<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/NCT03006471</url>
  </required_header>
  <id_info>
    <org_study_id>DAPA-BP variability</org_study_id>
    <nct_id>NCT03006471</nct_id>
  </id_info>
  <brief_title>Effect of Dapagliflozin on Blood Pressure Variability in Prediabetes and Prehypertension</brief_title>
  <official_title>Effect of Dapagliflozin on Blood Pressure Variability in Patients With Prediabetes and Prehypertension Without Pharmacological Treatment</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Guadalajara</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Guadalajara</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Prediabetes is defined as an intermediate metabolic state that leads to the development of&#xD;
      type 2 diabetes mellitus (DM2) and the prehypertension is a category assigned to identify&#xD;
      patients who are at risk of developing hypertension (AH), in both pathologies the&#xD;
      abnormalities in the variation of blood pressure (BP) has been related to organ damage, its&#xD;
      evaluation is performed by ambulatory blood pressure monitoring (ABPM).&#xD;
&#xD;
      Dapagliflozin is a selective and reversible inhibitor of the sodium-glucose co-transporter&#xD;
      type 2 (SGLT-2), which reduces renal reabsorption of glucose and promotes the excretion of&#xD;
      glucose through the urine, in the way that glucose blood. Another reported effects is the&#xD;
      decrease on BP, so it would be interesting to evaluate this effects in patients with&#xD;
      prediabetes and prehypertension, as a potential therapy to treat disorders and to prevent&#xD;
      progression to DM2 and Hypertension, respectively.&#xD;
&#xD;
      The aim of this study is to evaluate the effect of Dapagliflozin on variability of blood&#xD;
      pressure in patients with prediabetes and prehypertension without pharmacological treatment.&#xD;
&#xD;
      The investigators hypothesis is that the administration of dapagliflozin decreases&#xD;
      variability of blood pressure in patients with prediabetes and prehypertension without&#xD;
      pharmacological treatment.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A randomized, double-blind, placebo-controlled clinical trial in 30 patients with a diagnosis&#xD;
      of prediabetes and prehypertension without treatment.&#xD;
&#xD;
      They will be assigned randomly two groups of 15 patients each to receive 10 mg of&#xD;
      Dapagliflozin (Forxiga, Astra Zeneca) or placebo, one per day before breakfast during 12&#xD;
      weeks.&#xD;
&#xD;
      There will be calculated body mass index (BMI) and blood pressure variability. This protocol&#xD;
      it's already approved by the local ethics committee and written informed consent it's going&#xD;
      to be obtained from all volunteers.&#xD;
&#xD;
      Statistical analysis will be presented through measures of central tendency and dispersion,&#xD;
      average and deviation standard for quantitative variables; frequencies and percentages for&#xD;
      variable qualitative. Qualitative variables will be analyzed by X2/ exact fisher test, will&#xD;
      be used for differences inter-group Mann-Whitney U Test and coefficient of variation,&#xD;
      Wilcoxon Test and index of variability for the within-groups differences. It will be&#xD;
      considered statistical significance p ≤0.05.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 30, 2016</start_date>
  <completion_date type="Actual">June 29, 2018</completion_date>
  <primary_completion_date type="Actual">March 30, 2018</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>24-hours Systolic Blood Pressure at Week 12</measure>
    <time_frame>Week 12</time_frame>
    <description>Blood pressure variability was evaluated with ambulatory blood pressure monitoring (ABPM) for 24 hours by oscillometric method Microlife WatchBP O3</description>
  </primary_outcome>
  <primary_outcome>
    <measure>24-hours Diastolic Blood Pressure at Week 12</measure>
    <time_frame>Week 12</time_frame>
    <description>Blood pressure variability was evaluated with ambulatory blood pressure monitoring (ABPM) for 24 hours by oscillometric method Microlife WatchBP O3</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Daytime Systolic Blood Pressure at Week 12</measure>
    <time_frame>Week 12</time_frame>
    <description>Blood pressure variability was evaluated with ambulatory blood pressure monitoring (ABPM) from 8 am. to 11 p.m. by oscillometric method Microlife WatchBP O3</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Daytime Diastolic Blood Pressure at Week 12</measure>
    <time_frame>Week 12</time_frame>
    <description>Blood pressure variability was evaluated with ambulatory blood pressure monitoring (ABPM) from 8 a.m. to p.m. by oscillometric method Microlife WatchBP O3</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Nighttime Systolic Blood Pressure at Week 12</measure>
    <time_frame>Week 12</time_frame>
    <description>Blood pressure variability was evaluated with ambulatory blood pressure monitoring (ABPM) from 11 p.m to 8 a.m. by oscillometric method Microlife WatchBP O3</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Nighttime Diastolic Blood Pressure at Week 12</measure>
    <time_frame>Week 12</time_frame>
    <description>Blood pressure variability was evaluated with ambulatory blood pressure monitoring (ABPM) from 11 p.m. to 8 a.m. by oscillometric method Microlife WatchBP O3</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Systolic Blood Pressure Weighted Standard Deviation at Week 12</measure>
    <time_frame>Week 12</time_frame>
    <description>Blood pressure variability will be evaluated with ambulatory blood pressure monitoring (ABPM) for 24 hours by oscillometric method Microlife WatchBP O3</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Diastolic Blood Pressure Weighted Standard Deviation at Week 12</measure>
    <time_frame>Week 12</time_frame>
    <description>Blood pressure variability was evaluated with ambulatory blood pressure monitoring (ABPM) for 24 hours by oscillometric method Microlife WatchBP O3</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Coefficient of Variation of 24-hours, Systolic Blood Pressure at Week 12</measure>
    <time_frame>Week 12</time_frame>
    <description>Blood pressure variability was evaluated with ambulatory blood pressure monitoring (ABPM) for 24 hours by oscillometric method Microlife WatchBP O3</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Coefficient of Variation of 24-hours, Diastolic Blood Pressure at Week 12</measure>
    <time_frame>Week 12</time_frame>
    <description>Blood pressure variability was evaluated with ambulatory blood pressure monitoring (ABPM) for 24 hours by oscillometric method Microlife WatchBP O3</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Coefficient of Variation Daytime, Systolic Blood Pressure at Week 12</measure>
    <time_frame>Week 12</time_frame>
    <description>Blood pressure variability was evaluated with ambulatory blood pressure monitoring (ABPM) from 8 a.m to 11 p.m. by oscillometric method Microlife WatchBP O3</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Coefficient of Variation Daytime, Diastolic Blood Pressure at Week 12</measure>
    <time_frame>Week 12</time_frame>
    <description>Blood pressure variability was evaluated with ambulatory blood pressure monitoring (ABPM) from 8 a.m. to 11 p.m. by oscillometric method Microlife WatchBP O3</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Coefficient of Variation Nighttime, Systolic Blood Pressure at Week 12</measure>
    <time_frame>Week 12</time_frame>
    <description>Blood pressure variability was evaluated with ambulatory blood pressure monitoring (ABPM) from 11 p.m. to 8 a.m. by oscillometric method Microlife WatchBP O3</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Coefficient of Variation Nighttime, Diastolic Blood Pressure at Week 12</measure>
    <time_frame>Week 12</time_frame>
    <description>Blood pressure variability was evaluated with ambulatory blood pressure monitoring (ABPM) from 11 p.m. to 8 a.m. by oscillometric method Microlife WatchBP O3</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Average Real Variability of Systolic Blood Pressure at Week 12</measure>
    <time_frame>Week 12</time_frame>
    <description>Blood pressure variability was evaluated with ambulatory blood pressure monitoring (ABPM) for 24 hours by oscillometric method Microlife WatchBP O3</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Average Real Variability of Diastolic Blood Pressure at Week 12</measure>
    <time_frame>Week 12</time_frame>
    <description>Blood pressure variability was evaluated with ambulatory blood pressure monitoring (ABPM) for 24 hours by oscillometric method Microlife WatchBP O3</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Participants With a Nondipper Circadian Blood Pressure Pattern at Week 12</measure>
    <time_frame>Week 12</time_frame>
    <description>Blood pressure variability was evaluated with ambulatory blood pressure monitoring (ABPM) for 24 hours by oscillometric method Microlife WatchBP O3</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Participants With a Dipper Circadian Blood Pressure Pattern at Week 12</measure>
    <time_frame>Week 12</time_frame>
    <description>Blood pressure variability was evaluated with ambulatory blood pressure monitoring (ABPM) for 24 hours by oscillometric method Microlife WatchBP O3</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Participants With a Dipper Reverse Circadian Blood Pattern at Week 12</measure>
    <time_frame>Week 12</time_frame>
    <description>Blood pressure variability was evaluated with ambulatory blood pressure monitoring (ABPM) for 24 hours by oscillometric method Microlife WatchBP O3</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Body Weight at Week 12</measure>
    <time_frame>Week 12</time_frame>
    <description>The body weight was measured with a bioimpedance balance</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Body Mass Index at Week 12</measure>
    <time_frame>Week 12</time_frame>
    <description>Body Mas Index was calculated with the Quetelet index formula</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Office Systolic Blood Pressure at Week 12</measure>
    <time_frame>Week 12</time_frame>
    <description>Blood pressure was measured using the Omron 907-E digital sphygmomanometer (Healthcare, Inc.)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Office of Diastolic Blood Pressure at Week 12</measure>
    <time_frame>Week 12</time_frame>
    <description>Blood pressure was measured using the Omron 907-E digital sphygmomanometer (Healthcare, Inc.)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fasting Plasma Glucose Levels at Week 12</measure>
    <time_frame>Week 12</time_frame>
    <description>The fasting glucose levels was evaluated with enzymatic/colorimetric techniques</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>2-hours Plasma Glucose After a Oral Glucose Tolerance Test at Week 12</measure>
    <time_frame>Week 12</time_frame>
    <description>2-hours plasma glucose after a oral glucose tolerance test (75 g of glucose load). Glucose was evaluated with enzymatic/ colorimetric technique</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Glycated Hemoglobin A1c (A1C) at Week 12</measure>
    <time_frame>Week 12</time_frame>
    <description>A1C was evaluated by Enzyme-Linked ImmunoSorbent Assay (ELISA)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Daytime Mean Arterial Pressure at Week 12</measure>
    <time_frame>Week 12</time_frame>
    <description>The mean arterial pressure was evaluated with ambulatory blood pressure monitoring (ABPM) from 8 a.m. to 11 p.m. by oscillometric method Microlife WatchBP O3</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Nighttime Mean Arterial Pressure at Week 12</measure>
    <time_frame>Week 12</time_frame>
    <description>The Mean Arterial Pressure was evaluated with ambulatory blood pressure monitoring (ABPM) from 11 p.m. to 8 a.m. by oscillometric method Microlife WatchBP O3</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Daytime Hypertensive Load at Week 12</measure>
    <time_frame>Week 12</time_frame>
    <description>The hypertensive load was evaluated with ambulatory blood pressure monitoring (ABPM) from 8 a.m. to 11 p.m. by oscillometric method Microlife WatchBP O3</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Nocturnal Hypertensive Load at Week 12</measure>
    <time_frame>Week 12</time_frame>
    <description>The Hypertensive Load was evaluated with ambulatory blood pressure monitoring (ABPM) from 11 p.m. to a.m. by oscillometric method Microlife WatchBP O3</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Prediabetes at Week 12</measure>
    <time_frame>Week 12</time_frame>
    <description>Prediabetes was diagnosed with the criteria of the American Diabetes Association.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Prehypertension at Week 12</measure>
    <time_frame>Week 12</time_frame>
    <description>Prehypertension was diagnosed with the criteria of the Eighth Joint National Committee.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Prediabetes Plus Prehypertension at Week 12</measure>
    <time_frame>Week 12</time_frame>
    <description>Criteria of the American Diabetes Association and Eighth Joint National Committee were used to diagnosed prediabetes and prehypertension.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">30</enrollment>
  <condition>PreDiabetes</condition>
  <condition>Prehypertension</condition>
  <arm_group>
    <arm_group_label>Dapagliflozin</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Dapagliflozin capsules, 10 mg, one per day before breakfast during 12 weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo capsules, one per day before breakfast during 12 weeks.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Dapagliflozin</intervention_name>
    <description>10 mg, one per day before breakfast during 12 weeks.</description>
    <arm_group_label>Dapagliflozin</arm_group_label>
    <other_name>Forxiga</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo - Cap</intervention_name>
    <description>one per day before breakfast during 12 weeks.</description>
    <arm_group_label>Placebo</arm_group_label>
    <other_name>Calcined magnesium</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Informed consent signed&#xD;
&#xD;
          -  Patients both sexes, age between 30 and 60 years&#xD;
&#xD;
          -  Diagnosis of prediabetes according American Diabetes Association criteria (fasting&#xD;
             blood glucose levels between 100-126 mg/dl; postprandial blood glucose levels after an&#xD;
             oral glucose tolerance test with 75 of oral glucose between 140-199 mg/dl; or&#xD;
             glycosylated hemoglobin between 5.7-6.4%)&#xD;
&#xD;
          -  Diagnosis of prehypertension according (JNC8) Eighth Joint National Committee blood&#xD;
             pressure between 120-139/ 80-89 mmHg.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Women with confirmed or suspected pregnancy&#xD;
&#xD;
          -  Women under lactation and/or puerperium&#xD;
&#xD;
          -  Hypersensibility to ingredients of intervention&#xD;
&#xD;
          -  Physical impossibility for taking pills&#xD;
&#xD;
          -  Known uncontrolled renal, hepatic, heart or thyroid diseased&#xD;
&#xD;
          -  Diabetes diagnosis&#xD;
&#xD;
          -  Previous treatment for glucose or blood pressure Triglycerides ≥400 mg/dL&#xD;
&#xD;
          -  Total cholesterol ≥240 mg/dL&#xD;
&#xD;
          -  History of cardiovascular disease&#xD;
&#xD;
          -  Worker per shift / night&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>30 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>MANUEL GONZALEZ, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Guadalajara</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Instituto de Terapeútica Experimental y Clínica. Centro Universitario de Ciencias de la Salud. Universidad de Guadalajara</name>
      <address>
        <city>Guadalajara</city>
        <state>Jalisco</state>
        <zip>44340</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Mexico</country>
  </location_countries>
  <verification_date>October 2020</verification_date>
  <study_first_submitted>December 13, 2016</study_first_submitted>
  <study_first_submitted_qc>December 29, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 30, 2016</study_first_posted>
  <results_first_submitted>August 27, 2020</results_first_submitted>
  <results_first_submitted_qc>September 19, 2020</results_first_submitted_qc>
  <results_first_posted type="Actual">October 19, 2020</results_first_posted>
  <last_update_submitted>October 16, 2020</last_update_submitted>
  <last_update_submitted_qc>October 16, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">November 9, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Guadalajara</investigator_affiliation>
    <investigator_full_name>Manuel González Ortiz</investigator_full_name>
    <investigator_title>PhD</investigator_title>
  </responsible_party>
  <keyword>Prediabetes</keyword>
  <keyword>Prehypertension</keyword>
  <keyword>Variability of blood pressure</keyword>
  <keyword>ABPM</keyword>
  <keyword>Dapagliflozin</keyword>
  <keyword>SGLT2</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Prehypertension</mesh_term>
    <mesh_term>Prediabetic State</mesh_term>
    <mesh_term>Glucose Intolerance</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dapagliflozin</mesh_term>
  </intervention_browse>
  <provided_document_section>
    <provided_document>
      <document_type>Informed Consent Form</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>June 9, 2016</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/71/NCT03006471/ICF_000.pdf</document_url>
    </provided_document>
    <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>June 9, 2016</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/71/NCT03006471/Prot_SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Dapagliflozin</title>
          <description>Dapagliflozin capsules, 10 mg, one per day before breakfast during 12 weeks.&#xD;
Dapagliflozin: 10 mg, one per day before breakfast during 12 weeks.</description>
        </group>
        <group group_id="P2">
          <title>Placebo</title>
          <description>Placebo capsules, one per day before breakfast during 12 weeks.&#xD;
Placebo - Cap: one per day before breakfast during 12 weeks.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="15"/>
                <participants group_id="P2" count="15"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="13">Two patients did not complete the study due to early withdrawal</participants>
                <participants group_id="P2" count="13">Two patients did not complete the study due to early withdrawal</participants>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="2"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Dapagliflozin</title>
          <description>Dapagliflozin capsules, 10 mg, one per day before breakfast during 12 weeks.&#xD;
Dapagliflozin: 10 mg, one per day before breakfast during 12 weeks.</description>
        </group>
        <group group_id="B2">
          <title>Placebo</title>
          <description>Placebo capsules, one per day before breakfast during 12 weeks.&#xD;
Placebo - Cap: one per day before breakfast during 12 weeks.</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="15"/>
            <count group_id="B2" value="15"/>
            <count group_id="B3" value="30"/>
          </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="47" spread="7"/>
                    <measurement group_id="B2" value="50" spread="5"/>
                    <measurement group_id="B3" value="48.5" spread="6"/>
                  </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="11"/>
                    <measurement group_id="B2" value="8"/>
                    <measurement group_id="B3" value="19"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="7"/>
                    <measurement group_id="B3" value="11"/>
                  </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="15"/>
                    <measurement group_id="B2" value="15"/>
                    <measurement group_id="B3" value="30"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</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>
                  <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>
          <title>Region of Enrollment</title>
          <units>Mexico</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>Mexico</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="15"/>
                    <measurement group_id="B2" value="15"/>
                    <measurement group_id="B3" value="30"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Body weight</title>
          <description>The body weight was measured with a bioimpedance balance and the entered values reflect the body weight at baseline</description>
          <units>kg</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="74" spread="10"/>
                    <measurement group_id="B2" value="80" spread="12"/>
                    <measurement group_id="B3" value="77" spread="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Body Mass Index</title>
          <description>Body Mas Index was calculated with the Quetelet index formula and the entered values reflect the body mass index at baseline</description>
          <units>kg/m^2</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="30" spread="2"/>
                    <measurement group_id="B2" value="31" spread="2"/>
                    <measurement group_id="B3" value="30.5" spread="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Office Systolic blood pressure</title>
          <description>The office blood pressure was measured at baseline using the Omron 907-E digital sphygmomanometer (Healthcare, Inc.).</description>
          <units>mmHg</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="127" spread="7"/>
                    <measurement group_id="B2" value="127" spread="5"/>
                    <measurement group_id="B3" value="127" spread="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Office Diastolic blood pressure</title>
          <description>The office blood pressure was measured at baseline using the Omron 907-E digital sphygmomanometer (Healthcare, Inc.).</description>
          <units>mmHg</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="80.0" spread="6.0"/>
                    <measurement group_id="B2" value="81.0" spread="7.0"/>
                    <measurement group_id="B3" value="80.5" spread="6.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Fasting plasma glucose</title>
          <description>The fasting glucose level was evaluated with enzymatic/colorimetric techniques at baseline</description>
          <units>mmol/L</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="6.3" spread="0.3"/>
                    <measurement group_id="B2" value="6.0" spread="0.4"/>
                    <measurement group_id="B3" value="6.15" spread="0.35"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>2-hours plasma glucose after a oral glucose tolerance test</title>
          <description>2-hours glucose was evaluated with an oral glucose tolerance test (75 g of glucose load) using enzymatic/colorimetric technique at baseline</description>
          <units>mmol/L</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="8.4" spread="1.4"/>
                    <measurement group_id="B2" value="7.9" spread="2.4"/>
                    <measurement group_id="B3" value="8.15" spread="1.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Glycated hemoglobin A1c (A1C)</title>
          <description>Glycosylated hemoglobin was evaluated at baseline by ELISA technique</description>
          <units>percentage of A1C</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="5.9" spread="0.5"/>
                    <measurement group_id="B2" value="5.8" spread="0.3"/>
                    <measurement group_id="B3" value="5.85" spread="0.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>24-hours Systolic Blood pressure</title>
          <description>Blood pressure variability was evaluated with ambulatory blood pressure monitoring (ABPM) for 24 hours by oscillometric method Microlife WatchBP O3</description>
          <units>mmHg</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="121" spread="8"/>
                    <measurement group_id="B2" value="119" spread="9"/>
                    <measurement group_id="B3" value="120" spread="8.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>24-hours Diastolic Blood Pressure</title>
          <description>Blood pressure variability was evaluated with ambulatory blood pressure monitoring (ABPM) for 24 hours by oscillometric method Microlife WatchBP O3</description>
          <units>mmHg</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="73" spread="7"/>
                    <measurement group_id="B2" value="74" spread="7"/>
                    <measurement group_id="B3" value="73.5" spread="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Daytime Systolic Blood Pressure</title>
          <description>Blood pressure variability was evaluated with ambulatory blood pressure monitoring (ABPM) from 8 a.m. to 11 p.m. by oscillometric method Microlife WatchBP O3</description>
          <units>mmHg</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="124" spread="8"/>
                    <measurement group_id="B2" value="122" spread="11"/>
                    <measurement group_id="B3" value="123" spread="9.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Daytime Diastolic Blood Pressure</title>
          <description>Blood pressure variability was evaluated with ambulatory blood pressure monitoring (ABPM) from 8 a.m. to 11 p.m. by oscillometric method Microlife WatchBP O3</description>
          <units>mmHg</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="75" spread="7"/>
                    <measurement group_id="B2" value="76" spread="7"/>
                    <measurement group_id="B3" value="75.5" spread="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Nightime Systolic Blood Pressure</title>
          <description>Blood pressure variability was evaluated with ambulatory blood pressure monitoring (ABPM) from 11 p.m to 8 a.m. by oscillometric method Microlife WatchBP O3</description>
          <units>mmHg</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="114" spread="11"/>
                    <measurement group_id="B2" value="114" spread="13"/>
                    <measurement group_id="B3" value="114" spread="12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Nightime Diastolic Blood Pressure</title>
          <description>Blood pressure variability was evaluated with ambulatory blood pressure monitoring (ABPM) from 11 p.m to 8 a.m. by oscillometric method Microlife WatchBP O3</description>
          <units>mmHg</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="68" spread="7"/>
                    <measurement group_id="B2" value="69" spread="8"/>
                    <measurement group_id="B3" value="68.5" spread="7.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Systolic Blood Pressure weighted Standard Deviation</title>
          <description>Blood pressure variability was evaluated with ambulatory blood pressure monitoring (ABPM) for 24 hours by oscillometric method Microlife WatchBP O3</description>
          <units>mmHg</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="9.2" spread="1.9"/>
                    <measurement group_id="B2" value="9.8" spread="3.3"/>
                    <measurement group_id="B3" value="9.5" spread="2.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Diastolic Blood Pressure weighted Standard Deviation</title>
          <description>Blood pressure variability was evaluated with ambulatory blood pressure monitoring (ABPM) for 24 hours by oscillometric method Microlife WatchBP O3</description>
          <units>mmHg</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="6.9" spread="1.8"/>
                    <measurement group_id="B2" value="7.7" spread="2.0"/>
                    <measurement group_id="B3" value="7.3" spread="1.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Coefficient of variation of 24-hours, Systolic Blood Pressure</title>
          <description>Blood pressure variability was evaluated with ambulatory blood pressure monitoring (ABPM) for 24 hours by oscillometric method Microlife WatchBP O3.</description>
          <units>Percentage of Coefficient of variability</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="8.9" spread="2.2"/>
                    <measurement group_id="B2" value="9.2" spread="3.0"/>
                    <measurement group_id="B3" value="9.05" spread="1.91"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Coefficient of variation of 24-hours, Diastolic Blood Pressure</title>
          <description>Blood pressure variability was evaluated with ambulatory blood pressure monitoring (ABPM) for 24 hours by oscillometric method Microlife WatchBP O3.</description>
          <units>Percentage of Coefficient of variability</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="11.1" spread="2.9"/>
                    <measurement group_id="B2" value="12.3" spread="2.9"/>
                    <measurement group_id="B3" value="11.7" spread="2.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Coefficient of variation of daytime, Systolic Blood Pressure</title>
          <description>Blood pressure variability was evaluated with ambulatory blood pressure monitoring (ABPM) from 8 a.m. to 11 p.m. by oscillometric method Microlife WatchBP O3</description>
          <units>Percentage of Coefficient of variability</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="7.3" spread="2.2"/>
                    <measurement group_id="B2" value="8.1" spread="3.4"/>
                    <measurement group_id="B3" value="7.7" spread="2.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Coefficient of variation of daytime, Diastolic Blood Pressure</title>
          <description>Blood pressure variability was evaluated with ambulatory blood pressure monitoring (ABPM) from 8 a.m. to 11 p.m. by oscillometric method Microlife WatchBP O3</description>
          <units>Percentage of Coefficient of variability</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="8.9" spread="2.0"/>
                    <measurement group_id="B2" value="10.0" spread="3.6"/>
                    <measurement group_id="B3" value="9.45" spread="2.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Coefficient of variation of nighttime, Systolic Blood Pressure</title>
          <description>Blood pressure variability was evaluated with ambulatory blood pressure monitoring (ABPM) from 11 p.m to 8 a.m. by oscillometric method Microlife WatchBP O3</description>
          <units>Percentage of Coefficient of variability</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="8.3" spread="2.1"/>
                    <measurement group_id="B2" value="8.9" spread="3.3"/>
                    <measurement group_id="B3" value="8.6" spread="2.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Coefficient of variation of nighttime, Diastolic Blood Pressure</title>
          <description>Blood pressure variability was evaluated with ambulatory blood pressure monitoring (ABPM) from 11 p.m. to 8 a.m. by oscillometric method Microlife WatchBP O3</description>
          <units>Percentage of Coefficient of variability</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="10.9" spread="4.2"/>
                    <measurement group_id="B2" value="11.9" spread="3.8"/>
                    <measurement group_id="B3" value="11.4" spread="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Average real variability of Systolic Blood Pressure</title>
          <description>Blood pressure variability was evaluated with ambulatory blood pressure monitoring (ABPM) for 24 hours by oscillometric method Microlife WatchBP O3</description>
          <units>mmHg</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="9.5" spread="2.5"/>
                    <measurement group_id="B2" value="9.3" spread="2.0"/>
                    <measurement group_id="B3" value="9.4" spread="2.25"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Average real variability of Diastolic Blood Pressure</title>
          <description>Blood pressure variability was evaluated with ambulatory blood pressure monitoring (ABPM) for 24 hours by oscillometric method Microlife WatchBP O3</description>
          <units>mmHg</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="6.5" spread="1.4"/>
                    <measurement group_id="B2" value="6.6" spread="1.2"/>
                    <measurement group_id="B3" value="6.55" spread="1.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Number of Participants with a Nondipper circadian blood pressure pattern</title>
          <description>Blood pressure variability was evaluated with ambulatory blood pressure monitoring (ABPM) for 24 hours by oscillometric method Microlife WatchBP O3</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                    <measurement group_id="B2" value="8"/>
                    <measurement group_id="B3" value="17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Number of Participants with a Dipper circadian blood pressure pattern</title>
          <description>Blood pressure variability was evaluated with ambulatory blood pressure monitoring (ABPM) for 24 hours by oscillometric method Microlife WatchBP O3</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Number of Participants with a Dipper reverse circadian blood pressure pattern</title>
          <description>Blood pressure variability was evaluated with ambulatory blood pressure monitoring (ABPM) for 24 hours by oscillometric method Microlife WatchBP O3</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Daytime Mean Arterial Pressure</title>
          <description>The mean arterial pressure was evaluated with ambulatory blood pressure monitoring (ABPM) from 8 a.m. to 11 p.m. by oscillometric method Microlife WatchBP O3</description>
          <units>mmHg</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="92" spread="7"/>
                    <measurement group_id="B2" value="91" spread="8"/>
                    <measurement group_id="B3" value="91.5" spread="7.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Nighttime Mean Arterial Pressure</title>
          <description>The mean arterial pressure was evaluated with ambulatory blood pressure monitoring (ABPM) from 11 p.m. to 8 a.m. by oscillometric method Microlife WatchBP O3</description>
          <units>mmHg</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="85" spread="8"/>
                    <measurement group_id="B2" value="84" spread="9"/>
                    <measurement group_id="B3" value="84.5" spread="8.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Daytime hypertensive load</title>
          <description>The hypertensive load was evaluated with ambulatory blood pressure monitoring (ABPM) from 8 a.m. to 11 p.m. by oscillometric method Microlife WatchBP O3</description>
          <units>mmHg</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="30.7" spread="23.5"/>
                    <measurement group_id="B2" value="29.7" spread="29.5"/>
                    <measurement group_id="B3" value="30.2" spread="26.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Nocturnal hypertensive load</title>
          <description>The hypertensive load was evaluated with ambulatory blood pressure monitoring (ABPM) from 11 p.m. to 8 a.m. by oscillometric method Microlife WatchBP O3</description>
          <units>mmHg</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="51.1" spread="32.3"/>
                    <measurement group_id="B2" value="45.2" spread="32.4"/>
                    <measurement group_id="B3" value="48.15" spread="32.35"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>24-hours Systolic Blood Pressure at Week 12</title>
        <description>Blood pressure variability was evaluated with ambulatory blood pressure monitoring (ABPM) for 24 hours by oscillometric method Microlife WatchBP O3</description>
        <time_frame>Week 12</time_frame>
        <population>Each study group had 2 less participants at the end of the investigation due to withdrawal by subject, as mentioned in the participant flow, so the analysis of this outcome is calculated with those who finished the intervention</population>
        <group_list>
          <group group_id="O1">
            <title>Dapagliflozin</title>
            <description>Dapagliflozin capsules, 10 mg, one per day before breakfast during 12 weeks.&#xD;
Dapagliflozin: 10 mg, one per day before breakfast during 12 weeks.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Placebo capsules, one per day before breakfast during 12 weeks.&#xD;
Placebo - Cap: one per day before breakfast during 12 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>24-hours Systolic Blood Pressure at Week 12</title>
          <description>Blood pressure variability was evaluated with ambulatory blood pressure monitoring (ABPM) for 24 hours by oscillometric method Microlife WatchBP O3</description>
          <population>Each study group had 2 less participants at the end of the investigation due to withdrawal by subject, as mentioned in the participant flow, so the analysis of this outcome is calculated with those who finished the intervention</population>
          <units>mmHg</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="13"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="117" spread="11"/>
                    <measurement group_id="O2" value="120" spread="13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Results showed in this section are the result of the differences between baseline and final values in placebo group</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.755</p_value>
            <p_value_desc>The threshold for statistical significance was p=0.05</p_value_desc>
            <method>Wilcoxon (Mann-Whitney)</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>Results showed in this section are the result of the differences between baseline and final values in dapagliflozin group</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.046</p_value>
            <p_value_desc>The threshold for statistical significance was p=0.05</p_value_desc>
            <method>Wilcoxon (Mann-Whitney)</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>24-hours Diastolic Blood Pressure at Week 12</title>
        <description>Blood pressure variability was evaluated with ambulatory blood pressure monitoring (ABPM) for 24 hours by oscillometric method Microlife WatchBP O3</description>
        <time_frame>Week 12</time_frame>
        <population>Each study group had 2 less participants at the end of the investigation due to withdrawal by subject, as mentioned in the participant flow, so the analysis of this outcome is calculated with those who finished the intervention</population>
        <group_list>
          <group group_id="O1">
            <title>Dapagliflozin</title>
            <description>Dapagliflozin capsules, 10 mg, one per day before breakfast during 12 weeks.&#xD;
Dapagliflozin: 10 mg, one per day before breakfast during 12 weeks.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Placebo capsules, one per day before breakfast during 12 weeks.&#xD;
Placebo - Cap: one per day before breakfast during 12 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>24-hours Diastolic Blood Pressure at Week 12</title>
          <description>Blood pressure variability was evaluated with ambulatory blood pressure monitoring (ABPM) for 24 hours by oscillometric method Microlife WatchBP O3</description>
          <population>Each study group had 2 less participants at the end of the investigation due to withdrawal by subject, as mentioned in the participant flow, so the analysis of this outcome is calculated with those who finished the intervention</population>
          <units>mmHg</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="13"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="73" spread="8"/>
                    <measurement group_id="O2" value="75" spread="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Results showed in this section are the result of the differences between baseline and final values in placebo group</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.752</p_value>
            <p_value_desc>The threshold for statistical significance was p=0.05</p_value_desc>
            <method>Wilcoxon (Mann-Whitney)</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>Results showed in this section are the result of the differences between baseline and final values in dapagliflozin group</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.582</p_value>
            <p_value_desc>The threshold for statistical significance was p=0.05</p_value_desc>
            <method>Wilcoxon (Mann-Whitney)</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Daytime Systolic Blood Pressure at Week 12</title>
        <description>Blood pressure variability was evaluated with ambulatory blood pressure monitoring (ABPM) from 8 am. to 11 p.m. by oscillometric method Microlife WatchBP O3</description>
        <time_frame>Week 12</time_frame>
        <population>Each study group had 2 less participants at the end of the investigation due to withdrawal by subject, as mentioned in the participant flow, so the analysis of this outcome is calculated with those who finished the intervention</population>
        <group_list>
          <group group_id="O1">
            <title>Dapagliflozin</title>
            <description>Dapagliflozin capsules, 10 mg, one per day before breakfast during 12 weeks.&#xD;
Dapagliflozin: 10 mg, one per day before breakfast during 12 weeks.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Placebo capsules, one per day before breakfast during 12 weeks.&#xD;
Placebo - Cap: one per day before breakfast during 12 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Daytime Systolic Blood Pressure at Week 12</title>
          <description>Blood pressure variability was evaluated with ambulatory blood pressure monitoring (ABPM) from 8 am. to 11 p.m. by oscillometric method Microlife WatchBP O3</description>
          <population>Each study group had 2 less participants at the end of the investigation due to withdrawal by subject, as mentioned in the participant flow, so the analysis of this outcome is calculated with those who finished the intervention</population>
          <units>mmHg</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="13"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="121" spread="11"/>
                    <measurement group_id="O2" value="122" spread="14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Results showed in this section are the result of the differences between baseline and final values in placebo group</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.814</p_value>
            <p_value_desc>The threshold for statistical significance was p=0.05</p_value_desc>
            <method>Wilcoxon (Mann-Whitney)</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>Results showed in this section are the result of the differences between baseline and final values in dapagliflozin group</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.220</p_value>
            <p_value_desc>The threshold for statistical significance was p=0.05</p_value_desc>
            <method>Wilcoxon (Mann-Whitney)</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Daytime Diastolic Blood Pressure at Week 12</title>
        <description>Blood pressure variability was evaluated with ambulatory blood pressure monitoring (ABPM) from 8 a.m. to p.m. by oscillometric method Microlife WatchBP O3</description>
        <time_frame>Week 12</time_frame>
        <population>Each study group had 2 less participants at the end of the investigation due to withdrawal by subject, as mentioned in the participant flow, so the analysis of this outcome is calculated with those who finished the intervention</population>
        <group_list>
          <group group_id="O1">
            <title>Dapagliflozin</title>
            <description>Dapagliflozin capsules, 10 mg, one per day before breakfast during 12 weeks.&#xD;
Dapagliflozin: 10 mg, one per day before breakfast during 12 weeks.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Placebo capsules, one per day before breakfast during 12 weeks.&#xD;
Placebo - Cap: one per day before breakfast during 12 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Daytime Diastolic Blood Pressure at Week 12</title>
          <description>Blood pressure variability was evaluated with ambulatory blood pressure monitoring (ABPM) from 8 a.m. to p.m. by oscillometric method Microlife WatchBP O3</description>
          <population>Each study group had 2 less participants at the end of the investigation due to withdrawal by subject, as mentioned in the participant flow, so the analysis of this outcome is calculated with those who finished the intervention</population>
          <units>mmHg</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="13"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="76" spread="9"/>
                    <measurement group_id="O2" value="77" spread="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Results showed in this section are the result of the differences between baseline and final values in placebo group</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.624</p_value>
            <p_value_desc>The threshold for statistical significance was p=0.05</p_value_desc>
            <method>Wilcoxon (Mann-Whitney)</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>Results showed in this section are the result of the differences between baseline and final values in dapagliflozin group</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>1.000</p_value>
            <p_value_desc>The threshold for statistical significance was p=0.05</p_value_desc>
            <method>Wilcoxon (Mann-Whitney)</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Nighttime Systolic Blood Pressure at Week 12</title>
        <description>Blood pressure variability was evaluated with ambulatory blood pressure monitoring (ABPM) from 11 p.m to 8 a.m. by oscillometric method Microlife WatchBP O3</description>
        <time_frame>Week 12</time_frame>
        <population>Each study group had 2 less participants at the end of the investigation due to withdrawal by subject, as mentioned in the participant flow, so the analysis of this outcome is calculated with those who finished the intervention</population>
        <group_list>
          <group group_id="O1">
            <title>Dapagliflozin</title>
            <description>Dapagliflozin capsules, 10 mg, one per day before breakfast during 12 weeks.&#xD;
Dapagliflozin: 10 mg, one per day before breakfast during 12 weeks.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Placebo capsules, one per day before breakfast during 12 weeks.&#xD;
Placebo - Cap: one per day before breakfast during 12 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Nighttime Systolic Blood Pressure at Week 12</title>
          <description>Blood pressure variability was evaluated with ambulatory blood pressure monitoring (ABPM) from 11 p.m to 8 a.m. by oscillometric method Microlife WatchBP O3</description>
          <population>Each study group had 2 less participants at the end of the investigation due to withdrawal by subject, as mentioned in the participant flow, so the analysis of this outcome is calculated with those who finished the intervention</population>
          <units>mmHg</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="13"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="108" spread="10"/>
                    <measurement group_id="O2" value="115" spread="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Results showed in this section are the result of the differences between baseline and final values in placebo group</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.906</p_value>
            <p_value_desc>The threshold for statistical significance was p=0.05</p_value_desc>
            <method>Wilcoxon (Mann-Whitney)</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>Results showed in this section are the result of the differences between baseline and final values in dapagliflozin group</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.017</p_value>
            <p_value_desc>The threshold for statistical significance was p=0.05</p_value_desc>
            <method>Wilcoxon (Mann-Whitney)</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Nighttime Diastolic Blood Pressure at Week 12</title>
        <description>Blood pressure variability was evaluated with ambulatory blood pressure monitoring (ABPM) from 11 p.m. to 8 a.m. by oscillometric method Microlife WatchBP O3</description>
        <time_frame>Week 12</time_frame>
        <population>Each study group had 2 less participants at the end of the investigation due to withdrawal by subject, as mentioned in the participant flow, so the analysis of this outcome is calculated with those who finished the intervention</population>
        <group_list>
          <group group_id="O1">
            <title>Dapagliflozin</title>
            <description>Dapagliflozin capsules, 10 mg, one per day before breakfast during 12 weeks.&#xD;
Dapagliflozin: 10 mg, one per day before breakfast during 12 weeks.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Placebo capsules, one per day before breakfast during 12 weeks.&#xD;
Placebo - Cap: one per day before breakfast during 12 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Nighttime Diastolic Blood Pressure at Week 12</title>
          <description>Blood pressure variability was evaluated with ambulatory blood pressure monitoring (ABPM) from 11 p.m. to 8 a.m. by oscillometric method Microlife WatchBP O3</description>
          <population>Each study group had 2 less participants at the end of the investigation due to withdrawal by subject, as mentioned in the participant flow, so the analysis of this outcome is calculated with those who finished the intervention</population>
          <units>mmHg</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="13"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="67" spread="7"/>
                    <measurement group_id="O2" value="72" spread="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Results showed in this section are the result of the differences between baseline and final values in placebo group</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.454</p_value>
            <p_value_desc>The threshold for statistical significance was p=0.05</p_value_desc>
            <method>Wilcoxon (Mann-Whitney)</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>Results showed in this section are the result of the differences between baseline and final values in dapagliflozin group</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.115</p_value>
            <p_value_desc>The threshold for statistical significance was p=0.05</p_value_desc>
            <method>Wilcoxon (Mann-Whitney)</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Systolic Blood Pressure Weighted Standard Deviation at Week 12</title>
        <description>Blood pressure variability will be evaluated with ambulatory blood pressure monitoring (ABPM) for 24 hours by oscillometric method Microlife WatchBP O3</description>
        <time_frame>Week 12</time_frame>
        <population>Each study group had 2 less participants at the end of the investigation due to withdrawal by subject, as mentioned in the participant flow, so the analysis of this outcome is calculated with those who finished the intervention</population>
        <group_list>
          <group group_id="O1">
            <title>Dapagliflozin</title>
            <description>Dapagliflozin capsules, 10 mg, one per day before breakfast during 12 weeks.&#xD;
Dapagliflozin: 10 mg, one per day before breakfast during 12 weeks.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Placebo capsules, one per day before breakfast during 12 weeks.&#xD;
Placebo - Cap: one per day before breakfast during 12 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Systolic Blood Pressure Weighted Standard Deviation at Week 12</title>
          <description>Blood pressure variability will be evaluated with ambulatory blood pressure monitoring (ABPM) for 24 hours by oscillometric method Microlife WatchBP O3</description>
          <population>Each study group had 2 less participants at the end of the investigation due to withdrawal by subject, as mentioned in the participant flow, so the analysis of this outcome is calculated with those who finished the intervention</population>
          <units>mmHg</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="13"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9.8" spread="3.5"/>
                    <measurement group_id="O2" value="10.3" spread="2.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Results showed in this section are the result of the differences between baseline and final values in placebo group</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.422</p_value>
            <p_value_desc>The threshold for statistical significance was p=0.05</p_value_desc>
            <method>Wilcoxon (Mann-Whitney)</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>Results showed in this section are the result of the differences between baseline and final values in dapagliflozin group</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.917</p_value>
            <p_value_desc>The threshold for statistical significance was p=0.05</p_value_desc>
            <method>Wilcoxon (Mann-Whitney)</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Diastolic Blood Pressure Weighted Standard Deviation at Week 12</title>
        <description>Blood pressure variability was evaluated with ambulatory blood pressure monitoring (ABPM) for 24 hours by oscillometric method Microlife WatchBP O3</description>
        <time_frame>Week 12</time_frame>
        <population>Each study group had 2 less participants at the end of the investigation due to withdrawal by subject, as mentioned in the participant flow, so the analysis of this outcome is calculated with those who finished the intervention</population>
        <group_list>
          <group group_id="O1">
            <title>Dapagliflozin</title>
            <description>Dapagliflozin capsules, 10 mg, one per day before breakfast during 12 weeks.&#xD;
Dapagliflozin: 10 mg, one per day before breakfast during 12 weeks.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Placebo capsules, one per day before breakfast during 12 weeks.&#xD;
Placebo - Cap: one per day before breakfast during 12 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Diastolic Blood Pressure Weighted Standard Deviation at Week 12</title>
          <description>Blood pressure variability was evaluated with ambulatory blood pressure monitoring (ABPM) for 24 hours by oscillometric method Microlife WatchBP O3</description>
          <population>Each study group had 2 less participants at the end of the investigation due to withdrawal by subject, as mentioned in the participant flow, so the analysis of this outcome is calculated with those who finished the intervention</population>
          <units>mmHg</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="13"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.0" spread="3.6"/>
                    <measurement group_id="O2" value="8.3" spread="2.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Results showed in this section are the result of the differences between baseline and final values in placebo group</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.650</p_value>
            <p_value_desc>The threshold for statistical significance was p=0.05</p_value_desc>
            <method>Wilcoxon (Mann-Whitney)</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>Results showed in this section are the result of the differences between baseline and final values in dapagliflozin group</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.108</p_value>
            <p_value_desc>The threshold for statistical significance was p=0.05</p_value_desc>
            <method>Wilcoxon (Mann-Whitney)</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Coefficient of Variation of 24-hours, Systolic Blood Pressure at Week 12</title>
        <description>Blood pressure variability was evaluated with ambulatory blood pressure monitoring (ABPM) for 24 hours by oscillometric method Microlife WatchBP O3</description>
        <time_frame>Week 12</time_frame>
        <population>Each study group had 2 less participants at the end of the investigation due to withdrawal by subject, as mentioned in the participant flow, so the analysis of this outcome is calculated with those who finished the intervention</population>
        <group_list>
          <group group_id="O1">
            <title>Dapagliflozin</title>
            <description>Dapagliflozin capsules, 10 mg, one per day before breakfast during 12 weeks.&#xD;
Dapagliflozin: 10 mg, one per day before breakfast during 12 weeks.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Placebo capsules, one per day before breakfast during 12 weeks.&#xD;
Placebo - Cap: one per day before breakfast during 12 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Coefficient of Variation of 24-hours, Systolic Blood Pressure at Week 12</title>
          <description>Blood pressure variability was evaluated with ambulatory blood pressure monitoring (ABPM) for 24 hours by oscillometric method Microlife WatchBP O3</description>
          <population>Each study group had 2 less participants at the end of the investigation due to withdrawal by subject, as mentioned in the participant flow, so the analysis of this outcome is calculated with those who finished the intervention</population>
          <units>Percentage of Coefficient of variability</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="13"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9.9" spread="3.4"/>
                    <measurement group_id="O2" value="9.5" spread="1.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Results showed in this section are the result of the differences between baseline and final values in placebo group</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.875</p_value>
            <p_value_desc>The threshold for statistical significance was p=0.05</p_value_desc>
            <method>Wilcoxon (Mann-Whitney)</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>Results showed in this section are the result of the differences between baseline and final values of waist circumference in dapagliflozin group</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.196</p_value>
            <p_value_desc>The threshold for statistical significance was p=0.05</p_value_desc>
            <method>Wilcoxon (Mann-Whitney)</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Coefficient of Variation of 24-hours, Diastolic Blood Pressure at Week 12</title>
        <description>Blood pressure variability was evaluated with ambulatory blood pressure monitoring (ABPM) for 24 hours by oscillometric method Microlife WatchBP O3</description>
        <time_frame>Week 12</time_frame>
        <population>Each study group had 2 less participants at the end of the investigation due to withdrawal by subject, as mentioned in the participant flow, so the analysis of this outcome is calculated with those who finished the intervention</population>
        <group_list>
          <group group_id="O1">
            <title>Dapagliflozin</title>
            <description>Dapagliflozin capsules, 10 mg, one per day before breakfast during 12 weeks.&#xD;
Dapagliflozin: 10 mg, one per day before breakfast during 12 weeks.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Placebo capsules, one per day before breakfast during 12 weeks.&#xD;
Placebo - Cap: one per day before breakfast during 12 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Coefficient of Variation of 24-hours, Diastolic Blood Pressure at Week 12</title>
          <description>Blood pressure variability was evaluated with ambulatory blood pressure monitoring (ABPM) for 24 hours by oscillometric method Microlife WatchBP O3</description>
          <population>Each study group had 2 less participants at the end of the investigation due to withdrawal by subject, as mentioned in the participant flow, so the analysis of this outcome is calculated with those who finished the intervention</population>
          <units>Percentage of Coefficient of variability</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="13"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12.3" spread="4.8"/>
                    <measurement group_id="O2" value="11.3" spread="2.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Results showed in this section are the result of the differences between baseline and final values in placebo group</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.552</p_value>
            <p_value_desc>The threshold for statistical significance was p=0.05</p_value_desc>
            <method>Wilcoxon (Mann-Whitney)</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>Results showed in this section are the result of the differences between baseline and final values in dapagliflozin group</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.087</p_value>
            <p_value_desc>The threshold for statistical significance was p=0.05</p_value_desc>
            <method>Wilcoxon (Mann-Whitney)</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Coefficient of Variation Daytime, Systolic Blood Pressure at Week 12</title>
        <description>Blood pressure variability was evaluated with ambulatory blood pressure monitoring (ABPM) from 8 a.m to 11 p.m. by oscillometric method Microlife WatchBP O3</description>
        <time_frame>Week 12</time_frame>
        <population>Each study group had 2 less participants at the end of the investigation due to withdrawal by subject, as mentioned in the participant flow, so the analysis of this outcome is calculated with those who finished the intervention</population>
        <group_list>
          <group group_id="O1">
            <title>Dapagliflozin</title>
            <description>Dapagliflozin capsules, 10 mg, one per day before breakfast during 12 weeks.&#xD;
Dapagliflozin: 10 mg, one per day before breakfast during 12 weeks.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Placebo capsules, one per day before breakfast during 12 weeks.&#xD;
Placebo - Cap: one per day before breakfast during 12 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Coefficient of Variation Daytime, Systolic Blood Pressure at Week 12</title>
          <description>Blood pressure variability was evaluated with ambulatory blood pressure monitoring (ABPM) from 8 a.m to 11 p.m. by oscillometric method Microlife WatchBP O3</description>
          <population>Each study group had 2 less participants at the end of the investigation due to withdrawal by subject, as mentioned in the participant flow, so the analysis of this outcome is calculated with those who finished the intervention</population>
          <units>Percentage of Coefficient of variability</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="13"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.7" spread="2.4"/>
                    <measurement group_id="O2" value="8.4" spread="2.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Results showed in this section are the result of the differences between baseline and final values in placebo group</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.814</p_value>
            <p_value_desc>The threshold for statistical significance was p=0.05</p_value_desc>
            <method>Wilcoxon (Mann-Whitney)</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>Results showed in this section are the result of the differences between baseline and final values in dapagliflozin group</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.463</p_value>
            <p_value_desc>The threshold for statistical significance was p=0.05</p_value_desc>
            <method>Wilcoxon (Mann-Whitney)</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Coefficient of Variation Daytime, Diastolic Blood Pressure at Week 12</title>
        <description>Blood pressure variability was evaluated with ambulatory blood pressure monitoring (ABPM) from 8 a.m. to 11 p.m. by oscillometric method Microlife WatchBP O3</description>
        <time_frame>Week 12</time_frame>
        <population>Each study group had 2 less participants at the end of the investigation due to withdrawal by subject, as mentioned in the participant flow, so the analysis of this outcome is calculated with those who finished the intervention</population>
        <group_list>
          <group group_id="O1">
            <title>Dapagliflozin</title>
            <description>Dapagliflozin capsules, 10 mg, one per day before breakfast during 12 weeks.&#xD;
Dapagliflozin: 10 mg, one per day before breakfast during 12 weeks.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Placebo capsules, one per day before breakfast during 12 weeks.&#xD;
Placebo - Cap: one per day before breakfast during 12 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Coefficient of Variation Daytime, Diastolic Blood Pressure at Week 12</title>
          <description>Blood pressure variability was evaluated with ambulatory blood pressure monitoring (ABPM) from 8 a.m. to 11 p.m. by oscillometric method Microlife WatchBP O3</description>
          <population>Each study group had 2 less participants at the end of the investigation due to withdrawal by subject, as mentioned in the participant flow, so the analysis of this outcome is calculated with those who finished the intervention</population>
          <units>Percentage of Coefficient of variability</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="13"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10.2" spread="4.2"/>
                    <measurement group_id="O2" value="9.2" spread="3.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Results showed in this section are the result of the differences between baseline and final values in placebo group</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.530</p_value>
            <p_value_desc>The threshold for statistical significance was p=0.05</p_value_desc>
            <method>Wilcoxon (Mann-Whitney)</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>Results showed in this section are the result of the differences between baseline and final values in dapagliflozin group</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.507</p_value>
            <p_value_desc>The threshold for statistical significance was p=0.05</p_value_desc>
            <method>Wilcoxon (Mann-Whitney)</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Coefficient of Variation Nighttime, Systolic Blood Pressure at Week 12</title>
        <description>Blood pressure variability was evaluated with ambulatory blood pressure monitoring (ABPM) from 11 p.m. to 8 a.m. by oscillometric method Microlife WatchBP O3</description>
        <time_frame>Week 12</time_frame>
        <population>Each study group had 2 less participants at the end of the investigation due to withdrawal by subject, as mentioned in the participant flow, so the analysis of this outcome is calculated with those who finished the intervention</population>
        <group_list>
          <group group_id="O1">
            <title>Dapagliflozin</title>
            <description>Dapagliflozin capsules, 10 mg, one per day before breakfast during 12 weeks.&#xD;
Dapagliflozin: 10 mg, one per day before breakfast during 12 weeks.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Placebo capsules, one per day before breakfast during 12 weeks.&#xD;
Placebo - Cap: one per day before breakfast during 12 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Coefficient of Variation Nighttime, Systolic Blood Pressure at Week 12</title>
          <description>Blood pressure variability was evaluated with ambulatory blood pressure monitoring (ABPM) from 11 p.m. to 8 a.m. by oscillometric method Microlife WatchBP O3</description>
          <population>Each study group had 2 less participants at the end of the investigation due to withdrawal by subject, as mentioned in the participant flow, so the analysis of this outcome is calculated with those who finished the intervention</population>
          <units>Percentage of Coefficient of variability</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="13"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.4" spread="3.2"/>
                    <measurement group_id="O2" value="10.6" spread="4.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Results showed in this section are the result of the differences between baseline and final values in placebo group</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.152</p_value>
            <p_value_desc>The threshold for statistical significance was p=0.05</p_value_desc>
            <method>Wilcoxon (Mann-Whitney)</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>Results showed in this section are the result of the differences between baseline and final values in dapagliflozin group</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.972</p_value>
            <p_value_desc>The threshold for statistical significance was p=0.05</p_value_desc>
            <method>Wilcoxon (Mann-Whitney)</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Coefficient of Variation Nighttime, Diastolic Blood Pressure at Week 12</title>
        <description>Blood pressure variability was evaluated with ambulatory blood pressure monitoring (ABPM) from 11 p.m. to 8 a.m. by oscillometric method Microlife WatchBP O3</description>
        <time_frame>Week 12</time_frame>
        <population>Each study group had 2 less participants at the end of the investigation due to withdrawal by subject, as mentioned in the participant flow, so the analysis of this outcome is calculated with those who finished the intervention</population>
        <group_list>
          <group group_id="O1">
            <title>Dapagliflozin</title>
            <description>Dapagliflozin capsules, 10 mg, one per day before breakfast during 12 weeks.&#xD;
Dapagliflozin: 10 mg, one per day before breakfast during 12 weeks.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Placebo capsules, one per day before breakfast during 12 weeks.&#xD;
Placebo - Cap: one per day before breakfast during 12 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Coefficient of Variation Nighttime, Diastolic Blood Pressure at Week 12</title>
          <description>Blood pressure variability was evaluated with ambulatory blood pressure monitoring (ABPM) from 11 p.m. to 8 a.m. by oscillometric method Microlife WatchBP O3</description>
          <population>Each study group had 2 less participants at the end of the investigation due to withdrawal by subject, as mentioned in the participant flow, so the analysis of this outcome is calculated with those who finished the intervention</population>
          <units>Percentage of Coefficient of variability</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="13"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12.3" spread="4.7"/>
                    <measurement group_id="O2" value="13.5" spread="5.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Results showed in this section are the result of the differences between baseline and final values in placebo group</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.152</p_value>
            <p_value_desc>The threshold for statistical significance was p=0.05</p_value_desc>
            <method>Wilcoxon (Mann-Whitney)</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>Results showed in this section are the result of the differences between baseline and final values in dapagliflozin group</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.158</p_value>
            <p_value_desc>The threshold for statistical significance was p=0.05</p_value_desc>
            <method>Wilcoxon (Mann-Whitney)</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Average Real Variability of Systolic Blood Pressure at Week 12</title>
        <description>Blood pressure variability was evaluated with ambulatory blood pressure monitoring (ABPM) for 24 hours by oscillometric method Microlife WatchBP O3</description>
        <time_frame>Week 12</time_frame>
        <population>Each study group had 2 less participants at the end of the investigation due to withdrawal by subject, as mentioned in the participant flow, so the analysis of this outcome is calculated with those who finished the intervention</population>
        <group_list>
          <group group_id="O1">
            <title>Dapagliflozin</title>
            <description>Dapagliflozin capsules, 10 mg, one per day before breakfast during 12 weeks.&#xD;
Dapagliflozin: 10 mg, one per day before breakfast during 12 weeks.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Placebo capsules, one per day before breakfast during 12 weeks.&#xD;
Placebo - Cap: one per day before breakfast during 12 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Average Real Variability of Systolic Blood Pressure at Week 12</title>
          <description>Blood pressure variability was evaluated with ambulatory blood pressure monitoring (ABPM) for 24 hours by oscillometric method Microlife WatchBP O3</description>
          <population>Each study group had 2 less participants at the end of the investigation due to withdrawal by subject, as mentioned in the participant flow, so the analysis of this outcome is calculated with those who finished the intervention</population>
          <units>mmHg</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="13"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10.0" spread="2.6"/>
                    <measurement group_id="O2" value="9.2" spread="2.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Results showed in this section are the result of the differences between baseline and final values in placebo group</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.944</p_value>
            <p_value_desc>The threshold for statistical significance was p=0.05</p_value_desc>
            <method>Wilcoxon (Mann-Whitney)</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>Results showed in this section are the result of the differences between baseline and final values in dapagliflozin group</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.650</p_value>
            <p_value_desc>The threshold for statistical significance was p=0.05</p_value_desc>
            <method>Wilcoxon (Mann-Whitney)</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Average Real Variability of Diastolic Blood Pressure at Week 12</title>
        <description>Blood pressure variability was evaluated with ambulatory blood pressure monitoring (ABPM) for 24 hours by oscillometric method Microlife WatchBP O3</description>
        <time_frame>Week 12</time_frame>
        <population>Each study group had 2 less participants at the end of the investigation due to withdrawal by subject, as mentioned in the participant flow, so the analysis of this outcome is calculated with those who finished the intervention</population>
        <group_list>
          <group group_id="O1">
            <title>Dapagliflozin</title>
            <description>Dapagliflozin capsules, 10 mg, one per day before breakfast during 12 weeks.&#xD;
Dapagliflozin: 10 mg, one per day before breakfast during 12 weeks.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Placebo capsules, one per day before breakfast during 12 weeks.&#xD;
Placebo - Cap: one per day before breakfast during 12 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Average Real Variability of Diastolic Blood Pressure at Week 12</title>
          <description>Blood pressure variability was evaluated with ambulatory blood pressure monitoring (ABPM) for 24 hours by oscillometric method Microlife WatchBP O3</description>
          <population>Each study group had 2 less participants at the end of the investigation due to withdrawal by subject, as mentioned in the participant flow, so the analysis of this outcome is calculated with those who finished the intervention</population>
          <units>mmHg</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="13"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.8" spread="1.4"/>
                    <measurement group_id="O2" value="7.0" spread="1.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Results showed in this section are the result of the differences between baseline and final values in placebo group</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.087</p_value>
            <p_value_desc>The threshold for statistical significance was p=0.05</p_value_desc>
            <method>Wilcoxon (Mann-Whitney)</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>Results showed in this section are the result of the differences between baseline and final values in dapagliflozin group</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.345</p_value>
            <p_value_desc>The threshold for statistical significance was p=0.05</p_value_desc>
            <method>Wilcoxon (Mann-Whitney)</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants With a Nondipper Circadian Blood Pressure Pattern at Week 12</title>
        <description>Blood pressure variability was evaluated with ambulatory blood pressure monitoring (ABPM) for 24 hours by oscillometric method Microlife WatchBP O3</description>
        <time_frame>Week 12</time_frame>
        <population>Each study group had 2 less participants at the end of the investigation due to withdrawal by subject, as mentioned in the participant flow, so the analysis of this outcome is calculated with those who finished the intervention</population>
        <group_list>
          <group group_id="O1">
            <title>Dapagliflozin</title>
            <description>Dapagliflozin capsules, 10 mg, one per day before breakfast during 12 weeks.&#xD;
Dapagliflozin: 10 mg, one per day before breakfast during 12 weeks.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Placebo capsules, one per day before breakfast during 12 weeks.&#xD;
Placebo - Cap: one per day before breakfast during 12 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With a Nondipper Circadian Blood Pressure Pattern at Week 12</title>
          <description>Blood pressure variability was evaluated with ambulatory blood pressure monitoring (ABPM) for 24 hours by oscillometric method Microlife WatchBP O3</description>
          <population>Each study group had 2 less participants at the end of the investigation due to withdrawal by subject, as mentioned in the participant flow, so the analysis of this outcome is calculated with those who finished the intervention</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="13"/>
                <count group_id="O2" value="13"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Results showed in this section are the result of the differences between change of intervention group</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.115</p_value>
            <p_value_desc>The threshold for statistical significance was p=0.05</p_value_desc>
            <method>Chi-squared</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants With a Dipper Circadian Blood Pressure Pattern at Week 12</title>
        <description>Blood pressure variability was evaluated with ambulatory blood pressure monitoring (ABPM) for 24 hours by oscillometric method Microlife WatchBP O3</description>
        <time_frame>Week 12</time_frame>
        <population>Each study group had 2 less participants at the end of the investigation due to withdrawal by subject, as mentioned in the participant flow, so the analysis of this outcome is calculated with those who finished the intervention</population>
        <group_list>
          <group group_id="O1">
            <title>Dapagliflozin</title>
            <description>Dapagliflozin capsules, 10 mg, one per day before breakfast during 12 weeks.&#xD;
Dapagliflozin: 10 mg, one per day before breakfast during 12 weeks.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Placebo capsules, one per day before breakfast during 12 weeks.&#xD;
Placebo - Cap: one per day before breakfast during 12 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With a Dipper Circadian Blood Pressure Pattern at Week 12</title>
          <description>Blood pressure variability was evaluated with ambulatory blood pressure monitoring (ABPM) for 24 hours by oscillometric method Microlife WatchBP O3</description>
          <population>Each study group had 2 less participants at the end of the investigation due to withdrawal by subject, as mentioned in the participant flow, so the analysis of this outcome is calculated with those who finished the intervention</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="13"/>
                <count group_id="O2" value="13"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8"/>
                    <measurement group_id="O2" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Results showed in this section are the result of the differences between change of intervention groups</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.047</p_value>
            <p_value_desc>The threshold for statistical significance was p=0.05</p_value_desc>
            <method>Chi-squared</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants With a Dipper Reverse Circadian Blood Pattern at Week 12</title>
        <description>Blood pressure variability was evaluated with ambulatory blood pressure monitoring (ABPM) for 24 hours by oscillometric method Microlife WatchBP O3</description>
        <time_frame>Week 12</time_frame>
        <population>Each study group had 2 less participants at the end of the investigation due to withdrawal by subject, as mentioned in the participant flow, so the analysis of this outcome is calculated with those who finished the intervention</population>
        <group_list>
          <group group_id="O1">
            <title>Dapagliflozin</title>
            <description>Dapagliflozin capsules, 10 mg, one per day before breakfast during 12 weeks.&#xD;
Dapagliflozin: 10 mg, one per day before breakfast during 12 weeks.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Placebo capsules, one per day before breakfast during 12 weeks.&#xD;
Placebo - Cap: one per day before breakfast during 12 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With a Dipper Reverse Circadian Blood Pattern at Week 12</title>
          <description>Blood pressure variability was evaluated with ambulatory blood pressure monitoring (ABPM) for 24 hours by oscillometric method Microlife WatchBP O3</description>
          <population>Each study group had 2 less participants at the end of the investigation due to withdrawal by subject, as mentioned in the participant flow, so the analysis of this outcome is calculated with those who finished the intervention</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="13"/>
                <count group_id="O2" value="13"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Results showed in this section are the result of the differences between change of intervention groups</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.539</p_value>
            <p_value_desc>The threshold for statistical significance was p=0.05</p_value_desc>
            <method>Chi-squared</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Body Weight at Week 12</title>
        <description>The body weight was measured with a bioimpedance balance</description>
        <time_frame>Week 12</time_frame>
        <population>Each study group had 2 less participants at the end of the investigation due to withdrawal by subject, as mentioned in the participant flow, so the analysis of this outcome is calculated with those who finished the intervention</population>
        <group_list>
          <group group_id="O1">
            <title>Dapagliflozin</title>
            <description>Dapagliflozin capsules, 10 mg, one per day before breakfast during 12 weeks.&#xD;
Dapagliflozin: 10 mg, one per day before breakfast during 12 weeks.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Placebo capsules, one per day before breakfast during 12 weeks.&#xD;
Placebo - Cap: one per day before breakfast during 12 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Body Weight at Week 12</title>
          <description>The body weight was measured with a bioimpedance balance</description>
          <population>Each study group had 2 less participants at the end of the investigation due to withdrawal by subject, as mentioned in the participant flow, so the analysis of this outcome is calculated with those who finished the intervention</population>
          <units>kg</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="13"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="73" spread="10"/>
                    <measurement group_id="O2" value="78" spread="12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Results showed in this section are the result of the differences between baseline and final values in placebo group</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.844</p_value>
            <p_value_desc>The threshold for statistical significance was p=0.05</p_value_desc>
            <method>Wilcoxon (Mann-Whitney)</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>Results showed in this section are the result of the differences between baseline and final values in dapagliflozin group</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.010</p_value>
            <p_value_desc>The threshold for statistical significance was p=0.05</p_value_desc>
            <method>Wilcoxon (Mann-Whitney)</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Body Mass Index at Week 12</title>
        <description>Body Mas Index was calculated with the Quetelet index formula</description>
        <time_frame>Week 12</time_frame>
        <population>Each study group had 2 less participants at the end of the investigation due to withdrawal by subject, as mentioned in the participant flow, so the analysis of this outcome is calculated with those who finished the intervention</population>
        <group_list>
          <group group_id="O1">
            <title>Dapagliflozin</title>
            <description>Dapagliflozin capsules, 10 mg, one per day before breakfast during 12 weeks.&#xD;
Dapagliflozin: 10 mg, one per day before breakfast during 12 weeks.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Placebo capsules, one per day before breakfast during 12 weeks.&#xD;
Placebo - Cap: one per day before breakfast during 12 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Body Mass Index at Week 12</title>
          <description>Body Mas Index was calculated with the Quetelet index formula</description>
          <population>Each study group had 2 less participants at the end of the investigation due to withdrawal by subject, as mentioned in the participant flow, so the analysis of this outcome is calculated with those who finished the intervention</population>
          <units>kg/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="13"/>
                <count group_id="O2" value="13"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="28" spread="2"/>
                    <measurement group_id="O2" value="29" spread="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Results showed in this section are the result of the differences between baseline and final values in placebo group</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.814</p_value>
            <p_value_desc>The threshold for statistical significance was p=0.05</p_value_desc>
            <method>Wilcoxon (Mann-Whitney)</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>Results showed in this section are the result of the differences between baseline and final values in dapagliflozin group</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.011</p_value>
            <p_value_desc>The threshold for statistical significance was p=0.05</p_value_desc>
            <method>Wilcoxon (Mann-Whitney)</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Office Systolic Blood Pressure at Week 12</title>
        <description>Blood pressure was measured using the Omron 907-E digital sphygmomanometer (Healthcare, Inc.)</description>
        <time_frame>Week 12</time_frame>
        <population>Each study group had 2 less participants at the end of the investigation due to withdrawal by subject, as mentioned in the participant flow, so the analysis of this outcome is calculated with those who finished the intervention</population>
        <group_list>
          <group group_id="O1">
            <title>Dapagliflozin</title>
            <description>Dapagliflozin capsules, 10 mg, one per day before breakfast during 12 weeks.&#xD;
Dapagliflozin: 10 mg, one per day before breakfast during 12 weeks.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Placebo capsules, one per day before breakfast during 12 weeks.&#xD;
Placebo - Cap: one per day before breakfast during 12 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Office Systolic Blood Pressure at Week 12</title>
          <description>Blood pressure was measured using the Omron 907-E digital sphygmomanometer (Healthcare, Inc.)</description>
          <population>Each study group had 2 less participants at the end of the investigation due to withdrawal by subject, as mentioned in the participant flow, so the analysis of this outcome is calculated with those who finished the intervention</population>
          <units>mmHg</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="13"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="119" spread="8"/>
                    <measurement group_id="O2" value="130" spread="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Results showed in this section are the result of the differences between baseline and final values in placebo group</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.221</p_value>
            <p_value_desc>The threshold for statistical significance was p=0.05</p_value_desc>
            <method>Wilcoxon (Mann-Whitney)</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>Results showed in this section are the result of the differences between baseline and final values in dapagliflozin group</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.001</p_value>
            <p_value_desc>The threshold for statistical significance was p=0.05</p_value_desc>
            <method>Wilcoxon (Mann-Whitney)</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Office of Diastolic Blood Pressure at Week 12</title>
        <description>Blood pressure was measured using the Omron 907-E digital sphygmomanometer (Healthcare, Inc.)</description>
        <time_frame>Week 12</time_frame>
        <population>Each study group had 2 less participants at the end of the investigation due to withdrawal by subject, as mentioned in the participant flow, so the analysis of this outcome is calculated with those who finished the intervention</population>
        <group_list>
          <group group_id="O1">
            <title>Dapagliflozin</title>
            <description>Dapagliflozin capsules, 10 mg, one per day before breakfast during 12 weeks.&#xD;
Dapagliflozin: 10 mg, one per day before breakfast during 12 weeks.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Placebo capsules, one per day before breakfast during 12 weeks.&#xD;
Placebo - Cap: one per day before breakfast during 12 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Office of Diastolic Blood Pressure at Week 12</title>
          <description>Blood pressure was measured using the Omron 907-E digital sphygmomanometer (Healthcare, Inc.)</description>
          <population>Each study group had 2 less participants at the end of the investigation due to withdrawal by subject, as mentioned in the participant flow, so the analysis of this outcome is calculated with those who finished the intervention</population>
          <units>mmHg</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="13"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="75" spread="6"/>
                    <measurement group_id="O2" value="82" spread="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Results showed in this section are the result of the differences between baseline and final values in placebo group</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.461</p_value>
            <p_value_desc>The threshold for statistical significance was p=0.05</p_value_desc>
            <method>Wilcoxon (Mann-Whitney)</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>Results showed in this section are the result of the differences between baseline and final values in dapagliflozin group</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.011</p_value>
            <p_value_desc>The threshold for statistical significance was p=0.05</p_value_desc>
            <method>Wilcoxon (Mann-Whitney)</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Fasting Plasma Glucose Levels at Week 12</title>
        <description>The fasting glucose levels was evaluated with enzymatic/colorimetric techniques</description>
        <time_frame>Week 12</time_frame>
        <population>Each study group had 2 less participants at the end of the investigation due to withdrawal by subject, as mentioned in the participant flow, so the analysis of this outcome is calculated with those who finished the intervention</population>
        <group_list>
          <group group_id="O1">
            <title>Dapagliflozin</title>
            <description>Dapagliflozin capsules, 10 mg, one per day before breakfast during 12 weeks.&#xD;
Dapagliflozin: 10 mg, one per day before breakfast during 12 weeks.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Placebo capsules, one per day before breakfast during 12 weeks.&#xD;
Placebo - Cap: one per day before breakfast during 12 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Fasting Plasma Glucose Levels at Week 12</title>
          <description>The fasting glucose levels was evaluated with enzymatic/colorimetric techniques</description>
          <population>Each study group had 2 less participants at the end of the investigation due to withdrawal by subject, as mentioned in the participant flow, so the analysis of this outcome is calculated with those who finished the intervention</population>
          <units>mmol/L</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="13"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.8" spread="0.5"/>
                    <measurement group_id="O2" value="6.1" spread="0.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Results showed in this section are the result of the differences between baseline and final values in placebo group</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.285</p_value>
            <p_value_desc>The threshold for statistical significance was p=0.05</p_value_desc>
            <method>Wilcoxon (Mann-Whitney)</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>Results showed in this section are the result of the differences between baseline and final values in dapagliflozin group</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.002</p_value>
            <p_value_desc>The threshold for statistical significance was p=0.05</p_value_desc>
            <method>Wilcoxon (Mann-Whitney)</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>2-hours Plasma Glucose After a Oral Glucose Tolerance Test at Week 12</title>
        <description>2-hours plasma glucose after a oral glucose tolerance test (75 g of glucose load). Glucose was evaluated with enzymatic/ colorimetric technique</description>
        <time_frame>Week 12</time_frame>
        <population>Each study group had 2 less participants at the end of the investigation due to withdrawal by subject, as mentioned in the participant flow, so the analysis of this outcome is calculated with those who finished the intervention</population>
        <group_list>
          <group group_id="O1">
            <title>Dapagliflozin</title>
            <description>Dapagliflozin capsules, 10 mg, one per day before breakfast during 12 weeks.&#xD;
Dapagliflozin: 10 mg, one per day before breakfast during 12 weeks.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Placebo capsules, one per day before breakfast during 12 weeks.&#xD;
Placebo - Cap: one per day before breakfast during 12 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>2-hours Plasma Glucose After a Oral Glucose Tolerance Test at Week 12</title>
          <description>2-hours plasma glucose after a oral glucose tolerance test (75 g of glucose load). Glucose was evaluated with enzymatic/ colorimetric technique</description>
          <population>Each study group had 2 less participants at the end of the investigation due to withdrawal by subject, as mentioned in the participant flow, so the analysis of this outcome is calculated with those who finished the intervention</population>
          <units>mmol/L</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="13"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.8" spread="1.8"/>
                    <measurement group_id="O2" value="8.3" spread="2.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Results showed in this section are the result of the differences between baseline and final values in placebo group</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.701</p_value>
            <p_value_desc>The threshold for statistical significance was p=0.05</p_value_desc>
            <method>Wilcoxon (Mann-Whitney)</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>Results showed in this section are the result of the differences between baseline and final values in dapagliflozin group</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.081</p_value>
            <p_value_desc>The threshold for statistical significance was p=0.05</p_value_desc>
            <method>Wilcoxon (Mann-Whitney)</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Glycated Hemoglobin A1c (A1C) at Week 12</title>
        <description>A1C was evaluated by Enzyme-Linked ImmunoSorbent Assay (ELISA)</description>
        <time_frame>Week 12</time_frame>
        <population>Each study group had 2 less participants at the end of the investigation due to withdrawal by subject, as mentioned in the participant flow, so the analysis of this outcome is calculated with those who finished the intervention</population>
        <group_list>
          <group group_id="O1">
            <title>Dapagliflozin</title>
            <description>Dapagliflozin capsules, 10 mg, one per day before breakfast during 12 weeks.&#xD;
Dapagliflozin: 10 mg, one per day before breakfast during 12 weeks.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Placebo capsules, one per day before breakfast during 12 weeks.&#xD;
Placebo - Cap: one per day before breakfast during 12 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Glycated Hemoglobin A1c (A1C) at Week 12</title>
          <description>A1C was evaluated by Enzyme-Linked ImmunoSorbent Assay (ELISA)</description>
          <population>Each study group had 2 less participants at the end of the investigation due to withdrawal by subject, as mentioned in the participant flow, so the analysis of this outcome is calculated with those who finished the intervention</population>
          <units>percentage of A1C</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="13"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.4" spread="0.4"/>
                    <measurement group_id="O2" value="5.9" spread="0.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Results showed in this section are the result of the differences between baseline and final values in placebo group</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.581</p_value>
            <p_value_desc>The threshold for statistical significance was p=0.05</p_value_desc>
            <method>Wilcoxon (Mann-Whitney)</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>Results showed in this section are the result of the differences between baseline and final values of HDL-cholesterol on dapagliflozin group</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.004</p_value>
            <p_value_desc>The threshold for statistical significance was p=0.05</p_value_desc>
            <method>Wilcoxon (Mann-Whitney)</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Daytime Mean Arterial Pressure at Week 12</title>
        <description>The mean arterial pressure was evaluated with ambulatory blood pressure monitoring (ABPM) from 8 a.m. to 11 p.m. by oscillometric method Microlife WatchBP O3</description>
        <time_frame>Week 12</time_frame>
        <population>Each study group had 2 less participants at the end of the investigation due to withdrawal by subject, as mentioned in the participant flow, so the analysis of this outcome is calculated with those who finished the intervention</population>
        <group_list>
          <group group_id="O1">
            <title>Dapagliflozin</title>
            <description>Dapagliflozin capsules, 10 mg, one per day before breakfast during 12 weeks.&#xD;
Dapagliflozin: 10 mg, one per day before breakfast during 12 weeks.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Placebo capsules, one per day before breakfast during 12 weeks.&#xD;
Placebo - Cap: one per day before breakfast during 12 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Daytime Mean Arterial Pressure at Week 12</title>
          <description>The mean arterial pressure was evaluated with ambulatory blood pressure monitoring (ABPM) from 8 a.m. to 11 p.m. by oscillometric method Microlife WatchBP O3</description>
          <population>Each study group had 2 less participants at the end of the investigation due to withdrawal by subject, as mentioned in the participant flow, so the analysis of this outcome is calculated with those who finished the intervention</population>
          <units>mmHg</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="13"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="92" spread="11"/>
                    <measurement group_id="O2" value="92" spread="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Results showed in this section are the result of the differences between baseline and final values in placebo group</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.727</p_value>
            <p_value_desc>The threshold for statistical significance was p=0.05</p_value_desc>
            <method>Wilcoxon (Mann-Whitney)</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>Results showed in this section are the result of the differences between baseline and final values in dapagliflozin group</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.451</p_value>
            <p_value_desc>The threshold for statistical significance was p=0.05</p_value_desc>
            <method>Wilcoxon (Mann-Whitney)</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Nighttime Mean Arterial Pressure at Week 12</title>
        <description>The Mean Arterial Pressure was evaluated with ambulatory blood pressure monitoring (ABPM) from 11 p.m. to 8 a.m. by oscillometric method Microlife WatchBP O3</description>
        <time_frame>Week 12</time_frame>
        <population>Each study group had 2 less participants at the end of the investigation due to withdrawal by subject, as mentioned in the participant flow, so the analysis of this outcome is calculated with those who finished the intervention</population>
        <group_list>
          <group group_id="O1">
            <title>Dapagliflozin</title>
            <description>Dapagliflozin capsules, 10 mg, one per day before breakfast during 12 weeks.&#xD;
Dapagliflozin: 10 mg, one per day before breakfast during 12 weeks.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Placebo capsules, one per day before breakfast during 12 weeks.&#xD;
Placebo - Cap: one per day before breakfast during 12 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Nighttime Mean Arterial Pressure at Week 12</title>
          <description>The Mean Arterial Pressure was evaluated with ambulatory blood pressure monitoring (ABPM) from 11 p.m. to 8 a.m. by oscillometric method Microlife WatchBP O3</description>
          <population>Each study group had 2 less participants at the end of the investigation due to withdrawal by subject, as mentioned in the participant flow, so the analysis of this outcome is calculated with those who finished the intervention</population>
          <units>mmHg</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="13"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="84" spread="9"/>
                    <measurement group_id="O2" value="87" spread="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Results showed in this section are the result of the differences between baseline and final values in placebo group</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.463</p_value>
            <p_value_desc>The threshold for statistical significance was p=0.05</p_value_desc>
            <method>Wilcoxon (Mann-Whitney)</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>Results showed in this section are the result of the differences between baseline and final values in dapagliflozin group</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.043</p_value>
            <p_value_desc>The threshold for statistical significance was p=0.05</p_value_desc>
            <method>Wilcoxon (Mann-Whitney)</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Daytime Hypertensive Load at Week 12</title>
        <description>The hypertensive load was evaluated with ambulatory blood pressure monitoring (ABPM) from 8 a.m. to 11 p.m. by oscillometric method Microlife WatchBP O3</description>
        <time_frame>Week 12</time_frame>
        <population>Each study group had 2 less participants at the end of the investigation due to withdrawal by subject, as mentioned in the participant flow, so the analysis of this outcome is calculated with those who finished the intervention</population>
        <group_list>
          <group group_id="O1">
            <title>Dapagliflozin</title>
            <description>Dapagliflozin capsules, 10 mg, one per day before breakfast during 12 weeks.&#xD;
Dapagliflozin: 10 mg, one per day before breakfast during 12 weeks.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Placebo capsules, one per day before breakfast during 12 weeks.&#xD;
Placebo - Cap: one per day before breakfast during 12 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Daytime Hypertensive Load at Week 12</title>
          <description>The hypertensive load was evaluated with ambulatory blood pressure monitoring (ABPM) from 8 a.m. to 11 p.m. by oscillometric method Microlife WatchBP O3</description>
          <population>Each study group had 2 less participants at the end of the investigation due to withdrawal by subject, as mentioned in the participant flow, so the analysis of this outcome is calculated with those who finished the intervention</population>
          <units>percentage of hypertensive load</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="13"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="28.6" spread="29.8"/>
                    <measurement group_id="O2" value="34.1" spread="35.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Results showed in this section are the result of the differences between baseline and final values in placebo group</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.807</p_value>
            <p_value_desc>The threshold for statistical significance was p=0.05</p_value_desc>
            <method>Wilcoxon (Mann-Whitney)</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>Results showed in this section are the result of the differences between baseline and final values in dapagliflozin group</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.754</p_value>
            <p_value_desc>The threshold for statistical significance was p=0.05</p_value_desc>
            <method>Wilcoxon (Mann-Whitney)</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Nocturnal Hypertensive Load at Week 12</title>
        <description>The Hypertensive Load was evaluated with ambulatory blood pressure monitoring (ABPM) from 11 p.m. to a.m. by oscillometric method Microlife WatchBP O3</description>
        <time_frame>Week 12</time_frame>
        <population>Each study group had 2 less participants at the end of the investigation due to withdrawal by subject, as mentioned in the participant flow, so the analysis of this outcome is calculated with those who finished the intervention</population>
        <group_list>
          <group group_id="O1">
            <title>Dapagliflozin</title>
            <description>Dapagliflozin capsules, 10 mg, one per day before breakfast during 12 weeks.&#xD;
Dapagliflozin: 10 mg, one per day before breakfast during 12 weeks.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Placebo capsules, one per day before breakfast during 12 weeks.&#xD;
Placebo - Cap: one per day before breakfast during 12 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Nocturnal Hypertensive Load at Week 12</title>
          <description>The Hypertensive Load was evaluated with ambulatory blood pressure monitoring (ABPM) from 11 p.m. to a.m. by oscillometric method Microlife WatchBP O3</description>
          <population>Each study group had 2 less participants at the end of the investigation due to withdrawal by subject, as mentioned in the participant flow, so the analysis of this outcome is calculated with those who finished the intervention</population>
          <units>percentage of hypertensive load</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="13"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="38.1" spread="32.0"/>
                    <measurement group_id="O2" value="52.0" spread="32.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Results showed in this section are the result of the differences between baseline and final values in placebo group</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.507</p_value>
            <p_value_desc>The threshold for statistical significance was p=0.05</p_value_desc>
            <method>Wilcoxon (Mann-Whitney)</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>Results showed in this section are the result of the differences between baseline and final values in dapagliflozin group</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.015</p_value>
            <p_value_desc>The threshold for statistical significance was p=0.05</p_value_desc>
            <method>Wilcoxon (Mann-Whitney)</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Prediabetes at Week 12</title>
        <description>Prediabetes was diagnosed with the criteria of the American Diabetes Association.</description>
        <time_frame>Week 12</time_frame>
        <population>Each study group had 2 less participants at the end of the investigation due to withdrawal by subject, as mentioned in the participant flow, so the analysis of this outcome is calculated with those who finished the intervention</population>
        <group_list>
          <group group_id="O1">
            <title>Dapagliflozin</title>
            <description>Dapagliflozin capsules, 10 mg, one per day before breakfast during 12 weeks.&#xD;
Dapagliflozin: 10 mg, one per day before breakfast during 12 weeks.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Placebo capsules, one per day before breakfast during 12 weeks.&#xD;
Placebo - Cap: one per day before breakfast during 12 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Prediabetes at Week 12</title>
          <description>Prediabetes was diagnosed with the criteria of the American Diabetes Association.</description>
          <population>Each study group had 2 less participants at the end of the investigation due to withdrawal by subject, as mentioned in the participant flow, so the analysis of this outcome is calculated with those who finished the intervention</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="13"/>
                <count group_id="O2" value="13"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Results showed in this section are the result of the differences between intervention groups</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.039</p_value>
            <p_value_desc>The threshold for statistical significance was p=0.05</p_value_desc>
            <method>Fisher Exact</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Prehypertension at Week 12</title>
        <description>Prehypertension was diagnosed with the criteria of the Eighth Joint National Committee.</description>
        <time_frame>Week 12</time_frame>
        <population>Each study group had 2 less participants at the end of the investigation due to withdrawal by subject, as mentioned in the participant flow, so the analysis of this outcome is calculated with those who finished the intervention</population>
        <group_list>
          <group group_id="O1">
            <title>Dapagliflozin</title>
            <description>Dapagliflozin capsules, 10 mg, one per day before breakfast during 12 weeks.&#xD;
Dapagliflozin: 10 mg, one per day before breakfast during 12 weeks.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Placebo capsules, one per day before breakfast during 12 weeks.&#xD;
Placebo - Cap: one per day before breakfast during 12 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Prehypertension at Week 12</title>
          <description>Prehypertension was diagnosed with the criteria of the Eighth Joint National Committee.</description>
          <population>Each study group had 2 less participants at the end of the investigation due to withdrawal by subject, as mentioned in the participant flow, so the analysis of this outcome is calculated with those who finished the intervention</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="13"/>
                <count group_id="O2" value="13"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Results showed in this section are the result of the differences between intervention groups</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.011</p_value>
            <method>Fisher Exact</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Prediabetes Plus Prehypertension at Week 12</title>
        <description>Criteria of the American Diabetes Association and Eighth Joint National Committee were used to diagnosed prediabetes and prehypertension.</description>
        <time_frame>Week 12</time_frame>
        <population>Each study group had 2 less participants at the end of the investigation due to withdrawal by subject, as mentioned in the participant flow, so the analysis of this outcome is calculated with those who finished the intervention</population>
        <group_list>
          <group group_id="O1">
            <title>Dapagliflozin</title>
            <description>Dapagliflozin capsules, 10 mg, one per day before breakfast during 12 weeks.&#xD;
Dapagliflozin: 10 mg, one per day before breakfast during 12 weeks.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Placebo capsules, one per day before breakfast during 12 weeks.&#xD;
Placebo - Cap: one per day before breakfast during 12 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Prediabetes Plus Prehypertension at Week 12</title>
          <description>Criteria of the American Diabetes Association and Eighth Joint National Committee were used to diagnosed prediabetes and prehypertension.</description>
          <population>Each study group had 2 less participants at the end of the investigation due to withdrawal by subject, as mentioned in the participant flow, so the analysis of this outcome is calculated with those who finished the intervention</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="13"/>
                <count group_id="O2" value="13"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Results showed in this section are the result of the differences between intervention groups</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.096</p_value>
            <p_value_desc>The threshold for statistical significance was p=0.05</p_value_desc>
            <method>Fisher Exact</method>
          </analysis>
        </analysis_list>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Through study completion, an average of 12 weeks</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Dapagliflozin</title>
          <description>Dapagliflozin capsules, 10 mg, one per day before breakfast during 12 weeks.&#xD;
Dapagliflozin: 10 mg, one per day before breakfast during 12 weeks.</description>
        </group>
        <group group_id="E2">
          <title>Placebo</title>
          <description>Placebo capsules, one per day before breakfast during 12 weeks.&#xD;
Placebo - Cap: one per day before breakfast during 12 weeks.</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="15"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="15"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="15"/>
              </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="3" subjects_at_risk="15"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="15"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Cervicovaginal infection</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="15"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="15"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Urinary tract infections</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="15"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="15"/>
              </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>DR. MANUEL GONZALEZ ORTIZ</name_or_title>
      <organization>INSITITUTO DE TERAPEUTICA EXPERIMENTAL Y CLINICA, UNIVERSITY OF GUADALAJARA</organization>
      <phone>+52 3310585200 ext 34212</phone>
      <email>uiec@prodigy.net.mx</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/NCT03006471
org study id: DAPA-BP variability
nct id: NCT03006471
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Prediabetes is defined as an intermediate metabolic state that leads to the development of
      type 2 diabetes mellitus (DM2) and the prehypertension is a category assigned to identify
      patients who are at risk of developing hypertension (AH), in both pathologies the
      abnormalities in the variation of blood pressure (BP) has been related to organ damage, its
      evaluation is performed by ambulatory blood pressure monitoring (ABPM).

      Dapagliflozin is a selective and reversible inhibitor of the sodium-glucose co-transporter
      type 2 (SGLT-2), which reduces renal reabsorption of glucose and promotes the excretion of
      glucose through the urine, in the way that glucose blood. Another reported effects is the
      decrease on BP, so it would be interesting to evaluate this effects in patients with
      prediabetes and prehypertension, as a potential therapy to treat disorders and to prevent
      progression to DM2 and Hypertension, respectively.

      The aim of this study is to evaluate the effect of Dapagliflozin on variability of blood
      pressure in patients with prediabetes and prehypertension without pharmacological treatment.

      The investigators hypothesis is that the administration of dapagliflozin decreases
      variability of blood pressure in patients with prediabetes and prehypertension without
      pharmacological treatment.
A randomized, double-blind, placebo-controlled clinical trial in 30 patients with a diagnosis
      of prediabetes and prehypertension without treatment.

      They will be assigned randomly two groups of 15 patients each to receive 10 mg of
      Dapagliflozin (Forxiga, Astra Zeneca) or placebo, one per day before breakfast during 12
      weeks.

      There will be calculated body mass index (BMI) and blood pressure variability. This protocol
      it's already approved by the local ethics committee and written informed consent it's going
      to be obtained from all volunteers.

      Statistical analysis will be presented through measures of central tendency and dispersion,
      average and deviation standard for quantitative variables; frequencies and percentages for
      variable qualitative. Qualitative variables will be analyzed by X2/ exact fisher test, will
      be used for differences inter-group Mann-Whitney U Test and coefficient of variation,
      Wilcoxon Test and index of variability for the within-groups differences. It will be
      considered statistical significance p ≤0.05.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: 24-hours Systolic Blood Pressure at Week 12
time frame: Week 12
description: Blood pressure variability was evaluated with ambulatory blood pressure monitoring (ABPM) for 24 hours by oscillometric method Microlife WatchBP O3
measure: 24-hours Diastolic Blood Pressure at Week 12
time frame: Week 12
description: Blood pressure variability was evaluated with ambulatory blood pressure monitoring (ABPM) for 24 hours by oscillometric method Microlife WatchBP O3
measure: Daytime Systolic Blood Pressure at Week 12
time frame: Week 12
description: Blood pressure variability was evaluated with ambulatory blood pressure monitoring (ABPM) from 8 am. to 11 p.m. by oscillometric method Microlife WatchBP O3
measure: Daytime Diastolic Blood Pressure at Week 12
time frame: Week 12
description: Blood pressure variability was evaluated with ambulatory blood pressure monitoring (ABPM) from 8 a.m. to p.m. by oscillometric method Microlife WatchBP O3
measure: Nighttime Systolic Blood Pressure at Week 12
time frame: Week 12
description: Blood pressure variability was evaluated with ambulatory blood pressure monitoring (ABPM) from 11 p.m to 8 a.m. by oscillometric method Microlife WatchBP O3
measure: Nighttime Diastolic Blood Pressure at Week 12
time frame: Week 12
description: Blood pressure variability was evaluated with ambulatory blood pressure monitoring (ABPM) from 11 p.m. to 8 a.m. by oscillometric method Microlife WatchBP O3
measure: Systolic Blood Pressure Weighted Standard Deviation at Week 12
time frame: Week 12
description: Blood pressure variability will be evaluated with ambulatory blood pressure monitoring (ABPM) for 24 hours by oscillometric method Microlife WatchBP O3
measure: Diastolic Blood Pressure Weighted Standard Deviation at Week 12
time frame: Week 12
description: Blood pressure variability was evaluated with ambulatory blood pressure monitoring (ABPM) for 24 hours by oscillometric method Microlife WatchBP O3
measure: Coefficient of Variation of 24-hours, Systolic Blood Pressure at Week 12
time frame: Week 12
description: Blood pressure variability was evaluated with ambulatory blood pressure monitoring (ABPM) for 24 hours by oscillometric method Microlife WatchBP O3
measure: Coefficient of Variation of 24-hours, Diastolic Blood Pressure at Week 12
time frame: Week 12
description: Blood pressure variability was evaluated with ambulatory blood pressure monitoring (ABPM) for 24 hours by oscillometric method Microlife WatchBP O3
measure: Coefficient of Variation Daytime, Systolic Blood Pressure at Week 12
time frame: Week 12
description: Blood pressure variability was evaluated with ambulatory blood pressure monitoring (ABPM) from 8 a.m to 11 p.m. by oscillometric method Microlife WatchBP O3
measure: Coefficient of Variation Daytime, Diastolic Blood Pressure at Week 12
time frame: Week 12
description: Blood pressure variability was evaluated with ambulatory blood pressure monitoring (ABPM) from 8 a.m. to 11 p.m. by oscillometric method Microlife WatchBP O3
measure: Coefficient of Variation Nighttime, Systolic Blood Pressure at Week 12
time frame: Week 12
description: Blood pressure variability was evaluated with ambulatory blood pressure monitoring (ABPM) from 11 p.m. to 8 a.m. by oscillometric method Microlife WatchBP O3
measure: Coefficient of Variation Nighttime, Diastolic Blood Pressure at Week 12
time frame: Week 12
description: Blood pressure variability was evaluated with ambulatory blood pressure monitoring (ABPM) from 11 p.m. to 8 a.m. by oscillometric method Microlife WatchBP O3
measure: Average Real Variability of Systolic Blood Pressure at Week 12
time frame: Week 12
description: Blood pressure variability was evaluated with ambulatory blood pressure monitoring (ABPM) for 24 hours by oscillometric method Microlife WatchBP O3
measure: Average Real Variability of Diastolic Blood Pressure at Week 12
time frame: Week 12
description: Blood pressure variability was evaluated with ambulatory blood pressure monitoring (ABPM) for 24 hours by oscillometric method Microlife WatchBP O3
measure: Number of Participants With a Nondipper Circadian Blood Pressure Pattern at Week 12
time frame: Week 12
description: Blood pressure variability was evaluated with ambulatory blood pressure monitoring (ABPM) for 24 hours by oscillometric method Microlife WatchBP O3
measure: Number of Participants With a Dipper Circadian Blood Pressure Pattern at Week 12
time frame: Week 12
description: Blood pressure variability was evaluated with ambulatory blood pressure monitoring (ABPM) for 24 hours by oscillometric method Microlife WatchBP O3
measure: Number of Participants With a Dipper Reverse Circadian Blood Pattern at Week 12
time frame: Week 12
description: Blood pressure variability was evaluated with ambulatory blood pressure monitoring (ABPM) for 24 hours by oscillometric method Microlife WatchBP O3
measure: Body Weight at Week 12
time frame: Week 12
description: The body weight was measured with a bioimpedance balance
measure: Body Mass Index at Week 12
time frame: Week 12
description: Body Mas Index was calculated with the Quetelet index formula
measure: Office Systolic Blood Pressure at Week 12
time frame: Week 12
description: Blood pressure was measured using the Omron 907-E digital sphygmomanometer (Healthcare, Inc.)
measure: Office of Diastolic Blood Pressure at Week 12
time frame: Week 12
description: Blood pressure was measured using the Omron 907-E digital sphygmomanometer (Healthcare, Inc.)
measure: Fasting Plasma Glucose Levels at Week 12
time frame: Week 12
description: The fasting glucose levels was evaluated with enzymatic/colorimetric techniques
measure: 2-hours Plasma Glucose After a Oral Glucose Tolerance Test at Week 12
time frame: Week 12
description: 2-hours plasma glucose after a oral glucose tolerance test (75 g of glucose load). Glucose was evaluated with enzymatic/ colorimetric technique
measure: Glycated Hemoglobin A1c (A1C) at Week 12
time frame: Week 12
description: A1C was evaluated by Enzyme-Linked ImmunoSorbent Assay (ELISA)
measure: Daytime Mean Arterial Pressure at Week 12
time frame: Week 12
description: The mean arterial pressure was evaluated with ambulatory blood pressure monitoring (ABPM) from 8 a.m. to 11 p.m. by oscillometric method Microlife WatchBP O3
measure: Nighttime Mean Arterial Pressure at Week 12
time frame: Week 12
description: The Mean Arterial Pressure was evaluated with ambulatory blood pressure monitoring (ABPM) from 11 p.m. to 8 a.m. by oscillometric method Microlife WatchBP O3
measure: Daytime Hypertensive Load at Week 12
time frame: Week 12
description: The hypertensive load was evaluated with ambulatory blood pressure monitoring (ABPM) from 8 a.m. to 11 p.m. by oscillometric method Microlife WatchBP O3
measure: Nocturnal Hypertensive Load at Week 12
time frame: Week 12
description: The Hypertensive Load was evaluated with ambulatory blood pressure monitoring (ABPM) from 11 p.m. to a.m. by oscillometric method Microlife WatchBP O3
measure: Number of Participants With Prediabetes at Week 12
time frame: Week 12
description: Prediabetes was diagnosed with the criteria of the American Diabetes Association.
measure: Number of Participants With Prehypertension at Week 12
time frame: Week 12
description: Prehypertension was diagnosed with the criteria of the Eighth Joint National Committee.
measure: Number of Participants With Prediabetes Plus Prehypertension at Week 12
time frame: Week 12
description: Criteria of the American Diabetes Association and Eighth Joint National Committee were used to diagnosed prediabetes and prehypertension.
arm group label: Dapagliflozin
arm group type: Experimental
description: Dapagliflozin capsules, 10 mg, one per day before breakfast during 12 weeks.
arm group label: Placebo
arm group type: Placebo Comparator
description: Placebo capsules, one per day before breakfast during 12 weeks.
intervention type: Drug
intervention name: Dapagliflozin
description: 10 mg, one per day before breakfast during 12 weeks.
arm group label: Dapagliflozin
other name: Forxiga
intervention type: Drug
intervention name: Placebo - Cap
description: one per day before breakfast during 12 weeks.
arm group label: Placebo
other name: Calcined magnesium
criteria: 
gender: All
minimum age: 30 Years
maximum age: 60 Years
healthy volunteers: No
last name: MANUEL GONZALEZ, PhD
role: Principal Investigator
affiliation: University of Guadalajara
facility: 
country: Mexico
responsible party type: Principal Investigator
investigator affiliation: University of Guadalajara
investigator full name: Manuel González Ortiz
investigator title: PhD
mesh term: Prehypertension
mesh term: Prediabetic State
mesh term: Glucose Intolerance
mesh term: Dapagliflozin
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 