<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/NCT03764631</url>
  </required_header>
  <id_info>
    <org_study_id>1245-0149</org_study_id>
    <nct_id>NCT03764631</nct_id>
  </id_info>
  <brief_title>Post-authorization Safety Study in Type 2 Diabetic Patients in Saudi Arabia Treated With Empagliflozin to Assess the Incidence of Ketoacidosis, Severe Complications of Urinary Tract Infection, Volume Depletion, and Dehydration</brief_title>
  <official_title>Post-authorization Safety Study in Patients With Type 2 Diabetes Mellitus to Assess the Incidence of Ketoacidosis, Severe Complications of Urinary Tract Infection, Volume Depletion, and Dehydration Among Patients Treated With Empagliflozin or DPP-4 Inhibitors in Saudi Arabia</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Boehringer Ingelheim</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Boehringer Ingelheim</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The objectives of this study are to assess the risk of ketoacidosis, severe urinary tract&#xD;
      infections, volume depletion, and dehydration associated in patients with T2DM initiating&#xD;
      Empagliflozin compared to patient initiating a dipeptidyl peptidase-4 (DPP-4) inhibitors over&#xD;
      a 12-month period of follow-up, including the month of Ramadan&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 26, 2018</start_date>
  <completion_date type="Actual">January 11, 2021</completion_date>
  <primary_completion_date type="Actual">January 11, 2021</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Number of Participants With Ketoacidosis</measure>
    <time_frame>Up to 12 months after the index date (defined as the date on which each identified new user received the index prescription for Empagliflozin or DPP-4 inhibitor).</time_frame>
    <description>Ketoacidosis is defined as a serious complication of diabetes characterized by high levels of ketones in the body due to lack of insulin and low food intake.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Participants With Severe Urinary Tract Infections (UTIs)</measure>
    <time_frame>Up to 12 months after index date (defined as the date on which each identified new user received the index prescription for Empagliflozin or DPP-4 inhibitor).</time_frame>
    <description>Severe UTIs is defined as pyelonephritis or urosepsis.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Participants With Volume Depletion</measure>
    <time_frame>Up to 12 months after index date (defined as the date on which each identified new user received the index prescription for Empagliflozin or DPP-4 inhibitor).</time_frame>
    <description>Volume depletion is defined as the reduction in the extracellular fluids.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Participants With Dehydration</measure>
    <time_frame>Up to 12 months after index date (defined as the date on which each identified new user received the index prescription for Empagliflozin or DPP-4 inhibitor).</time_frame>
    <description>Dehydration is defined as the loss of total body water that leads to hypertonicity.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Ketoacidosis During Ramadan Periods</measure>
    <time_frame>Up to day 29.</time_frame>
    <description>Ketoacidosis is defined as a serious complication of diabetes characterized by high level of ketones in the body due to lack of insulin and low food intake.&#xD;
Ramadan period is defined as the first day of Ramadan to 29th day of Ramadan based on the Islamic Hijri calendar. The following Ramadan periods were included in this study:&#xD;
Ramadan month 2019: 5. May to 4. Jun 2019 (± 1 to 2 days)&#xD;
Ramadan month 2020: 23. April to 23. May 2020 (± 1 to 2 days).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Severe Urinary Tract Infections (UTIs) During Ramadan Periods</measure>
    <time_frame>Up to day 29.</time_frame>
    <description>Severe UTIs is defined as pyelonephritis or urosepsis.&#xD;
Ramadan period is defined as the first day of Ramadan to 29th day of Ramadan based on the Islamic Hijri calendar. The following Ramadan periods were included in this study:&#xD;
Ramadan month 2019: 5. May to 4. Jun 2019 (± 1 to 2 days)&#xD;
Ramadan month 2020: 23. April to 23. May 2020 (± 1 to 2 days).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Volume Depletion During Ramadan Periods</measure>
    <time_frame>Up to day 29.</time_frame>
    <description>Volume depletion is defined as the reduction in the extracellular fluids.&#xD;
Ramadan period is defined as the first day of Ramadan to 29th day of Ramadan based on the Islamic Hijri calendar. The following Ramadan periods were included in this study:&#xD;
Ramadan month 2019: 5. May to 4. Jun 2019 (± 1 to 2 days)&#xD;
Ramadan month 2020: 23. April to 23. May 2020 (± 1 to 2 days).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Dehydration During Ramadan Periods</measure>
    <time_frame>Up to day 29.</time_frame>
    <description>Dehydration is defined as the loss of total body water that leads to hypertonicity.&#xD;
Ramadan period is defined as the first day of Ramadan to 29th day of Ramadan based on the Islamic Hijri calendar. The following Ramadan periods were included in this study:&#xD;
Ramadan month 2019: 5. May to 4. Jun 2019 (± 1 to 2 days)&#xD;
Ramadan month 2020: 23. April to 23. May 2020 (± 1 to 2 days).</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">1502</enrollment>
  <condition>Diabetes Mellitus, Type 2</condition>
  <arm_group>
    <arm_group_label>subjects with Type 2 Diabetes mellitus</arm_group_label>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Empagliflozin</intervention_name>
    <description>Drug</description>
    <arm_group_label>subjects with Type 2 Diabetes mellitus</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Dipeptidyl-peptidase 4 (DPP-4) inhibitors</intervention_name>
    <description>Dipeptidyl-peptidase 4 - Drug</description>
    <arm_group_label>subjects with Type 2 Diabetes mellitus</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Main diagnosis for study entry&#xD;
&#xD;
        -Patients diagnosed with T2DM will be included.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients who have signed Informed consent form.&#xD;
&#xD;
          -  The patients will be at least 18 years old at index date, diagnosed with Type 2&#xD;
             diabetes mellitus (T2DM) in Saudi Arabia, and who will initiate Empagliflozin or&#xD;
             Dipeptidyl-peptidase 4 (DPP4) inhibitors treatment according to the local label and at&#xD;
             the discretion of the treating physician during the study period, who have not used&#xD;
             other sodium/glucose co-transporter 2 (SGLT2) or DPP4 inhibitors during the previous&#xD;
             12 months.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Known hypersensitivity to Empagliflozin, the comparator DPP-4 inhibitors or any of&#xD;
             their excipients&#xD;
&#xD;
          -  Patients for whom Empagliflozin or the comparator DPP-4 inhibitor is contraindicated&#xD;
             according Saudi Food and Drug Authority (SFDA) approved label&#xD;
&#xD;
          -  Patients prescribed fixed-dose combinations of SGLT2 inhibitors with DPP-4 inhibitors&#xD;
             will be excluded.&#xD;
&#xD;
          -  The same inclusion and exclusion criteria will be applied to the comparator group,&#xD;
             which will include new users of DPP-4 inhibitors.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ahmed Mansour, +201028866717</last_name>
    <role>Study Chair</role>
    <affiliation>ahmed.mansour@boehringer-ingelheim.com</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Abha International Private Hospital</name>
      <address>
        <city>Abha</city>
        <zip>61431</zip>
        <country>Saudi Arabia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>DAFA Special Polyclinic</name>
      <address>
        <city>Jeddah</city>
        <zip>21214</zip>
        <country>Saudi Arabia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ghassan Najeeb Pharaon Hospital</name>
      <address>
        <city>Jeddah</city>
        <zip>21412</zip>
        <country>Saudi Arabia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>International Medical Center</name>
      <address>
        <city>Jeddah</city>
        <zip>21451</zip>
        <country>Saudi Arabia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dr.Bakhsh Hospital</name>
      <address>
        <city>Jeddah</city>
        <zip>21452</zip>
        <country>Saudi Arabia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dr. Soliman Fakeeh Hospital</name>
      <address>
        <city>Jeddah</city>
        <zip>21461</zip>
        <country>Saudi Arabia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Saudi German Hospital</name>
      <address>
        <city>Jeddah</city>
        <zip>21461</zip>
        <country>Saudi Arabia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Al Abeer Medical Center</name>
      <address>
        <city>Jeddah</city>
        <zip>21573</zip>
        <country>Saudi Arabia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Al-Abeer Medical Center</name>
      <address>
        <city>Jeddah</city>
        <zip>21573</zip>
        <country>Saudi Arabia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Al Abeer Polyclinic</name>
      <address>
        <city>Jeddah</city>
        <zip>23531</zip>
        <country>Saudi Arabia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Al Rahman Polyclinic</name>
      <address>
        <city>Makkah</city>
        <zip>24232</zip>
        <country>Saudi Arabia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Shifa Hospital</name>
      <address>
        <city>Makkah</city>
        <zip>24232</zip>
        <country>Saudi Arabia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Al-Noor Specialist Hospital</name>
      <address>
        <city>Makkah</city>
        <zip>24241</zip>
        <country>Saudi Arabia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Al Zafer Hospital</name>
      <address>
        <city>Najran</city>
        <zip>66261</zip>
        <country>Saudi Arabia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Obesity, Endocrine and Metabolism Center</name>
      <address>
        <city>Riyadh</city>
        <zip>11525</zip>
        <country>Saudi Arabia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Riyadh Medical Center</name>
      <address>
        <city>Riyadh</city>
        <zip>11533</zip>
        <country>Saudi Arabia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Alalam Medical Center</name>
      <address>
        <city>Riyadh</city>
        <zip>13214</zip>
        <country>Saudi Arabia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Prince Fahad bin Sultan hospital</name>
      <address>
        <city>Tabuk</city>
        <zip>47311</zip>
        <country>Saudi Arabia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Al Hada Armed Forces Hospital</name>
      <address>
        <city>Taif</city>
        <zip>21944</zip>
        <country>Saudi Arabia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Al Amal Medical Group</name>
      <address>
        <city>Yanbu</city>
        <zip>46455</zip>
        <country>Saudi Arabia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Alansari Specialist Hospital</name>
      <address>
        <city>Yanbu</city>
        <zip>46455</zip>
        <country>Saudi Arabia</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Saudi Arabia</country>
  </location_countries>
  <link>
    <url>http://www.mystudywindow.com</url>
    <description>Related Info</description>
  </link>
  <verification_date>February 2022</verification_date>
  <study_first_submitted>November 26, 2018</study_first_submitted>
  <study_first_submitted_qc>December 4, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 5, 2018</study_first_posted>
  <results_first_submitted>December 21, 2021</results_first_submitted>
  <results_first_submitted_qc>February 9, 2022</results_first_submitted_qc>
  <results_first_posted type="Actual">February 10, 2022</results_first_posted>
  <last_update_submitted>February 9, 2022</last_update_submitted>
  <last_update_submitted_qc>February 9, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">February 10, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Urinary Tract Infections</mesh_term>
    <mesh_term>Diabetes Mellitus</mesh_term>
    <mesh_term>Diabetes Mellitus, Type 2</mesh_term>
    <mesh_term>Dehydration</mesh_term>
    <mesh_term>Ketosis</mesh_term>
    <mesh_term>Hypovolemia</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Empagliflozin</mesh_term>
    <mesh_term>Dipeptidyl-Peptidase IV Inhibitors</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
    <ipd_description>Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents, except for the following exclusions:&#xD;
Studies in products where Boehringer Ingelheim is not the license holder;&#xD;
studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials;&#xD;
Studies conducted in a single center or targeting rare diseases (because of limitations with anonymization).&#xD;
Requestors can use the following link http:// trials.boehringer-ingelheim.com/ to:&#xD;
find information in order to request access to clinical study data, for listed studies.&#xD;
request access to clinical study documents that meet criteria, and upon a signed 'Document Sharing Agreement.</ipd_description>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>September 23, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/31/NCT03764631/Prot_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>April 17, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/31/NCT03764631/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>A non-interventional study with new data collection from patients with type 2 diabetes mellitus in Saudi Arabia. The study used a &quot;new users&quot; design and compared new users of Empagliflozin to new users of Dipeptidyl peptidase-4 (DPP-4) inhibitors.</recruitment_details>
      <pre_assignment_details>Only patients who met all of the inclusion and none of the exclusion criteria were enrolled into the study after signing the informed consent form.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Empagliflozin</title>
          <description>Patients with type 2 diabetes mellitus (T2DM) and newly using Empagliflozin (e.g. Patients had not used other Sodium/Glucose co-transporter 2 (SLGT2) or Dipeptidyl peptidase-4 (DPP-4) inhibitors during the previous 12 months). Empagliflozin was administered according to the approved labels in Saudi Arabia. Patients were followed up for 12 months after the index date.</description>
        </group>
        <group group_id="P2">
          <title>DPP-4 Inhibitors</title>
          <description>Patients with type 2 diabetes mellitus (T2DM) and newly using Dipeptidyl peptidase-4 (DPP-4) inhibitors (e.g. patients had not used other Sodium/Glucose co-transporter 2 (SLGT2) or DPP-4 inhibitors during the previous 12 months). DPP-4 inhibitors were administered according to the approved labels in Saudi Arabia. Patients were followed up for 12 months after the index date.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="751"/>
                <participants group_id="P2" count="751"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="710"/>
                <participants group_id="P2" count="698"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="41"/>
                <participants group_id="P2" count="53"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Personal Reasons</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Switching Therapy</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="3"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="33"/>
                <participants group_id="P2" count="41"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>No data as study site was closed</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="6"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Enrolled Set: All patients with type 2 diabetes mellitus included in this study who signed the informed consent.</population>
      <group_list>
        <group group_id="B1">
          <title>Empagliflozin</title>
          <description>Patients with type 2 diabetes mellitus (T2DM) and newly using Empagliflozin (e.g. Patients had not used other Sodium/Glucose co-transporter 2 (SLGT2) or Dipeptidyl peptidase-4 (DPP-4) inhibitors during the previous 12 months). Empagliflozin was administered according to the approved labels in Saudi Arabia. Patients were followed up for 12 months after the index date.</description>
        </group>
        <group group_id="B2">
          <title>DPP-4 Inhibitors</title>
          <description>Patients with type 2 diabetes mellitus (T2DM) and newly using Dipeptidyl peptidase-4 (DPP-4) inhibitors (e.g. patients had not used other Sodium/Glucose co-transporter 2 (SLGT2) or DPP-4 inhibitors during the previous 12 months). DPP-4 inhibitors were administered according to the approved labels in Saudi Arabia. Patients were followed up for 12 months after the index date.</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="751"/>
            <count group_id="B2" value="751"/>
            <count group_id="B3" value="1502"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="751"/>
                    <count group_id="B2" value="751"/>
                    <count group_id="B3" value="1502"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="52.1" spread="10.3"/>
                    <measurement group_id="B2" value="52.9" spread="10.7"/>
                    <measurement group_id="B3" value="52.5" spread="10.5"/>
                  </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>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="751"/>
                    <count group_id="B2" value="751"/>
                    <count group_id="B3" value="1502"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="273"/>
                    <measurement group_id="B2" value="264"/>
                    <measurement group_id="B3" value="537"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="478"/>
                    <measurement group_id="B2" value="487"/>
                    <measurement group_id="B3" value="965"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race and Ethnicity Not Collected</title>
          <population>Race and Ethnicity were not collected from any participant.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="0"/>
                    <count group_id="B2" value="0"/>
                    <count group_id="B3" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants With Ketoacidosis</title>
        <description>Ketoacidosis is defined as a serious complication of diabetes characterized by high levels of ketones in the body due to lack of insulin and low food intake.</description>
        <time_frame>Up to 12 months after the index date (defined as the date on which each identified new user received the index prescription for Empagliflozin or DPP-4 inhibitor).</time_frame>
        <population>Enrolled Set: All patients with type 2 diabetes mellitus included in the study who signed the informed consent.</population>
        <group_list>
          <group group_id="O1">
            <title>Empagliflozin</title>
            <description>Patients with type 2 diabetes mellitus (T2DM) and newly using Empagliflozin (e.g. Patients had not used other Sodium/Glucose co-transporter 2 (SLGT2) or Dipeptidyl peptidase-4 (DPP-4) inhibitors during the previous 12 months). Empagliflozin was administered according to the approved labels in Saudi Arabia. Patients were followed up for 12 months after the index date.</description>
          </group>
          <group group_id="O2">
            <title>DPP-4 Inhibitors</title>
            <description>Patients with type 2 diabetes mellitus (T2DM) and newly using Dipeptidyl peptidase-4 (DPP-4) inhibitors (e.g. patients had not used other Sodium/Glucose co-transporter 2 (SLGT2) or DPP-4 inhibitors during the previous 12 months). DPP-4 inhibitors were administered according to the approved labels in Saudi Arabia. Patients were followed up for 12 months after the index date.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Ketoacidosis</title>
          <description>Ketoacidosis is defined as a serious complication of diabetes characterized by high levels of ketones in the body due to lack of insulin and low food intake.</description>
          <population>Enrolled Set: All patients with type 2 diabetes mellitus included in the study who signed the informed consent.</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="751"/>
                <count group_id="O2" value="751"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants With Severe Urinary Tract Infections (UTIs)</title>
        <description>Severe UTIs is defined as pyelonephritis or urosepsis.</description>
        <time_frame>Up to 12 months after index date (defined as the date on which each identified new user received the index prescription for Empagliflozin or DPP-4 inhibitor).</time_frame>
        <population>Enrolled Set: All patients with type 2 diabetes mellitus included in the study who signed the informed consent.</population>
        <group_list>
          <group group_id="O1">
            <title>Empagliflozin</title>
            <description>Patients with type 2 diabetes mellitus (T2DM) and newly using Empagliflozin (e.g. Patients had not used other Sodium/Glucose co-transporter 2 (SLGT2) or Dipeptidyl peptidase-4 (DPP-4) inhibitors during the previous 12 months). Empagliflozin was administered according to the approved labels in Saudi Arabia. Patients were followed up for 12 months after the index date.</description>
          </group>
          <group group_id="O2">
            <title>DPP-4 Inhibitors</title>
            <description>Patients with type 2 diabetes mellitus (T2DM) and newly using Dipeptidyl peptidase-4 (DPP-4) inhibitors (e.g. patients had not used other Sodium/Glucose co-transporter 2 (SLGT2) or DPP-4 inhibitors during the previous 12 months). DPP-4 inhibitors were administered according to the approved labels in Saudi Arabia. Patients were followed up for 12 months after the index date.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Severe Urinary Tract Infections (UTIs)</title>
          <description>Severe UTIs is defined as pyelonephritis or urosepsis.</description>
          <population>Enrolled Set: All patients with type 2 diabetes mellitus included in the study who signed the informed consent.</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="751"/>
                <count group_id="O2" value="751"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants With Volume Depletion</title>
        <description>Volume depletion is defined as the reduction in the extracellular fluids.</description>
        <time_frame>Up to 12 months after index date (defined as the date on which each identified new user received the index prescription for Empagliflozin or DPP-4 inhibitor).</time_frame>
        <population>Enrolled Set: All patients with type 2 diabetes mellitus included in the study who signed informed consent.</population>
        <group_list>
          <group group_id="O1">
            <title>Empagliflozin</title>
            <description>Patients with type 2 diabetes mellitus (T2DM) and newly using Empagliflozin (e.g. Patients had not used other Sodium/Glucose co-transporter 2 (SLGT2) or Dipeptidyl peptidase-4 (DPP-4) inhibitors during the previous 12 months). Empagliflozin was administered according to the approved labels in Saudi Arabia. Patients were followed up for 12 months after the index date.</description>
          </group>
          <group group_id="O2">
            <title>DPP-4 Inhibitors</title>
            <description>Patients with type 2 diabetes mellitus (T2DM) and newly using Dipeptidyl peptidase-4 (DPP-4) inhibitors (e.g. patients had not used other Sodium/Glucose co-transporter 2 (SLGT2) or DPP-4 inhibitors during the previous 12 months). DPP-4 inhibitors were administered according to the approved labels in Saudi Arabia. Patients were followed up for 12 months after the index date.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Volume Depletion</title>
          <description>Volume depletion is defined as the reduction in the extracellular fluids.</description>
          <population>Enrolled Set: All patients with type 2 diabetes mellitus included in the study who signed informed consent.</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="751"/>
                <count group_id="O2" value="751"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                    <measurement group_id="O2" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants With Dehydration</title>
        <description>Dehydration is defined as the loss of total body water that leads to hypertonicity.</description>
        <time_frame>Up to 12 months after index date (defined as the date on which each identified new user received the index prescription for Empagliflozin or DPP-4 inhibitor).</time_frame>
        <population>Enrolled Set: All patients with type 2 diabetes mellitus included in the study who signed informed consent.</population>
        <group_list>
          <group group_id="O1">
            <title>Empagliflozin</title>
            <description>Patients with type 2 diabetes mellitus (T2DM) and newly using Empagliflozin (e.g. Patients had not used other Sodium/Glucose co-transporter 2 (SLGT2) or Dipeptidyl peptidase-4 (DPP-4) inhibitors during the previous 12 months). Empagliflozin was administered according to the approved labels in Saudi Arabia. Patients were followed up for 12 months after the index date.</description>
          </group>
          <group group_id="O2">
            <title>DPP-4 Inhibitors</title>
            <description>Patients with type 2 diabetes mellitus (T2DM) and newly using Dipeptidyl peptidase-4 (DPP-4) inhibitors (e.g. patients had not used other Sodium/Glucose co-transporter 2 (SLGT2) or DPP-4 inhibitors during the previous 12 months). DPP-4 inhibitors were administered according to the approved labels in Saudi Arabia. Patients were followed up for 12 months after the index date.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Dehydration</title>
          <description>Dehydration is defined as the loss of total body water that leads to hypertonicity.</description>
          <population>Enrolled Set: All patients with type 2 diabetes mellitus included in the study who signed informed consent.</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="751"/>
                <count group_id="O2" value="751"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Ketoacidosis During Ramadan Periods</title>
        <description>Ketoacidosis is defined as a serious complication of diabetes characterized by high level of ketones in the body due to lack of insulin and low food intake.&#xD;
Ramadan period is defined as the first day of Ramadan to 29th day of Ramadan based on the Islamic Hijri calendar. The following Ramadan periods were included in this study:&#xD;
Ramadan month 2019: 5. May to 4. Jun 2019 (± 1 to 2 days)&#xD;
Ramadan month 2020: 23. April to 23. May 2020 (± 1 to 2 days).</description>
        <time_frame>Up to day 29.</time_frame>
        <population>Enrolled Set: All patients with type 2 diabetes mellitus included in the study who signed the informed consent.</population>
        <group_list>
          <group group_id="O1">
            <title>Empagliflozin</title>
            <description>Patients with type 2 diabetes mellitus (T2DM) and newly using Empagliflozin (e.g. Patients had not used other Sodium/Glucose co-transporter 2 (SLGT2) or Dipeptidyl peptidase-4 (DPP-4) inhibitors during the previous 12 months). Empagliflozin was administered according to the approved labels in Saudi Arabia. Patients were followed up for 12 months after the index date.</description>
          </group>
          <group group_id="O2">
            <title>DPP-4 Inhibitors</title>
            <description>Patients with type 2 diabetes mellitus (T2DM) and newly using Dipeptidyl peptidase-4 (DPP-4) inhibitors (e.g. patients had not used other Sodium/Glucose co-transporter 2 (SLGT2) or DPP-4 inhibitors during the previous 12 months). DPP-4 inhibitors were administered according to the approved labels in Saudi Arabia. Patients were followed up for 12 months after the index date.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Ketoacidosis During Ramadan Periods</title>
          <description>Ketoacidosis is defined as a serious complication of diabetes characterized by high level of ketones in the body due to lack of insulin and low food intake.&#xD;
Ramadan period is defined as the first day of Ramadan to 29th day of Ramadan based on the Islamic Hijri calendar. The following Ramadan periods were included in this study:&#xD;
Ramadan month 2019: 5. May to 4. Jun 2019 (± 1 to 2 days)&#xD;
Ramadan month 2020: 23. April to 23. May 2020 (± 1 to 2 days).</description>
          <population>Enrolled Set: All patients with type 2 diabetes mellitus included in the study who signed the informed consent.</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="751"/>
                <count group_id="O2" value="751"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Ramadan month 2019</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Ramadan month 2020</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Severe Urinary Tract Infections (UTIs) During Ramadan Periods</title>
        <description>Severe UTIs is defined as pyelonephritis or urosepsis.&#xD;
Ramadan period is defined as the first day of Ramadan to 29th day of Ramadan based on the Islamic Hijri calendar. The following Ramadan periods were included in this study:&#xD;
Ramadan month 2019: 5. May to 4. Jun 2019 (± 1 to 2 days)&#xD;
Ramadan month 2020: 23. April to 23. May 2020 (± 1 to 2 days).</description>
        <time_frame>Up to day 29.</time_frame>
        <population>Enrolled Set: All patients with type 2 diabetes mellitus included in the study who signed the informed consent.</population>
        <group_list>
          <group group_id="O1">
            <title>Empagliflozin</title>
            <description>Patients with type 2 diabetes mellitus (T2DM) and newly using Empagliflozin (e.g. Patients had not used other Sodium/Glucose co-transporter 2 (SLGT2) or Dipeptidyl peptidase-4 (DPP-4) inhibitors during the previous 12 months). Empagliflozin was administered according to the approved labels in Saudi Arabia. Patients were followed up for 12 months after the index date.</description>
          </group>
          <group group_id="O2">
            <title>DPP-4 Inhibitors</title>
            <description>Patients with type 2 diabetes mellitus (T2DM) and newly using Dipeptidyl peptidase-4 (DPP-4) inhibitors (e.g. patients had not used other Sodium/Glucose co-transporter 2 (SLGT2) or DPP-4 inhibitors during the previous 12 months). DPP-4 inhibitors were administered according to the approved labels in Saudi Arabia. Patients were followed up for 12 months after the index date.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Severe Urinary Tract Infections (UTIs) During Ramadan Periods</title>
          <description>Severe UTIs is defined as pyelonephritis or urosepsis.&#xD;
Ramadan period is defined as the first day of Ramadan to 29th day of Ramadan based on the Islamic Hijri calendar. The following Ramadan periods were included in this study:&#xD;
Ramadan month 2019: 5. May to 4. Jun 2019 (± 1 to 2 days)&#xD;
Ramadan month 2020: 23. April to 23. May 2020 (± 1 to 2 days).</description>
          <population>Enrolled Set: All patients with type 2 diabetes mellitus included in the study who signed the informed consent.</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="751"/>
                <count group_id="O2" value="751"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Ramadan month 2019</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Ramadan month 2020</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Volume Depletion During Ramadan Periods</title>
        <description>Volume depletion is defined as the reduction in the extracellular fluids.&#xD;
Ramadan period is defined as the first day of Ramadan to 29th day of Ramadan based on the Islamic Hijri calendar. The following Ramadan periods were included in this study:&#xD;
Ramadan month 2019: 5. May to 4. Jun 2019 (± 1 to 2 days)&#xD;
Ramadan month 2020: 23. April to 23. May 2020 (± 1 to 2 days).</description>
        <time_frame>Up to day 29.</time_frame>
        <population>Enrolled Set: All patients with type 2 diabetes mellitus included in the study who signed the informed consent.</population>
        <group_list>
          <group group_id="O1">
            <title>Empagliflozin</title>
            <description>Patients with type 2 diabetes mellitus (T2DM) and newly using Empagliflozin (e.g. Patients had not used other Sodium/Glucose co-transporter 2 (SLGT2) or Dipeptidyl peptidase-4 (DPP-4) inhibitors during the previous 12 months). Empagliflozin was administered according to the approved labels in Saudi Arabia. Patients were followed up for 12 months after the index date.</description>
          </group>
          <group group_id="O2">
            <title>DPP-4 Inhibitors</title>
            <description>Patients with type 2 diabetes mellitus (T2DM) and newly using Dipeptidyl peptidase-4 (DPP-4) inhibitors (e.g. patients had not used other Sodium/Glucose co-transporter 2 (SLGT2) or DPP-4 inhibitors during the previous 12 months). DPP-4 inhibitors were administered according to the approved labels in Saudi Arabia. Patients were followed up for 12 months after the index date.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Volume Depletion During Ramadan Periods</title>
          <description>Volume depletion is defined as the reduction in the extracellular fluids.&#xD;
Ramadan period is defined as the first day of Ramadan to 29th day of Ramadan based on the Islamic Hijri calendar. The following Ramadan periods were included in this study:&#xD;
Ramadan month 2019: 5. May to 4. Jun 2019 (± 1 to 2 days)&#xD;
Ramadan month 2020: 23. April to 23. May 2020 (± 1 to 2 days).</description>
          <population>Enrolled Set: All patients with type 2 diabetes mellitus included in the study who signed the informed consent.</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="751"/>
                <count group_id="O2" value="751"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Ramadan month 2019</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Ramadan month 2020</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Dehydration During Ramadan Periods</title>
        <description>Dehydration is defined as the loss of total body water that leads to hypertonicity.&#xD;
Ramadan period is defined as the first day of Ramadan to 29th day of Ramadan based on the Islamic Hijri calendar. The following Ramadan periods were included in this study:&#xD;
Ramadan month 2019: 5. May to 4. Jun 2019 (± 1 to 2 days)&#xD;
Ramadan month 2020: 23. April to 23. May 2020 (± 1 to 2 days).</description>
        <time_frame>Up to day 29.</time_frame>
        <population>Enrolled Set: All patients with type 2 diabetes mellitus included in the study who signed the informed consent.</population>
        <group_list>
          <group group_id="O1">
            <title>Empagliflozin</title>
            <description>Patients with type 2 diabetes mellitus (T2DM) and newly using Empagliflozin (e.g. Patients had not used other Sodium/Glucose co-transporter 2 (SLGT2) or Dipeptidyl peptidase-4 (DPP-4) inhibitors during the previous 12 months). Empagliflozin was administered according to the approved labels in Saudi Arabia. Patients were followed up for 12 months after the index date.</description>
          </group>
          <group group_id="O2">
            <title>DPP-4 Inhibitors</title>
            <description>Patients with type 2 diabetes mellitus (T2DM) and newly using Dipeptidyl peptidase-4 (DPP-4) inhibitors (e.g. patients had not used other Sodium/Glucose co-transporter 2 (SLGT2) or DPP-4 inhibitors during the previous 12 months). DPP-4 inhibitors were administered according to the approved labels in Saudi Arabia. Patients were followed up for 12 months after the index date.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Dehydration During Ramadan Periods</title>
          <description>Dehydration is defined as the loss of total body water that leads to hypertonicity.&#xD;
Ramadan period is defined as the first day of Ramadan to 29th day of Ramadan based on the Islamic Hijri calendar. The following Ramadan periods were included in this study:&#xD;
Ramadan month 2019: 5. May to 4. Jun 2019 (± 1 to 2 days)&#xD;
Ramadan month 2020: 23. April to 23. May 2020 (± 1 to 2 days).</description>
          <population>Enrolled Set: All patients with type 2 diabetes mellitus included in the study who signed the informed consent.</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="751"/>
                <count group_id="O2" value="751"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Ramadan month 2019</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Ramadan month 2020</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Up to 12 months.</time_frame>
      <desc>Enrolled Set: All patients with type 2 diabetes mellitus included in this study who signed the informed consent.</desc>
      <group_list>
        <group group_id="E1">
          <title>Empagliflozin</title>
          <description>Patients with type 2 diabetes mellitus (T2DM) and newly using Empagliflozin (e.g. Patients had not used other Sodium/Glucose co-transporter 2 (SLGT2) or Dipeptidyl peptidase-4 (DPP-4) inhibitors during the previous 12 months). Empagliflozin was administered according to the approved labels in Saudi Arabia. Patients were followed up for 12 months after the index date.</description>
        </group>
        <group group_id="E2">
          <title>DPP-4 Inhibitors</title>
          <description>Patients with type 2 diabetes mellitus (T2DM) and newly using Dipeptidyl peptidase-4 (DPP-4) inhibitors (e.g. patients had not used other Sodium/Glucose co-transporter 2 (SLGT2) or DPP-4 inhibitors during the previous 12 months). DPP-4 inhibitors were administered according to the approved labels in Saudi Arabia. Patients were followed up for 12 months after the index date.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA 21.1</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <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="751"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="751"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="751"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="751"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Myocardial ischaemia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="751"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="751"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Anal fissure</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="751"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="751"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Hernia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="751"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="751"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Pneumonia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="751"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="751"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Diabetic ketoacidosis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="751"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="751"/>
              </event>
              <event>
                <sub_title>Obesity</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="751"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="751"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Lung adenocarcinoma</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="751"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="751"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Acute kidney injury</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="751"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="751"/>
              </event>
              <event>
                <sub_title>End stage renal disease</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="751"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="751"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="751"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="751"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI's intellectual property rights.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Boehringer Ingelheim, Call Centre</name_or_title>
      <organization>Boehringer Ingelheim</organization>
      <phone>1-800-243-0127</phone>
      <email>clintriage.rdg@boehringer-ingelheim.com</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/NCT03764631
org study id: 1245-0149
nct id: NCT03764631
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
is us export: No
The objectives of this study are to assess the risk of ketoacidosis, severe urinary tract
      infections, volume depletion, and dehydration associated in patients with T2DM initiating
      Empagliflozin compared to patient initiating a dipeptidyl peptidase-4 (DPP-4) inhibitors over
      a 12-month period of follow-up, including the month of Ramadan
observational model: Cohort
time perspective: Prospective
measure: Number of Participants With Ketoacidosis
time frame: Up to 12 months after the index date (defined as the date on which each identified new user received the index prescription for Empagliflozin or DPP-4 inhibitor).
description: Ketoacidosis is defined as a serious complication of diabetes characterized by high levels of ketones in the body due to lack of insulin and low food intake.
measure: Number of Participants With Severe Urinary Tract Infections (UTIs)
time frame: Up to 12 months after index date (defined as the date on which each identified new user received the index prescription for Empagliflozin or DPP-4 inhibitor).
description: Severe UTIs is defined as pyelonephritis or urosepsis.
measure: Number of Participants With Volume Depletion
time frame: Up to 12 months after index date (defined as the date on which each identified new user received the index prescription for Empagliflozin or DPP-4 inhibitor).
description: Volume depletion is defined as the reduction in the extracellular fluids.
measure: Number of Participants With Dehydration
time frame: Up to 12 months after index date (defined as the date on which each identified new user received the index prescription for Empagliflozin or DPP-4 inhibitor).
description: Dehydration is defined as the loss of total body water that leads to hypertonicity.
measure: Number of Participants With Ketoacidosis During Ramadan Periods
time frame: Up to day 29.
description: Ketoacidosis is defined as a serious complication of diabetes characterized by high level of ketones in the body due to lack of insulin and low food intake.
Ramadan period is defined as the first day of Ramadan to 29th day of Ramadan based on the Islamic Hijri calendar. The following Ramadan periods were included in this study:
Ramadan month 2019: 5. May to 4. Jun 2019 (± 1 to 2 days)
Ramadan month 2020: 23. April to 23. May 2020 (± 1 to 2 days).
measure: Number of Participants With Severe Urinary Tract Infections (UTIs) During Ramadan Periods
time frame: Up to day 29.
description: Severe UTIs is defined as pyelonephritis or urosepsis.
Ramadan period is defined as the first day of Ramadan to 29th day of Ramadan based on the Islamic Hijri calendar. The following Ramadan periods were included in this study:
Ramadan month 2019: 5. May to 4. Jun 2019 (± 1 to 2 days)
Ramadan month 2020: 23. April to 23. May 2020 (± 1 to 2 days).
measure: Number of Participants With Volume Depletion During Ramadan Periods
time frame: Up to day 29.
description: Volume depletion is defined as the reduction in the extracellular fluids.
Ramadan period is defined as the first day of Ramadan to 29th day of Ramadan based on the Islamic Hijri calendar. The following Ramadan periods were included in this study:
Ramadan month 2019: 5. May to 4. Jun 2019 (± 1 to 2 days)
Ramadan month 2020: 23. April to 23. May 2020 (± 1 to 2 days).
measure: Number of Participants With Dehydration During Ramadan Periods
time frame: Up to day 29.
description: Dehydration is defined as the loss of total body water that leads to hypertonicity.
Ramadan period is defined as the first day of Ramadan to 29th day of Ramadan based on the Islamic Hijri calendar. The following Ramadan periods were included in this study:
Ramadan month 2019: 5. May to 4. Jun 2019 (± 1 to 2 days)
Ramadan month 2020: 23. April to 23. May 2020 (± 1 to 2 days).
arm group label: subjects with Type 2 Diabetes mellitus
intervention type: Drug
intervention name: Empagliflozin
description: Drug
arm group label: subjects with Type 2 Diabetes mellitus
intervention type: Drug
intervention name: Dipeptidyl-peptidase 4 (DPP-4) inhibitors
description: Dipeptidyl-peptidase 4 - Drug
arm group label: subjects with Type 2 Diabetes mellitus
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Ahmed Mansour, +201028866717
role: Study Chair
affiliation: ahmed.mansour@boehringer-ingelheim.com
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country: Saudi Arabia
url: http://www.mystudywindow.com
description: Related Info
responsible party type: Sponsor
mesh term: Urinary Tract Infections
mesh term: Diabetes Mellitus
mesh term: Diabetes Mellitus, Type 2
mesh term: Dehydration
mesh term: Ketosis
mesh term: Hypovolemia
mesh term: Empagliflozin
mesh term: Dipeptidyl-Peptidase IV Inhibitors
sharing ipd: Undecided
ipd description: Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents, except for the following exclusions:
Studies in products where Boehringer Ingelheim is not the license holder;
studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials;
Studies conducted in a single center or targeting rare diseases (because of limitations with anonymization).
Requestors can use the following link http:// trials.boehringer-ingelheim.com/ to:
find information in order to request access to clinical study data, for listed studies.
request access to clinical study documents that meet criteria, and upon a signed 'Document Sharing Agreement.
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 