<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/NCT02197078</url>
  </required_header>
  <id_info>
    <org_study_id>1218.163</org_study_id>
    <nct_id>NCT02197078</nct_id>
  </id_info>
  <brief_title>Active Surveillance Research Program for the Assessment of the Safety and the Effectiveness of Linagliptin</brief_title>
  <official_title>Active Surveillance Research Program for the Assessment of the Safety and the Effectiveness of Linagliptin</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Boehringer Ingelheim</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Eli Lilly and Company</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Boehringer Ingelheim</source>
  <brief_summary>
    <textblock>
      This protocol is for a series of comparative effectiveness and safety analyses within&#xD;
      periodically updated cohorts of patients initiating linagliptin, other DPP-4 inhibitors, and&#xD;
      other oral hypoglycemic medications, followed longitudinally for the occurrence of a variety&#xD;
      of health outcomes. The primary analysis will be conducted among patients without prior&#xD;
      within-class medication use.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 30, 2014</start_date>
  <completion_date type="Actual">February 26, 2019</completion_date>
  <primary_completion_date type="Actual">February 26, 2019</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>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Number of Participants With Major Adverse Cardiovascular Event</measure>
    <time_frame>Up to 5 years and 7 months</time_frame>
    <description>Number of participants with major adverse cardiovascular event is presented by the number of patients reported a composite of:&#xD;
Coronary revascularization (elective and non-elective procedure)&#xD;
Acute coronary syndrome (ACS), including acute myocardial infarction (MI)&#xD;
Stroke (Ischemic and hemorrhagic stroke)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Participants With Coronary Revascularization</measure>
    <time_frame>Up to 5 years and 7 month</time_frame>
    <description>Number of participants with coronary revascularization (elective and non-elective procedure)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Participants With Acute Coronary Syndrome</measure>
    <time_frame>Up to 5 years and 7 months</time_frame>
    <description>Number of participants with acute coronary syndrome (ACS). The definition for ACS included acute myocardial infarction (MI), but acute MI was not assessed separately.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Participants With Stroke</measure>
    <time_frame>Up to 5 years and 7 months</time_frame>
    <description>Number of participants with ischemic or hemorrhagic stroke. Both types of stroke were included in the definition for stroke, but were not assessed separately</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Heart Failure Hospitalization</measure>
    <time_frame>Up to 5 years and 7 months</time_frame>
    <description>Number of participants with heart failure hospitalization</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Incident End Stage Renal Disease</measure>
    <time_frame>Up to 5 years and 7 months</time_frame>
    <description>Number of participants with incident end stage renal disease (ESRD)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Acute Renal Failure</measure>
    <time_frame>Up to 5 years and 7 months</time_frame>
    <description>Number of participants with acute renal failure</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Acute Renal Failure Requiring Dialysis</measure>
    <time_frame>Up to 5 years and 7 months</time_frame>
    <description>Number of patients with acute renal failure requiring dialysis</description>
  </secondary_outcome>
  <number_of_groups>4</number_of_groups>
  <enrollment type="Actual">189426</enrollment>
  <condition>Diabetes Mellitus, Type 2</condition>
  <arm_group>
    <arm_group_label>Glitazones</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>Linagliptin</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>Sulfonylurea</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>Within-class comparators</arm_group_label>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        T2DM patients aged 18 or older, initiating antidiabetic treatment after at least 6 months&#xD;
        of continuous enrollment&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion criteria:&#xD;
&#xD;
          -  A dispensing of an oral hypoglycemic medication&#xD;
&#xD;
          -  A diagnosis of type 2 diabetes mellitus (T2DM)&#xD;
&#xD;
        Exclusion criteria:&#xD;
&#xD;
          -  less than 18 years old&#xD;
&#xD;
          -  missing or ambiguous age or sex information&#xD;
&#xD;
          -  at least one diagnosis of type 1 diabetes mellitus&#xD;
&#xD;
          -  less than 6 months enrolment in the database preceding the date of the first&#xD;
             dispensing&#xD;
&#xD;
          -  secondary diabetes&#xD;
&#xD;
          -  history of cancer&#xD;
&#xD;
          -  end-stage renal disease (ESRD)&#xD;
&#xD;
          -  HIV&#xD;
&#xD;
          -  organ transplant&#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>Boehringer Ingelheim</last_name>
    <role>Study Chair</role>
    <affiliation>Boehringer Ingelheim</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Brigham and Women's Hospital</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02120</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>http://trials.boehringer-ingelheim.com/</url>
    <description>Related Info</description>
  </link>
  <verification_date>March 2020</verification_date>
  <study_first_submitted>July 21, 2014</study_first_submitted>
  <study_first_submitted_qc>July 21, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 22, 2014</study_first_posted>
  <results_first_submitted>February 19, 2020</results_first_submitted>
  <results_first_submitted_qc>March 19, 2020</results_first_submitted_qc>
  <results_first_posted type="Actual">April 2, 2020</results_first_posted>
  <last_update_submitted>March 19, 2020</last_update_submitted>
  <last_update_submitted_qc>March 19, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">April 2, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Diabetes Mellitus, Type 2</mesh_term>
  </condition_browse>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>July 3, 2014</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/78/NCT02197078/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>From Clinformatics and MarketScan source data, patients with a recorded diagnosis of type 2 diabetes mellitus (T2DM) who initiated linagliptin, sitagliptin, saxagliptin, alogliptin, pioglitazone, or 2nd generation sulfonylureas were identified between May 2011 and December 2016.</recruitment_details>
      <pre_assignment_details>Only participants with no use of a medication in the same class or comparator class during the 6 months prior to index date, who were at least 18 years of age and enrolled for a minimum of 6 months in the data source before treatment initiation were included.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Other DPP-4I - Clinformatics</title>
          <description>1:1 propensity score matched cohort of initiators of other Dipeptidyl peptidase-4 (DPP-4) and initiators of linagliptin, within Clinformatics database</description>
        </group>
        <group group_id="P2">
          <title>Linagliptin 1 - Clinformatics</title>
          <description>1:1 propensity score matched cohort of initiators of other Dipeptidyl peptidase-4 (DPP-4) and initiators of linagliptin, within Clinformatics database</description>
        </group>
        <group group_id="P3">
          <title>Pioglitazone - Clinformatics</title>
          <description>1:1 propensity score matched cohort of initiators of pioglitazone and initiators of linagliptin, within Clinformatics database</description>
        </group>
        <group group_id="P4">
          <title>Linagliptin 2 - Clinformatics</title>
          <description>1:1 propensity score matched cohort of initiators of pioglitazone and initiators of linagliptin, within Clinformatics database</description>
        </group>
        <group group_id="P5">
          <title>2nd Gen SUs - Clinformatics</title>
          <description>1:1 propensity score matched cohort of initiators of second generation sulfonylureas (2nd gen SUs) and initiators of linagliptin, within Clinformatics database</description>
        </group>
        <group group_id="P6">
          <title>Linagliptin 3 - Clinformatics</title>
          <description>1:1 propensity score matched cohort of initiators of second generation sulfonylureas (2nd gen SUs) and initiators of linagliptin, within Clinformatics database</description>
        </group>
        <group group_id="P7">
          <title>Other DPP-4I - MarketScan</title>
          <description>1:1 propensity score matched cohort of initiators of other Dipeptidyl peptidase-4 (DPP-4) and initiators of linagliptin, within MarketScan database</description>
        </group>
        <group group_id="P8">
          <title>Linagliptin 1 - MarketScan</title>
          <description>1:1 propensity score matched cohort of initiators of other Dipeptidyl peptidase-4 (DPP-4) and initiators of linagliptin, within MarketScan database</description>
        </group>
        <group group_id="P9">
          <title>Pioglitazone - MarketScan</title>
          <description>1:1 propensity score matched cohort of initiators of pioglitazone and initiators of linagliptin, within MarketScan database</description>
        </group>
        <group group_id="P10">
          <title>Linagliptin 2 - MarketScan</title>
          <description>1:1 propensity score matched cohort of initiators of pioglitazone and initiators of linagliptin, within MarketScan database</description>
        </group>
        <group group_id="P11">
          <title>2nd Gen SUs - MarketScan</title>
          <description>1:1 propensity score matched cohort of initiators of second generation of sulfonylureas (2nd gen SUs) and initiators of linagliptin, within MarketScan database</description>
        </group>
        <group group_id="P12">
          <title>Linagliptin 3 - MarketScan</title>
          <description>1:1 propensity score matched cohort of initiators of second generation of sulfonylureas (2nd gen SUs) and initiators of linagliptin, within MarketScan database</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="14688"/>
                <participants group_id="P2" count="14688"/>
                <participants group_id="P3" count="10614"/>
                <participants group_id="P4" count="10614"/>
                <participants group_id="P5" count="9538"/>
                <participants group_id="P6" count="9538"/>
                <participants group_id="P7" count="25135"/>
                <participants group_id="P8" count="25135"/>
                <participants group_id="P9" count="18996"/>
                <participants group_id="P10" count="18996"/>
                <participants group_id="P11" count="15742"/>
                <participants group_id="P12" count="15742"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="14688"/>
                <participants group_id="P2" count="14688"/>
                <participants group_id="P3" count="10614"/>
                <participants group_id="P4" count="10614"/>
                <participants group_id="P5" count="9538"/>
                <participants group_id="P6" count="9538"/>
                <participants group_id="P7" count="25135"/>
                <participants group_id="P8" count="25135"/>
                <participants group_id="P9" count="18996"/>
                <participants group_id="P10" count="18996"/>
                <participants group_id="P11" count="15742"/>
                <participants group_id="P12" count="15742"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="0"/>
                <participants group_id="P9" count="0"/>
                <participants group_id="P10" count="0"/>
                <participants group_id="P11" count="0"/>
                <participants group_id="P12" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Participants, who initiated linagliptin, other DPP-4, pioglitazone, or second generation sulfonylureas, were identified from Clinformatics and MarketScan between May 2011 and December 2016.Within each database, a 1:1 propensity score matching was performed between initiators of linagliptin and intiators of each comparator group.</population>
      <group_list>
        <group group_id="B1">
          <title>Other DPP-4I - Clinformatics</title>
          <description>1:1 propensity score matched cohort of initiators of other Dipeptidyl peptidase-4 (DPP-4) and initiators of linagliptin, within Clinformatics database</description>
        </group>
        <group group_id="B2">
          <title>Linagliptin 1 - Clinformatics</title>
          <description>1:1 propensity score matched cohort of initiators of other Dipeptidyl peptidase-4 (DPP-4) and initiators of linagliptin, within Clinformatics database</description>
        </group>
        <group group_id="B3">
          <title>Pioglitazone - Clinformatics</title>
          <description>1:1 propensity score matched cohort of initiators of pioglitazone and initiators of linagliptin, within Clinformatics database</description>
        </group>
        <group group_id="B4">
          <title>Linagliptin 2 - Clinformatics</title>
          <description>1:1 propensity score matched cohort of initiators of pioglitazone and initiators of linagliptin, within Clinformatics database</description>
        </group>
        <group group_id="B5">
          <title>2nd Gen SUs - Clinformatics</title>
          <description>1:1 propensity score matched cohort of initiators of second generation sulfonylureas (2nd gen SUs) and initiators of linagliptin, within Clinformatics database</description>
        </group>
        <group group_id="B6">
          <title>Linagliptin 3 - Clinformatics</title>
          <description>1:1 propensity score matched cohort of initiators of second generation sulfonylureas (2nd gen SUs) and initiators of linagliptin, within Clinformatics database</description>
        </group>
        <group group_id="B7">
          <title>Other DPP-4I - MarketScan</title>
          <description>1:1 propensity score matched cohort of initiators of other Dipeptidyl peptidase-4 (DPP-4) and initiators of linagliptin, within MarketScan database</description>
        </group>
        <group group_id="B8">
          <title>Linagliptin 1 - MarketScan</title>
          <description>1:1 propensity score matched cohort of initiators of other Dipeptidyl peptidase-4 (DPP-4) and initiators of linagliptin, within MarketScan database</description>
        </group>
        <group group_id="B9">
          <title>Pioglitazone - MarketScan</title>
          <description>1:1 propensity score matched cohort of initiators of pioglitazone and initiators of linagliptin, within MarketScan database</description>
        </group>
        <group group_id="B10">
          <title>Linagliptin 2 - MarketScan</title>
          <description>1:1 propensity score matched cohort of initiators of pioglitazone and initiators of linagliptin, within MarketScan database</description>
        </group>
        <group group_id="B11">
          <title>2nd Gen SUs - MarketScan</title>
          <description>1:1 propensity score matched cohort of initiators of second generation of sulfonylureas (2nd gen SUs) and initiators of linagliptin, within MarketScan database</description>
        </group>
        <group group_id="B12">
          <title>Linagliptin 3 - MarketScan</title>
          <description>1:1 propensity score matched cohort of initiators of second generation of sulfonylureas (2nd gen SUs) and initiators of linagliptin, within MarketScan database</description>
        </group>
        <group group_id="B13">
          <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="14688"/>
            <count group_id="B2" value="14688"/>
            <count group_id="B3" value="10614"/>
            <count group_id="B4" value="10614"/>
            <count group_id="B5" value="9538"/>
            <count group_id="B6" value="9538"/>
            <count group_id="B7" value="25135"/>
            <count group_id="B8" value="25135"/>
            <count group_id="B9" value="18996"/>
            <count group_id="B10" value="18996"/>
            <count group_id="B11" value="15742"/>
            <count group_id="B12" value="15742"/>
            <count group_id="B13" value="189426"/>
          </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="14688"/>
                    <count group_id="B2" value="14688"/>
                    <count group_id="B3" value="10614"/>
                    <count group_id="B4" value="10614"/>
                    <count group_id="B5" value="9538"/>
                    <count group_id="B6" value="9538"/>
                    <count group_id="B7" value="25135"/>
                    <count group_id="B8" value="25135"/>
                    <count group_id="B9" value="18996"/>
                    <count group_id="B10" value="18996"/>
                    <count group_id="B11" value="15742"/>
                    <count group_id="B12" value="15742"/>
                    <count group_id="B13" value="189426"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="56.31" spread="12.45"/>
                    <measurement group_id="B2" value="56.30" spread="12.35"/>
                    <measurement group_id="B3" value="56.53" spread="12.48"/>
                    <measurement group_id="B4" value="56.77" spread="12.54"/>
                    <measurement group_id="B5" value="55.03" spread="12.18"/>
                    <measurement group_id="B6" value="55.00" spread="12.21"/>
                    <measurement group_id="B7" value="55.25" spread="11.26"/>
                    <measurement group_id="B8" value="55.27" spread="11.36"/>
                    <measurement group_id="B9" value="54.71" spread="11.22"/>
                    <measurement group_id="B10" value="54.73" spread="11.28"/>
                    <measurement group_id="B11" value="54.41" spread="11.28"/>
                    <measurement group_id="B12" value="54.40" spread="11.31"/>
                    <measurement group_id="B13" value="55.39" spread="11.83"/>
                  </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="14688"/>
                    <count group_id="B2" value="14688"/>
                    <count group_id="B3" value="10614"/>
                    <count group_id="B4" value="10614"/>
                    <count group_id="B5" value="9538"/>
                    <count group_id="B6" value="9538"/>
                    <count group_id="B7" value="25135"/>
                    <count group_id="B8" value="25135"/>
                    <count group_id="B9" value="18996"/>
                    <count group_id="B10" value="18996"/>
                    <count group_id="B11" value="15742"/>
                    <count group_id="B12" value="15742"/>
                    <count group_id="B13" value="189426"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="6118"/>
                    <measurement group_id="B2" value="6098"/>
                    <measurement group_id="B3" value="4266"/>
                    <measurement group_id="B4" value="4337"/>
                    <measurement group_id="B5" value="3985"/>
                    <measurement group_id="B6" value="3968"/>
                    <measurement group_id="B7" value="10377"/>
                    <measurement group_id="B8" value="10309"/>
                    <measurement group_id="B9" value="7805"/>
                    <measurement group_id="B10" value="7850"/>
                    <measurement group_id="B11" value="6527"/>
                    <measurement group_id="B12" value="6582"/>
                    <measurement group_id="B13" value="78222"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="8570"/>
                    <measurement group_id="B2" value="8590"/>
                    <measurement group_id="B3" value="6348"/>
                    <measurement group_id="B4" value="6277"/>
                    <measurement group_id="B5" value="5553"/>
                    <measurement group_id="B6" value="5570"/>
                    <measurement group_id="B7" value="14758"/>
                    <measurement group_id="B8" value="14826"/>
                    <measurement group_id="B9" value="11191"/>
                    <measurement group_id="B10" value="11146"/>
                    <measurement group_id="B11" value="9215"/>
                    <measurement group_id="B12" value="9160"/>
                    <measurement group_id="B13" value="111204"/>
                  </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 group_id="B4" value="0"/>
                    <count group_id="B5" value="0"/>
                    <count group_id="B6" value="0"/>
                    <count group_id="B7" value="0"/>
                    <count group_id="B8" value="0"/>
                    <count group_id="B9" value="0"/>
                    <count group_id="B10" value="0"/>
                    <count group_id="B11" value="0"/>
                    <count group_id="B12" value="0"/>
                    <count group_id="B13" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B13" 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 Major Adverse Cardiovascular Event</title>
        <description>Number of participants with major adverse cardiovascular event is presented by the number of patients reported a composite of:&#xD;
Coronary revascularization (elective and non-elective procedure)&#xD;
Acute coronary syndrome (ACS), including acute myocardial infarction (MI)&#xD;
Stroke (Ischemic and hemorrhagic stroke)</description>
        <time_frame>Up to 5 years and 7 months</time_frame>
        <population>1:1 propensity score matched cohorts of linagliptin initiators and comparator groups initiators, identified from Clinformatics and MarketScan database between May 2011 and December 2016</population>
        <group_list>
          <group group_id="O1">
            <title>Other DPP-4I - Clinformatics</title>
            <description>1:1 propensity score matched cohort of initiators of other Dipeptidyl peptidase-4 (DPP-4) and initiators of linagliptin, within Clinformatics database</description>
          </group>
          <group group_id="O2">
            <title>Linagliptin 1 - Clinformatics</title>
            <description>1:1 propensity score matched cohort of initiators of other Dipeptidyl peptidase-4 (DPP-4) and initiators of linagliptin, within Clinformatics database</description>
          </group>
          <group group_id="O3">
            <title>Pioglitazone - Clinformatics</title>
            <description>1:1 propensity score matched cohort of initiators of pioglitazone and initiators of linagliptin, within Clinformatics database</description>
          </group>
          <group group_id="O4">
            <title>Linagliptin 2 - Clinformatics</title>
            <description>1:1 propensity score matched cohort of initiators of pioglitazone and initiators of linagliptin, within Clinformatics database</description>
          </group>
          <group group_id="O5">
            <title>2nd Gen SUs - Clinformatics</title>
            <description>1:1 propensity score matched cohort of initiators of second generation sulfonylureas (2nd gen SUs) and initiators of linagliptin, within Clinformatics database</description>
          </group>
          <group group_id="O6">
            <title>Linagliptin 3 - Clinformatics</title>
            <description>1:1 propensity score matched cohort of initiators of second generation sulfonylureas (2nd gen SUs) and initiators of linagliptin, within Clinformatics database</description>
          </group>
          <group group_id="O7">
            <title>Other DPP-4I - MarketScan</title>
            <description>1:1 propensity score matched cohort of initiators of other Dipeptidyl peptidase-4 (DPP-4) and initiators of linagliptin, within MarketScan database</description>
          </group>
          <group group_id="O8">
            <title>Linagliptin 1 - MarketScan</title>
            <description>1:1 propensity score matched cohort of initiators of other Dipeptidyl peptidase-4 (DPP-4) and initiators of linagliptin, within MarketScan database</description>
          </group>
          <group group_id="O9">
            <title>Pioglitazone - MarketScan</title>
            <description>1:1 propensity score matched cohort of initiators of pioglitazone and initiators of linagliptin, within MarketScan database</description>
          </group>
          <group group_id="O10">
            <title>Linagliptin 2 - MarketScan</title>
            <description>1:1 propensity score matched cohort of initiators of pioglitazone and initiators of linagliptin, within MarketScan database</description>
          </group>
          <group group_id="O11">
            <title>2nd Gen SUs - MarketScan</title>
            <description>1:1 propensity score matched cohort of initiators of second generation of sulfonylureas (2nd gen SUs) and initiators of linagliptin, within MarketScan database</description>
          </group>
          <group group_id="O12">
            <title>Linagliptin 3 - MarketScan</title>
            <description>1:1 propensity score matched cohort of initiators of second generation of sulfonylureas (2nd gen SUs) and initiators of linagliptin, within MarketScan database</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Major Adverse Cardiovascular Event</title>
          <description>Number of participants with major adverse cardiovascular event is presented by the number of patients reported a composite of:&#xD;
Coronary revascularization (elective and non-elective procedure)&#xD;
Acute coronary syndrome (ACS), including acute myocardial infarction (MI)&#xD;
Stroke (Ischemic and hemorrhagic stroke)</description>
          <population>1:1 propensity score matched cohorts of linagliptin initiators and comparator groups initiators, identified from Clinformatics and MarketScan database between May 2011 and December 2016</population>
          <units>Participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="14688"/>
                <count group_id="O2" value="14688"/>
                <count group_id="O3" value="10614"/>
                <count group_id="O4" value="10614"/>
                <count group_id="O5" value="9538"/>
                <count group_id="O6" value="9538"/>
                <count group_id="O7" value="25135"/>
                <count group_id="O8" value="25135"/>
                <count group_id="O9" value="18996"/>
                <count group_id="O10" value="18996"/>
                <count group_id="O11" value="15742"/>
                <count group_id="O12" value="15742"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="165"/>
                    <measurement group_id="O2" value="151"/>
                    <measurement group_id="O3" value="120"/>
                    <measurement group_id="O4" value="102"/>
                    <measurement group_id="O5" value="127"/>
                    <measurement group_id="O6" value="82"/>
                    <measurement group_id="O7" value="403"/>
                    <measurement group_id="O8" value="369"/>
                    <measurement group_id="O9" value="262"/>
                    <measurement group_id="O10" value="270"/>
                    <measurement group_id="O11" value="259"/>
                    <measurement group_id="O12" value="194"/>
                  </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>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Hazard Ratio (HR)</param_type>
            <param_value>0.82</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.66</ci_lower_limit>
            <ci_upper_limit>1.03</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Hazard Ratio (HR)</param_type>
            <param_value>0.85</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.65</ci_lower_limit>
            <ci_upper_limit>1.10</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O5</group_id>
              <group_id>O6</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Hazard Ratio (HR)</param_type>
            <param_value>0.65</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.49</ci_lower_limit>
            <ci_upper_limit>0.86</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O7</group_id>
              <group_id>O8</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Hazard Ratio (HR)</param_type>
            <param_value>0.95</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.83</ci_lower_limit>
            <ci_upper_limit>1.10</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O9</group_id>
              <group_id>O10</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Hazard Ratio (HR)</param_type>
            <param_value>1.01</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.85</ci_lower_limit>
            <ci_upper_limit>1.19</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O11</group_id>
              <group_id>O12</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Hazard Ratio (HR)</param_type>
            <param_value>0.80</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.66</ci_lower_limit>
            <ci_upper_limit>0.96</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants With Coronary Revascularization</title>
        <description>Number of participants with coronary revascularization (elective and non-elective procedure)</description>
        <time_frame>Up to 5 years and 7 month</time_frame>
        <population>1:1 propensity score matched cohorts of linagliptin initiators and comparator groups initiators, identified from Clinformatics and MarketScan database between May 2011 and December 2016.</population>
        <group_list>
          <group group_id="O1">
            <title>Other DPP-4I - Clinformatics</title>
            <description>1:1 propensity score matched cohort of initiators of other Dipeptidyl peptidase-4 (DPP-4) and initiators of linagliptin, within Clinformatics database</description>
          </group>
          <group group_id="O2">
            <title>Linagliptin 1 - Clinformatics</title>
            <description>1:1 propensity score matched cohort of initiators of other Dipeptidyl peptidase-4 (DPP-4) and initiators of linagliptin, within Clinformatics database</description>
          </group>
          <group group_id="O3">
            <title>Pioglitazone - Clinformatics</title>
            <description>1:1 propensity score matched cohort of initiators of pioglitazone and initiators of linagliptin, within Clinformatics database</description>
          </group>
          <group group_id="O4">
            <title>Linagliptin 2 - Clinformatics</title>
            <description>1:1 propensity score matched cohort of initiators of pioglitazone and initiators of linagliptin, within Clinformatics database</description>
          </group>
          <group group_id="O5">
            <title>2nd Gen SUs - Clinformatics</title>
            <description>1:1 propensity score matched cohort of initiators of second generation sulfonylureas (2nd gen SUs) and initiators of linagliptin, within Clinformatics database</description>
          </group>
          <group group_id="O6">
            <title>Linagliptin 3 - Clinformatics</title>
            <description>1:1 propensity score matched cohort of initiators of second generation sulfonylureas (2nd gen SUs) and initiators of linagliptin, within Clinformatics database</description>
          </group>
          <group group_id="O7">
            <title>Other DPP-4I - MarketScan</title>
            <description>1:1 propensity score matched cohort of initiators of other Dipeptidyl peptidase-4 (DPP-4) and initiators of linagliptin, within MarketScan database</description>
          </group>
          <group group_id="O8">
            <title>Linagliptin 1 - MarketScan</title>
            <description>1:1 propensity score matched cohort of initiators of other Dipeptidyl peptidase-4 (DPP-4) and initiators of linagliptin, within MarketScan database</description>
          </group>
          <group group_id="O9">
            <title>Pioglitazone - MarketScan</title>
            <description>1:1 propensity score matched cohort of initiators of pioglitazone and initiators of linagliptin, within MarketScan database</description>
          </group>
          <group group_id="O10">
            <title>Linagliptin 2 - MarketScan</title>
            <description>1:1 propensity score matched cohort of initiators of pioglitazone and initiators of linagliptin, within MarketScan database</description>
          </group>
          <group group_id="O11">
            <title>2nd Gen SUs - MarketScan</title>
            <description>1:1 propensity score matched cohort of initiators of second generation of sulfonylureas (2nd gen SUs) and initiators of linagliptin, within MarketScan database</description>
          </group>
          <group group_id="O12">
            <title>Linagliptin 3 - MarketScan</title>
            <description>1:1 propensity score matched cohort of initiators of second generation of sulfonylureas (2nd gen SUs) and initiators of linagliptin, within MarketScan database</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Coronary Revascularization</title>
          <description>Number of participants with coronary revascularization (elective and non-elective procedure)</description>
          <population>1:1 propensity score matched cohorts of linagliptin initiators and comparator groups initiators, identified from Clinformatics and MarketScan database between May 2011 and December 2016.</population>
          <units>Participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="14688"/>
                <count group_id="O2" value="14688"/>
                <count group_id="O3" value="10614"/>
                <count group_id="O4" value="10614"/>
                <count group_id="O5" value="9538"/>
                <count group_id="O6" value="9538"/>
                <count group_id="O7" value="25135"/>
                <count group_id="O8" value="25135"/>
                <count group_id="O9" value="18996"/>
                <count group_id="O10" value="18996"/>
                <count group_id="O11" value="15742"/>
                <count group_id="O12" value="15742"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="82"/>
                    <measurement group_id="O2" value="81"/>
                    <measurement group_id="O3" value="67"/>
                    <measurement group_id="O4" value="54"/>
                    <measurement group_id="O5" value="67"/>
                    <measurement group_id="O6" value="46"/>
                    <measurement group_id="O7" value="181"/>
                    <measurement group_id="O8" value="181"/>
                    <measurement group_id="O9" value="129"/>
                    <measurement group_id="O10" value="133"/>
                    <measurement group_id="O11" value="125"/>
                    <measurement group_id="O12" value="94"/>
                  </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>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Hazard Ratio (HR)</param_type>
            <param_value>0.90</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.66</ci_lower_limit>
            <ci_upper_limit>1.23</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Hazard Ratio (HR)</param_type>
            <param_value>0.81</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.57</ci_lower_limit>
            <ci_upper_limit>1.16</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O5</group_id>
              <group_id>O6</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Hazard Ratio (HR)</param_type>
            <param_value>0.70</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.48</ci_lower_limit>
            <ci_upper_limit>1.01</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O7</group_id>
              <group_id>O8</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Hazard Ratio (HR)</param_type>
            <param_value>1.04</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.85</ci_lower_limit>
            <ci_upper_limit>1.28</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O9</group_id>
              <group_id>O10</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Hazard Ratio (HR)</param_type>
            <param_value>1.01</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.79</ci_lower_limit>
            <ci_upper_limit>1.28</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O11</group_id>
              <group_id>O12</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Hazard Ratio (HR)</param_type>
            <param_value>0.81</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.62</ci_lower_limit>
            <ci_upper_limit>1.06</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants With Acute Coronary Syndrome</title>
        <description>Number of participants with acute coronary syndrome (ACS). The definition for ACS included acute myocardial infarction (MI), but acute MI was not assessed separately.</description>
        <time_frame>Up to 5 years and 7 months</time_frame>
        <population>1:1 propensity score matched cohorts of linagliptin initiators and comparator groups initiators, identified from Clinformatics and MarketScan database between May 2011 and December 2016.</population>
        <group_list>
          <group group_id="O1">
            <title>Other DPP-4I - Clinformatics</title>
            <description>1:1 propensity score matched cohort of initiators of other Dipeptidyl peptidase-4 (DPP-4) and initiators of linagliptin, within Clinformatics database</description>
          </group>
          <group group_id="O2">
            <title>Linagliptin 1 - Clinformatics</title>
            <description>1:1 propensity score matched cohort of initiators of other Dipeptidyl peptidase-4 (DPP-4) and initiators of linagliptin, within Clinformatics database</description>
          </group>
          <group group_id="O3">
            <title>Pioglitazone - Clinformatics</title>
            <description>1:1 propensity score matched cohort of initiators of pioglitazone and initiators of linagliptin, within Clinformatics database</description>
          </group>
          <group group_id="O4">
            <title>Linagliptin 2 - Clinformatics</title>
            <description>1:1 propensity score matched cohort of initiators of pioglitazone and initiators of linagliptin, within Clinformatics database</description>
          </group>
          <group group_id="O5">
            <title>2nd Gen SUs - Clinformatics</title>
            <description>1:1 propensity score matched cohort of initiators of second generation sulfonylureas (2nd gen SUs) and initiators of linagliptin, within Clinformatics database</description>
          </group>
          <group group_id="O6">
            <title>Linagliptin 3 - Clinformatics</title>
            <description>1:1 propensity score matched cohort of initiators of second generation sulfonylureas (2nd gen SUs) and initiators of linagliptin, within Clinformatics database</description>
          </group>
          <group group_id="O7">
            <title>Other DPP-4I - MarketScan</title>
            <description>1:1 propensity score matched cohort of initiators of other Dipeptidyl peptidase-4 (DPP-4) and initiators of linagliptin, within MarketScan database</description>
          </group>
          <group group_id="O8">
            <title>Linagliptin 1 - MarketScan</title>
            <description>1:1 propensity score matched cohort of initiators of other Dipeptidyl peptidase-4 (DPP-4) and initiators of linagliptin, within MarketScan database</description>
          </group>
          <group group_id="O9">
            <title>Pioglitazone - MarketScan</title>
            <description>1:1 propensity score matched cohort of initiators of pioglitazone and initiators of linagliptin, within MarketScan database</description>
          </group>
          <group group_id="O10">
            <title>Linagliptin 2 - MarketScan</title>
            <description>1:1 propensity score matched cohort of initiators of pioglitazone and initiators of linagliptin, within MarketScan database</description>
          </group>
          <group group_id="O11">
            <title>2nd Gen SUs - MarketScan</title>
            <description>1:1 propensity score matched cohort of initiators of second generation of sulfonylureas (2nd gen SUs) and initiators of linagliptin, within MarketScan database</description>
          </group>
          <group group_id="O12">
            <title>Linagliptin 3 - MarketScan</title>
            <description>1:1 propensity score matched cohort of initiators of second generation of sulfonylureas (2nd gen SUs) and initiators of linagliptin, within MarketScan database</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Acute Coronary Syndrome</title>
          <description>Number of participants with acute coronary syndrome (ACS). The definition for ACS included acute myocardial infarction (MI), but acute MI was not assessed separately.</description>
          <population>1:1 propensity score matched cohorts of linagliptin initiators and comparator groups initiators, identified from Clinformatics and MarketScan database between May 2011 and December 2016.</population>
          <units>Participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="14688"/>
                <count group_id="O2" value="14688"/>
                <count group_id="O3" value="10614"/>
                <count group_id="O4" value="10614"/>
                <count group_id="O5" value="9538"/>
                <count group_id="O6" value="9538"/>
                <count group_id="O7" value="25135"/>
                <count group_id="O8" value="25135"/>
                <count group_id="O9" value="18996"/>
                <count group_id="O10" value="18996"/>
                <count group_id="O11" value="15742"/>
                <count group_id="O12" value="15742"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="93"/>
                    <measurement group_id="O2" value="72"/>
                    <measurement group_id="O3" value="76"/>
                    <measurement group_id="O4" value="48"/>
                    <measurement group_id="O5" value="72"/>
                    <measurement group_id="O6" value="43"/>
                    <measurement group_id="O7" value="238"/>
                    <measurement group_id="O8" value="221"/>
                    <measurement group_id="O9" value="163"/>
                    <measurement group_id="O10" value="160"/>
                    <measurement group_id="O11" value="161"/>
                    <measurement group_id="O12" value="115"/>
                  </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>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Hazard Ratio (HR)</param_type>
            <param_value>0.69</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.51</ci_lower_limit>
            <ci_upper_limit>0.94</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Hazard Ratio (HR)</param_type>
            <param_value>0.63</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.44</ci_lower_limit>
            <ci_upper_limit>0.90</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O5</group_id>
              <group_id>O6</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Hazard Ratio (HR)</param_type>
            <param_value>0.60</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.41</ci_lower_limit>
            <ci_upper_limit>0.88</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O7</group_id>
              <group_id>O8</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Hazard Ratio (HR)</param_type>
            <param_value>0.97</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.81</ci_lower_limit>
            <ci_upper_limit>1.17</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O9</group_id>
              <group_id>O10</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Hazard Ratio (HR)</param_type>
            <param_value>0.96</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.77</ci_lower_limit>
            <ci_upper_limit>1.19</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O11</group_id>
              <group_id>O12</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Hazard Ratio (HR)</param_type>
            <param_value>0.76</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.60</ci_lower_limit>
            <ci_upper_limit>0.97</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants With Stroke</title>
        <description>Number of participants with ischemic or hemorrhagic stroke. Both types of stroke were included in the definition for stroke, but were not assessed separately</description>
        <time_frame>Up to 5 years and 7 months</time_frame>
        <population>1:1 propensity score matched cohorts of linagliptin initiators and comparator groups initiators, identified from Clinformatics and MarketScan database between May 2011 and December 2016.</population>
        <group_list>
          <group group_id="O1">
            <title>Other DPP-4I - Clinformatics</title>
            <description>1:1 propensity score matched cohort of initiators of other Dipeptidyl peptidase-4 (DPP-4) and initiators of linagliptin, within Clinformatics database</description>
          </group>
          <group group_id="O2">
            <title>Linagliptin 1 - Clinformatics</title>
            <description>1:1 propensity score matched cohort of initiators of other Dipeptidyl peptidase-4 (DPP-4) and initiators of linagliptin, within Clinformatics database</description>
          </group>
          <group group_id="O3">
            <title>Pioglitazone - Clinformatics</title>
            <description>1:1 propensity score matched cohort of initiators of pioglitazone and initiators of linagliptin, within Clinformatics database</description>
          </group>
          <group group_id="O4">
            <title>Linagliptin 2 - Clinformatics</title>
            <description>1:1 propensity score matched cohort of initiators of pioglitazone and initiators of linagliptin, within Clinformatics database</description>
          </group>
          <group group_id="O5">
            <title>2nd Gen SUs - Clinformatics</title>
            <description>1:1 propensity score matched cohort of initiators of second generation sulfonylureas (2nd gen SUs) and initiators of linagliptin, within Clinformatics database</description>
          </group>
          <group group_id="O6">
            <title>Linagliptin 3 - Clinformatics</title>
            <description>1:1 propensity score matched cohort of initiators of second generation sulfonylureas (2nd gen SUs) and initiators of linagliptin, within Clinformatics database</description>
          </group>
          <group group_id="O7">
            <title>Other DPP-4I - MarketScan</title>
            <description>1:1 propensity score matched cohort of initiators of other Dipeptidyl peptidase-4 (DPP-4) and initiators of linagliptin, within MarketScan database</description>
          </group>
          <group group_id="O8">
            <title>Linagliptin 1 - MarketScan</title>
            <description>1:1 propensity score matched cohort of initiators of other Dipeptidyl peptidase-4 (DPP-4) and initiators of linagliptin, within MarketScan database</description>
          </group>
          <group group_id="O9">
            <title>Pioglitazone - MarketScan</title>
            <description>1:1 propensity score matched cohort of initiators of pioglitazone and initiators of linagliptin, within MarketScan database</description>
          </group>
          <group group_id="O10">
            <title>Linagliptin 2 - MarketScan</title>
            <description>1:1 propensity score matched cohort of initiators of pioglitazone and initiators of linagliptin, within MarketScan database</description>
          </group>
          <group group_id="O11">
            <title>2nd Gen SUs - MarketScan</title>
            <description>1:1 propensity score matched cohort of initiators of second generation of sulfonylureas (2nd gen SUs) and initiators of linagliptin, within MarketScan database</description>
          </group>
          <group group_id="O12">
            <title>Linagliptin 3 - MarketScan</title>
            <description>1:1 propensity score matched cohort of initiators of second generation of sulfonylureas (2nd gen SUs) and initiators of linagliptin, within MarketScan database</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Stroke</title>
          <description>Number of participants with ischemic or hemorrhagic stroke. Both types of stroke were included in the definition for stroke, but were not assessed separately</description>
          <population>1:1 propensity score matched cohorts of linagliptin initiators and comparator groups initiators, identified from Clinformatics and MarketScan database between May 2011 and December 2016.</population>
          <units>Participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="14688"/>
                <count group_id="O2" value="14688"/>
                <count group_id="O3" value="10614"/>
                <count group_id="O4" value="10614"/>
                <count group_id="O5" value="9538"/>
                <count group_id="O6" value="9538"/>
                <count group_id="O7" value="25135"/>
                <count group_id="O8" value="25135"/>
                <count group_id="O9" value="18996"/>
                <count group_id="O10" value="18996"/>
                <count group_id="O11" value="15742"/>
                <count group_id="O12" value="15742"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="42"/>
                    <measurement group_id="O2" value="42"/>
                    <measurement group_id="O3" value="30"/>
                    <measurement group_id="O4" value="30"/>
                    <measurement group_id="O5" value="37"/>
                    <measurement group_id="O6" value="16"/>
                    <measurement group_id="O7" value="113"/>
                    <measurement group_id="O8" value="104"/>
                    <measurement group_id="O9" value="66"/>
                    <measurement group_id="O10" value="74"/>
                    <measurement group_id="O11" value="76"/>
                    <measurement group_id="O12" value="53"/>
                  </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>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Hazard Ratio (HR)</param_type>
            <param_value>0.89</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.58</ci_lower_limit>
            <ci_upper_limit>1.38</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Hazard Ratio (HR)</param_type>
            <param_value>0.99</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.60</ci_lower_limit>
            <ci_upper_limit>1.64</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O5</group_id>
              <group_id>O6</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Hazard Ratio (HR)</param_type>
            <param_value>0.44</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.24</ci_lower_limit>
            <ci_upper_limit>0.78</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O7</group_id>
              <group_id>O8</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Hazard Ratio (HR)</param_type>
            <param_value>0.96</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.73</ci_lower_limit>
            <ci_upper_limit>1.25</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O9</group_id>
              <group_id>O10</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Hazard Ratio (HR)</param_type>
            <param_value>1.09</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.78</ci_lower_limit>
            <ci_upper_limit>1.52</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O11</group_id>
              <group_id>O12</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Hazard Ratio (HR)</param_type>
            <param_value>0.74</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.52</ci_lower_limit>
            <ci_upper_limit>1.05</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Heart Failure Hospitalization</title>
        <description>Number of participants with heart failure hospitalization</description>
        <time_frame>Up to 5 years and 7 months</time_frame>
        <population>1:1 propensity score matched cohorts of linagliptin initiators and comparator groups initiators, identified from Clinformatics and MarketScan database between May 2011 and December 2016.</population>
        <group_list>
          <group group_id="O1">
            <title>Other DPP-4I - Clinformatics</title>
            <description>1:1 propensity score matched cohort of initiators of other Dipeptidyl peptidase-4 (DPP-4) and initiators of linagliptin, within Clinformatics database</description>
          </group>
          <group group_id="O2">
            <title>Linagliptin 1 - Clinformatics</title>
            <description>1:1 propensity score matched cohort of initiators of other Dipeptidyl peptidase-4 (DPP-4) and initiators of linagliptin, within Clinformatics database</description>
          </group>
          <group group_id="O3">
            <title>Pioglitazone - Clinformatics</title>
            <description>1:1 propensity score matched cohort of initiators of pioglitazone and initiators of linagliptin, within Clinformatics database</description>
          </group>
          <group group_id="O4">
            <title>Linagliptin 2 - Clinformatics</title>
            <description>1:1 propensity score matched cohort of initiators of pioglitazone and initiators of linagliptin, within Clinformatics database</description>
          </group>
          <group group_id="O5">
            <title>2nd Gen SUs - Clinformatics</title>
            <description>1:1 propensity score matched cohort of initiators of second generation sulfonylureas (2nd gen SUs) and initiators of linagliptin, within Clinformatics database</description>
          </group>
          <group group_id="O6">
            <title>Linagliptin 3 - Clinformatics</title>
            <description>1:1 propensity score matched cohort of initiators of second generation sulfonylureas (2nd gen SUs) and initiators of linagliptin, within Clinformatics database</description>
          </group>
          <group group_id="O7">
            <title>Other DPP-4I - MarketScan</title>
            <description>1:1 propensity score matched cohort of initiators of other Dipeptidyl peptidase-4 (DPP-4) and initiators of linagliptin, within MarketScan database</description>
          </group>
          <group group_id="O8">
            <title>Linagliptin 1 - MarketScan</title>
            <description>1:1 propensity score matched cohort of initiators of other Dipeptidyl peptidase-4 (DPP-4) and initiators of linagliptin, within MarketScan database</description>
          </group>
          <group group_id="O9">
            <title>Pioglitazone - MarketScan</title>
            <description>1:1 propensity score matched cohort of initiators of pioglitazone and initiators of linagliptin, within MarketScan database</description>
          </group>
          <group group_id="O10">
            <title>Linagliptin 2 - MarketScan</title>
            <description>1:1 propensity score matched cohort of initiators of pioglitazone and initiators of linagliptin, within MarketScan database</description>
          </group>
          <group group_id="O11">
            <title>2nd Gen SUs - MarketScan</title>
            <description>1:1 propensity score matched cohort of initiators of second generation of sulfonylureas (2nd gen SUs) and initiators of linagliptin, within MarketScan database</description>
          </group>
          <group group_id="O12">
            <title>Linagliptin 3 - MarketScan</title>
            <description>1:1 propensity score matched cohort of initiators of second generation of sulfonylureas (2nd gen SUs) and initiators of linagliptin, within MarketScan database</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Heart Failure Hospitalization</title>
          <description>Number of participants with heart failure hospitalization</description>
          <population>1:1 propensity score matched cohorts of linagliptin initiators and comparator groups initiators, identified from Clinformatics and MarketScan database between May 2011 and December 2016.</population>
          <units>Participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="14688"/>
                <count group_id="O2" value="14688"/>
                <count group_id="O3" value="10614"/>
                <count group_id="O4" value="10614"/>
                <count group_id="O5" value="9538"/>
                <count group_id="O6" value="9538"/>
                <count group_id="O7" value="25135"/>
                <count group_id="O8" value="25135"/>
                <count group_id="O9" value="18996"/>
                <count group_id="O10" value="18996"/>
                <count group_id="O11" value="15742"/>
                <count group_id="O12" value="15742"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="53"/>
                    <measurement group_id="O2" value="90"/>
                    <measurement group_id="O3" value="27"/>
                    <measurement group_id="O4" value="51"/>
                    <measurement group_id="O5" value="43"/>
                    <measurement group_id="O6" value="47"/>
                    <measurement group_id="O7" value="117"/>
                    <measurement group_id="O8" value="111"/>
                    <measurement group_id="O9" value="58"/>
                    <measurement group_id="O10" value="65"/>
                    <measurement group_id="O11" value="66"/>
                    <measurement group_id="O12" value="49"/>
                  </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>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Hazard Ratio (HR)</param_type>
            <param_value>1.55</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>1.10</ci_lower_limit>
            <ci_upper_limit>2.18</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Hazard Ratio (HR)</param_type>
            <param_value>1.90</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>1.19</ci_lower_limit>
            <ci_upper_limit>3.03</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O5</group_id>
              <group_id>O6</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Hazard Ratio (HR)</param_type>
            <param_value>1.11</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.73</ci_lower_limit>
            <ci_upper_limit>1.68</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O7</group_id>
              <group_id>O8</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Hazard Ratio (HR)</param_type>
            <param_value>0.99</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.76</ci_lower_limit>
            <ci_upper_limit>1.29</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O9</group_id>
              <group_id>O10</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Hazard Ratio (HR)</param_type>
            <param_value>1.10</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.77</ci_lower_limit>
            <ci_upper_limit>1.56</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O11</group_id>
              <group_id>O12</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Hazard Ratio (HR)</param_type>
            <param_value>0.79</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.54</ci_lower_limit>
            <ci_upper_limit>1.14</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Incident End Stage Renal Disease</title>
        <description>Number of participants with incident end stage renal disease (ESRD)</description>
        <time_frame>Up to 5 years and 7 months</time_frame>
        <population>1:1 propensity score matched cohorts of linagliptin initiators and comparator groups initiators, identified from Clinformatics and MarketScan database between May 2011 and December 2016. For this outcome only, patients with ESRD at any time prior to and including the day of treatment initiation were excluded.</population>
        <group_list>
          <group group_id="O1">
            <title>Other DPP-4I - Clinformatics</title>
            <description>1:1 propensity score matched cohort of initiators of other Dipeptidyl peptidase-4 (DPP-4) and initiators of linagliptin, within Clinformatics database</description>
          </group>
          <group group_id="O2">
            <title>Linagliptin 1 - Clinformatics</title>
            <description>1:1 propensity score matched cohort of initiators of other Dipeptidyl peptidase-4 (DPP-4) and initiators of linagliptin, within Clinformatics database</description>
          </group>
          <group group_id="O3">
            <title>Pioglitazone - Clinformatics</title>
            <description>1:1 propensity score matched cohort of initiators of pioglitazone and initiators of linagliptin, within Clinformatics database</description>
          </group>
          <group group_id="O4">
            <title>Linagliptin 2 - Clinformatics</title>
            <description>1:1 propensity score matched cohort of initiators of pioglitazone and initiators of linagliptin, within Clinformatics database</description>
          </group>
          <group group_id="O5">
            <title>2nd Gen SUs - Clinformatics</title>
            <description>1:1 propensity score matched cohort of initiators of second generation sulfonylureas (2nd gen SUs) and initiators of linagliptin, within Clinformatics database</description>
          </group>
          <group group_id="O6">
            <title>Linagliptin 3 - Clinformatics</title>
            <description>1:1 propensity score matched cohort of initiators of second generation sulfonylureas (2nd gen SUs) and initiators of linagliptin, within Clinformatics database</description>
          </group>
          <group group_id="O7">
            <title>Other DPP-4I - MarketScan</title>
            <description>1:1 propensity score matched cohort of initiators of other Dipeptidyl peptidase-4 (DPP-4) and initiators of linagliptin, within MarketScan database</description>
          </group>
          <group group_id="O8">
            <title>Linagliptin 1 - MarketScan</title>
            <description>1:1 propensity score matched cohort of initiators of other Dipeptidyl peptidase-4 (DPP-4) and initiators of linagliptin, within MarketScan database</description>
          </group>
          <group group_id="O9">
            <title>Pioglitazone - MarketScan</title>
            <description>1:1 propensity score matched cohort of initiators of pioglitazone and initiators of linagliptin, within MarketScan database</description>
          </group>
          <group group_id="O10">
            <title>Linagliptin 2 - MarketScan</title>
            <description>1:1 propensity score matched cohort of initiators of pioglitazone and initiators of linagliptin, within MarketScan database</description>
          </group>
          <group group_id="O11">
            <title>2nd Gen SUs - MarketScan</title>
            <description>1:1 propensity score matched cohort of initiators of second generation of sulfonylureas (2nd gen SUs) and initiators of linagliptin, within MarketScan database</description>
          </group>
          <group group_id="O12">
            <title>Linagliptin 3 - MarketScan</title>
            <description>1:1 propensity score matched cohort of initiators of second generation of sulfonylureas (2nd gen SUs) and initiators of linagliptin, within MarketScan database</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Incident End Stage Renal Disease</title>
          <description>Number of participants with incident end stage renal disease (ESRD)</description>
          <population>1:1 propensity score matched cohorts of linagliptin initiators and comparator groups initiators, identified from Clinformatics and MarketScan database between May 2011 and December 2016. For this outcome only, patients with ESRD at any time prior to and including the day of treatment initiation were excluded.</population>
          <units>Participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="14472"/>
                <count group_id="O2" value="14472"/>
                <count group_id="O3" value="10467"/>
                <count group_id="O4" value="10467"/>
                <count group_id="O5" value="9422"/>
                <count group_id="O6" value="9422"/>
                <count group_id="O7" value="24714"/>
                <count group_id="O8" value="24741"/>
                <count group_id="O9" value="18689"/>
                <count group_id="O10" value="18689"/>
                <count group_id="O11" value="15500"/>
                <count group_id="O12" value="15500"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="49"/>
                    <measurement group_id="O2" value="75"/>
                    <measurement group_id="O3" value="28"/>
                    <measurement group_id="O4" value="48"/>
                    <measurement group_id="O5" value="38"/>
                    <measurement group_id="O6" value="43"/>
                    <measurement group_id="O7" value="90"/>
                    <measurement group_id="O8" value="116"/>
                    <measurement group_id="O9" value="39"/>
                    <measurement group_id="O10" value="61"/>
                    <measurement group_id="O11" value="53"/>
                    <measurement group_id="O12" value="57"/>
                  </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>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Hazard Ratio (HR)</param_type>
            <param_value>1.40</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.97</ci_lower_limit>
            <ci_upper_limit>2.00</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Hazard Ratio (HR)</param_type>
            <param_value>1.71</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>1.07</ci_lower_limit>
            <ci_upper_limit>2.72</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O5</group_id>
              <group_id>O6</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Hazard Ratio (HR)</param_type>
            <param_value>1.16</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.75</ci_lower_limit>
            <ci_upper_limit>1.79</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O7</group_id>
              <group_id>O8</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Hazard Ratio (HR)</param_type>
            <param_value>1.34</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>1.01</ci_lower_limit>
            <ci_upper_limit>1.76</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O9</group_id>
              <group_id>O10</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Hazard Ratio (HR)</param_type>
            <param_value>1.52</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>1.02</ci_lower_limit>
            <ci_upper_limit>2.27</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O11</group_id>
              <group_id>O12</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Hazard Ratio (HR)</param_type>
            <param_value>1.17</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.81</ci_lower_limit>
            <ci_upper_limit>1.71</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Acute Renal Failure</title>
        <description>Number of participants with acute renal failure</description>
        <time_frame>Up to 5 years and 7 months</time_frame>
        <population>1:1 propensity score matched cohorts of linagliptin initiators and comparator groups initiators, identified from Clinformatics and MarketScan database between May 2011 and December 2016.</population>
        <group_list>
          <group group_id="O1">
            <title>Other DPP-4I - Clinformatics</title>
            <description>1:1 propensity score matched cohort of initiators of other Dipeptidyl peptidase-4 (DPP-4) and initiators of linagliptin, within Clinformatics database</description>
          </group>
          <group group_id="O2">
            <title>Linagliptin 1 - Clinformatics</title>
            <description>1:1 propensity score matched cohort of initiators of other Dipeptidyl peptidase-4 (DPP-4) and initiators of linagliptin, within Clinformatics database</description>
          </group>
          <group group_id="O3">
            <title>Pioglitazone - Clinformatics</title>
            <description>1:1 propensity score matched cohort of initiators of pioglitazone and initiators of linagliptin, within Clinformatics database</description>
          </group>
          <group group_id="O4">
            <title>Linagliptin 2 - Clinformatics</title>
            <description>1:1 propensity score matched cohort of initiators of pioglitazone and initiators of linagliptin, within Clinformatics database</description>
          </group>
          <group group_id="O5">
            <title>2nd Gen SUs - Clinformatics</title>
            <description>1:1 propensity score matched cohort of initiators of second generation sulfonylureas (2nd gen SUs) and initiators of linagliptin, within Clinformatics database</description>
          </group>
          <group group_id="O6">
            <title>Linagliptin 3 - Clinformatics</title>
            <description>1:1 propensity score matched cohort of initiators of second generation sulfonylureas (2nd gen SUs) and initiators of linagliptin, within Clinformatics database</description>
          </group>
          <group group_id="O7">
            <title>Other DPP-4I - MarketScan</title>
            <description>1:1 propensity score matched cohort of initiators of other Dipeptidyl peptidase-4 (DPP-4) and initiators of linagliptin, within MarketScan database</description>
          </group>
          <group group_id="O8">
            <title>Linagliptin 1 - MarketScan</title>
            <description>1:1 propensity score matched cohort of initiators of other Dipeptidyl peptidase-4 (DPP-4) and initiators of linagliptin, within MarketScan database</description>
          </group>
          <group group_id="O9">
            <title>Pioglitazone - MarketScan</title>
            <description>1:1 propensity score matched cohort of initiators of pioglitazone and initiators of linagliptin, within MarketScan database</description>
          </group>
          <group group_id="O10">
            <title>Linagliptin 2 - MarketScan</title>
            <description>1:1 propensity score matched cohort of initiators of pioglitazone and initiators of linagliptin, within MarketScan database</description>
          </group>
          <group group_id="O11">
            <title>2nd Gen SUs - MarketScan</title>
            <description>1:1 propensity score matched cohort of initiators of second generation of sulfonylureas (2nd gen SUs) and initiators of linagliptin, within MarketScan database</description>
          </group>
          <group group_id="O12">
            <title>Linagliptin 3 - MarketScan</title>
            <description>1:1 propensity score matched cohort of initiators of second generation of sulfonylureas (2nd gen SUs) and initiators of linagliptin, within MarketScan database</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Acute Renal Failure</title>
          <description>Number of participants with acute renal failure</description>
          <population>1:1 propensity score matched cohorts of linagliptin initiators and comparator groups initiators, identified from Clinformatics and MarketScan database between May 2011 and December 2016.</population>
          <units>Participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="14688"/>
                <count group_id="O2" value="14688"/>
                <count group_id="O3" value="10614"/>
                <count group_id="O4" value="10614"/>
                <count group_id="O5" value="9538"/>
                <count group_id="O6" value="9538"/>
                <count group_id="O7" value="25135"/>
                <count group_id="O8" value="25135"/>
                <count group_id="O9" value="18996"/>
                <count group_id="O10" value="18996"/>
                <count group_id="O11" value="15742"/>
                <count group_id="O12" value="15742"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="222"/>
                    <measurement group_id="O2" value="300"/>
                    <measurement group_id="O3" value="152"/>
                    <measurement group_id="O4" value="198"/>
                    <measurement group_id="O5" value="163"/>
                    <measurement group_id="O6" value="167"/>
                    <measurement group_id="O7" value="433"/>
                    <measurement group_id="O8" value="430"/>
                    <measurement group_id="O9" value="240"/>
                    <measurement group_id="O10" value="263"/>
                    <measurement group_id="O11" value="238"/>
                    <measurement group_id="O12" value="200"/>
                  </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>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Hazard Ratio (HR)</param_type>
            <param_value>1.24</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>1.04</ci_lower_limit>
            <ci_upper_limit>1.47</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Hazard Ratio (HR)</param_type>
            <param_value>1.31</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>1.06</ci_lower_limit>
            <ci_upper_limit>1.61</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O5</group_id>
              <group_id>O6</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Hazard Ratio (HR)</param_type>
            <param_value>1.04</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.84</ci_lower_limit>
            <ci_upper_limit>1.29</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O7</group_id>
              <group_id>O8</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Hazard Ratio (HR)</param_type>
            <param_value>1.04</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.91</ci_lower_limit>
            <ci_upper_limit>1.19</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O9</group_id>
              <group_id>O10</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Hazard Ratio (HR)</param_type>
            <param_value>1.07</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.90</ci_lower_limit>
            <ci_upper_limit>1.27</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O11</group_id>
              <group_id>O12</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Hazard Ratio (HR)</param_type>
            <param_value>0.91</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.75</ci_lower_limit>
            <ci_upper_limit>1.09</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Acute Renal Failure Requiring Dialysis</title>
        <description>Number of patients with acute renal failure requiring dialysis</description>
        <time_frame>Up to 5 years and 7 months</time_frame>
        <population>1:1 propensity score matched cohorts of linagliptin initiators and comparator groups initiators, identified from Clinformatics and MarketScan database between May 2011 and December 2016.</population>
        <group_list>
          <group group_id="O1">
            <title>Other DPP-4I - Clinformatics</title>
            <description>1:1 propensity score matched cohort of initiators of other Dipeptidyl peptidase-4 (DPP-4) and initiators of linagliptin, within Clinformatics database</description>
          </group>
          <group group_id="O2">
            <title>Linagliptin 1 - Clinformatics</title>
            <description>1:1 propensity score matched cohort of initiators of other Dipeptidyl peptidase-4 (DPP-4) and initiators of linagliptin, within Clinformatics database</description>
          </group>
          <group group_id="O3">
            <title>Pioglitazone - Clinformatics</title>
            <description>1:1 propensity score matched cohort of initiators of pioglitazone and initiators of linagliptin, within Clinformatics database</description>
          </group>
          <group group_id="O4">
            <title>Linagliptin 2 - Clinformatics</title>
            <description>1:1 propensity score matched cohort of initiators of pioglitazone and initiators of linagliptin, within Clinformatics database</description>
          </group>
          <group group_id="O5">
            <title>2nd Gen SUs - Clinformatics</title>
            <description>1:1 propensity score matched cohort of initiators of second generation sulfonylureas (2nd gen SUs) and initiators of linagliptin, within Clinformatics database</description>
          </group>
          <group group_id="O6">
            <title>Linagliptin 3 - Clinformatics</title>
            <description>1:1 propensity score matched cohort of initiators of second generation sulfonylureas (2nd gen SUs) and initiators of linagliptin, within Clinformatics database</description>
          </group>
          <group group_id="O7">
            <title>Other DPP-4I - MarketScan</title>
            <description>1:1 propensity score matched cohort of initiators of other Dipeptidyl peptidase-4 (DPP-4) and initiators of linagliptin, within MarketScan database</description>
          </group>
          <group group_id="O8">
            <title>Linagliptin 1 - MarketScan</title>
            <description>1:1 propensity score matched cohort of initiators of other Dipeptidyl peptidase-4 (DPP-4) and initiators of linagliptin, within MarketScan database</description>
          </group>
          <group group_id="O9">
            <title>Pioglitazone - MarketScan</title>
            <description>1:1 propensity score matched cohort of initiators of pioglitazone and initiators of linagliptin, within MarketScan database</description>
          </group>
          <group group_id="O10">
            <title>Linagliptin 2 - MarketScan</title>
            <description>1:1 propensity score matched cohort of initiators of pioglitazone and initiators of linagliptin, within MarketScan database</description>
          </group>
          <group group_id="O11">
            <title>2nd Gen SUs - MarketScan</title>
            <description>1:1 propensity score matched cohort of initiators of second generation of sulfonylureas (2nd gen SUs) and initiators of linagliptin, within MarketScan database</description>
          </group>
          <group group_id="O12">
            <title>Linagliptin 3 - MarketScan</title>
            <description>1:1 propensity score matched cohort of initiators of second generation of sulfonylureas (2nd gen SUs) and initiators of linagliptin, within MarketScan database</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Acute Renal Failure Requiring Dialysis</title>
          <description>Number of patients with acute renal failure requiring dialysis</description>
          <population>1:1 propensity score matched cohorts of linagliptin initiators and comparator groups initiators, identified from Clinformatics and MarketScan database between May 2011 and December 2016.</population>
          <units>Participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="14688"/>
                <count group_id="O2" value="14688"/>
                <count group_id="O3" value="10614"/>
                <count group_id="O4" value="10614"/>
                <count group_id="O5" value="9538"/>
                <count group_id="O6" value="9538"/>
                <count group_id="O7" value="25135"/>
                <count group_id="O8" value="25135"/>
                <count group_id="O9" value="18996"/>
                <count group_id="O10" value="18996"/>
                <count group_id="O11" value="15742"/>
                <count group_id="O12" value="15742"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7"/>
                    <measurement group_id="O2" value="13"/>
                    <measurement group_id="O3" value="6"/>
                    <measurement group_id="O4" value="10"/>
                    <measurement group_id="O5" value="5"/>
                    <measurement group_id="O6" value="9"/>
                    <measurement group_id="O7" value="14"/>
                    <measurement group_id="O8" value="16"/>
                    <measurement group_id="O9" value="9"/>
                    <measurement group_id="O10" value="9"/>
                    <measurement group_id="O11" value="7"/>
                    <measurement group_id="O12" value="11"/>
                  </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>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Hazard Ratio (HR)</param_type>
            <param_value>1.62</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.64</ci_lower_limit>
            <ci_upper_limit>4.06</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Hazard Ratio (HR)</param_type>
            <param_value>1.67</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.61</ci_lower_limit>
            <ci_upper_limit>4.58</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O5</group_id>
              <group_id>O6</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Hazard Ratio (HR)</param_type>
            <param_value>1.84</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.62</ci_lower_limit>
            <ci_upper_limit>5.48</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O7</group_id>
              <group_id>O8</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Hazard Ratio (HR)</param_type>
            <param_value>1.17</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.57</ci_lower_limit>
            <ci_upper_limit>2.40</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O9</group_id>
              <group_id>O10</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Hazard Ratio (HR)</param_type>
            <param_value>0.96</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.38</ci_lower_limit>
            <ci_upper_limit>2.43</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O11</group_id>
              <group_id>O12</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Hazard Ratio (HR)</param_type>
            <param_value>1.65</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.64</ci_lower_limit>
            <ci_upper_limit>4.27</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
    </outcome_list>

    <reported_events>
      <desc>As this is a non-interventional study with secondary use of data retrieved from a US health claims database, safety monitoring and safety reporting on an individual case level is not applicable.</desc>
      <group_list>
        <group group_id="E1">
          <title>Other DPP-4I - Clinformatics</title>
          <description>1:1 propensity score matched cohort of initiators of other Dipeptidyl peptidase-4 (DPP-4) and initiators of linagliptin, within Clinformatics database</description>
        </group>
        <group group_id="E2">
          <title>Linagliptin 1 - Clinformatics</title>
          <description>1:1 propensity score matched cohort of initiators of other Dipeptidyl peptidase-4 (DPP-4) and initiators of linagliptin, within Clinformatics database</description>
        </group>
        <group group_id="E3">
          <title>Pioglitazone - Clinformatics</title>
          <description>1:1 propensity score matched cohort of initiators of pioglitazone and initiators of linagliptin, within Clinformatics database</description>
        </group>
        <group group_id="E4">
          <title>Linagliptin 2 - Clinformatics</title>
          <description>1:1 propensity score matched cohort of initiators of pioglitazone and initiators of linagliptin, within Clinformatics database</description>
        </group>
        <group group_id="E5">
          <title>2nd Gen SUs - Clinformatics</title>
          <description>1:1 propensity score matched cohort of initiators of second generation sulfonylureas (2nd gen SUs) and initiators of linagliptin, within Clinformatics database</description>
        </group>
        <group group_id="E6">
          <title>Linagliptin 3 - Clinformatics</title>
          <description>1:1 propensity score matched cohort of initiators of second generation sulfonylureas (2nd gen SUs) and initiators of linagliptin, within Clinformatics database</description>
        </group>
        <group group_id="E7">
          <title>Other DPP-4I - MarketScan</title>
          <description>1:1 propensity score matched cohort of initiators of other Dipeptidyl peptidase-4 (DPP-4) and initiators of linagliptin, within MarketScan database</description>
        </group>
        <group group_id="E8">
          <title>Linagliptin 1 - MarketScan</title>
          <description>1:1 propensity score matched cohort of initiators of other Dipeptidyl peptidase-4 (DPP-4) and initiators of linagliptin, within MarketScan database</description>
        </group>
        <group group_id="E9">
          <title>Pioglitazone - MarketScan</title>
          <description>1:1 propensity score matched cohort of initiators of pioglitazone and initiators of linagliptin, within MarketScan database</description>
        </group>
        <group group_id="E10">
          <title>Linagliptin 2 - MarketScan</title>
          <description>1:1 propensity score matched cohort of initiators of pioglitazone and initiators of linagliptin, within MarketScan database</description>
        </group>
        <group group_id="E11">
          <title>2nd Gen SUs - MarketScan</title>
          <description>1:1 propensity score matched cohort of initiators of second generation of sulfonylureas (2nd gen SUs) and initiators of linagliptin, within MarketScan database</description>
        </group>
        <group group_id="E12">
          <title>Linagliptin 3 - MarketScan</title>
          <description>1:1 propensity score matched cohort of initiators of second generation of sulfonylureas (2nd gen SUs) and initiators of linagliptin, within MarketScan database</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="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="0"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</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="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="0"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <limitations_and_caveats>Pioglitazone is contraindicated among patients with heart failure and edema. This suggests pioglitazone may not be a proper comparator in the assessment of the association between linagliptin and heart failure hospitalization or renal outcomes.</limitations_and_caveats>
    <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/NCT02197078
org study id: 1218.163
nct id: NCT02197078
lead sponsor: 
collaborator: 
This protocol is for a series of comparative effectiveness and safety analyses within
      periodically updated cohorts of patients initiating linagliptin, other DPP-4 inhibitors, and
      other oral hypoglycemic medications, followed longitudinally for the occurrence of a variety
      of health outcomes. The primary analysis will be conducted among patients without prior
      within-class medication use.
observational model: Cohort
time perspective: Retrospective
measure: Number of Participants With Major Adverse Cardiovascular Event
time frame: Up to 5 years and 7 months
description: Number of participants with major adverse cardiovascular event is presented by the number of patients reported a composite of:
Coronary revascularization (elective and non-elective procedure)
Acute coronary syndrome (ACS), including acute myocardial infarction (MI)
Stroke (Ischemic and hemorrhagic stroke)
measure: Number of Participants With Coronary Revascularization
time frame: Up to 5 years and 7 month
description: Number of participants with coronary revascularization (elective and non-elective procedure)
measure: Number of Participants With Acute Coronary Syndrome
time frame: Up to 5 years and 7 months
description: Number of participants with acute coronary syndrome (ACS). The definition for ACS included acute myocardial infarction (MI), but acute MI was not assessed separately.
measure: Number of Participants With Stroke
time frame: Up to 5 years and 7 months
description: Number of participants with ischemic or hemorrhagic stroke. Both types of stroke were included in the definition for stroke, but were not assessed separately
measure: Number of Participants With Heart Failure Hospitalization
time frame: Up to 5 years and 7 months
description: Number of participants with heart failure hospitalization
measure: Number of Participants With Incident End Stage Renal Disease
time frame: Up to 5 years and 7 months
description: Number of participants with incident end stage renal disease (ESRD)
measure: Number of Participants With Acute Renal Failure
time frame: Up to 5 years and 7 months
description: Number of participants with acute renal failure
measure: Number of Participants With Acute Renal Failure Requiring Dialysis
time frame: Up to 5 years and 7 months
description: Number of patients with acute renal failure requiring dialysis
arm group label: Glitazones
arm group label: Linagliptin
arm group label: Sulfonylurea
arm group label: Within-class comparators
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Boehringer Ingelheim
role: Study Chair
affiliation: Boehringer Ingelheim
facility: 
country: United States
url: http://trials.boehringer-ingelheim.com/
description: Related Info
responsible party type: Sponsor
mesh term: Diabetes Mellitus, Type 2
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: Pioglitazone is contraindicated among patients with heart failure and edema. This suggests pioglitazone may not be a proper comparator in the assessment of the association between linagliptin and heart failure hospitalization or renal outcomes.
point of contact: 