<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/NCT01719003</url>
  </required_header>
  <id_info>
    <org_study_id>1276.1</org_study_id>
    <secondary_id>2010-021375-92</secondary_id>
    <nct_id>NCT01719003</nct_id>
  </id_info>
  <brief_title>Safety and Efficacy Study of Empagliflozin and Metformin for 24 Weeks in Treatment Naive Patients With Type 2 Diabetes</brief_title>
  <official_title>A 24-week Phase III Randomized, Double-blind, Parallel Group Study to Evaluate the Efficacy and Safety of Twice Daily Oral Administration of Empagliflozin + Metformin Compared With the Individual Components of Empagliflozin or Metformin in Drug Naive Patients With Type 2 Diabetes Mellitus</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 study will investigate the efficacy and safety of two doses (high and low) of&#xD;
      empagliflozin in combination with metformin (500 mg and 1000 mg) administered twice daily in&#xD;
      patients with type 2 diabetes mellitus (T2DM). Study will compare four dose combinations of&#xD;
      empagliflozin + metformin versus each individual component after 24 weeks of treatment.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>October 2012</start_date>
  <completion_date type="Actual">December 2014</completion_date>
  <primary_completion_date type="Actual">November 2014</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 (Glycosylated Haemoglobin) Change From Baseline at Week 24</measure>
    <time_frame>baseline and 24 weeks</time_frame>
    <description>Change from baseline in HbA1c (%) after 24 weeks of treatment. &quot;Baseline&quot; refers to the last observation before the start of any randomised trial treatment medication. Means presented are the adjusted means</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>FPG (Fasting Plasma Glucose) Change From Baseline at Week 24</measure>
    <time_frame>baseline and 24 weeks</time_frame>
    <description>Change from baseline in FPG (mg/dL) after 24 weeks of treatment. &quot;Baseline&quot; refers to the last observation before the start of any randomised trial treatment medication. Means presented are the adjusted means.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Body Weight Change From Baseline at Week 24</measure>
    <time_frame>baseline and 24 weeks</time_frame>
    <description>Change from baseline in body weight (kg) after 24 weeks of treatment. &quot;Baseline&quot; refers to the last observation before the start of any randomised trial treatment. medication. Means presented are the adjusted means.</description>
  </secondary_outcome>
  <number_of_arms>9</number_of_arms>
  <enrollment type="Actual">1413</enrollment>
  <condition>Diabetes Mellitus, Type 2</condition>
  <condition>Hyperglycemia</condition>
  <arm_group>
    <arm_group_label>Empagliflozin low dose qd</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Empagliflozin low dose once daily</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Empagliflozin high dose qd</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Empagliflozin high dose once daily</description>
  </arm_group>
  <arm_group>
    <arm_group_label>OL empa high dose + met 1000 mg bid</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Open label empagliflozin high dose split twice daily + metformin 1000 mg twice daily - Patients are no longer enrolled into this arm because of change in the inclusion criteria in protocol version 2.0 all patients are now enrolled into remaining double-blind arms. Patients already enrolled in the open-label arm according to protocol version 1.0 can complete the study.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Empagliflozin low dose + met 500 mg bid</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Empagliflozin low dose split twice daily + metformin 500 mg twice daily</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Empagliflozin low dose + met 1000 mg bid</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Empagliflozin low dose split twice daily + metformin 1000 mg twice daily</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Empagliflozin high dose + met 500 mg bid</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Empagliflozin high dose split twice daily + metformin 500 mg twice daily</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Empagliflozin high dose + met 1000mg bid</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Empagliflozin high dose split twice daily + metformin 1000 mg twice daily</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Metformin 500 mg bid</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Metformin 500 mg twice daily</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Metformin 1000 mg bid</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Metformin 1000 mg twice daily</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Metformin 500 mg bid</intervention_name>
    <description>Metformin 500 mg twice daily</description>
    <arm_group_label>Empagliflozin low dose + met 500 mg bid</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Metformin 1000 mg bid</intervention_name>
    <description>Metformin 1000 mg twice daily</description>
    <arm_group_label>OL empa high dose + met 1000 mg bid</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Empagliflozin low dose qd</intervention_name>
    <description>Empagliflozin low dose once daily</description>
    <arm_group_label>Empagliflozin low dose qd</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Empagliflozin high dose qd</intervention_name>
    <description>Empagliflozin high dose once daily</description>
    <arm_group_label>Empagliflozin high dose qd</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Empagliflozin low dose bid</intervention_name>
    <description>Empagliflozin low dose split twice daily</description>
    <arm_group_label>Empagliflozin low dose + met 500 mg bid</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Metformin 500 mg bid</intervention_name>
    <description>Metformin 500 mg twice daily</description>
    <arm_group_label>Empagliflozin high dose + met 500 mg bid</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Empagliflozin high dose bid</intervention_name>
    <description>Empagliflozin high dose split twice daily</description>
    <arm_group_label>OL empa high dose + met 1000 mg bid</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Empagliflozin low dose bid</intervention_name>
    <description>Empagliflozin low dose split twice daily</description>
    <arm_group_label>Empagliflozin low dose + met 1000 mg bid</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Metformin 1000 mg bid</intervention_name>
    <description>Metformin 1000 mg twice daily</description>
    <arm_group_label>Empagliflozin high dose + met 1000mg bid</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Metformin 500 mg bid</intervention_name>
    <description>Metformin 500 mg twice daily</description>
    <arm_group_label>Metformin 500 mg bid</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Metformin 1000 mg bid</intervention_name>
    <description>Metformin 1000 mg twice daily</description>
    <arm_group_label>Metformin 1000 mg bid</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Empagliflozin high dose bid</intervention_name>
    <description>Empagliflozin high dose split twice daily</description>
    <arm_group_label>Empagliflozin high dose + met 1000mg bid</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Metformin 1000 mg bid</intervention_name>
    <description>Metformin 1000 mg twice daily</description>
    <arm_group_label>Empagliflozin low dose + met 1000 mg bid</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Empagliflozin high dose bid</intervention_name>
    <description>Empagliflozin high dose split twice daily</description>
    <arm_group_label>Empagliflozin high dose + met 500 mg bid</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion criteria:&#xD;
&#xD;
          1. Diagnosis of type 2 diabetes mellitus prior to informed consent&#xD;
&#xD;
          2. Male and female patients on diet and exercise regimen who are drug-naive, defined as&#xD;
             absence of any oral antidiabetic therapy for 12 weeks prior to randomization&#xD;
&#xD;
          3. HbA1c &gt;=7.5% and &lt;= 12% (&gt;=58.5 mmol/mol and &lt;=107.7 mmol/mol)&#xD;
&#xD;
          4. Body Mass Index (BMI) &lt;= 45 kg/m2 at screening&#xD;
&#xD;
        Exclusion criteria:&#xD;
&#xD;
          1. Uncontrolled hyperglycemia with a glucose level &gt;240 mg/dl (&gt;13.3 mmol/L) after an&#xD;
             overnight fast during placebo run-in and confirmed by a second laboratory measurement&#xD;
             (not on the same day)&#xD;
&#xD;
          2. Any antidiabetic drug within 12 weeks prior to randomization&#xD;
&#xD;
          3. Impaired renal function, defined as estimated creatinine clearance rate (eCCr) &lt;60&#xD;
             ml/min (Cockcroft-Gault formula) as determined during screening and/or run-in period&#xD;
&#xD;
          4. Contraindications to metformin according to the local label&#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>1276.1.10014 Boehringer Ingelheim Investigational Site</name>
      <address>
        <city>Birmingham</city>
        <state>Alabama</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>1276.1.10019 Boehringer Ingelheim Investigational Site</name>
      <address>
        <city>Birmingham</city>
        <state>Alabama</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>1276.1.10044 Boehringer Ingelheim Investigational Site</name>
      <address>
        <city>Hot Springs</city>
        <state>Alaska</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>1276.1.10010 Boehringer Ingelheim Investigational Site</name>
      <address>
        <city>Glendale</city>
        <state>Arizona</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>1276.1.10035 Boehringer Ingelheim Investigational Site</name>
      <address>
        <city>Searcy</city>
        <state>Arkansas</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>1276.1.10046 Boehringer Ingelheim Investigational Site</name>
      <address>
        <city>Chula Vista</city>
        <state>California</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>1276.1.10006 Boehringer Ingelheim Investigational Site</name>
      <address>
        <city>Huntington Beach</city>
        <state>California</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>1276.1.10043 Boehringer Ingelheim Investigational Site</name>
      <address>
        <city>La Mesa</city>
        <state>California</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>1276.1.10009 Boehringer Ingelheim Investigational Site</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>1276.1.10040 Boehringer Ingelheim Investigational Site</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>1276.1.10045 Boehringer Ingelheim Investigational Site</name>
      <address>
        <city>Oceanside</city>
        <state>California</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>1276.1.10042 Boehringer Ingelheim Investigational Site</name>
      <address>
        <city>Colorado Springs</city>
        <state>Colorado</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>1276.1.10001 Boehringer Ingelheim Investigational Site</name>
      <address>
        <city>Denver</city>
        <state>Colorado</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>1276.1.10003 Boehringer Ingelheim Investigational Site</name>
      <address>
        <city>Northglenn</city>
        <state>Colorado</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>1276.1.10026 Boehringer Ingelheim Investigational Site</name>
      <address>
        <city>Fort Lauderdale</city>
        <state>Florida</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>1276.1.10024 Boehringer Ingelheim Investigational Site</name>
      <address>
        <city>Oldsmar</city>
        <state>Florida</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>1276.1.10027 Boehringer Ingelheim Investigational Site</name>
      <address>
        <city>Port Orange</city>
        <state>Florida</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>1276.1.10023 Boehringer Ingelheim Investigational Site</name>
      <address>
        <city>Marietta</city>
        <state>Georgia</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>1276.1.10034 Boehringer Ingelheim Investigational Site</name>
      <address>
        <city>Evansville</city>
        <state>Indiana</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>1276.1.10032 Boehringer Ingelheim Investigational Site</name>
      <address>
        <city>Fall River</city>
        <state>Massachusetts</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>1276.1.10036 Boehringer Ingelheim Investigational Site</name>
      <address>
        <city>Bridgman</city>
        <state>Michigan</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>1276.1.10037 Boehringer Ingelheim Investigational Site</name>
      <address>
        <city>Hazelwood</city>
        <state>Missouri</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>1276.1.10007 Boehringer Ingelheim Investigational Site</name>
      <address>
        <city>Las Vegas</city>
        <state>Nevada</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>1276.1.10015 Boehringer Ingelheim Investigational Site</name>
      <address>
        <city>Union</city>
        <state>New Jersey</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>1276.1.10033 Boehringer Ingelheim Investigational Site</name>
      <address>
        <city>Asheboro</city>
        <state>North Carolina</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>1276.1.10022 Boehringer Ingelheim Investigational Site</name>
      <address>
        <city>Burlington</city>
        <state>North Carolina</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>1276.1.10002 Boehringer Ingelheim Investigational Site</name>
      <address>
        <city>Lenoir</city>
        <state>North Carolina</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>1276.1.10005 Boehringer Ingelheim Investigational Site</name>
      <address>
        <city>Cincinnati</city>
        <state>Ohio</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>1276.1.10011 Boehringer Ingelheim Investigational Site</name>
      <address>
        <city>Gallipolis</city>
        <state>Ohio</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>1276.1.10030 Boehringer Ingelheim Investigational Site</name>
      <address>
        <city>Columbia</city>
        <state>South Carolina</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>1276.1.10008 Boehringer Ingelheim Investigational Site</name>
      <address>
        <city>Greer</city>
        <state>South Carolina</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>1276.1.10013 Boehringer Ingelheim Investigational Site</name>
      <address>
        <city>Hodges</city>
        <state>South Carolina</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>1276.1.10017 Boehringer Ingelheim Investigational Site</name>
      <address>
        <city>Humboldt</city>
        <state>Tennessee</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>1276.1.10018 Boehringer Ingelheim Investigational Site</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>1276.1.10025 Boehringer Ingelheim Investigational Site</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>1276.1.10028 Boehringer Ingelheim Investigational Site</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>1276.1.10016 Boehringer Ingelheim Investigational Site</name>
      <address>
        <city>Kingwood</city>
        <state>Texas</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>1276.1.10021 Boehringer Ingelheim Investigational Site</name>
      <address>
        <city>San Antonio</city>
        <state>Texas</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>1276.1.10041 Boehringer Ingelheim Investigational Site</name>
      <address>
        <city>San Antonio</city>
        <state>Texas</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>1276.1.10004 Boehringer Ingelheim Investigational Site</name>
      <address>
        <city>Manassas</city>
        <state>Virginia</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>1276.1.10012 Boehringer Ingelheim Investigational Site</name>
      <address>
        <city>Wenatchee</city>
        <state>Washington</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>1276.1.55008 Boehringer Ingelheim Investigational Site</name>
      <address>
        <city>Belém</city>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>1276.1.55003 Boehringer Ingelheim Investigational Site</name>
      <address>
        <city>Brasilia</city>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>1276.1.55006 Boehringer Ingelheim Investigational Site</name>
      <address>
        <city>Fortaleza</city>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>1276.1.55007 Boehringer Ingelheim Investigational Site</name>
      <address>
        <city>Fortaleza</city>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>1276.1.55009 Boehringer Ingelheim Investigational Site</name>
      <address>
        <city>Fortaleza</city>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>1276.1.55004 Boehringer Ingelheim Investigational Site</name>
      <address>
        <city>Goiania</city>
        <country>Brazil</country>
      </address>
    </facility>
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        <country>Russian Federation</country>
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  <location>
    <facility>
      <name>1276.1.70007 Boehringer Ingelheim Investigational Site</name>
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        <country>Russian Federation</country>
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  <location>
    <facility>
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        <country>Russian Federation</country>
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  <location>
    <facility>
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        <country>Russian Federation</country>
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  <location>
    <facility>
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        <country>Russian Federation</country>
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  <location>
    <facility>
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        <country>Russian Federation</country>
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  <location>
    <facility>
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        <country>Russian Federation</country>
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  <location>
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        <country>Russian Federation</country>
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  <location>
    <facility>
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        <country>Serbia</country>
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  </location>
  <location>
    <facility>
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  <location>
    <facility>
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  <location>
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  <location>
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  <location>
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        <country>Serbia</country>
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  <location>
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        <country>Serbia</country>
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  <location>
    <facility>
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        <city>Zajecar</city>
        <country>Serbia</country>
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  <location>
    <facility>
      <name>1276.1.34048 Boehringer Ingelheim Investigational Site</name>
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        <city>Alicante</city>
        <country>Spain</country>
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  <location>
    <facility>
      <name>1276.1.34050 Boehringer Ingelheim Investigational Site</name>
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        <city>Alzira</city>
        <country>Spain</country>
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  <location>
    <facility>
      <name>1276.1.34028 Boehringer Ingelheim Investigational Site</name>
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        <city>Madrid</city>
        <country>Spain</country>
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  <location>
    <facility>
      <name>1276.1.34045 Boehringer Ingelheim Investigational Site</name>
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        <city>pozuelo de Alarcon</city>
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  <location>
    <facility>
      <name>1276.1.34034 Boehringer Ingelheim Investigational Site</name>
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        <city>Sabadell (Barcelona)</city>
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  <location>
    <facility>
      <name>1276.1.34027 Boehringer Ingelheim Investigational Site</name>
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  <location>
    <facility>
      <name>1276.1.34052 Boehringer Ingelheim Investigational Site</name>
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        <country>Spain</country>
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  <location>
    <facility>
      <name>1276.1.34051 Boehringer Ingelheim Investigational Site</name>
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        <city>Zaragoza</city>
        <country>Spain</country>
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  <location>
    <facility>
      <name>1276.1.88005 Boehringer Ingelheim Investigational Site</name>
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        <country>Taiwan</country>
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  <location>
    <facility>
      <name>1276.1.88002 Boehringer Ingelheim Investigational Site</name>
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        <country>Taiwan</country>
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  <location>
    <facility>
      <name>1276.1.88001 Boehringer Ingelheim Investigational Site</name>
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        <country>Taiwan</country>
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  <location>
    <facility>
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  <location>
    <facility>
      <name>1276.1.88004 Boehringer Ingelheim Investigational Site</name>
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        <city>Taichung</city>
        <country>Taiwan</country>
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  <location>
    <facility>
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        <city>Taipei</city>
        <country>Taiwan</country>
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  <location>
    <facility>
      <name>1276.1.66001 Boehringer Ingelheim Investigational Site</name>
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        <country>Thailand</country>
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  <location>
    <facility>
      <name>1276.1.66003 Boehringer Ingelheim Investigational Site</name>
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        <country>Thailand</country>
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  <location>
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        <city>Nakhon Ratchasima</city>
        <country>Thailand</country>
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  <location>
    <facility>
      <name>1276.1.90003 Boehringer Ingelheim Investigational Site</name>
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        <city>Ankara</city>
        <country>Turkey</country>
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  <location>
    <facility>
      <name>1276.1.90004 Boehringer Ingelheim Investigational Site</name>
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        <country>Turkey</country>
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  <location>
    <facility>
      <name>1276.1.90006 Boehringer Ingelheim Investigational Site</name>
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        <country>Turkey</country>
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  <location>
    <facility>
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  <location>
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  <location>
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  <location>
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  <location>
    <facility>
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        <city>Bradford on Avon</city>
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  <location>
    <facility>
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  <location>
    <facility>
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        <city>Dagenham</city>
        <country>United Kingdom</country>
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  </location>
  <location>
    <facility>
      <name>1276.1.44004 Boehringer Ingelheim Investigational Site</name>
      <address>
        <city>Doncaster</city>
        <country>United Kingdom</country>
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  </location>
  <location>
    <facility>
      <name>1276.1.44008 Boehringer Ingelheim Investigational Site</name>
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  <location>
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  <location>
    <facility>
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      <address>
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  </location>
  <location>
    <facility>
      <name>1276.1.44011 Boehringer Ingelheim Investigational Site</name>
      <address>
        <city>Mortimer</city>
        <country>United Kingdom</country>
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  <location>
    <facility>
      <name>1276.1.44009 Boehringer Ingelheim Investigational Site</name>
      <address>
        <city>Sandbach</city>
        <country>United Kingdom</country>
      </address>
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  </location>
  <location_countries>
    <country>Brazil</country>
    <country>Canada</country>
    <country>Czech Republic</country>
    <country>Egypt</country>
    <country>France</country>
    <country>Germany</country>
    <country>Guatemala</country>
    <country>Korea, Republic of</country>
    <country>Lebanon</country>
    <country>Malaysia</country>
    <country>Mexico</country>
    <country>Peru</country>
    <country>Philippines</country>
    <country>Russian Federation</country>
    <country>Serbia</country>
    <country>Spain</country>
    <country>Taiwan</country>
    <country>Thailand</country>
    <country>Turkey</country>
    <country>United Kingdom</country>
    <country>United States</country>
  </location_countries>
  <removed_countries>
    <country>India</country>
    <country>Indonesia</country>
    <country>United Arab Emirates</country>
  </removed_countries>
  <link>
    <url>http://trials.boehringer-ingelheim.com</url>
    <description>Related Info</description>
  </link>
  <verification_date>January 2016</verification_date>
  <study_first_submitted>October 30, 2012</study_first_submitted>
  <study_first_submitted_qc>October 30, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 1, 2012</study_first_posted>
  <results_first_submitted>November 23, 2015</results_first_submitted>
  <results_first_submitted_qc>January 22, 2016</results_first_submitted_qc>
  <results_first_posted type="Estimate">February 19, 2016</results_first_posted>
  <last_update_submitted>January 22, 2016</last_update_submitted>
  <last_update_submitted_qc>January 22, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">February 19, 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>
    <mesh_term>Hyperglycemia</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Metformin</mesh_term>
    <mesh_term>Empagliflozin</mesh_term>
  </intervention_browse>

  <clinical_results>

    <participant_flow>
      <recruitment_details>With the first global protocol amendment (13-Dec-2012), the HbA1c inclusion criterion changed and further enrolment in the open label (OL) group was stopped, but the patients already entered in the OL group could continue until the scheduled end of the study.</recruitment_details>
      <pre_assignment_details>Patients with an (Glycosylated Haemoglobin) HbA1c &gt;10.0% at screening and meeting all other inclusion criteria were initially directly included in an OL treatment group</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Empagliflozin 12.5 mg Bid+ Metformin 1000 mg Bid</title>
          <description>Oral administration of Empagliflozin 12.5 mg and Metformin 1000 mg twice daily (bid)</description>
        </group>
        <group group_id="P2">
          <title>Empagliflozin 12.5 mg Bid+ Metformin 500 mg Bid</title>
          <description>Oral administration of Empagliflozin 12.5 mg and Metformin 500 mg bid</description>
        </group>
        <group group_id="P3">
          <title>Empagliflozin 5 mg Bid + Metformin 1000 mg Bid</title>
          <description>Oral administration of Empagliflozin 5 mg and Metformin 1000 mg bid</description>
        </group>
        <group group_id="P4">
          <title>Empagliflozin 5 mg Bid + Metformin 500 mg Bid</title>
          <description>Oral administration of Empagliflozin 5 mg and Metformin 500 mg bid</description>
        </group>
        <group group_id="P5">
          <title>Empagliflozin 25 mg qd</title>
          <description>Oral administration of Empagliflozin 25 mg once daily (qd)</description>
        </group>
        <group group_id="P6">
          <title>Empagliflozin 10 mg qd</title>
          <description>Oral administration of Empagliflozin 10 mg qd</description>
        </group>
        <group group_id="P7">
          <title>Metformin 1000 mg Bid</title>
          <description>Oral administration of Metformin 1000 mg bid</description>
        </group>
        <group group_id="P8">
          <title>Metformin 500 mg Bid</title>
          <description>Oral administration of Metformin 500 mg bid</description>
        </group>
        <group group_id="P9">
          <title>Empagliflozin 12.5 mg Bid + Metformin 1000 mg Bid OL</title>
          <description>Oral administration of Empagliflozin 12.5 mg and Metformin 1000 mg bid in an open label (OL)</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="170"/>
                <participants group_id="P2" count="170"/>
                <participants group_id="P3" count="171"/>
                <participants group_id="P4" count="169"/>
                <participants group_id="P5" count="167"/>
                <participants group_id="P6" count="172"/>
                <participants group_id="P7" count="170"/>
                <participants group_id="P8" count="171"/>
                <participants group_id="P9" count="53"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="161"/>
                <participants group_id="P2" count="153"/>
                <participants group_id="P3" count="154"/>
                <participants group_id="P4" count="156"/>
                <participants group_id="P5" count="150"/>
                <participants group_id="P6" count="160"/>
                <participants group_id="P7" count="150"/>
                <participants group_id="P8" count="151"/>
                <participants group_id="P9" count="49"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="9"/>
                <participants group_id="P2" count="17"/>
                <participants group_id="P3" count="17"/>
                <participants group_id="P4" count="13"/>
                <participants group_id="P5" count="17"/>
                <participants group_id="P6" count="12"/>
                <participants group_id="P7" count="20"/>
                <participants group_id="P8" count="20"/>
                <participants group_id="P9" count="4"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Non compliant with protocol</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="1"/>
                <participants group_id="P5" count="2"/>
                <participants group_id="P6" count="1"/>
                <participants group_id="P7" count="2"/>
                <participants group_id="P8" count="3"/>
                <participants group_id="P9" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="6"/>
                <participants group_id="P2" count="5"/>
                <participants group_id="P3" count="4"/>
                <participants group_id="P4" count="3"/>
                <participants group_id="P5" count="4"/>
                <participants group_id="P6" count="3"/>
                <participants group_id="P7" count="6"/>
                <participants group_id="P8" count="5"/>
                <participants group_id="P9" count="0"/>
              </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="6"/>
                <participants group_id="P3" count="7"/>
                <participants group_id="P4" count="2"/>
                <participants group_id="P5" count="3"/>
                <participants group_id="P6" count="4"/>
                <participants group_id="P7" count="3"/>
                <participants group_id="P8" count="2"/>
                <participants group_id="P9" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Refusal to continue, not due to AE</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="5"/>
                <participants group_id="P3" count="4"/>
                <participants group_id="P4" count="4"/>
                <participants group_id="P5" count="4"/>
                <participants group_id="P6" count="3"/>
                <participants group_id="P7" count="8"/>
                <participants group_id="P8" count="7"/>
                <participants group_id="P9" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Reason other than those specified</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="2"/>
                <participants group_id="P4" count="3"/>
                <participants group_id="P5" count="4"/>
                <participants group_id="P6" count="1"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="3"/>
                <participants group_id="P9" count="1"/>
              </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="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="1"/>
                <participants group_id="P8" count="0"/>
                <participants group_id="P9" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Full analysis set (FAS): FAS comprised all randomised patients treated with at least 1 dose of trial medication, with a baseline and at least 1 on-treatment HbA1c assessment.</population>
      <group_list>
        <group group_id="B1">
          <title>Empagliflozin 12.5 mg Bid+ Metformin 1000 mg Bid</title>
          <description>Oral administration of Empagliflozin 12.5 mg and Metformin 1000 mg twice daily (bid)</description>
        </group>
        <group group_id="B2">
          <title>Empagliflozin 12.5 mg Bid+ Metformin 500 mg Bid</title>
          <description>Oral administration of Empagliflozin 12.5 mg and Metformin 500 mg bid</description>
        </group>
        <group group_id="B3">
          <title>Empagliflozin 5 mg Bid + Metformin 1000 mg Bid</title>
          <description>Oral administration of Empagliflozin 5 mg and Metformin 1000 mg bid</description>
        </group>
        <group group_id="B4">
          <title>Empagliflozin 5 mg Bid + Metformin 500 mg Bid</title>
          <description>Oral administration of Empagliflozin 5 mg and Metformin 500 mg bid</description>
        </group>
        <group group_id="B5">
          <title>Empagliflozin 25 mg qd</title>
          <description>Oral administration of Empagliflozin 25 mg once daily (qd)</description>
        </group>
        <group group_id="B6">
          <title>Empagliflozin 10 mg qd</title>
          <description>Oral administration of Empagliflozin 10 mg qd</description>
        </group>
        <group group_id="B7">
          <title>Metformin 1000 mg Bid</title>
          <description>Oral administration of Metformin 1000 mg bid</description>
        </group>
        <group group_id="B8">
          <title>Metformin 500 mg Bid</title>
          <description>Oral administration of Metformin 500 mg bid</description>
        </group>
        <group group_id="B9">
          <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="169"/>
            <count group_id="B2" value="165"/>
            <count group_id="B3" value="167"/>
            <count group_id="B4" value="161"/>
            <count group_id="B5" value="164"/>
            <count group_id="B6" value="169"/>
            <count group_id="B7" value="164"/>
            <count group_id="B8" value="168"/>
            <count group_id="B9" value="1327"/>
          </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="53.6" spread="10.7"/>
                    <measurement group_id="B2" value="51.0" spread="10.7"/>
                    <measurement group_id="B3" value="52.3" spread="11.3"/>
                    <measurement group_id="B4" value="52.2" spread="11.7"/>
                    <measurement group_id="B5" value="53.3" spread="10.7"/>
                    <measurement group_id="B6" value="53.1" spread="10.7"/>
                    <measurement group_id="B7" value="51.6" spread="10.8"/>
                    <measurement group_id="B8" value="53.4" spread="10.9"/>
                    <measurement group_id="B9" value="52.6" spread="10.9"/>
                  </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="81"/>
                    <measurement group_id="B2" value="60"/>
                    <measurement group_id="B3" value="68"/>
                    <measurement group_id="B4" value="64"/>
                    <measurement group_id="B5" value="81"/>
                    <measurement group_id="B6" value="72"/>
                    <measurement group_id="B7" value="72"/>
                    <measurement group_id="B8" value="82"/>
                    <measurement group_id="B9" value="580"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="88"/>
                    <measurement group_id="B2" value="105"/>
                    <measurement group_id="B3" value="99"/>
                    <measurement group_id="B4" value="97"/>
                    <measurement group_id="B5" value="83"/>
                    <measurement group_id="B6" value="97"/>
                    <measurement group_id="B7" value="92"/>
                    <measurement group_id="B8" value="86"/>
                    <measurement group_id="B9" value="747"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>HbA1c (Glycosylated Haemoglobin) Change From Baseline at Week 24</title>
        <description>Change from baseline in HbA1c (%) after 24 weeks of treatment. &quot;Baseline&quot; refers to the last observation before the start of any randomised trial treatment medication. Means presented are the adjusted means</description>
        <time_frame>baseline and 24 weeks</time_frame>
        <population>FAS observed cases (OC) (Only patients with available data are analysed)</population>
        <group_list>
          <group group_id="O1">
            <title>Empagliflozin 12.5 mg Bid+ Metformin 1000 mg Bid</title>
            <description>Oral administration of Empagliflozin 12.5 mg and Metformin 1000 mg twice daily (bid)</description>
          </group>
          <group group_id="O2">
            <title>Empagliflozin 12.5 mg Bid+ Metformin 500 mg Bid</title>
            <description>Oral administration of Empagliflozin 12.5 mg and Metformin 500 mg bid</description>
          </group>
          <group group_id="O3">
            <title>Empagliflozin 5 mg Bid + Metformin 1000 mg Bid</title>
            <description>Oral administration of Empagliflozin 5 mg and Metformin 1000 mg bid</description>
          </group>
          <group group_id="O4">
            <title>Empagliflozin 5 mg Bid + Metformin 500 mg Bid</title>
            <description>Oral administration of Empagliflozin 5 mg and Metformin 500 mg bid</description>
          </group>
          <group group_id="O5">
            <title>Empagliflozin 25 mg qd</title>
            <description>Oral administration of Empagliflozin 25 mg once daily (qd)</description>
          </group>
          <group group_id="O6">
            <title>Empagliflozin 10 mg qd</title>
            <description>Oral administration of Empagliflozin 10 mg qd</description>
          </group>
          <group group_id="O7">
            <title>Metformin 1000 mg Bid</title>
            <description>Oral administration of Metformin 1000 mg bid</description>
          </group>
          <group group_id="O8">
            <title>Metformin 500 mg Bid</title>
            <description>Oral administration of Metformin 500 mg bid</description>
          </group>
        </group_list>
        <measure>
          <title>HbA1c (Glycosylated Haemoglobin) Change From Baseline at Week 24</title>
          <description>Change from baseline in HbA1c (%) after 24 weeks of treatment. &quot;Baseline&quot; refers to the last observation before the start of any randomised trial treatment medication. Means presented are the adjusted means</description>
          <population>FAS observed cases (OC) (Only patients with available data are analysed)</population>
          <units>percentage of HbA1c</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="159"/>
                <count group_id="O2" value="149"/>
                <count group_id="O3" value="151"/>
                <count group_id="O4" value="153"/>
                <count group_id="O5" value="143"/>
                <count group_id="O6" value="156"/>
                <count group_id="O7" value="146"/>
                <count group_id="O8" value="142"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.08" spread="0.08"/>
                    <measurement group_id="O2" value="-1.93" spread="0.08"/>
                    <measurement group_id="O3" value="-2.07" spread="0.08"/>
                    <measurement group_id="O4" value="-1.98" spread="0.08"/>
                    <measurement group_id="O5" value="-1.36" spread="0.08"/>
                    <measurement group_id="O6" value="-1.35" spread="0.08"/>
                    <measurement group_id="O7" value="-1.75" spread="0.09"/>
                    <measurement group_id="O8" value="-1.18" spread="0.08"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O7</group_id>
            </group_id_list>
            <groups_desc>Restricted maximum likelihood (REML)-based mixed model repeated measures (MMRM) approach comparing the change from baseline of HbA1c (in units of %) after 24 weeks of double-blind treatment.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.0056</p_value>
            <method>Mixed Models Analysis</method>
            <method_desc>'Baseline HbA1c':linear covariate;'treatment','baseline renal function','region','visit' &amp; 'visit by treatment interaction':fixed effects.</method_desc>
            <param_type>Adjusted mean</param_type>
            <param_value>-0.33</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.12</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.56</ci_lower_limit>
            <ci_upper_limit>-0.10</ci_upper_limit>
            <estimate_desc>Empagliflozin 12.5 mg bid+ Metformin 1000 mg bid minus Metformin 1000 mg bid</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O5</group_id>
            </group_id_list>
            <groups_desc>Restricted maximum likelihood (REML)-based mixed model repeated measures (MMRM) approach comparing the change from baseline of HbA1c (in units of %) after 24 weeks of double-blind treatment.</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>'Baseline HbA1c':linear covariate;'treatment','baseline renal function','region','visit' &amp; 'visit by treatment interaction':fixed effects.</method_desc>
            <param_type>Adjusted mean</param_type>
            <param_value>-0.72</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.12</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.95</ci_lower_limit>
            <ci_upper_limit>-0.48</ci_upper_limit>
            <estimate_desc>Empagliflozin 12.5 mg bid+ Metformin 1000 mg bid minus Empagliflozin 25 mg qd</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O8</group_id>
            </group_id_list>
            <groups_desc>Restricted maximum likelihood (REML)-based mixed model repeated measures (MMRM) approach comparing the change from baseline of HbA1c (in units of %) after 24 weeks of double-blind treatment.</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>'Baseline HbA1c':linear covariate;'treatment','baseline renal function','region','visit' &amp; 'visit by treatment interaction':fixed effects.</method_desc>
            <param_type>Adjusted Mean</param_type>
            <param_value>-0.75</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.12</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.98</ci_lower_limit>
            <ci_upper_limit>-0.51</ci_upper_limit>
            <estimate_desc>Empagliflozin 12.5 mg bid+ Metformin 500 mg bid minus Metformin 500 mg bid</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O5</group_id>
            </group_id_list>
            <groups_desc>Restricted maximum likelihood (REML)-based mixed model repeated measures (MMRM) approach comparing the change from baseline of HbA1c (in units of %) after 24 weeks of double-blind treatment.</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>'Baseline HbA1c':linear covariate;'treatment','baseline renal function','region','visit' &amp; 'visit by treatment interaction':fixed effects.</method_desc>
            <param_type>Adjusted mean</param_type>
            <param_value>-0.57</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.12</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.81</ci_lower_limit>
            <ci_upper_limit>-0.34</ci_upper_limit>
            <estimate_desc>Empagliflozin 12.5 mg bid+ Metformin 500 mg bid minus Empagliflozin 25 mg qd</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
              <group_id>O7</group_id>
            </group_id_list>
            <groups_desc>Restricted maximum likelihood (REML)-based mixed model repeated measures (MMRM) approach comparing the change from baseline of HbA1c (in units of %) after 24 weeks of double-blind treatment</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.0062</p_value>
            <method>Mixed Models Analysis</method>
            <method_desc>'Baseline HbA1c':linear covariate;'treatment','baseline renal function','region','visit' &amp; 'visit by treatment interaction':fixed effects.</method_desc>
            <param_type>Adjusted mean</param_type>
            <param_value>-0.33</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.12</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.56</ci_lower_limit>
            <ci_upper_limit>-0.09</ci_upper_limit>
            <estimate_desc>Empagliflozin 5 mg bid + Metformin 1000 mg bid minus Metformin 1000 mg bid</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
              <group_id>O6</group_id>
            </group_id_list>
            <groups_desc>Restricted maximum likelihood (REML)-based mixed model repeated measures (MMRM) approach comparing the change from baseline of HbA1c (in units of %) after 24 weeks of double-blind treatment.</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>'Baseline HbA1c':linear covariate;'treatment','baseline renal function','region','visit' &amp; 'visit by treatment interaction':fixed effects.</method_desc>
            <param_type>Adjusted Mean</param_type>
            <param_value>-0.72</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.12</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.95</ci_lower_limit>
            <ci_upper_limit>-0.49</ci_upper_limit>
            <estimate_desc>Empagliflozin 5 mg bid + Metformin 1000 mg bid minus Empagliflozin 10 mg qd</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O4</group_id>
              <group_id>O8</group_id>
            </group_id_list>
            <groups_desc>Restricted maximum likelihood (REML)-based mixed model repeated measures (MMRM) approach comparing the change from baseline of HbA1c (in units of %) after 24 weeks of double-blind treatment.</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>'Baseline HbA1c':linear covariate;'treatment','baseline renal function','region','visit' &amp; 'visit by treatment interaction':fixed effects.</method_desc>
            <param_type>Adjusted Mean</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_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.03</ci_lower_limit>
            <ci_upper_limit>-0.56</ci_upper_limit>
            <estimate_desc>Empagliflozin 5 mg bid + Metformin 500 mg bid minus Metformin 500 mg bid</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O4</group_id>
              <group_id>O6</group_id>
            </group_id_list>
            <groups_desc>Restricted maximum likelihood (REML)-based mixed model repeated measures (MMRM) approach comparing the change from baseline of HbA1c (in units of %) after 24 weeks of double-blind treatment.</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>'Baseline HbA1c':linear covariate;'treatment','baseline renal function','region','visit' &amp; 'visit by treatment interaction':fixed effects.</method_desc>
            <param_type>Adjusted mean</param_type>
            <param_value>-0.63</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.12</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.86</ci_lower_limit>
            <ci_upper_limit>-0.40</ci_upper_limit>
            <estimate_desc>Empagliflozin 5 mg bid + Metformin 500 mg bid minus Empagliflozin 10 mg qd</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O5</group_id>
              <group_id>O7</group_id>
            </group_id_list>
            <groups_desc>Restricted maximum likelihood (REML)-based mixed model repeated measures (MMRM) approach comparing the change from baseline of HbA1c (in units of %) after 24 weeks of double-blind treatment.</groups_desc>
            <non_inferiority_type>Non-Inferiority or Equivalence</non_inferiority_type>
            <non_inferiority_desc>The noninferiority of empagliflozin 10 mg qd against metformin 1000 mg bid were to be tested for HbA1c change from baseline to Week 24 at the level of α=0.025 (one-sided), through application of a non-inferiority margin of 0.35%.</non_inferiority_desc>
            <p_value>0.6246</p_value>
            <method>Mixed Models Analysis</method>
            <method_desc>'Baseline HbA1c':linear covariate;'treatment','baseline renal function','region','visit' &amp; 'visit by treatment interaction':fixed effects.</method_desc>
            <param_type>Adjusted mean</param_type>
            <param_value>0.39</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.12</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.15</ci_lower_limit>
            <ci_upper_limit>0.62</ci_upper_limit>
            <estimate_desc>Empagliflozin 25 mg qd minus Metformin 1000 mg bid</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O6</group_id>
              <group_id>O7</group_id>
            </group_id_list>
            <groups_desc>Restricted maximum likelihood (REML)-based mixed model repeated measures (MMRM) approach comparing the change from baseline of HbA1c (in units of %) after 24 weeks of double-blind treatment.</groups_desc>
            <non_inferiority_type>Non-Inferiority or Equivalence</non_inferiority_type>
            <non_inferiority_desc>The noninferiority of empagliflozin 10 mg qd against metformin 1000 mg bid were to be tested for HbA1c change from baseline to Week 24 at the level of α=0.025 (one-sided), through application of a non-inferiority margin of 0.35%.</non_inferiority_desc>
            <p_value>0.6558</p_value>
            <method>Mixed Models Analysis</method>
            <method_desc>'Baseline HbA1c':linear covariate;'treatment','baseline renal function','region','visit' &amp; 'visit by treatment interaction':fixed effects.</method_desc>
            <param_type>Adjusted mean</param_type>
            <param_value>0.40</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.12</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.16</ci_lower_limit>
            <ci_upper_limit>0.63</ci_upper_limit>
            <estimate_desc>Empagliflozin 10 mg qd minus Metformin 1000 mg bid</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>FPG (Fasting Plasma Glucose) Change From Baseline at Week 24</title>
        <description>Change from baseline in FPG (mg/dL) after 24 weeks of treatment. &quot;Baseline&quot; refers to the last observation before the start of any randomised trial treatment medication. Means presented are the adjusted means.</description>
        <time_frame>baseline and 24 weeks</time_frame>
        <population>FAS observed cases (OC) (Only patients with available data are analysed)</population>
        <group_list>
          <group group_id="O1">
            <title>Empagliflozin 12.5 mg Bid+ Metformin 1000 mg Bid</title>
            <description>Oral administration of Empagliflozin 12.5 mg and Metformin 1000 mg twice daily (bid)</description>
          </group>
          <group group_id="O2">
            <title>Empagliflozin 12.5 mg Bid+ Metformin 500 mg Bid</title>
            <description>Oral administration of Empagliflozin 12.5 mg and Metformin 500 mg bid</description>
          </group>
          <group group_id="O3">
            <title>Empagliflozin 5 mg Bid + Metformin 1000 mg Bid</title>
            <description>Oral administration of Empagliflozin 5 mg and Metformin 1000 mg bid</description>
          </group>
          <group group_id="O4">
            <title>Empagliflozin 5 mg Bid + Metformin 500 mg Bid</title>
            <description>Oral administration of Empagliflozin 5 mg and Metformin 500 mg bid</description>
          </group>
          <group group_id="O5">
            <title>Empagliflozin 25 mg qd</title>
            <description>Oral administration of Empagliflozin 25 mg once daily (qd)</description>
          </group>
          <group group_id="O6">
            <title>Empagliflozin 10 mg qd</title>
            <description>Oral administration of Empagliflozin 10 mg qd</description>
          </group>
          <group group_id="O7">
            <title>Metformin 1000 mg Bid</title>
            <description>Oral administration of Metformin 1000 mg bid</description>
          </group>
          <group group_id="O8">
            <title>Metformin 500 mg Bid</title>
            <description>Oral administration of Metformin 500 mg bid</description>
          </group>
        </group_list>
        <measure>
          <title>FPG (Fasting Plasma Glucose) Change From Baseline at Week 24</title>
          <description>Change from baseline in FPG (mg/dL) after 24 weeks of treatment. &quot;Baseline&quot; refers to the last observation before the start of any randomised trial treatment medication. Means presented are the adjusted means.</description>
          <population>FAS observed cases (OC) (Only patients with available data are analysed)</population>
          <units>mg/dL</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="158"/>
                <count group_id="O2" value="146"/>
                <count group_id="O3" value="146"/>
                <count group_id="O4" value="153"/>
                <count group_id="O5" value="139"/>
                <count group_id="O6" value="154"/>
                <count group_id="O7" value="145"/>
                <count group_id="O8" value="139"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-51.0" spread="2.4"/>
                    <measurement group_id="O2" value="-44.0" spread="2.4"/>
                    <measurement group_id="O3" value="-47.8" spread="2.4"/>
                    <measurement group_id="O4" value="-45.5" spread="2.4"/>
                    <measurement group_id="O5" value="-28.0" spread="2.5"/>
                    <measurement group_id="O6" value="-32.9" spread="2.4"/>
                    <measurement group_id="O7" value="-32.1" spread="2.4"/>
                    <measurement group_id="O8" value="-17.2" spread="2.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O7</group_id>
            </group_id_list>
            <groups_desc>Restricted maximum likelihood (REML)-based mixed model repeated measures (MMRM) approach comparing the change from baseline of FPG after 24 weeks of double-blind treatment.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>&lt;0.0001</p_value>
            <p_value_desc>Since previous step in the hierarchical testing failed (primary measure analyses 9 and 10), the analyses for secondary measures of FPG and body weight are considered exploratory and not confirmatory</p_value_desc>
            <method>Mixed Models Analysis</method>
            <method_desc>'Baseline HbA1c':linear covariate;'treatment','baseline renal function','region','visit' &amp; 'visit by treatment interaction':fixed effects.</method_desc>
            <param_type>Adjusted mean</param_type>
            <param_value>-18.8</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>3.4</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-25.5</ci_lower_limit>
            <ci_upper_limit>-12.2</ci_upper_limit>
            <estimate_desc>Empagliflozin 12.5 mg bid+ Metformin 1000 mg bid minus Metformin 1000 mg bid</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O5</group_id>
            </group_id_list>
            <groups_desc>Restricted maximum likelihood (REML)-based mixed model repeated measures (MMRM) approach comparing the change from baseline of FPG after 24 weeks of double-blind treatment.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>&lt;0.0001</p_value>
            <p_value_desc>Since previous step in the hierarchical testing failed (primary measure analyses 9 and 10), the analyses for secondary measures of FPG and body weight are considered exploratory and not confirmatory</p_value_desc>
            <method>Mixed Models Analysis</method>
            <method_desc>'Baseline HbA1c':linear covariate;'treatment','baseline renal function','region','visit' &amp; 'visit by treatment interaction':fixed effects.</method_desc>
            <param_type>Adjusted mean</param_type>
            <param_value>-23.0</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>3.4</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-29.7</ci_lower_limit>
            <ci_upper_limit>-16.3</ci_upper_limit>
            <estimate_desc>Empagliflozin 12.5 mg bid+ Metformin 1000 mg bid minus Empagliflozin 25 mg qd</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O8</group_id>
            </group_id_list>
            <groups_desc>Restricted maximum likelihood (REML)-based mixed model repeated measures (MMRM) approach comparing the change from baseline of FPG after 24 weeks of double-blind treatment.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>&lt;0.0001</p_value>
            <p_value_desc>Since previous step in the hierarchical testing failed (primary measure analyses 9 and 10), the analyses for secondary measures of FPG and body weight are considered exploratory and not confirmatory</p_value_desc>
            <method>Mixed Models Analysis</method>
            <method_desc>'Baseline HbA1c':linear covariate;'treatment','baseline renal function','region','visit' &amp; 'visit by treatment interaction':fixed effects.</method_desc>
            <param_type>Adjusted Mean</param_type>
            <param_value>-26.7</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>3.4</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-33.5</ci_lower_limit>
            <ci_upper_limit>-20.0</ci_upper_limit>
            <estimate_desc>Empagliflozin 12.5 mg bid+ Metformin 500 mg bid minus Metformin 500 mg bid</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O5</group_id>
            </group_id_list>
            <groups_desc>Restricted maximum likelihood (REML)-based mixed model repeated measures (MMRM) approach comparing the change from baseline of FPG after 24 weeks of double-blind treatment.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>&lt;0.0001</p_value>
            <p_value_desc>Since previous step in the hierarchical testing failed (primary measure analyses 9 and 10), the analyses for secondary measures of FPG and body weight are considered exploratory and not confirmatory</p_value_desc>
            <method>Mixed Models Analysis</method>
            <method_desc>'Baseline HbA1c':linear covariate;'treatment','baseline renal function','region','visit' &amp; 'visit by treatment interaction':fixed effects.</method_desc>
            <param_type>Adjusted mean</param_type>
            <param_value>-16.0</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>3.4</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-22.8</ci_lower_limit>
            <ci_upper_limit>-9.2</ci_upper_limit>
            <estimate_desc>Empagliflozin 12.5 mg bid+ Metformin 500 mg bid minus Empagliflozin 25 mg qd</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
              <group_id>O7</group_id>
            </group_id_list>
            <groups_desc>Restricted maximum likelihood (REML)-based mixed model repeated measures (MMRM) approach comparing the change from baseline of FPG of double-blind treatment</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>&lt;0.0001</p_value>
            <p_value_desc>Since previous step in the hierarchical testing failed (primary measure analyses 9 and 10), the analyses for secondary measures of FPG and body weight are considered exploratory and not confirmatory</p_value_desc>
            <method>Mixed Models Analysis</method>
            <method_desc>'Baseline HbA1c':linear covariate;'treatment','baseline renal function','region','visit' &amp; 'visit by treatment interaction':fixed effects.</method_desc>
            <param_type>Adjusted mean</param_type>
            <param_value>-15.6</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>3.4</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-22.3</ci_lower_limit>
            <ci_upper_limit>-8.9</ci_upper_limit>
            <estimate_desc>Empagliflozin 5 mg bid + Metformin 1000 mg bid minus Metformin 1000 mg bid</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
              <group_id>O6</group_id>
            </group_id_list>
            <groups_desc>Restricted maximum likelihood (REML)-based mixed model repeated measures (MMRM) approach comparing the change from baseline of FPG after 24 weeks of double-blind treatment.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>&lt;0.0001</p_value>
            <p_value_desc>Since previous step in the hierarchical testing failed (primary measure analyses 9 and 10), the analyses for secondary measures of FPG and body weight are considered exploratory and not confirmatory</p_value_desc>
            <method>Mixed Models Analysis</method>
            <method_desc>'Baseline HbA1c':linear covariate;'treatment','baseline renal function','region','visit' &amp; 'visit by treatment interaction':fixed effects.</method_desc>
            <param_type>Adjusted Mean</param_type>
            <param_value>-14.8</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>3.4</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-21.4</ci_lower_limit>
            <ci_upper_limit>-8.2</ci_upper_limit>
            <estimate_desc>Empagliflozin 5 mg bid + Metformin 1000 mg bid minus Empagliflozin 10 mg qd</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O4</group_id>
              <group_id>O8</group_id>
            </group_id_list>
            <groups_desc>Restricted maximum likelihood (REML)-based mixed model repeated measures (MMRM) approach comparing the change from baseline of FPG after 24 weeks of double-blind treatment.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>&lt;0.0001</p_value>
            <p_value_desc>Since previous step in the hierarchical testing failed (primary measure analyses 9 and 10), the analyses for secondary measures of FPG and body weight are considered exploratory and not confirmatory</p_value_desc>
            <method>Mixed Models Analysis</method>
            <method_desc>'Baseline HbA1c':linear covariate;'treatment','baseline renal function','region','visit' &amp; 'visit by treatment interaction':fixed effects.</method_desc>
            <param_type>Adjusted Mean</param_type>
            <param_value>-28.2</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>3.4</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-35.0</ci_lower_limit>
            <ci_upper_limit>-21.5</ci_upper_limit>
            <estimate_desc>Empagliflozin 5 mg bid + Metformin 500 mg bid minus Metformin 500 mg bid</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O4</group_id>
              <group_id>O6</group_id>
            </group_id_list>
            <groups_desc>Restricted maximum likelihood (REML)-based mixed model repeated measures (MMRM) approach comparing the change from baseline of FPG after 24 weeks of double-blind treatment.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.0002</p_value>
            <p_value_desc>Since previous step in the hierarchical testing failed (primary measure analyses 9 and 10), the analyses for secondary measures of FPG and body weight are considered exploratory and not confirmatory</p_value_desc>
            <method>Mixed Models Analysis</method>
            <method_desc>'Baseline HbA1c':linear covariate;'treatment','baseline renal function','region','visit' &amp; 'visit by treatment interaction':fixed effects.</method_desc>
            <param_type>Adjusted mean</param_type>
            <param_value>-12.6</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>3.4</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-19.1</ci_lower_limit>
            <ci_upper_limit>-6.0</ci_upper_limit>
            <estimate_desc>Empagliflozin 5 mg bid + Metformin 500 mg bid minus Empagliflozin 10 mg qd</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Body Weight Change From Baseline at Week 24</title>
        <description>Change from baseline in body weight (kg) after 24 weeks of treatment. &quot;Baseline&quot; refers to the last observation before the start of any randomised trial treatment. medication. Means presented are the adjusted means.</description>
        <time_frame>baseline and 24 weeks</time_frame>
        <population>FAS observed cases (OC) (Only patients with available data are analysed)</population>
        <group_list>
          <group group_id="O1">
            <title>Empagliflozin 12.5 mg Bid+ Metformin 1000 mg Bid</title>
            <description>Oral administration of Empagliflozin 12.5 mg and Metformin 1000 mg twice daily (bid)</description>
          </group>
          <group group_id="O2">
            <title>Empagliflozin 12.5 mg Bid+ Metformin 500 mg Bid</title>
            <description>Oral administration of Empagliflozin 12.5 mg and Metformin 500 mg bid</description>
          </group>
          <group group_id="O3">
            <title>Empagliflozin 5 mg Bid + Metformin 1000 mg Bid</title>
            <description>Oral administration of Empagliflozin 5 mg and Metformin 1000 mg bid</description>
          </group>
          <group group_id="O4">
            <title>Empagliflozin 5 mg Bid + Metformin 500 mg Bid</title>
            <description>Oral administration of Empagliflozin 5 mg and Metformin 500 mg bid</description>
          </group>
          <group group_id="O5">
            <title>Empagliflozin 25 mg qd</title>
            <description>Oral administration of Empagliflozin 25 mg once daily (qd)</description>
          </group>
          <group group_id="O6">
            <title>Empagliflozin 10 mg qd</title>
            <description>Oral administration of Empagliflozin 10 mg qd</description>
          </group>
          <group group_id="O7">
            <title>Metformin 1000 mg Bid</title>
            <description>Oral administration of Metformin 1000 mg bid</description>
          </group>
          <group group_id="O8">
            <title>Metformin 500 mg Bid</title>
            <description>Oral administration of Metformin 500 mg bid</description>
          </group>
        </group_list>
        <measure>
          <title>Body Weight Change From Baseline at Week 24</title>
          <description>Change from baseline in body weight (kg) after 24 weeks of treatment. &quot;Baseline&quot; refers to the last observation before the start of any randomised trial treatment. medication. Means presented are the adjusted means.</description>
          <population>FAS observed cases (OC) (Only patients with available data are analysed)</population>
          <units>kg</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="160"/>
                <count group_id="O2" value="149"/>
                <count group_id="O3" value="150"/>
                <count group_id="O4" value="155"/>
                <count group_id="O5" value="143"/>
                <count group_id="O6" value="155"/>
                <count group_id="O7" value="148"/>
                <count group_id="O8" value="140"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-3.78" spread="0.29"/>
                    <measurement group_id="O2" value="-3.04" spread="0.30"/>
                    <measurement group_id="O3" value="-3.48" spread="0.30"/>
                    <measurement group_id="O4" value="-2.77" spread="0.30"/>
                    <measurement group_id="O5" value="-2.38" spread="0.30"/>
                    <measurement group_id="O6" value="-2.39" spread="0.29"/>
                    <measurement group_id="O7" value="-1.27" spread="0.30"/>
                    <measurement group_id="O8" value="-0.52" spread="0.30"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O7</group_id>
            </group_id_list>
            <groups_desc>Restricted maximum likelihood (REML)-based mixed model repeated measures (MMRM) approach comparing the change from baseline of body weight after 24 weeks of double-blind treatment.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>&lt;0.0001</p_value>
            <p_value_desc>Since previous step in the hierarchical testing failed (primary measure analyses 9 and 10), the analyses for secondary measures of FPG and body weight are considered exploratory and not confirmatory</p_value_desc>
            <method>Mixed Models Analysis</method>
            <method_desc>'Baseline HbA1c':linear covariate;'treatment','baseline renal function','region','visit' &amp; 'visit by treatment interaction':fixed effects.</method_desc>
            <param_type>Adjusted mean</param_type>
            <param_value>-2.50</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.42</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-3.33</ci_lower_limit>
            <ci_upper_limit>-1.68</ci_upper_limit>
            <estimate_desc>Empagliflozin 12.5 mg bid+ Metformin 1000 mg bid minus Metformin 1000 mg bid</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O8</group_id>
            </group_id_list>
            <groups_desc>Restricted maximum likelihood (REML)-based mixed model repeated measures (MMRM) approach comparing the change from baseline of body weight after 24 weeks of double-blind treatment.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>&lt;0.0001</p_value>
            <p_value_desc>Since previous step in the hierarchical testing failed (primary measure analyses 9 and 10), the analyses for secondary measures of FPG and body weight are considered exploratory and not confirmatory</p_value_desc>
            <method>Mixed Models Analysis</method>
            <method_desc>'Baseline HbA1c':linear covariate;'treatment','baseline renal function','region','visit' &amp; 'visit by treatment interaction':fixed effects.</method_desc>
            <param_type>Adjusted Mean</param_type>
            <param_value>-2.52</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.42</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-3.35</ci_lower_limit>
            <ci_upper_limit>-1.69</ci_upper_limit>
            <estimate_desc>Empagliflozin 12.5 mg bid+ Metformin 500 mg bid minus Metformin 500 mg bid</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
              <group_id>O7</group_id>
            </group_id_list>
            <groups_desc>Restricted maximum likelihood (REML)-based mixed model repeated measures (MMRM) approach comparing the change from baseline of body weight after 24 weeks of double-blind treatment</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>&lt;0.0001</p_value>
            <p_value_desc>Since previous step in the hierarchical testing failed (primary measure analyses 9 and 10), the analyses for secondary measures of FPG and body weight are considered exploratory and not confirmatory</p_value_desc>
            <method>Mixed Models Analysis</method>
            <method_desc>'Baseline HbA1c':linear covariate;'treatment','baseline renal function','region','visit' &amp; 'visit by treatment interaction':fixed effects.</method_desc>
            <param_type>Adjusted mean</param_type>
            <param_value>-2.20</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.42</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-3.03</ci_lower_limit>
            <ci_upper_limit>-1.37</ci_upper_limit>
            <estimate_desc>Empagliflozin 5 mg bid + Metformin 1000 mg bid minus Metformin 1000 mg bid</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O4</group_id>
              <group_id>O8</group_id>
            </group_id_list>
            <groups_desc>Restricted maximum likelihood (REML)-based mixed model repeated measures (MMRM) approach comparing the change from baseline of body weight after 24 weeks of double-blind treatment.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>&lt;0.0001</p_value>
            <p_value_desc>Since previous step in the hierarchical testing failed (primary measure analyses 9 and 10), the analyses for secondary measures of FPG and body weight are considered exploratory and not confirmatory</p_value_desc>
            <method>Mixed Models Analysis</method>
            <method_desc>'Baseline HbA1c':linear covariate;'treatment','baseline renal function','region','visit' &amp; 'visit by treatment interaction':fixed effects.</method_desc>
            <param_type>Adjusted Mean</param_type>
            <param_value>-2.26</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.42</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-3.09</ci_lower_limit>
            <ci_upper_limit>-1.43</ci_upper_limit>
            <estimate_desc>Empagliflozin 5 mg bid + Metformin 500 mg bid minus Metformin 500 mg bid</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Adverse events with an onset after the first dose of randomised trial medication up to a period of 7 days after the last dose (Up to 237 days)</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Empagliflozin 12.5 mg Bid+ Metformin 1000 mg Bid</title>
          <description>Oral administration of Empagliflozin 12.5 mg and Metformin 1000 mg twice daily (bid)</description>
        </group>
        <group group_id="E2">
          <title>Empagliflozin 12.5 mg Bid+ Metformin 500 mg Bid</title>
          <description>Oral administration of Empagliflozin 12.5 mg and Metformin 500 mg bid</description>
        </group>
        <group group_id="E3">
          <title>Empagliflozin 5 mg Bid + Metformin 1000 mg Bid</title>
          <description>Oral administration of Empagliflozin 5 mg and Metformin 1000 mg bid</description>
        </group>
        <group group_id="E4">
          <title>Empagliflozin 5 mg Bid + Metformin 500 mg Bid</title>
          <description>Oral administration of Empagliflozin 5 mg and Metformin 500 mg bid</description>
        </group>
        <group group_id="E5">
          <title>Empagliflozin 25 mg qd</title>
          <description>Oral administration of Empagliflozin 25 mg once daily (qd)</description>
        </group>
        <group group_id="E6">
          <title>Empagliflozin 10 mg qd</title>
          <description>Oral administration of Empagliflozin 10 mg qd</description>
        </group>
        <group group_id="E7">
          <title>Metformin 1000 mg Bid</title>
          <description>Oral administration of Metformin 1000 mg bid</description>
        </group>
        <group group_id="E8">
          <title>Metformin 500 mg Bid</title>
          <description>Oral administration of Metformin 500 mg bid</description>
        </group>
        <group group_id="E9">
          <title>Empagliflozin 12.5 mg Bid + Metformin 1000 mg Bid OL</title>
          <description>Oral administration of Empagliflozin 12.5 mg and Metformin 1000 mg bid in an open label (OL)</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="2" subjects_at_risk="170"/>
                <counts group_id="E2" subjects_affected="6" subjects_at_risk="170"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="171"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="169"/>
                <counts group_id="E5" subjects_affected="3" subjects_at_risk="167"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="172"/>
                <counts group_id="E7" subjects_affected="3" subjects_at_risk="170"/>
                <counts group_id="E8" subjects_affected="3" subjects_at_risk="171"/>
                <counts group_id="E9" subjects_affected="2" subjects_at_risk="53"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Anaemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="170"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="170"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="171"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="169"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="167"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="172"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="170"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="171"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="53"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Acute myocardial infarction</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="170"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="170"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="171"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="169"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="167"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="172"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="170"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="171"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Tachycardia paroxysmal</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="170"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="170"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="171"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="169"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="167"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="172"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="170"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="171"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Angina unstable</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="170"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="170"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="171"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="169"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="167"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="172"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="170"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="171"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="53"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Pancreatitis acute</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="170"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="170"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="171"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="169"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="167"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="172"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="170"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="171"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="53"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Chest pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="170"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="170"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="171"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="169"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="167"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="172"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="170"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="171"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="53"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>Bile duct stone</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="170"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="170"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="171"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="169"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="167"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="172"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="170"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="171"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Cholangitis acute</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="170"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="170"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="171"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="169"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="167"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="172"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="170"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="171"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Cholelithiasis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="170"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="170"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="171"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="169"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="167"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="172"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="170"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="171"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Hepatic cirrhosis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="170"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="170"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="171"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="169"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="167"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="172"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="170"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="171"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="53"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Appendicitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="170"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="170"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="171"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="169"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="167"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="172"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="170"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="171"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Dengue fever</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="170"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="170"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="171"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="169"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="167"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="172"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="170"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="171"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Herpes simplex encephalitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="170"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="170"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="171"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="169"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="167"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="172"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="170"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="171"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Nasal abscess</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="170"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="170"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="171"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="169"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="167"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="172"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="170"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="171"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="53"/>
              </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="170"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="170"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="171"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="169"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="167"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="172"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="170"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="171"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Rib fracture</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="170"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="170"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="171"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="169"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="167"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="172"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="170"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="171"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="53"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Diabetes mellitus inadequate control</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="170"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="170"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="171"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="169"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="167"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="172"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="170"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="171"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Hypomagnesaemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="170"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="170"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="171"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="169"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="167"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="172"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="170"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="171"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="53"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Chronic lymphocytic leukaemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="170"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="170"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="171"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="169"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="167"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="172"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="170"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="171"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Uterine leiomyoma</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="170"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="170"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="171"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="169"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="167"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="172"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="170"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="171"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="53"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Cerebral infarction</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="170"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="170"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="171"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="169"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="167"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="172"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="170"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="171"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Cerebrovascular accident</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="170"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="170"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="171"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="169"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="167"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="172"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="170"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="171"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="53"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Haematuria</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="170"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="170"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="171"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="169"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="167"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="172"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="170"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="171"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="53"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Chronic obstructive pulmonary disease</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="170"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="170"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="171"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="169"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="167"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="172"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="170"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="171"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="53"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Hypertensive crisis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="170"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="170"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="171"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="169"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="167"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="172"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="170"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="171"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Peripheral arterial occlusive disease</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="170"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="170"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="171"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="169"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="167"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="172"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="170"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="171"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Peripheral ischaemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="170"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="170"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="171"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="169"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="167"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="172"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="170"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="171"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="53"/>
              </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="48" subjects_at_risk="170"/>
                <counts group_id="E2" subjects_affected="40" subjects_at_risk="170"/>
                <counts group_id="E3" subjects_affected="35" subjects_at_risk="171"/>
                <counts group_id="E4" subjects_affected="42" subjects_at_risk="169"/>
                <counts group_id="E5" subjects_affected="41" subjects_at_risk="167"/>
                <counts group_id="E6" subjects_affected="36" subjects_at_risk="172"/>
                <counts group_id="E7" subjects_affected="53" subjects_at_risk="170"/>
                <counts group_id="E8" subjects_affected="38" subjects_at_risk="171"/>
                <counts group_id="E9" subjects_affected="16" subjects_at_risk="53"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" subjects_affected="12" subjects_at_risk="170"/>
                <counts group_id="E2" subjects_affected="6" subjects_at_risk="170"/>
                <counts group_id="E3" subjects_affected="5" subjects_at_risk="171"/>
                <counts group_id="E4" subjects_affected="9" subjects_at_risk="169"/>
                <counts group_id="E5" subjects_affected="6" subjects_at_risk="167"/>
                <counts group_id="E6" subjects_affected="2" subjects_at_risk="172"/>
                <counts group_id="E7" subjects_affected="24" subjects_at_risk="170"/>
                <counts group_id="E8" subjects_affected="6" subjects_at_risk="171"/>
                <counts group_id="E9" subjects_affected="4" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Gastritis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="170"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="170"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="171"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="169"/>
                <counts group_id="E5" subjects_affected="2" subjects_at_risk="167"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="172"/>
                <counts group_id="E7" subjects_affected="4" subjects_at_risk="170"/>
                <counts group_id="E8" subjects_affected="2" subjects_at_risk="171"/>
                <counts group_id="E9" subjects_affected="3" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="170"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="170"/>
                <counts group_id="E3" subjects_affected="5" subjects_at_risk="171"/>
                <counts group_id="E4" subjects_affected="5" subjects_at_risk="169"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="167"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="172"/>
                <counts group_id="E7" subjects_affected="3" subjects_at_risk="170"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="171"/>
                <counts group_id="E9" subjects_affected="3" subjects_at_risk="53"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Upper respiratory tract infection</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="170"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="170"/>
                <counts group_id="E3" subjects_affected="8" subjects_at_risk="171"/>
                <counts group_id="E4" subjects_affected="4" subjects_at_risk="169"/>
                <counts group_id="E5" subjects_affected="7" subjects_at_risk="167"/>
                <counts group_id="E6" subjects_affected="5" subjects_at_risk="172"/>
                <counts group_id="E7" subjects_affected="5" subjects_at_risk="170"/>
                <counts group_id="E8" subjects_affected="10" subjects_at_risk="171"/>
                <counts group_id="E9" subjects_affected="3" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" subjects_affected="18" subjects_at_risk="170"/>
                <counts group_id="E2" subjects_affected="17" subjects_at_risk="170"/>
                <counts group_id="E3" subjects_affected="12" subjects_at_risk="171"/>
                <counts group_id="E4" subjects_affected="9" subjects_at_risk="169"/>
                <counts group_id="E5" subjects_affected="13" subjects_at_risk="167"/>
                <counts group_id="E6" subjects_affected="12" subjects_at_risk="172"/>
                <counts group_id="E7" subjects_affected="14" subjects_at_risk="170"/>
                <counts group_id="E8" subjects_affected="12" subjects_at_risk="171"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="53"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Dyslipidaemia</sub_title>
                <counts group_id="E1" subjects_affected="8" subjects_at_risk="170"/>
                <counts group_id="E2" subjects_affected="6" subjects_at_risk="170"/>
                <counts group_id="E3" subjects_affected="8" subjects_at_risk="171"/>
                <counts group_id="E4" subjects_affected="15" subjects_at_risk="169"/>
                <counts group_id="E5" subjects_affected="11" subjects_at_risk="167"/>
                <counts group_id="E6" subjects_affected="15" subjects_at_risk="172"/>
                <counts group_id="E7" subjects_affected="8" subjects_at_risk="170"/>
                <counts group_id="E8" subjects_affected="7" subjects_at_risk="171"/>
                <counts group_id="E9" subjects_affected="2" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Hypoglycaemia</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="170"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="170"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="171"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="169"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="167"/>
                <counts group_id="E6" subjects_affected="2" subjects_at_risk="172"/>
                <counts group_id="E7" subjects_affected="2" subjects_at_risk="170"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="171"/>
                <counts group_id="E9" subjects_affected="3" subjects_at_risk="53"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="170"/>
                <counts group_id="E2" subjects_affected="9" subjects_at_risk="170"/>
                <counts group_id="E3" subjects_affected="4" subjects_at_risk="171"/>
                <counts group_id="E4" subjects_affected="5" subjects_at_risk="169"/>
                <counts group_id="E5" subjects_affected="3" subjects_at_risk="167"/>
                <counts group_id="E6" subjects_affected="4" subjects_at_risk="172"/>
                <counts group_id="E7" subjects_affected="4" subjects_at_risk="170"/>
                <counts group_id="E8" subjects_affected="7" subjects_at_risk="171"/>
                <counts group_id="E9" subjects_affected="3" subjects_at_risk="53"/>
              </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>800-243-0127 ext +1</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/NCT01719003
org study id: 1276.1
secondary id: 2010-021375-92
nct id: NCT01719003
lead sponsor: 
collaborator: 
This study will investigate the efficacy and safety of two doses (high and low) of
      empagliflozin in combination with metformin (500 mg and 1000 mg) administered twice daily in
      patients with type 2 diabetes mellitus (T2DM). Study will compare four dose combinations of
      empagliflozin + metformin versus each individual component after 24 weeks of treatment.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double
measure: HbA1c (Glycosylated Haemoglobin) Change From Baseline at Week 24
time frame: baseline and 24 weeks
description: Change from baseline in HbA1c (%) after 24 weeks of treatment. "Baseline" refers to the last observation before the start of any randomised trial treatment medication. Means presented are the adjusted means
measure: FPG (Fasting Plasma Glucose) Change From Baseline at Week 24
time frame: baseline and 24 weeks
description: Change from baseline in FPG (mg/dL) after 24 weeks of treatment. "Baseline" refers to the last observation before the start of any randomised trial treatment medication. Means presented are the adjusted means.
measure: Body Weight Change From Baseline at Week 24
time frame: baseline and 24 weeks
description: Change from baseline in body weight (kg) after 24 weeks of treatment. "Baseline" refers to the last observation before the start of any randomised trial treatment. medication. Means presented are the adjusted means.
arm group label: Empagliflozin low dose qd
arm group type: Experimental
description: Empagliflozin low dose once daily
arm group label: Empagliflozin high dose qd
arm group type: Experimental
description: Empagliflozin high dose once daily
arm group label: OL empa high dose + met 1000 mg bid
arm group type: Experimental
description: Open label empagliflozin high dose split twice daily + metformin 1000 mg twice daily - Patients are no longer enrolled into this arm because of change in the inclusion criteria in protocol version 2.0 all patients are now enrolled into remaining double-blind arms. Patients already enrolled in the open-label arm according to protocol version 1.0 can complete the study.
arm group label: Empagliflozin low dose + met 500 mg bid
arm group type: Experimental
description: Empagliflozin low dose split twice daily + metformin 500 mg twice daily
arm group label: Empagliflozin low dose + met 1000 mg bid
arm group type: Experimental
description: Empagliflozin low dose split twice daily + metformin 1000 mg twice daily
arm group label: Empagliflozin high dose + met 500 mg bid
arm group type: Experimental
description: Empagliflozin high dose split twice daily + metformin 500 mg twice daily
arm group label: Empagliflozin high dose + met 1000mg bid
arm group type: Experimental
description: Empagliflozin high dose split twice daily + metformin 1000 mg twice daily
arm group label: Metformin 500 mg bid
arm group type: Experimental
description: Metformin 500 mg twice daily
arm group label: Metformin 1000 mg bid
arm group type: Experimental
description: Metformin 1000 mg twice daily
intervention type: Drug
intervention name: Metformin 500 mg bid
description: Metformin 500 mg twice daily
arm group label: Empagliflozin low dose + met 500 mg bid
intervention type: Drug
intervention name: Metformin 1000 mg bid
description: Metformin 1000 mg twice daily
arm group label: OL empa high dose + met 1000 mg bid
intervention type: Drug
intervention name: Empagliflozin low dose qd
description: Empagliflozin low dose once daily
arm group label: Empagliflozin low dose qd
intervention type: Drug
intervention name: Empagliflozin high dose qd
description: Empagliflozin high dose once daily
arm group label: Empagliflozin high dose qd
intervention type: Drug
intervention name: Empagliflozin low dose bid
description: Empagliflozin low dose split twice daily
arm group label: Empagliflozin low dose + met 500 mg bid
intervention type: Drug
intervention name: Metformin 500 mg bid
description: Metformin 500 mg twice daily
arm group label: Empagliflozin high dose + met 500 mg bid
intervention type: Drug
intervention name: Empagliflozin high dose bid
description: Empagliflozin high dose split twice daily
arm group label: OL empa high dose + met 1000 mg bid
intervention type: Drug
intervention name: Empagliflozin low dose bid
description: Empagliflozin low dose split twice daily
arm group label: Empagliflozin low dose + met 1000 mg bid
intervention type: Drug
intervention name: Metformin 1000 mg bid
description: Metformin 1000 mg twice daily
arm group label: Empagliflozin high dose + met 1000mg bid
intervention type: Drug
intervention name: Metformin 500 mg bid
description: Metformin 500 mg twice daily
arm group label: Metformin 500 mg bid
intervention type: Drug
intervention name: Metformin 1000 mg bid
description: Metformin 1000 mg twice daily
arm group label: Metformin 1000 mg bid
intervention type: Drug
intervention name: Empagliflozin high dose bid
description: Empagliflozin high dose split twice daily
arm group label: Empagliflozin high dose + met 1000mg bid
intervention type: Drug
intervention name: Metformin 1000 mg bid
description: Metformin 1000 mg twice daily
arm group label: Empagliflozin low dose + met 1000 mg bid
intervention type: Drug
intervention name: Empagliflozin high dose bid
description: Empagliflozin high dose split twice daily
arm group label: Empagliflozin high dose + met 500 mg bid
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: Brazil
country: Canada
country: Czech Republic
country: Egypt
country: France
country: Germany
country: Guatemala
country: Korea, Republic of
country: Lebanon
country: Malaysia
country: Mexico
country: Peru
country: Philippines
country: Russian Federation
country: Serbia
country: Spain
country: Taiwan
country: Thailand
country: Turkey
country: United Kingdom
country: United States
country: India
country: Indonesia
country: United Arab Emirates
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: Hyperglycemia
mesh term: Metformin
mesh term: Empagliflozin
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 