<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/NCT01734785</url>
  </required_header>
  <id_info>
    <org_study_id>1275.9</org_study_id>
    <secondary_id>2012-002270-31</secondary_id>
    <nct_id>NCT01734785</nct_id>
  </id_info>
  <brief_title>Safety and Efficacy of the Combination of Empagliflozin and Linagliptin Compared to Linagliptin Alone Over 24 Weeks in Patients With Type 2 Diabetes</brief_title>
  <official_title>A Phase III, Randomised, Double-blind, Parallel Group, 24 Week Study to Evaluate Efficacy and Safety of Once Daily Empagliflozin 10 mg and 25 mg Compared to Placebo, All Administered as Oral Fixed Dose Combinations With Linagliptin 5 mg, in Patients With Type 2 Diabetes Mellitus and Insufficient Glycaemic Control After 16 Weeks Treatment With Linagliptin 5 mg Once Daily on Metformin Background Therapy.</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 trial compare the use of two different doses of Empagliflozin to placebo, in T2DM&#xD;
      patients on 16 wks linagliptin treatment and metformin background therapy.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>January 2013</start_date>
  <completion_date type="Actual">March 2015</completion_date>
  <primary_completion_date type="Actual">March 2015</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double</masking>
  </study_design_info>
  <primary_outcome>
    <measure>HbA1c Change From Baseline After 24 Weeks Double-blind Randomized Treatment</measure>
    <time_frame>Baseline and 24 weeks</time_frame>
    <description>Change from baseline in Glycated haemoglobin (HbA1c) [%] after 24 weeks of treatment with double-blind trial medication. Baseline was defined as the last observation before the first intake of any double-blind randomised trial medication. The term 'baseline' was not used to refer to measurements before the administration of open-label medication.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Fasting Plasma Glucose (FPG) Change From Baseline After 24 Weeks of Double-blind Treatment.</measure>
    <time_frame>Baseline and 24 weeks</time_frame>
    <description>Change from baseline FPG (mmol/L) after 24 weeks of treatment with double-blind trial medication.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Body Weight Change From Baseline After 24 Weeks of Double-blind Treatment</measure>
    <time_frame>Baseline and 24 weeks</time_frame>
    <description>Change from baseline Body weight after 24 weeks of treatment with double-blind trial medication.</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">607</enrollment>
  <condition>Diabetes Mellitus, Type 2</condition>
  <arm_group>
    <arm_group_label>Linagliptin</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>5 mg once daily</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Empaglifozin + Linagliptin low dose</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>1 tablet once daily</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Empagliflozin + Linagliptin high dose</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>1 tablet once daily</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Linagliptin</intervention_name>
    <description>tablet</description>
    <arm_group_label>Linagliptin</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Empagliflozin + Linagliptin</intervention_name>
    <description>Fixed dose combination.</description>
    <arm_group_label>Empaglifozin + Linagliptin low dose</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Empagliflozin + Linagliptin</intervention_name>
    <description>Fixed dose combination</description>
    <arm_group_label>Empaglifozin + Linagliptin low dose</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Empagliflozin + Linagliptin</intervention_name>
    <description>Fixed dose combination</description>
    <arm_group_label>Empagliflozin + Linagliptin high dose</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Empaglifozin placebo + Linagliptin placebo</intervention_name>
    <description>Matching Empaglifozin + Linagliptin low dose</description>
    <arm_group_label>Linagliptin</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Empagliflozin + Linagliptin</intervention_name>
    <description>Fixed dose combination.</description>
    <arm_group_label>Empagliflozin + Linagliptin high dose</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion criteria:&#xD;
&#xD;
          1. Diagnosis of type 2 diabetes mellitus.&#xD;
&#xD;
          2. Male and female patients on diet and exercise regimen, pre-treated with immediate&#xD;
             release metformin for at least 12 weeks, and patients should be on a dose higher or&#xD;
             equal to 1500 mg/day of metformin, or maximum tolerated dose, or maximum dose as per&#xD;
             local label.&#xD;
&#xD;
          3. HbA1c higher or equal to 8.0% and lower or equal to 10.5% at screening visit.&#xD;
&#xD;
          4. Age 18 years or more at screening.&#xD;
&#xD;
          5. Body Mass Index lower or equal to 45 kg/m2 at screening visit.&#xD;
&#xD;
          6. Signed and dated written informed consent.&#xD;
&#xD;
        Exclusion criteria:&#xD;
&#xD;
          1. Uncontrolled hyperglycemia with glucose level above 270 mg/dl (above 15 mmol/dl) after&#xD;
             an overnight fast.&#xD;
&#xD;
          2. Use of any other antidiabetic drug (except metformin background therapy).&#xD;
&#xD;
          3. Acute coronary syndrome, stroke or TIA within 3 months prior to informed consent.&#xD;
&#xD;
          4. Indication of liver disease.&#xD;
&#xD;
          5. Impaired renal function.&#xD;
&#xD;
          6. Gastrointestinal surgery.&#xD;
&#xD;
          7. Treatment with anti-obesity drugs within 3 months prior to screening, or any other&#xD;
             treatment at the time of screening (i.e. surgery, aggressive diet regimen, etc.)&#xD;
             leading to unstable body weight.&#xD;
&#xD;
          8. Current treatment with systemic steroids at time of informed consent or uncontrolled&#xD;
             endocrine disorder except type 2 diabetes mellitus.&#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>1275.9.01013 Boehringer Ingelheim Investigational Site</name>
      <address>
        <city>Gulf Shores</city>
        <state>Alabama</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>1275.9.01009 Boehringer Ingelheim Investigational Site</name>
      <address>
        <city>Norwalk</city>
        <state>California</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>1275.9.01015 Boehringer Ingelheim Investigational Site</name>
      <address>
        <city>San Diego</city>
        <state>California</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>1275.9.01017 Boehringer Ingelheim Investigational Site</name>
      <address>
        <city>San Diego</city>
        <state>California</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>1275.9.01011 Boehringer Ingelheim Investigational Site</name>
      <address>
        <city>Northglenn</city>
        <state>Colorado</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>1275.9.01010 Boehringer Ingelheim Investigational Site</name>
      <address>
        <city>Coral Gables</city>
        <state>Florida</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>1275.9.01004 Boehringer Ingelheim Investigational Site</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>1275.9.01006 Boehringer Ingelheim Investigational Site</name>
      <address>
        <city>Oldsmar</city>
        <state>Florida</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>1275.9.01001 Boehringer Ingelheim Investigational Site</name>
      <address>
        <city>Palm Coast</city>
        <state>Florida</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>1275.9.01027 Boehringer Ingelheim Investigational Site</name>
      <address>
        <city>Port Orange</city>
        <state>Florida</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>1275.9.01029 Boehringer Ingelheim Investigational Site</name>
      <address>
        <city>Blue Ridge</city>
        <state>Georgia</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>1275.9.01003 Boehringer Ingelheim Investigational Site</name>
      <address>
        <city>Marietta</city>
        <state>Georgia</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>1275.9.01022 Boehringer Ingelheim Investigational Site</name>
      <address>
        <city>Savannah</city>
        <state>Georgia</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>1275.9.01031 Boehringer Ingelheim Investigational Site</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>1275.9.01019 Boehringer Ingelheim Investigational Site</name>
      <address>
        <city>Methuen</city>
        <state>Massachusetts</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>1275.9.01024 Boehringer Ingelheim Investigational Site</name>
      <address>
        <city>Troy</city>
        <state>Michigan</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>1275.9.01023 Boehringer Ingelheim Investigational Site</name>
      <address>
        <city>St. Louis</city>
        <state>Missouri</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>1275.9.01002 Boehringer Ingelheim Investigational Site</name>
      <address>
        <city>Omaha</city>
        <state>Nebraska</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>1275.9.01007 Boehringer Ingelheim Investigational Site</name>
      <address>
        <city>Newington</city>
        <state>New Hampshire</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>1275.9.01016 Boehringer Ingelheim Investigational Site</name>
      <address>
        <city>Asheboro</city>
        <state>North Carolina</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>1275.9.01025 Boehringer Ingelheim Investigational Site</name>
      <address>
        <city>Burlington</city>
        <state>North Carolina</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>1275.9.01014 Boehringer Ingelheim Investigational Site</name>
      <address>
        <city>Shelby</city>
        <state>North Carolina</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>1275.9.01028 Boehringer Ingelheim Investigational Site</name>
      <address>
        <city>Winston-Salem</city>
        <state>North Carolina</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>1275.9.01018 Boehringer Ingelheim Investigational Site</name>
      <address>
        <city>Dayton</city>
        <state>Ohio</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>1275.9.01005 Boehringer Ingelheim Investigational Site</name>
      <address>
        <city>Corvallis</city>
        <state>Oregon</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>1275.9.01032 Boehringer Ingelheim Investigational Site</name>
      <address>
        <city>Corpus Christi</city>
        <state>Texas</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>1275.9.01030 Boehringer Ingelheim Investigational Site</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>1275.9.01021 Boehringer Ingelheim Investigational Site</name>
      <address>
        <city>San Antonio</city>
        <state>Texas</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>1275.9.61009 Boehringer Ingelheim Investigational Site</name>
      <address>
        <city>Liverpool</city>
        <state>New South Wales</state>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>1275.9.61001 Boehringer Ingelheim Investigational Site</name>
      <address>
        <city>St Leonards</city>
        <state>New South Wales</state>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>1275.9.61003 Boehringer Ingelheim Investigational Site</name>
      <address>
        <city>Carina Heights</city>
        <state>Queensland</state>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>1275.9.61002 Boehringer Ingelheim Investigational Site</name>
      <address>
        <city>Herston</city>
        <state>Queensland</state>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>1275.9.61006 Boehringer Ingelheim Investigational Site</name>
      <address>
        <city>Malvern</city>
        <state>Victoria</state>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>1275.9.61007 Boehringer Ingelheim Investigational Site</name>
      <address>
        <city>Nedlands</city>
        <state>Western Australia</state>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>1275.9.55002 Boehringer Ingelheim Investigational Site</name>
      <address>
        <city>Brasilia</city>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>1275.9.55005 Boehringer Ingelheim Investigational Site</name>
      <address>
        <city>Goiania</city>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>1275.9.55001 Boehringer Ingelheim Investigational Site</name>
      <address>
        <city>Sao Paulo</city>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>1275.9.55003 Boehringer Ingelheim Investigational Site</name>
      <address>
        <city>Sao Paulo</city>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>1275.9.55004 Boehringer Ingelheim Investigational Site</name>
      <address>
        <city>Sao Paulo</city>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>1275.9.01101 Boehringer Ingelheim Investigational Site</name>
      <address>
        <city>Burnaby</city>
        <state>British Columbia</state>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>1275.9.01103 Boehringer Ingelheim Investigational Site</name>
      <address>
        <city>Victoria</city>
        <state>British Columbia</state>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>1275.9.01105 Boehringer Ingelheim Investigational Site</name>
      <address>
        <city>Cornwall</city>
        <state>Ontario</state>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>1275.9.01106 Boehringer Ingelheim Investigational Site</name>
      <address>
        <city>Hamilton</city>
        <state>Ontario</state>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>1275.9.01104 Boehringer Ingelheim Investigational Site</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>1275.9.01102 Boehringer Ingelheim Investigational Site</name>
      <address>
        <city>Waterloo</city>
        <state>Ontario</state>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>1275.9.34008 Boehringer Ingelheim Investigational Site</name>
      <address>
        <city>Barcelona</city>
        <country>El Salvador</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>1275.9.33006 Boehringer Ingelheim Investigational Site</name>
      <address>
        <city>Bourg des Comptes</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>1275.9.33008 Boehringer Ingelheim Investigational Site</name>
      <address>
        <city>Dessenheim</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>1275.9.33003 Boehringer Ingelheim Investigational Site</name>
      <address>
        <city>La Riche</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>1275.9.33012 Boehringer Ingelheim Investigational Site</name>
      <address>
        <city>Paris</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>1275.9.33002 Boehringer Ingelheim Investigational Site</name>
      <address>
        <city>Saint Avertin</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>1275.9.33005 Boehringer Ingelheim Investigational Site</name>
      <address>
        <city>Savonnieres</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>1275.9.33004 Boehringer Ingelheim Investigational Site</name>
      <address>
        <city>Tours</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>1275.9.82006 Boehringer Ingelheim Investigational Site</name>
      <address>
        <city>Daejeon</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>1275.9.82009 Boehringer Ingelheim Investigational Site</name>
      <address>
        <city>Deagu</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>1275.9.82002 Boehringer Ingelheim Investigational Site</name>
      <address>
        <city>Goyang</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>1275.9.82004 Boehringer Ingelheim Investigational Site</name>
      <address>
        <city>Seongnam</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>1275.9.82001 Boehringer Ingelheim Investigational Site</name>
      <address>
        <city>Seoul</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>1275.9.82005 Boehringer Ingelheim Investigational Site</name>
      <address>
        <city>Seoul</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>1275.9.82007 Boehringer Ingelheim Investigational Site</name>
      <address>
        <city>Seoul</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>1275.9.82008 Boehringer Ingelheim Investigational Site</name>
      <address>
        <city>Seoul</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>1275.9.82010 Boehringer Ingelheim Investigational Site</name>
      <address>
        <city>Seoul</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>1275.9.64005 Boehringer Ingelheim Investigational Site</name>
      <address>
        <city>Auckland, New Zealand</city>
        <country>New Zealand</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>1275.9.64006 Boehringer Ingelheim Investigational Site</name>
      <address>
        <city>Auckland, New Zealand</city>
        <country>New Zealand</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>1275.9.64008 Boehringer Ingelheim Investigational Site</name>
      <address>
        <city>Birkenhead Auckland</city>
        <country>New Zealand</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>1275.9.64007 Boehringer Ingelheim Investigational Site</name>
      <address>
        <city>Christchurch Central</city>
        <country>New Zealand</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>1275.9.64004 Boehringer Ingelheim Investigational Site</name>
      <address>
        <city>Christchurch, New Zealand</city>
        <country>New Zealand</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>1275.9.64002 Boehringer Ingelheim Investigational Site</name>
      <address>
        <city>Otahuhu Auckland</city>
        <country>New Zealand</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>1275.9.64001 Boehringer Ingelheim Investigational Site</name>
      <address>
        <city>Takapuna Auckland</city>
        <country>New Zealand</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>1275.9.64003 Boehringer Ingelheim Investigational Site</name>
      <address>
        <city>Tauranga, New Zealand</city>
        <country>New Zealand</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>1275.9.47001 Boehringer Ingelheim Investigational Site</name>
      <address>
        <city>Bergen</city>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>1275.9.47002 Boehringer Ingelheim Investigational Site</name>
      <address>
        <city>Oslo</city>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>1275.9.47003 Boehringer Ingelheim Investigational Site</name>
      <address>
        <city>Oslo</city>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>1275.9.47007 Boehringer Ingelheim Investigational Site</name>
      <address>
        <city>Oslo</city>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>1275.9.47006 Boehringer Ingelheim Investigational Site</name>
      <address>
        <city>Svelvik</city>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>1275.9.34011 Boehringer Ingelheim Investigational Site</name>
      <address>
        <city>A Coruña</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>1275.9.34009 Boehringer Ingelheim Investigational Site</name>
      <address>
        <city>Alicante</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>1275.9.34005 Boehringer Ingelheim Investigational Site</name>
      <address>
        <city>Badía del Vallès - Barcelona</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>1275.9.34001 Boehringer Ingelheim Investigational Site</name>
      <address>
        <city>Barcelona</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>1275.9.34003 Boehringer Ingelheim Investigational Site</name>
      <address>
        <city>Barcelona</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>1275.9.34004 Boehringer Ingelheim Investigational Site</name>
      <address>
        <city>Barcelona</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>1275.9.34002 Boehringer Ingelheim Investigational Site</name>
      <address>
        <city>Sevilla</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>1275.9.34010 Boehringer Ingelheim Investigational Site</name>
      <address>
        <city>Valencia</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>1275.9.34006 Boehringer Ingelheim Investigational Site</name>
      <address>
        <city>Vic</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>1275.9.88606 Boehringer Ingelheim Investigational Site</name>
      <address>
        <city>Kaohsiung</city>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>1275.9.88607 Boehringer Ingelheim Investigational Site</name>
      <address>
        <city>Kaohsiung</city>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>1275.9.88602 Boehringer Ingelheim Investigational Site</name>
      <address>
        <city>New Taipei</city>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>1275.9.88603 Boehringer Ingelheim Investigational Site</name>
      <address>
        <city>Taichung</city>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>1275.9.88604 Boehringer Ingelheim Investigational Site</name>
      <address>
        <city>Taichung</city>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>1275.9.88605 Boehringer Ingelheim Investigational Site</name>
      <address>
        <city>Tainan</city>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Australia</country>
    <country>Brazil</country>
    <country>Canada</country>
    <country>El Salvador</country>
    <country>France</country>
    <country>Korea, Republic of</country>
    <country>New Zealand</country>
    <country>Norway</country>
    <country>Spain</country>
    <country>Taiwan</country>
    <country>United States</country>
  </location_countries>
  <removed_countries>
    <country>Bulgaria</country>
    <country>India</country>
    <country>Italy</country>
    <country>Romania</country>
  </removed_countries>
  <link>
    <url>http://trials.boehringer-ingelheim.com/</url>
    <description>Related Info</description>
  </link>
  <verification_date>June 2016</verification_date>
  <study_first_submitted>November 16, 2012</study_first_submitted>
  <study_first_submitted_qc>November 27, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 28, 2012</study_first_posted>
  <results_first_submitted>March 17, 2016</results_first_submitted>
  <results_first_submitted_qc>March 17, 2016</results_first_submitted_qc>
  <results_first_posted type="Estimate">April 18, 2016</results_first_posted>
  <last_update_submitted>June 9, 2016</last_update_submitted>
  <last_update_submitted_qc>June 9, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 11, 2016</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>Empagliflozin</mesh_term>
    <mesh_term>Linagliptin</mesh_term>
  </intervention_browse>

  <clinical_results>

    <participant_flow>
      <pre_assignment_details>16-week open-label (OL) lina 5 period followed by a 1-week OL period with additional placebo administration preceded randomisation to double-blind treatment. Patients were randomised to double blind treatment only when they had not met glycaemic control criteria after the 16-week OL period. All treatments were administered in addition to metformin.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Empagliflozin 25 mg</title>
          <description>Patients received 1 fixed dose combination (FDC) Empagliflozin (empa) 25/lina 5 mg tablet and two placebo tablet (1 matching placebo tablet to lina 5 and 1 matching placebo tablet to FDC empa 10/lina 5), administered orally, once every day for 24 weeks during the double blind treatment period.</description>
        </group>
        <group group_id="P2">
          <title>Empagliflozin 10 mg</title>
          <description>Patients received 1 FDC empa 10/lina 5 mg tablet and two placebo tablet (1 matching placebo tablet to lina 5 and 1 matching placebo tablet to FDC empa 25/lina 5), administered orally, once every day for 24 weeks during the double blind treatment period.</description>
        </group>
        <group group_id="P3">
          <title>Placebo</title>
          <description>Patients received 1 lina 5 mg tablet and two placebo tablet (1 matching placebo tablet to FDC empa 25/lina 5 and 1 matching placebo tablet to FDC empa 10/lina 5), administered orally, once every day for 24 weeks during the double blind treatment period.</description>
        </group>
        <group group_id="P4">
          <title>Linagliptin 5 mg</title>
          <description>Patients received 5mg dose of Linagliptin (lina 5), administered orally, once daily for 16 weeks during the OL treatment period, thereafter patients received 1 matching placebo tablet to FDC empa 25/lina 5, and 1 matching placebo tablet to FDC empa 10/lina 5 per day in addition to lina 5 OL, for 1 week during the open-label placebo add-on treatment period.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Open-Label Period</title>
          <milestone_list>
            <milestone>
              <title>STARTED</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="606"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>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="333"/>
              </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="273"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Adverse Event</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="9"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lack of Efficacy</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="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Protocol Violation</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="13"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</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="14"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</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="12"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Other Reasons</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="224"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
        <period>
          <title>Double-Blind Period</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="111"/>
                <participants group_id="P2" count="112"/>
                <participants group_id="P3" count="110"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="106"/>
                <participants group_id="P2" count="103"/>
                <participants group_id="P3" count="105"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="5"/>
                <participants group_id="P2" count="9"/>
                <participants group_id="P3" count="5"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="3"/>
                <participants group_id="P3" count="2"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lack of Efficacy</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Protocol Violation</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="1"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="4"/>
                <participants group_id="P3" count="2"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Not treated</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>The treated set (TS) consisted of all patients who were randomised and treated with at least 1 dose of study drug during the double-blind part of the trial.</population>
      <group_list>
        <group group_id="B1">
          <title>Empagliflozin 25 mg</title>
          <description>Patients received 1 FDC Empagliflozin (empa) 25/lina 5 mg tablet and two placebo tablet (1 matching placebo tablet to lina 5 and 1 matching placebo tablet to FDC empa 10/lina 5), administered orally, once every day for 24 weeks during the double blind treatment period.</description>
        </group>
        <group group_id="B2">
          <title>Empagliflozin 10 mg</title>
          <description>Patients received 1 FDC empa 10/lina 5 mg tablet and two placebo tablet (1 matching placebo tablet to lina 5 and 1 matching placebo tablet to FDC empa 25/lina 5), administered orally, once every day for 24 weeks during the double blind treatment period.</description>
        </group>
        <group group_id="B3">
          <title>Placebo</title>
          <description>Patients received 1 lina 5 mg tablet and two placebo tablet (1 matching placebo tablet to FDC empa 25/lina 5 and 1 matching placebo tablet to FDC empa 10/lina 5), administered orally, once every day for 24 weeks during the double blind treatment period.</description>
        </group>
        <group group_id="B4">
          <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="110"/>
            <count group_id="B2" value="112"/>
            <count group_id="B3" value="110"/>
            <count group_id="B4" value="332"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="55.4" spread="9.9"/>
                    <measurement group_id="B2" value="54.3" spread="9.5"/>
                    <measurement group_id="B3" value="55.9" spread="9.6"/>
                    <measurement group_id="B4" value="55.2" spread="9.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="39"/>
                    <measurement group_id="B2" value="46"/>
                    <measurement group_id="B3" value="49"/>
                    <measurement group_id="B4" value="134"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="71"/>
                    <measurement group_id="B2" value="66"/>
                    <measurement group_id="B3" value="61"/>
                    <measurement group_id="B4" value="198"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>HbA1c Change From Baseline After 24 Weeks Double-blind Randomized Treatment</title>
        <description>Change from baseline in Glycated haemoglobin (HbA1c) [%] after 24 weeks of treatment with double-blind trial medication. Baseline was defined as the last observation before the first intake of any double-blind randomised trial medication. The term 'baseline' was not used to refer to measurements before the administration of open-label medication.</description>
        <time_frame>Baseline and 24 weeks</time_frame>
        <population>The full analysis set (FAS) consisted of all patients in the treated set (TS) who had a baseline HbA1c assessment and at least 1 on-treatment HbA1c assessment during the double-blind part of the trial. Observed Case (OC): In the OC analysis, values after the use of rescue medication were set to missing.</population>
        <group_list>
          <group group_id="O1">
            <title>Empagliflozin 25 mg</title>
            <description>Patients received 1 FDC Empagliflozin (empa) 25/lina 5 mg tablet and two placebo tablet (1 matching placebo tablet to lina 5 and 1 matching placebo tablet to FDC empa 10/lina 5), administered orally, once every day for 24 weeks during the double blind treatment period.</description>
          </group>
          <group group_id="O2">
            <title>Empagliflozin 10 mg</title>
            <description>Patients received 1 FDC empa 10/lina 5 mg tablet and two placebo tablet (1 matching placebo tablet to lina 5 and 1 matching placebo tablet to FDC empa 25/lina 5), administered orally, once every day for 24 weeks during the double blind treatment period.</description>
          </group>
          <group group_id="O3">
            <title>Placebo</title>
            <description>Patients received 1 lina 5 mg tablet and two placebo tablet (1 matching placebo tablet to FDC empa 25/lina 5 and 1 matching placebo tablet to FDC empa 10/lina 5), administered orally, once every day for 24 weeks during the double blind treatment period.</description>
          </group>
        </group_list>
        <measure>
          <title>HbA1c Change From Baseline After 24 Weeks Double-blind Randomized Treatment</title>
          <description>Change from baseline in Glycated haemoglobin (HbA1c) [%] after 24 weeks of treatment with double-blind trial medication. Baseline was defined as the last observation before the first intake of any double-blind randomised trial medication. The term 'baseline' was not used to refer to measurements before the administration of open-label medication.</description>
          <population>The full analysis set (FAS) consisted of all patients in the treated set (TS) who had a baseline HbA1c assessment and at least 1 on-treatment HbA1c assessment during the double-blind part of the trial. Observed Case (OC): In the OC analysis, values after the use of rescue medication were set to missing.</population>
          <units>Percentage of HbA1c</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="110"/>
                <count group_id="O2" value="109"/>
                <count group_id="O3" value="106"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.56" spread="0.08"/>
                    <measurement group_id="O2" value="-0.65" spread="0.08"/>
                    <measurement group_id="O3" value="0.14" spread="0.09"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Superiority of Empagliflozin 25 mg vs. placebo: change in HbA1c using a restricted maximum likelihood (REML)- based mixed model repeated measures (MMRM) approach. Model includes baseline HbA1c as linear covariate(s) &amp; baseline Estimated glomerula filtration rate (eGFR), geographical region, treatment, visit, visit by treatment interaction as fixed effect(s).</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>&lt;0.0001</p_value>
            <method>Mixed Models Analysis</method>
            <method_desc>The unstructured covariance structure has been used to fit the mixed model.</method_desc>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-0.70</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.12</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_lower_limit>-0.93</ci_lower_limit>
            <ci_upper_limit>-0.46</ci_upper_limit>
            <estimate_desc>Mean Difference (Final Values) is actually the Adjusted mean difference calculated as Empagliflozin 25 mg minus Placebo.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Superiority of Empagliflozin 10 mg vs. placebo: change in HbA1c using a restricted maximum likelihood (REML)- based mixed model repeated measures (MMRM) approach. Model includes baseline HbA1c as linear covariate(s) &amp; baseline Estimated glomerula filtration rate (eGFR), geographical region, treatment, visit, visit by treatment interaction as fixed effect(s).</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>&lt;0.0001</p_value>
            <method>Mixed Models Analysis</method>
            <method_desc>The unstructured covariance structure has been used to fit the mixed model.</method_desc>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-0.79</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.12</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_lower_limit>-1.02</ci_lower_limit>
            <ci_upper_limit>-0.55</ci_upper_limit>
            <estimate_desc>Mean Difference (Final Values) is actually the Adjusted mean difference calculated as Empagliflozin 10 mg minus Placebo.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Fasting Plasma Glucose (FPG) Change From Baseline After 24 Weeks of Double-blind Treatment.</title>
        <description>Change from baseline FPG (mmol/L) after 24 weeks of treatment with double-blind trial medication.</description>
        <time_frame>Baseline and 24 weeks</time_frame>
        <population>FAS (OC)</population>
        <group_list>
          <group group_id="O1">
            <title>Empagliflozin 25 mg</title>
            <description>Patients received 1 FDC Empagliflozin (empa) 25/lina 5 mg tablet and two placebo tablet (1 matching placebo tablet to lina 5 and 1 matching placebo tablet to FDC empa 10/lina 5), administered orally, once every day for 24 weeks during the double blind treatment period.</description>
          </group>
          <group group_id="O2">
            <title>Empagliflozin 10 mg</title>
            <description>Patients received 1 FDC empa 10/lina 5 mg tablet and two placebo tablet (1 matching placebo tablet to lina 5 and 1 matching placebo tablet to FDC empa 25/lina 5), administered orally, once every day for 24 weeks during the double blind treatment period.</description>
          </group>
          <group group_id="O3">
            <title>Placebo</title>
            <description>Patients received 1 lina 5 mg tablet and two placebo tablet (1 matching placebo tablet to FDC empa 25/lina 5 and 1 matching placebo tablet to FDC empa 10/lina 5), administered orally, once every day for 24 weeks during the double blind treatment period.</description>
          </group>
        </group_list>
        <measure>
          <title>Fasting Plasma Glucose (FPG) Change From Baseline After 24 Weeks of Double-blind Treatment.</title>
          <description>Change from baseline FPG (mmol/L) after 24 weeks of treatment with double-blind trial medication.</description>
          <population>FAS (OC)</population>
          <units>mmol/L</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="109"/>
                <count group_id="O2" value="109"/>
                <count group_id="O3" value="106"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.75" spread="0.18"/>
                    <measurement group_id="O2" value="-1.46" spread="0.18"/>
                    <measurement group_id="O3" value="0.34" spread="0.19"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Superiority of Empagliflozin 25 mg vs. placebo: change in FPG using a restricted maximum likelihood (REML)- based mixed model repeated measures (MMRM) approach. Model includes baseline FPG, baseline HbA1c as linear covariate(s) &amp; baseline eGFR, geographical region, treatment, visit, visit by treatment interaction as fixed effect(s).</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>&lt;0.0001</p_value>
            <method>Mixed Models Analysis</method>
            <method_desc>The unstructured covariance structure has been used to fit the mixed model.</method_desc>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-2.09</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.26</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_lower_limit>-2.61</ci_lower_limit>
            <ci_upper_limit>-1.57</ci_upper_limit>
            <estimate_desc>Mean Difference (Final Values) is actually the Adjusted mean difference calculated as Empagliflozin 25 mg minus Placebo.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Superiority of Empagliflozin 10 mg vs. placebo: change in FPG using a restricted maximum likelihood (REML)- based mixed model repeated measures (MMRM) approach. Model includes baseline FPG, baseline HbA1c as linear covariate(s) &amp; baseline eGFR, geographical region, treatment, visit, visit by treatment interaction as fixed effect(s).</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>&lt;0.0001</p_value>
            <method>Mixed Models Analysis</method>
            <method_desc>The unstructured covariance structure has been used to fit the mixed model.</method_desc>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-1.80</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.26</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_lower_limit>-2.31</ci_lower_limit>
            <ci_upper_limit>-1.28</ci_upper_limit>
            <estimate_desc>Mean Difference (Final Values) is actually the Adjusted mean difference calculated as Empagliflozin 10 mg minus Placebo.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Body Weight Change From Baseline After 24 Weeks of Double-blind Treatment</title>
        <description>Change from baseline Body weight after 24 weeks of treatment with double-blind trial medication.</description>
        <time_frame>Baseline and 24 weeks</time_frame>
        <population>FAS (OC)</population>
        <group_list>
          <group group_id="O1">
            <title>Empagliflozin 25 mg</title>
            <description>Patients received 1 FDC Empagliflozin (empa) 25/lina 5 mg tablet and two placebo tablet (1 matching placebo tablet to lina 5 and 1 matching placebo tablet to FDC empa 10/lina 5), administered orally, once every day for 24 weeks during the double blind treatment period.</description>
          </group>
          <group group_id="O2">
            <title>Empagliflozin 10 mg</title>
            <description>Patients received 1 FDC empa 10/lina 5 mg tablet and two placebo tablet (1 matching placebo tablet to lina 5 and 1 matching placebo tablet to FDC empa 25/lina 5), administered orally, once every day for 24 weeks during the double blind treatment period.</description>
          </group>
          <group group_id="O3">
            <title>Placebo</title>
            <description>Patients received 1 lina 5 mg tablet and two placebo tablet (1 matching placebo tablet to FDC empa 25/lina 5 and 1 matching placebo tablet to FDC empa 10/lina 5), administered orally, once every day for 24 weeks during the double blind treatment period.</description>
          </group>
        </group_list>
        <measure>
          <title>Body Weight Change From Baseline After 24 Weeks of Double-blind Treatment</title>
          <description>Change from baseline Body weight after 24 weeks of treatment with double-blind trial medication.</description>
          <population>FAS (OC)</population>
          <units>kg</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="110"/>
                <count group_id="O2" value="109"/>
                <count group_id="O3" value="106"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.52" spread="0.25"/>
                    <measurement group_id="O2" value="-3.06" spread="0.25"/>
                    <measurement group_id="O3" value="-0.30" spread="0.26"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Superiority of Empagliflozin 25 mg vs. placebo: change in body weight using a restricted maximum likelihood (REML)- based mixed model repeated measures (MMRM) approach. Model includes baseline weight, baseline HbA1c as linear covariate(s) &amp; baseline eGFR, geographical region, treatment, visit, visit by treatment interaction as fixed effect(s).</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>&lt;0.0001</p_value>
            <method>Mixed Models Analysis</method>
            <method_desc>The unstructured covariance structure has been used to fit the mixed model.</method_desc>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-2.22</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.36</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_lower_limit>-2.92</ci_lower_limit>
            <ci_upper_limit>-1.52</ci_upper_limit>
            <estimate_desc>Mean Difference (Final Values) is actually the Adjusted mean difference calculated as Empagliflozin 25 mg minus Placebo.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Superiority of Empagliflozin 10 mg vs. placebo:change in body weight using a restricted maximum likelihood (REML)- based mixed model repeated measures (MMRM) approach. Model includes baseline weight, baseline HbA1c as linear covariate(s) &amp; baseline eGFR, geographical region, treatment, visit, visit by treatment interaction as fixed effect(s).</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>&lt;0.0001</p_value>
            <method>Mixed Models Analysis</method>
            <method_desc>The unstructured covariance structure has been used to fit the mixed model.</method_desc>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-2.77</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.36</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_lower_limit>-3.47</ci_lower_limit>
            <ci_upper_limit>-2.07</ci_upper_limit>
            <estimate_desc>Mean Difference (Final Values) is actually the Adjusted mean difference calculated as Empagliflozin 10 mg minus Placebo.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>From first drug administration until 7 days after the last drug administration, up to 126 days (open label treatment period) and 176 days (double blind treatment period).</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Empagliflozin 25 mg</title>
          <description>Patients received 1 FDC Empagliflozin (empa) 25/lina 5 mg tablet and two placebo tablet (1 matching placebo tablet to lina 5 and 1 matching placebo tablet to FDC empa 10/lina 5), administered orally, once every day for 24 weeks during the double blind treatment period.</description>
        </group>
        <group group_id="E2">
          <title>Empagliflozin 10 mg</title>
          <description>Patients received 1 FDC empa 10/lina 5 mg tablet and two placebo tablet (1 matching placebo tablet to lina 5 and 1 matching placebo tablet to FDC empa 25/lina 5), administered orally, once every day for 24 weeks during the double blind treatment period.</description>
        </group>
        <group group_id="E3">
          <title>Placebo</title>
          <description>Patients received 1 lina 5 mg tablet and two placebo tablet (1 matching placebo tablet to FDC empa 25/lina 5 and 1 matching placebo tablet to FDC empa 10/lina 5), administered orally, once every day for 24 weeks during the double blind treatment period.</description>
        </group>
        <group group_id="E4">
          <title>Linagliptin 5 mg</title>
          <description>Patients received 5mg dose of Linagliptin (lina 5), administered orally, once daily for 16 weeks during the OL treatment period, thereafter patients received 1 matching placebo tablet to FDC empa 25/lina 5, and 1 matching placebo tablet to FDC empa 10/lina 5 per day in addition to lina 5 OL, for 1 week during the open-label placebo add-on treatment period.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA 17.1</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="110"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="112"/>
                <counts group_id="E3" subjects_affected="10" subjects_at_risk="110"/>
                <counts group_id="E4" subjects_affected="18" subjects_at_risk="606"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Atrial fibrillation</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="110"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="112"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="110"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="606"/>
              </event>
              <event>
                <sub_title>Cardiac failure congestive</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="110"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="112"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="110"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="606"/>
              </event>
              <event>
                <sub_title>Coronary artery disease</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="110"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="112"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="110"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="606"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="110"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="112"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="110"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="606"/>
              </event>
              <event>
                <sub_title>Colitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="110"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="112"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="110"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="606"/>
              </event>
              <event>
                <sub_title>Gastritis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="110"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="112"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="110"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="606"/>
              </event>
              <event>
                <sub_title>Intestinal obstruction</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="110"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="112"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="110"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="606"/>
              </event>
              <event>
                <sub_title>Umbilical hernia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="110"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="112"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="110"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="606"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Oedema</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="110"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="112"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="110"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="606"/>
              </event>
              <event>
                <sub_title>Pyrexia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="110"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="112"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="110"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="606"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>Hepatotoxicity</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="110"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="112"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="110"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="606"/>
              </event>
              <event>
                <sub_title>Hypertransaminasaemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="110"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="112"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="110"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="606"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Immune system disorders</title>
            <event_list>
              <event>
                <sub_title>Hypersensitivity</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="110"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="112"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="110"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="606"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Abscess</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="110"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="112"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="110"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="606"/>
              </event>
              <event>
                <sub_title>Diarrhoea infectious</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="110"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="112"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="110"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="606"/>
              </event>
              <event>
                <sub_title>Erysipelas</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="110"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="112"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="110"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="606"/>
              </event>
              <event>
                <sub_title>Gastroenteritis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="110"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="112"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="110"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="606"/>
              </event>
              <event>
                <sub_title>Pharyngitis bacterial</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="110"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="112"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="110"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="606"/>
              </event>
              <event>
                <sub_title>Pneumonia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="110"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="112"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="110"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="606"/>
              </event>
              <event>
                <sub_title>Urosepsis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="110"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="112"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="110"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="606"/>
              </event>
              <event>
                <sub_title>Wound infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="110"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="112"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="110"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="606"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Accidental overdose</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="110"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="112"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="110"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="606"/>
              </event>
              <event>
                <sub_title>Jaw fracture</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="110"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="112"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="110"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="606"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Dehydration</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="110"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="112"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="110"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="606"/>
              </event>
              <event>
                <sub_title>Metabolic acidosis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="110"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="112"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="110"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="606"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Arthralgia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="110"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="112"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="110"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="606"/>
              </event>
              <event>
                <sub_title>Intervertebral disc disorder</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="110"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="112"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="110"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="606"/>
              </event>
              <event>
                <sub_title>Intervertebral disc protrusion</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="110"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="112"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="110"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="606"/>
              </event>
              <event>
                <sub_title>Osteoarthritis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="110"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="112"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="110"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="606"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Adenocarcinoma of colon</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="110"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="112"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="110"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="606"/>
              </event>
              <event>
                <sub_title>Basal cell carcinoma</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="110"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="112"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="110"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="606"/>
              </event>
              <event>
                <sub_title>Bladder neoplasm</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="110"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="112"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="110"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="606"/>
              </event>
              <event>
                <sub_title>Breast cancer</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="110"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="112"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="110"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="606"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Cervical radiculopathy</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="110"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="112"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="110"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="606"/>
              </event>
              <event>
                <sub_title>Hydrocephalus</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="110"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="112"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="110"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="606"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Pregnancy, puerperium and perinatal conditions</title>
            <event_list>
              <event>
                <sub_title>Abortion spontaneous</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="110"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="112"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="110"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="606"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Major depression</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="110"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="112"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="110"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="606"/>
              </event>
              <event>
                <sub_title>Mania</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="110"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="112"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="110"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="606"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Calculus ureteric</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="110"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="112"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="110"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="606"/>
              </event>
              <event>
                <sub_title>Hydronephrosis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="110"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="112"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="110"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="606"/>
              </event>
              <event>
                <sub_title>Nephrolithiasis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="110"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="112"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="110"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="606"/>
              </event>
              <event>
                <sub_title>Renal failure acute</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="110"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="112"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="110"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="606"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Reproductive system and breast disorders</title>
            <event_list>
              <event>
                <sub_title>Benign prostatic hyperplasia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="110"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="112"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="110"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="606"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Pneumothorax</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="110"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="112"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="110"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="606"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Surgical and medical procedures</title>
            <event_list>
              <event>
                <sub_title>Abortion induced</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="110"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="112"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="110"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="606"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA 17.1</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="11" subjects_at_risk="110"/>
                <counts group_id="E2" subjects_affected="19" subjects_at_risk="112"/>
                <counts group_id="E3" subjects_affected="34" subjects_at_risk="110"/>
                <counts group_id="E4" subjects_affected="78" subjects_at_risk="606"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Nasopharyngitis</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="110"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="112"/>
                <counts group_id="E3" subjects_affected="8" subjects_at_risk="110"/>
                <counts group_id="E4" subjects_affected="25" subjects_at_risk="606"/>
              </event>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="110"/>
                <counts group_id="E2" subjects_affected="8" subjects_at_risk="112"/>
                <counts group_id="E3" subjects_affected="7" subjects_at_risk="110"/>
                <counts group_id="E4" subjects_affected="28" subjects_at_risk="606"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Lipase increased</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="110"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="112"/>
                <counts group_id="E3" subjects_affected="6" subjects_at_risk="110"/>
                <counts group_id="E4" subjects_affected="10" subjects_at_risk="606"/>
              </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="1" subjects_at_risk="110"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="112"/>
                <counts group_id="E3" subjects_affected="7" subjects_at_risk="110"/>
                <counts group_id="E4" subjects_affected="6" subjects_at_risk="606"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="110"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="112"/>
                <counts group_id="E3" subjects_affected="8" subjects_at_risk="110"/>
                <counts group_id="E4" subjects_affected="14" subjects_at_risk="606"/>
              </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/NCT01734785
org study id: 1275.9
secondary id: 2012-002270-31
nct id: NCT01734785
lead sponsor: 
collaborator: 
This trial compare the use of two different doses of Empagliflozin to placebo, in T2DM
      patients on 16 wks linagliptin treatment and metformin background therapy.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double
measure: HbA1c Change From Baseline After 24 Weeks Double-blind Randomized Treatment
time frame: Baseline and 24 weeks
description: Change from baseline in Glycated haemoglobin (HbA1c) [%] after 24 weeks of treatment with double-blind trial medication. Baseline was defined as the last observation before the first intake of any double-blind randomised trial medication. The term 'baseline' was not used to refer to measurements before the administration of open-label medication.
measure: Fasting Plasma Glucose (FPG) Change From Baseline After 24 Weeks of Double-blind Treatment.
time frame: Baseline and 24 weeks
description: Change from baseline FPG (mmol/L) after 24 weeks of treatment with double-blind trial medication.
measure: Body Weight Change From Baseline After 24 Weeks of Double-blind Treatment
time frame: Baseline and 24 weeks
description: Change from baseline Body weight after 24 weeks of treatment with double-blind trial medication.
arm group label: Linagliptin
arm group type: Active Comparator
description: 5 mg once daily
arm group label: Empaglifozin + Linagliptin low dose
arm group type: Experimental
description: 1 tablet once daily
arm group label: Empagliflozin + Linagliptin high dose
arm group type: Experimental
description: 1 tablet once daily
intervention type: Drug
intervention name: Linagliptin
description: tablet
arm group label: Linagliptin
intervention type: Drug
intervention name: Empagliflozin + Linagliptin
description: Fixed dose combination.
arm group label: Empaglifozin + Linagliptin low dose
intervention type: Drug
intervention name: Empagliflozin + Linagliptin
description: Fixed dose combination
arm group label: Empaglifozin + Linagliptin low dose
intervention type: Drug
intervention name: Empagliflozin + Linagliptin
description: Fixed dose combination
arm group label: Empagliflozin + Linagliptin high dose
intervention type: Drug
intervention name: Empaglifozin placebo + Linagliptin placebo
description: Matching Empaglifozin + Linagliptin low dose
arm group label: Linagliptin
intervention type: Drug
intervention name: Empagliflozin + Linagliptin
description: Fixed dose combination.
arm group label: Empagliflozin + Linagliptin high dose
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Boehringer Ingelheim
role: Study Chair
affiliation: Boehringer Ingelheim
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country: Australia
country: Brazil
country: Canada
country: El Salvador
country: France
country: Korea, Republic of
country: New Zealand
country: Norway
country: Spain
country: Taiwan
country: United States
country: Bulgaria
country: India
country: Italy
country: Romania
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: Empagliflozin
mesh term: Linagliptin
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 