change</measure>
    <time_frame>Baseline to 3 weeks</time_frame>
    <description>Renal Glucose Production in T2DM and NGT subjects after dapagliflozin/placebo administration</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">32</enrollment>
  <condition>Diabetes Mellitus, Type 2</condition>
  <arm_group>
    <arm_group_label>T2DM individuals on Dapagliflozin</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Individuals with type 2 diabetes mellitus - dapagliflozin</description>
  </arm_group>
  <arm_group>
    <arm_group_label>T2DM individuals on Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Individuals with type 2 diabetes mellitus on placebo</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Normal Glucose Tolerance (NGT) on Dapagliflozin</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Individuals with normal glucose tolerance - dapagliflozin</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Normal Glucose Tolerance (NGT) Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Individuals with normal glucose tolerance - on placebo</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Dapagliflozin</intervention_name>
    <description>dapagliflozin, 10mg tablet</description>
    <arm_group_label>Normal Glucose Tolerance (NGT) on Dapagliflozin</arm_group_label>
    <arm_group_label>T2DM individuals on Dapagliflozin</arm_group_label>
    <other_name>Farxiga</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Placebo for dapagliflozin</description>
    <arm_group_label>Normal Glucose Tolerance (NGT) Placebo</arm_group_label>
    <arm_group_label>T2DM individuals on Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  25-35 kg/m^2&#xD;
&#xD;
          -  Normal Glucose Tolerance subjects (24)&#xD;
&#xD;
          -  Type 2 Diabetic Subjects (24)&#xD;
&#xD;
          -  Diabetic subjects must be on a stable dose (more than 3 months) of monotherapy or&#xD;
             combination therapy with metformin and/or a sulfonylurea&#xD;
&#xD;
          -  Diabetic subjects must have HbA1c &lt;8.0%&#xD;
&#xD;
          -  Other than diabetes, subjects must be in good general health as determined by physical&#xD;
             exam, medical history, blood chemistries, CBC (complete blood count), TSH&#xD;
             (thyroid-stimulating hormone), T4 (thyroxine), EKG (electrocardiogram) and&#xD;
             urinanalysis.&#xD;
&#xD;
          -  Only subjects whose body weight has been stable (± 3 lbs) over the preceding three&#xD;
             months and who do not participate in an excessively heavy exercise program will be&#xD;
             included.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subjects taking drugs known to affect glucose metabolism (other than metformin and&#xD;
             sulfonylurea) will be excluded.&#xD;
&#xD;
          -  Individuals with evidence of proliferative diabetic retinopathy, plasma creatinine&#xD;
             &gt;1.4 females or &gt;1.5 males, or 24-hour urine albumin excretion &gt; 300 mg will be&#xD;
             excluded.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Eugenio Cersosimo, MD,PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>The University of Texas Health Science Center at San Antonio</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Texas Health Science Center</name>
      <address>
        <city>San Antonio</city>
        <state>Texas</state>
        <zip>78229</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>May 2023</verification_date>
  <study_first_submitted>November 30, 2016</study_first_submitted>
  <study_first_submitted_qc>December 2, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 5, 2016</study_first_posted>
  <results_first_submitted>May 10, 2023</results_first_submitted>
  <results_first_submitted_qc>May 10, 2023</results_first_submitted_qc>
  <results_first_posted type="Actual">June 6, 2023</results_first_posted>
  <last_update_submitted>May 10, 2023</last_update_submitted>
  <last_update_submitted_qc>May 10, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">June 6, 2023</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, 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>
  <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>October 18, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/66/NCT02981966/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>T2DM Individuals on Dapagliflozin</title>
          <description>Individuals with type 2 diabetes mellitus - dapagliflozin&#xD;
Dapagliflozin: dapagliflozin, 10mg tablet</description>
        </group>
        <group group_id="P2">
          <title>T2DM Individuals on Placebo</title>
          <description>Individuals with type 2 diabetes mellitus on placebo&#xD;
Placebo: Placebo for dapagliflozin</description>
        </group>
        <group group_id="P3">
          <title>Normal Glucose Tolerance (NGT) on Dapagliflozin</title>
          <description>Individuals with normal glucose tolerance - dapagliflozin&#xD;
Dapagliflozin: dapagliflozin, 10mg tablet</description>
        </group>
        <group group_id="P4">
          <title>Normal Glucose Tolerance (NGT) Placebo</title>
          <description>Individuals with normal glucose tolerance - on placebo&#xD;
Placebo: Placebo for 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="13"/>
                <participants group_id="P2" count="7"/>
                <participants group_id="P3" count="8"/>
                <participants group_id="P4" count="4"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="13"/>
                <participants group_id="P2" count="7"/>
                <participants group_id="P3" count="8"/>
                <participants group_id="P4" count="4"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>T2DM Individuals on Dapagliflozin</title>
          <description>Individuals with type 2 diabetes mellitus - dapagliflozin&#xD;
Dapagliflozin: dapagliflozin, 10mg tablet</description>
        </group>
        <group group_id="B2">
          <title>T2DM Individuals on Placebo</title>
          <description>Individuals with type 2 diabetes mellitus on placebo&#xD;
Placebo: Placebo for dapagliflozin</description>
        </group>
        <group group_id="B3">
          <title>Normal Glucose Tolerance (NGT) on Dapagliflozin</title>
          <description>Individuals with normal glucose tolerance - dapagliflozin&#xD;
Dapagliflozin: dapagliflozin, 10mg tablet</description>
        </group>
        <group group_id="B4">
          <title>Normal Glucose Tolerance (NGT) Placebo</title>
          <description>Individuals with normal glucose tolerance - on placebo&#xD;
Placebo: Placebo for dapagliflozin</description>
        </group>
        <group group_id="B5">
          <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="13"/>
            <count group_id="B2" value="7"/>
            <count group_id="B3" value="8"/>
            <count group_id="B4" value="4"/>
            <count group_id="B5" value="32"/>
          </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="57" spread="3"/>
                    <measurement group_id="B2" value="58" spread="1.7"/>
                    <measurement group_id="B3" value="44" spread="2.2"/>
                    <measurement group_id="B4" value="47" spread="4.9"/>
                    <measurement group_id="B5" value="51.5" spread="2.95"/>
                  </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="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="13"/>
                    <measurement group_id="B2" value="7"/>
                    <measurement group_id="B3" value="8"/>
                    <measurement group_id="B4" value="4"/>
                    <measurement group_id="B5" value="32"/>
                  </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="4"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="6"/>
                    <measurement group_id="B4" value="1"/>
                    <measurement group_id="B5" value="14"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="2"/>
                    <measurement group_id="B4" value="3"/>
                    <measurement group_id="B5" value="18"/>
                  </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 group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="12"/>
                    <measurement group_id="B2" value="7"/>
                    <measurement group_id="B3" value="7"/>
                    <measurement group_id="B4" value="4"/>
                    <measurement group_id="B5" value="30"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                  </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 group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="13"/>
                    <measurement group_id="B2" value="7"/>
                    <measurement group_id="B3" value="8"/>
                    <measurement group_id="B4" value="4"/>
                    <measurement group_id="B5" value="32"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Endogenous Glucose Production Measurement</title>
        <description>Endogenous Glucose Production NGT subjects after dapagliflozin administration. Measured as free plasma glucose</description>
        <time_frame>3 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>T2DM Individuals on Dapagliflozin</title>
            <description>Individuals with type 2 diabetes mellitus - dapagliflozin&#xD;
Dapagliflozin: dapagliflozin, 10mg tablet</description>
          </group>
          <group group_id="O2">
            <title>T2DM Individuals on Placebo</title>
            <description>Individuals with type 2 diabetes mellitus on placebo&#xD;
Placebo: Placebo for dapagliflozin</description>
          </group>
          <group group_id="O3">
            <title>Normal Glucose Tolerance (NGT) on Dapagliflozin</title>
            <description>Individuals with normal glucose tolerance - dapagliflozin&#xD;
Dapagliflozin: dapagliflozin, 10mg tablet</description>
          </group>
          <group group_id="O4">
            <title>Normal Glucose Tolerance (NGT) Placebo</title>
            <description>Individuals with normal glucose tolerance - on placebo&#xD;
Placebo: Placebo for dapagliflozin</description>
          </group>
        </group_list>
        <measure>
          <title>Endogenous Glucose Production Measurement</title>
          <description>Endogenous Glucose Production NGT subjects after dapagliflozin administration. Measured as free plasma glucose</description>
          <units>mg/dl</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="13"/>
                <count group_id="O2" value="7"/>
                <count group_id="O3" value="8"/>
                <count group_id="O4" value="4"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="155" spread="6.4"/>
                    <measurement group_id="O2" value="121" spread="6.2"/>
                    <measurement group_id="O3" value="104" spread="4.2"/>
                    <measurement group_id="O4" value="98" spread="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Renal Glucose Production Measurement of Change</title>
        <description>Renal Glucose Production in T2DM and NGT subjects after dapagliflozin/placebo administration</description>
        <time_frame>Baseline to 3 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>T2DM Individuals on Dapagliflozin</title>
            <description>Individuals with type 2 diabetes mellitus - dapagliflozin&#xD;
Dapagliflozin: dapagliflozin, 10mg tablet</description>
          </group>
          <group group_id="O2">
            <title>T2DM Individuals on Placebo</title>
            <description>Individuals with type 2 diabetes mellitus on placebo&#xD;
Placebo: Placebo for dapagliflozin</description>
          </group>
          <group group_id="O3">
            <title>Normal Glucose Tolerance (NGT) on Dapagliflozin</title>
            <description>Individuals with normal glucose tolerance - dapagliflozin&#xD;
Dapagliflozin: dapagliflozin, 10mg tablet</description>
          </group>
          <group group_id="O4">
            <title>Normal Glucose Tolerance (NGT) Placebo</title>
            <description>Individuals with normal glucose tolerance - on placebo&#xD;
Placebo: Placebo for dapagliflozin</description>
          </group>
        </group_list>
        <measure>
          <title>Renal Glucose Production Measurement of Change</title>
          <description>Renal Glucose Production in T2DM and NGT subjects after dapagliflozin/placebo administration</description>
          <units>mg/kg.min</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="13"/>
                <count group_id="O2" value="7"/>
                <count group_id="O3" value="8"/>
                <count group_id="O4" value="4"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.09" spread="0.04"/>
                    <measurement group_id="O2" value="0.01" spread="0.03"/>
                    <measurement group_id="O3" value="0.03" spread="0.09"/>
                    <measurement group_id="O4" value="0.03" spread="0.09"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>3 weeks</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.17" spread="0.05"/>
                    <measurement group_id="O2" value="0.03" spread="0.05"/>
                    <measurement group_id="O3" value="0.09" spread="0.1"/>
                    <measurement group_id="O4" value="0.14" spread="0.12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>4 years</time_frame>
      <group_list>
        <group group_id="E1">
          <title>T2DM Individuals on Dapagliflozin</title>
          <description>Individuals with type 2 diabetes mellitus - dapagliflozin&#xD;
Dapagliflozin: dapagliflozin, 10mg tablet</description>
        </group>
        <group group_id="E2">
          <title>T2DM Individuals on Placebo</title>
          <description>Individuals with type 2 diabetes mellitus on placebo&#xD;
Placebo: Placebo for dapagliflozin</description>
        </group>
        <group group_id="E3">
          <title>Normal Glucose Tolerance (NGT) on Dapagliflozin</title>
          <description>Individuals with normal glucose tolerance - dapagliflozin&#xD;
Dapagliflozin: dapagliflozin, 10mg tablet</description>
        </group>
        <group group_id="E4">
          <title>Normal Glucose Tolerance (NGT) Placebo</title>
          <description>Individuals with normal glucose tolerance - on placebo&#xD;
Placebo: Placebo for 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="13"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="4"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="4"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_assessment>Non-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="0" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="4"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Transcient Syncope</sub_title>
                <description>Participants had been lying in bed and got up too soon from the bed and felt dizzy.</description>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="4"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT 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>Ralph DeFronzo, MD</name_or_title>
      <organization>UTexas_SanAntonio</organization>
      <phone>210-567-6691</phone>
      <email>defronzo@uthscsa.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/NCT02981966
org study id: HSC20160596H
nct id: NCT02981966
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
Researchers hope to determine the organ (liver and/or kidney) responsible for the increase in
      endogenous glucose production (EGP) following the induction of glucosuria (when glucose is
      excreted in detectable amounts in the urine) with an SGLT2 inhibitor, dapagliflozin.
Researchers will measure the rate of hepatic and renal glucose production following
      dapagliflozin administration to determine the site of increase in EGP, liver versus kidney.
      Researchers will measure the rate of whole body glucose production with 3-3H-glucose (a form
      of radioactive glucose) and renal glucose production by renal vein catheterization in T2DM
      (type 2 diabetes mellitus) and in lean healthy NGT (normal glucose tolerance) individuals.
      Because the increase in EGP is associated with an increase in plasma glucagon concentration
      and renal glucose production is stated to be unresponsive to glucagon, the investigators
      anticipate that the liver will be responsible, in part, for the increase in EGP.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Endogenous Glucose Production Measurement
time frame: 3 weeks
description: Endogenous Glucose Production NGT subjects after dapagliflozin administration. Measured as free plasma glucose
measure: Renal Glucose Production Measurement of Change
time frame: Baseline to 3 weeks
description: Renal Glucose Production in T2DM and NGT subjects after dapagliflozin/placebo administration
arm group label: T2DM individuals on Dapagliflozin
arm group type: Active Comparator
description: Individuals with type 2 diabetes mellitus - dapagliflozin
arm group label: T2DM individuals on Placebo
arm group type: Placebo Comparator
description: Individuals with type 2 diabetes mellitus on placebo
arm group label: Normal Glucose Tolerance (NGT) on Dapagliflozin
arm group type: Active Comparator
description: Individuals with normal glucose tolerance - dapagliflozin
arm group label: Normal Glucose Tolerance (NGT) Placebo
arm group type: Placebo Comparator
description: Individuals with normal glucose tolerance - on placebo
intervention type: Drug
intervention name: Dapagliflozin
description: dapagliflozin, 10mg tablet
arm group label: Normal Glucose Tolerance (NGT) on Dapagliflozin
arm group label: T2DM individuals on Dapagliflozin
other name: Farxiga
intervention type: Drug
intervention name: Placebo
description: Placebo for dapagliflozin
arm group label: Normal Glucose Tolerance (NGT) Placebo
arm group label: T2DM individuals on Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Eugenio Cersosimo, MD,PhD
role: Principal Investigator
affiliation: The University of Texas Health Science Center at San Antonio
facility: 
country: United States
responsible party type: Sponsor
mesh term: Diabetes Mellitus, Type 2
mesh term: Dapagliflozin
sharing ipd: No
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 