<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/NCT01707147</url>
  </required_header>
  <id_info>
    <org_study_id>1218.104</org_study_id>
    <nct_id>NCT01707147</nct_id>
  </id_info>
  <brief_title>A Non Interventional Study to Monitor the Safety and Effectiveness of Trajenta (Linagliptin, 5 mg, q.d) in Korean Patients With Type 2 Diabetes Mellitus</brief_title>
  <official_title>A Regulatory Requirement Non Interventional Study to Monitor the Safety and Effectiveness of Trajenta (Linagliptin, 5 mg, q.d) in Korean Patients With Type 2 Diabetes Mellitus(SELINA Study)</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>
      The aim of this study is to monitor safety and efficacy of treatment with linagliptin in&#xD;
      Korean patients with type 2 diabetes mellitus in routine clinical settings.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Study Design:&#xD;
&#xD;
      Post Marketing study- Observational study&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 16, 2012</start_date>
  <completion_date type="Actual">July 11, 2017</completion_date>
  <primary_completion_date type="Actual">July 11, 2017</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Percentage of Patients With Incidence of Adverse Events Who Had Taken at Least One Dose of Trajenta</measure>
    <time_frame>Up to 26 weeks (long-term surveillance)</time_frame>
    <description>Percentage of patients with incidence of any adverse events who had taken at least one dose of Trajenta.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline After 24 Weeks in Glycosylated Hemoglobin (HbA1c)</measure>
    <time_frame>Baseline and Week 24</time_frame>
    <description>Change from baseline after 24 weeks in Glycosylated Hemoglobin (HbA1c).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Patients With Occurrence of Treat to Target Effectiveness Response, That is HbA1c Under Treatment of &lt; 6.5% After 24 Weeks of Treatment</measure>
    <time_frame>24 Weeks</time_frame>
    <description>Percentage of patients with occurrence of treat to target effectiveness response, that is HbA1c under treatment of &lt; 6.5% after 24 weeks of treatment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Patients With Occurrence of Relative Effectiveness Response (HbA1c Lowering by at Least 0.5% After 24 Weeks of Treatment)</measure>
    <time_frame>24 Weeks</time_frame>
    <description>Percentage of patients with occurrence of relative effectiveness response (HbA1c lowering by at least 0.5% after 24 weeks of treatment).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline After 24 Weeks in Fasting Plasma Glucose (FPG)</measure>
    <time_frame>Baseline and Week 24</time_frame>
    <description>Change from baseline after 24 weeks in fasting plasma glucose (FPG).</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">3219</enrollment>
  <condition>Diabetes Mellitus, Type 2</condition>
  <arm_group>
    <arm_group_label>Patients with Type 2 Diabetes Mellitus</arm_group_label>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Trajenta tablet</intervention_name>
    <description>Linagliptin</description>
    <arm_group_label>Patients with Type 2 Diabetes Mellitus</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Korean patients with T2DM&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion criteria:&#xD;
&#xD;
        Patients who have been started on Trajenta in accordance with the approved label in Korea&#xD;
        Patients who have signed on the data release consent form&#xD;
&#xD;
        Exclusion criteria:&#xD;
&#xD;
        Patients with previous exposure to Trajenta and current participation in clinical trials&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>19 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>
      <address>
        <city>Multiple Locations</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <link>
    <url>http://trials.boehringer-ingelheim.com</url>
    <description>Related Info</description>
  </link>
  <verification_date>July 2018</verification_date>
  <study_first_submitted>October 1, 2012</study_first_submitted>
  <study_first_submitted_qc>October 15, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 16, 2012</study_first_posted>
  <results_first_submitted>July 6, 2018</results_first_submitted>
  <results_first_submitted_qc>July 6, 2018</results_first_submitted_qc>
  <results_first_posted type="Actual">January 11, 2019</results_first_posted>
  <last_update_submitted>July 6, 2018</last_update_submitted>
  <last_update_submitted_qc>July 6, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">January 11, 2019</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</mesh_term>
    <mesh_term>Diabetes Mellitus, Type 2</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Linagliptin</mesh_term>
  </intervention_browse>
  <provided_document_section>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>August 21, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/47/NCT01707147/SAP_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>February 22, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/47/NCT01707147/Prot_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>A regulatory requirement prospective, non-interventional, open-label, multi-centre national study to monitor the safety and effectiveness of Trajenta (Linagliptin, 5 milligram (mg), once daily) in Korean patients with type 2 diabetes mellitus</recruitment_details>
      <pre_assignment_details>All patients were screened for eligibility to participate in the trial. Patients attended a specialist sites which ensured that they met all strictly implemented inclusion/exclusion criteria. Patients were not to be entered to trial if any one of the specific entry criteria was violated.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Trajenta (Linagliptin) 5 mg</title>
          <description>Patients with type 2 diabetes mellitus were administered with Trajenta (Linagliptin) 5 mg once daily orally.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="3219"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="3119"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="100"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Administered Trajenta prior to contract</title>
              <participants_list>
                <participants group_id="P1" count="5"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Patients who have not taken Trajenta</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Follow-up failure</title>
              <participants_list>
                <participants group_id="P1" count="17"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Violated inclusion/exclusion criteria</title>
              <participants_list>
                <participants group_id="P1" count="77"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Safety analysis set: This analysis set included all patients who were administrated Trajenta at least once, except patients violating inclusion/exclusion criteria, dosage administration or lost to follow up.</population>
      <group_list>
        <group group_id="B1">
          <title>Trajenta (Linagliptin) 5 mg</title>
          <description>Patients with type 2 diabetes mellitus were administered with Trajenta (Linagliptin) 5 mg once daily orally.</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="3119"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <population>Number of patients in safety analysis set</population>
          <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="3119"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="61.24" spread="11.95"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <population>Number of patients in safety analysis set</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="3119"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1450"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1669"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race and Ethnicity Not Collected</title>
          <description>All patients in the safety set were Korean because this was an inclusion criteria</description>
          <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_list>
                </analyzed>
              </analyzed_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Patients With Incidence of Adverse Events Who Had Taken at Least One Dose of Trajenta</title>
        <description>Percentage of patients with incidence of any adverse events who had taken at least one dose of Trajenta.</description>
        <time_frame>Up to 26 weeks (long-term surveillance)</time_frame>
        <population>Safety analysis set: This analysis set included all patients who were administrated Trajenta at least once, except patients violating inclusion/exclusion criteria, dosage administration or lost to follow up.</population>
        <group_list>
          <group group_id="O1">
            <title>Trajenta (Linagliptin) 5 mg</title>
            <description>Patients with type 2 diabetes mellitus were administered with Trajenta (Linagliptin) 5 mg once daily orally.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Patients With Incidence of Adverse Events Who Had Taken at Least One Dose of Trajenta</title>
          <description>Percentage of patients with incidence of any adverse events who had taken at least one dose of Trajenta.</description>
          <population>Safety analysis set: This analysis set included all patients who were administrated Trajenta at least once, except patients violating inclusion/exclusion criteria, dosage administration or lost to follow up.</population>
          <units>Percentage of patients</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="3119"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.69"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline After 24 Weeks in Glycosylated Hemoglobin (HbA1c)</title>
        <description>Change from baseline after 24 weeks in Glycosylated Hemoglobin (HbA1c).</description>
        <time_frame>Baseline and Week 24</time_frame>
        <population>Effectiveness analysis set: This set includes all patients of the safety analysis set for whom HbA1c values were measured at both baseline and after drug administration.</population>
        <group_list>
          <group group_id="O1">
            <title>Trajenta (Linagliptin) 5 mg</title>
            <description>Patients with type 2 diabetes mellitus were administered with Trajenta (Linagliptin) 5 mg once daily orally.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline After 24 Weeks in Glycosylated Hemoglobin (HbA1c)</title>
          <description>Change from baseline after 24 weeks in Glycosylated Hemoglobin (HbA1c).</description>
          <population>Effectiveness analysis set: This set includes all patients of the safety analysis set for whom HbA1c values were measured at both baseline and after drug administration.</population>
          <units>Percentage of HbA1c</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="2171"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Before drug administration</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.98" spread="1.51"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>After drug administration</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.21" spread="1.22"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>&lt;0.0001</p_value>
            <method>Paired t-test</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-0.77</param_value>
            <dispersion_type>Standard Deviation</dispersion_type>
            <dispersion_value>1.50</dispersion_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>-0.71</ci_upper_limit>
            <estimate_desc>p-value of paired t-test for change from baseline is presented. 95% confidence interval for the mean was calculated using t-distribution.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Patients With Occurrence of Treat to Target Effectiveness Response, That is HbA1c Under Treatment of &lt; 6.5% After 24 Weeks of Treatment</title>
        <description>Percentage of patients with occurrence of treat to target effectiveness response, that is HbA1c under treatment of &lt; 6.5% after 24 weeks of treatment.</description>
        <time_frame>24 Weeks</time_frame>
        <population>Effectiveness analysis set</population>
        <group_list>
          <group group_id="O1">
            <title>Trajenta (Linagliptin) 5 mg</title>
            <description>Patients with type 2 diabetes mellitus were administered with Trajenta (Linagliptin) 5 mg once daily orally.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Patients With Occurrence of Treat to Target Effectiveness Response, That is HbA1c Under Treatment of &lt; 6.5% After 24 Weeks of Treatment</title>
          <description>Percentage of patients with occurrence of treat to target effectiveness response, that is HbA1c under treatment of &lt; 6.5% after 24 weeks of treatment.</description>
          <population>Effectiveness analysis set</population>
          <units>Percentage of patients</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="2171"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="26.02"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Patients With Occurrence of Relative Effectiveness Response (HbA1c Lowering by at Least 0.5% After 24 Weeks of Treatment)</title>
        <description>Percentage of patients with occurrence of relative effectiveness response (HbA1c lowering by at least 0.5% after 24 weeks of treatment).</description>
        <time_frame>24 Weeks</time_frame>
        <population>Effectiveness analysis set</population>
        <group_list>
          <group group_id="O1">
            <title>Trajenta (Linagliptin) 5 mg</title>
            <description>Patients with type 2 diabetes mellitus were administered with Trajenta (Linagliptin) 5 mg once daily orally.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Patients With Occurrence of Relative Effectiveness Response (HbA1c Lowering by at Least 0.5% After 24 Weeks of Treatment)</title>
          <description>Percentage of patients with occurrence of relative effectiveness response (HbA1c lowering by at least 0.5% after 24 weeks of treatment).</description>
          <population>Effectiveness analysis set</population>
          <units>Percentage of patients</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="2171"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="57.30"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline After 24 Weeks in Fasting Plasma Glucose (FPG)</title>
        <description>Change from baseline after 24 weeks in fasting plasma glucose (FPG).</description>
        <time_frame>Baseline and Week 24</time_frame>
        <population>Effectiveness analysis set: the patients with the data available for FPG</population>
        <group_list>
          <group group_id="O1">
            <title>Trajenta (Linagliptin) 5 mg</title>
            <description>Patients with type 2 diabetes mellitus were administered with Trajenta (Linagliptin) 5 mg once daily orally.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline After 24 Weeks in Fasting Plasma Glucose (FPG)</title>
          <description>Change from baseline after 24 weeks in fasting plasma glucose (FPG).</description>
          <population>Effectiveness analysis set: the patients with the data available for FPG</population>
          <units>Milligrams per Deciliter</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="2171"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Before drug administration</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1863"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="161.19" spread="55.38"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>After drug administration</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1820"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="143.51" spread="46.76"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>&lt;0.0001</p_value>
            <method>Paired t-test</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-18.05</param_value>
            <dispersion_type>Standard Deviation</dispersion_type>
            <dispersion_value>61.84</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-20.98</ci_lower_limit>
            <ci_upper_limit>-15.12</ci_upper_limit>
            <estimate_desc>p-value of paired t-test for change from baseline is presented. 95% confidence interval for the mean was calculated using t-distribution.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>From the entire surveillance period until re-examination period, up to 6 years.</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Trajenta (Linagliptin) 5 mg</title>
          <description>Patients with type 2 diabetes mellitus were administered with Trajenta (Linagliptin) 5 mg once daily orally.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA 20.0</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="3119"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="49" subjects_at_risk="3119"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Cardiac failure congestive</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="3119"/>
              </event>
              <event>
                <sub_title>Angina pectoris</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="3119"/>
              </event>
              <event>
                <sub_title>Acute myocardial infarction</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="3119"/>
              </event>
              <event>
                <sub_title>Angina unstable</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="3119"/>
              </event>
              <event>
                <sub_title>Cardiac arrest</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="3119"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Ear and labyrinth disorders</title>
            <event_list>
              <event>
                <sub_title>Vertigo</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="3119"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Diabetic retinopathy</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="3119"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Constipation</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="3119"/>
              </event>
              <event>
                <sub_title>Abdominal pain upper</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="3119"/>
              </event>
              <event>
                <sub_title>Enterocolitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="3119"/>
              </event>
              <event>
                <sub_title>Ileus</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="3119"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Chest pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="3119"/>
              </event>
              <event>
                <sub_title>Pyrexia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="3119"/>
              </event>
              <event>
                <sub_title>Face oedema</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="3119"/>
              </event>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="3119"/>
              </event>
              <event>
                <sub_title>Death</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="3119"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>Cholecystitis acute</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="3119"/>
              </event>
              <event>
                <sub_title>Cholangitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="3119"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Immune system disorders</title>
            <event_list>
              <event>
                <sub_title>Renal transplant failure</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="3119"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Gastroenteritis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="3119"/>
              </event>
              <event>
                <sub_title>Pneumonia</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="3119"/>
              </event>
              <event>
                <sub_title>Herpes zoster</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="3119"/>
              </event>
              <event>
                <sub_title>Cystitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="3119"/>
              </event>
              <event>
                <sub_title>Pyelonephritis acute</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="3119"/>
              </event>
              <event>
                <sub_title>Bronchitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="3119"/>
              </event>
              <event>
                <sub_title>Vestibular neuronitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="3119"/>
              </event>
              <event>
                <sub_title>Sepsis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="3119"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Meniscus injury</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="3119"/>
              </event>
              <event>
                <sub_title>Pneumoconiosis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="3119"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Hyperglycaemia</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="3119"/>
              </event>
              <event>
                <sub_title>Decreased appetite</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="3119"/>
              </event>
              <event>
                <sub_title>Dehydration</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="3119"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Metastases to liver</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="3119"/>
              </event>
              <event>
                <sub_title>Acute leukaemia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="3119"/>
              </event>
              <event>
                <sub_title>Basal cell carcinoma</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="3119"/>
              </event>
              <event>
                <sub_title>Non-small cell lung cancer</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="3119"/>
              </event>
              <event>
                <sub_title>Pericardial effusion malignant</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="3119"/>
              </event>
              <event>
                <sub_title>Gastric cancer</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="3119"/>
              </event>
              <event>
                <sub_title>Rectal cancer</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="3119"/>
              </event>
              <event>
                <sub_title>Pancreatic carcinoma</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="3119"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Cerebral infarction</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="3119"/>
              </event>
              <event>
                <sub_title>Dysarthria</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="3119"/>
              </event>
              <event>
                <sub_title>Dementia Alzheimer's type</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="3119"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Acute kidney injury</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="3119"/>
              </event>
              <event>
                <sub_title>End stage renal disease</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="3119"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Dyspnoea</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="3119"/>
              </event>
              <event>
                <sub_title>Chronic obstructive pulmonary disease</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="3119"/>
              </event>
              <event>
                <sub_title>Asthma</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="3119"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Diabetic foot</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="3119"/>
              </event>
              <event>
                <sub_title>Skin lesion</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="3119"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3119"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI's intellectual property rights.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Boehringer Ingelheim, Call Center</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/NCT01707147
org study id: 1218.104
nct id: NCT01707147
lead sponsor: 
collaborator: 
The aim of this study is to monitor safety and efficacy of treatment with linagliptin in
      Korean patients with type 2 diabetes mellitus in routine clinical settings.
Study Design:

      Post Marketing study- Observational study
observational model: Other
time perspective: Prospective
measure: Percentage of Patients With Incidence of Adverse Events Who Had Taken at Least One Dose of Trajenta
time frame: Up to 26 weeks (long-term surveillance)
description: Percentage of patients with incidence of any adverse events who had taken at least one dose of Trajenta.
measure: Change From Baseline After 24 Weeks in Glycosylated Hemoglobin (HbA1c)
time frame: Baseline and Week 24
description: Change from baseline after 24 weeks in Glycosylated Hemoglobin (HbA1c).
measure: Percentage of Patients With Occurrence of Treat to Target Effectiveness Response, That is HbA1c Under Treatment of < 6.5% After 24 Weeks of Treatment
time frame: 24 Weeks
description: Percentage of patients with occurrence of treat to target effectiveness response, that is HbA1c under treatment of < 6.5% after 24 weeks of treatment.
measure: Percentage of Patients With Occurrence of Relative Effectiveness Response (HbA1c Lowering by at Least 0.5% After 24 Weeks of Treatment)
time frame: 24 Weeks
description: Percentage of patients with occurrence of relative effectiveness response (HbA1c lowering by at least 0.5% after 24 weeks of treatment).
measure: Change From Baseline After 24 Weeks in Fasting Plasma Glucose (FPG)
time frame: Baseline and Week 24
description: Change from baseline after 24 weeks in fasting plasma glucose (FPG).
arm group label: Patients with Type 2 Diabetes Mellitus
intervention type: Drug
intervention name: Trajenta tablet
description: Linagliptin
arm group label: Patients with Type 2 Diabetes Mellitus
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 19 Years
maximum age: N/A
healthy volunteers: No
last name: Boehringer Ingelheim
role: Study Chair
affiliation: Boehringer Ingelheim
facility: 
country: Korea, Republic of
url: http://trials.boehringer-ingelheim.com
description: Related Info
responsible party type: Sponsor
mesh term: Diabetes Mellitus
mesh term: Diabetes Mellitus, Type 2
mesh term: Linagliptin
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 