<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/NCT01708902</url>
  </required_header>
  <id_info>
    <org_study_id>1288.18</org_study_id>
    <nct_id>NCT01708902</nct_id>
  </id_info>
  <brief_title>Study to Compare the Efficacy and Safety of Administration of the Fix Dose Combination of Linagliptin Plus Metformin in Drug naïve Type 2 Patients</brief_title>
  <official_title>A Phase III Randomised, Double-blind, Double-dummy, Parallel Group Study to Compare the Efficacy and Safety of Twice Daily Administration of the Fix Dose Combination of Linagliptin 2.5 mg + Metformin 500 mg, or of Linagliptin 2.5 mg + Metformin 1000 mg, With the Individual Components of Metformin (500 mg or 1000 mg, Twice Daily), and Linagliptin (5.0 mg, Once Daily) Over 24 Weeks in Treatment naïve Type 2 Diabetic Patients With Insufficient Glycaemic Control</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>
      Reduced factorial design study with 24 week randomized treatment of initial combination&#xD;
      therapy with linagliptin and metformin in T2DM patients&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>October 2012</start_date>
  <completion_date type="Actual">April 2014</completion_date>
  <primary_completion_date type="Actual">April 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>Factorial Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double</masking>
  </study_design_info>
  <primary_outcome>
    <measure>The Change From Baseline in HbA1c After 24 Weeks of Treatment in Main Group</measure>
    <time_frame>Baseline and week 24</time_frame>
    <description>The change from baseline in HbA1c after 24 weeks of treatment in main group.&#xD;
The mean was adjusted by baseline HbA1c and treatment group.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>The Change From Baseline in HbA1c After 24 Weeks of Treatment in Main Group - FAS (OC)</measure>
    <time_frame>Baseline and week 24</time_frame>
    <description>The change from baseline in HbA1c after 24 weeks of treatment in main group. Only subjects from the FAS with measured HbA1c values (observed cases [OC]) were considered.&#xD;
The mean was adjusted by treatment, baseline HbA1c, week and treatment*week.&#xD;
The sensitivity analysis was added as the primary analysis failed with borderline results.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>The Change From Baseline in HbA1c After 12 Weeks of Treatment in APG</measure>
    <time_frame>Baseline and week 12</time_frame>
    <description>The change from baseline in HbA1c after 12 weeks of treatment in additional parallel group (APG)&#xD;
The mean was adjusted by baseline HbA1c and treatment group.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>The Occurrence of Treat to Target Efficacy Response in Terms of HbA1c &lt; 7.0 % After 24 Weeks of Treatment in Main Group</measure>
    <time_frame>Week 24 (after first drug administration)</time_frame>
    <description>The occurrence of treat to target efficacy response in terms of HbA1c &lt; 7.0 % after 24 weeks of treatment in main group.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The Occurrence of Treat to Target Efficacy Response in Terms of HbA1c &lt; 7.0 % After 12 Weeks of Treatment in APG</measure>
    <time_frame>Week 12 (after first drug administration)</time_frame>
    <description>The occurrence of treat to target efficacy response in terms of HbA1c &lt; 7.0 % after 12 weeks of treatment in APG.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The Occurrence of Treat to Target Efficacy Response in Terms of HbA1c &lt; 6.5% After 24 Weeks of Treatment in Main Group</measure>
    <time_frame>Week 24 (after first drug administration)</time_frame>
    <description>The occurrence of treat to target efficacy response in terms of HbA1c &lt; 6.5% after 24 weeks of treatment in main group.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The Occurrence of Treat to Target Efficacy Response in Terms of HbA1c &lt; 6.5% After 12 Weeks of Treatment in APG</measure>
    <time_frame>Week 12 (after first drug administration)</time_frame>
    <description>The occurrence of treat to target efficacy response in terms of HbA1c &lt; 6.5% after 12 weeks of treatment in APG.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The Occurrence of Relative Efficacy Response in Main Group</measure>
    <time_frame>From baseline until week 24</time_frame>
    <description>The occurrence of relative efficacy response (HbA1c lowering by at least 0.5% after 24 weeks of treatment) in main group</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The Occurrence of Relative Efficacy Response in APG</measure>
    <time_frame>From baseline until week 12</time_frame>
    <description>The Occurrence of Relative Efficacy Response (HbA1c Lowering by at Least 0.5% After 12 Weeks of Treatment) in APG</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The Change in Fasting Plasma Glucose (FPG) From Baseline After 24 Weeks of Treatment in Main Group</measure>
    <time_frame>Baseline and week 24</time_frame>
    <description>The change in fasting plasma glucose (FPG) from baseline after 24 weeks of treatment in main group.&#xD;
Adjusted mean: The model includes continuous baseline HbA1c, continuous baseline FPG and treatment group.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The Change in Fasting Plasma Glucose (FPG) From Baseline After 12 Weeks of Treatment in APG</measure>
    <time_frame>Baseline and week 12</time_frame>
    <description>The Change in Fasting Plasma Glucose (FPG) From Baseline After 12 Weeks of Treatment in APG.&#xD;
Adjusted mean: The model includes continuous baseline HbA1c, continuous baseline FPG and treatment group.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The Frequency of Patients With Use of Rescue Therapy During 24 Week Treatment Period in Main Group</measure>
    <time_frame>From baseline until week 24</time_frame>
    <description>The frequency of patients with use of rescue therapy during 24 week treatment period in main group.&#xD;
For this analysis the main group contrast 'Metformin 1000mg BID, Linagliptin 2.5mg / Metformin 1000mg BID' could not be analysed due to lack of events in the Metformin 1000mg BID group.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The Frequency of Patients With Use of Rescue Therapy During 12 Week Treatment Period in APG</measure>
    <time_frame>From baseline until week 12</time_frame>
    <description>The Frequency of Patients With Use of Rescue Therapy During 12 Week Treatment Period in APG.</description>
  </secondary_outcome>
  <number_of_arms>5</number_of_arms>
  <enrollment type="Actual">876</enrollment>
  <condition>Diabetes Mellitus, Type 2</condition>
  <arm_group>
    <arm_group_label>linagliptin2.5mg / metformin500mg BID</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>patient to receive a tablet containing linagliptin 2.5mg and metformin 500mg BID</description>
  </arm_group>
  <arm_group>
    <arm_group_label>linagliptin2.5mg / metformin1000mg BID</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>patient to receive a tablet containing linagliptin 2.5mg and metformin 1000mg BID</description>
  </arm_group>
  <arm_group>
    <arm_group_label>metformin 500mg BID</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>patient to receive a tablet containing metformin 500mg BID</description>
  </arm_group>
  <arm_group>
    <arm_group_label>metformin 1000mg BID</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>patient to receive a tablet containing metformin 1000mg BID</description>
  </arm_group>
  <arm_group>
    <arm_group_label>linagliptin 5 mg QD</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>patient to receive a tablet containing linagliptin 5mg once daily</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>linagliptin2.5mg/metformin1000mg</intervention_name>
    <description>linagliptin2.5mg/metformin1000mg BID</description>
    <arm_group_label>metformin 1000mg BID</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>linagliptin2.5mg/metformin1000mg</intervention_name>
    <description>linagliptin2.5mg/metformin1000mg BID</description>
    <arm_group_label>linagliptin 5 mg QD</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>linagliptin 5mg</intervention_name>
    <description>linagliptin 5mg once daily</description>
    <arm_group_label>linagliptin2.5mg / metformin500mg BID</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Metformin 500mg</intervention_name>
    <description>Metformin 500mg BID</description>
    <arm_group_label>linagliptin2.5mg / metformin500mg BID</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>linagliptin2.5mg/metformin500mg</intervention_name>
    <description>linagliptin2.5mg/metformin500mg BID</description>
    <arm_group_label>metformin 500mg BID</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>linagliptin2.5mg/metformin500mg</intervention_name>
    <description>linagliptin2.5mg/metformin500mg BID</description>
    <arm_group_label>linagliptin 5 mg QD</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>linagliptin 5mg</intervention_name>
    <description>linagliptin 5mg once daily</description>
    <arm_group_label>linagliptin2.5mg / metformin1000mg BID</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Metformin 1000mg</intervention_name>
    <description>Metformin 1000mg BID</description>
    <arm_group_label>linagliptin2.5mg / metformin1000mg BID</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion criteria:&#xD;
&#xD;
          1. Diagnosis of Type 2 diabetes mellitus(T2DM) prior to informed consent&#xD;
&#xD;
          2. Male and female patients on diet and exercise regimen who are drug-naïve&#xD;
&#xD;
          3. Glycosylated haemoglobin A1c (HbA1c) at V1a &gt;/=7.5 %&lt;11% for main group and HbA1c &gt;/=&#xD;
             11.0 % for the additional parallel group&#xD;
&#xD;
          4. Age &gt;/= 18 and &lt;/= 80 years at Visit 1a (Screening)&#xD;
&#xD;
          5. Body Mass Index(BMI)&lt;/ = 40 kg/m2 at Visit 1a (Screening)&#xD;
&#xD;
          6. Signed and dated written informed consent by date of Visit 1a in accordance with good&#xD;
             clinical practice(GCP) and local legislation&#xD;
&#xD;
        Exclusion criteria:&#xD;
&#xD;
          1. Uncontrolled hyperglycaemia required for rescue medication during placebo run-in phase&#xD;
&#xD;
          2. In main group, the patients with investigational medicinal product(IMP) compliance &lt;&#xD;
             80 % or &gt;120 % during 2 weeks placebo run in period&#xD;
&#xD;
          3. Acute coronary syndrome stroke or Transient ischaemic attack (TIA) within 3 months&#xD;
             prior to randomisation&#xD;
&#xD;
          4. Impaired hepatic function, defined by serum levels of either Alanine&#xD;
             aminotransferase(ALT) ,Aspartate aminotransferase(AST), or alkaline phosphatase (AP)&#xD;
             above 3 x upper limit of normal (ULN) ,or total bilirubin above 1.5 x ULN as&#xD;
             determined at Visit 1a&#xD;
&#xD;
          5. Known hypersensitivity or allergy to linagliptin or its excipients or metformin or&#xD;
             placebo&#xD;
&#xD;
          6. Treatment with anti-obesity drugs 3 months prior to informed consent or any other&#xD;
             treatment at the time of screening&#xD;
&#xD;
          7. Alcohol or drug abuse within the 3 months prior to informed consent that would&#xD;
             interfere with trial participation or any ongoing condition leading to a decreased&#xD;
             compliance to study procedures or study drug intake in the opinion of the&#xD;
             investigator.&#xD;
&#xD;
          8. Concurrent participation in another clinical trial or any investigational therapy&#xD;
             within thirty days prior to signing the consent form or during the trial.&#xD;
&#xD;
          9. Pre-menopausal women (last menstruation &lt;/= 1 year prior to informed consent) who are&#xD;
             nursing or pregnant or are of child-bearing potential and are not practicing an&#xD;
             acceptable method of birth control, or do not plan to continue using this method&#xD;
             throughout the study&#xD;
&#xD;
         10. Current treatment with systemic steroids at time of informed consent or change in&#xD;
             dosage of thyroid hormones within 6 weeks prior to informed consent.&#xD;
&#xD;
         11. Renal failure or renal impairment at Visit 1a (screening) with an Estimated Glomerular&#xD;
             Filtration Rate(eGFR) &lt; 60 ml/min&#xD;
&#xD;
         12. Bariatric surgery within the past two years and other gastrointestinal surgeries that&#xD;
             induce chronic malabsorption&#xD;
&#xD;
         13. Dehydration by clinical judgement of the investigator&#xD;
&#xD;
         14. Clinical detected unstable or acute congestive heart failure&#xD;
&#xD;
         15. Acute or chronic metabolic acidosis (present in patient history)&#xD;
&#xD;
         16. Hereditary galactose intolerance&#xD;
&#xD;
         17. Known history of pancreatitis and chronic pancreatitis&#xD;
&#xD;
         18. Medical history of cancer (except for basal cell carcinoma) and/or treatment for&#xD;
             cancer within last 5 years.&#xD;
&#xD;
         19. Any other clinical condition that would jeopardize patients safety while participating&#xD;
             in this clinical trial at the discretion of investigator&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</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>1288.18.86001 Boehringer Ingelheim Investigational Site</name>
      <address>
        <city>Beijing</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>1288.18.86002 Boehringer Ingelheim Investigational Site</name>
      <address>
        <city>Beijing</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>1288.18.86003 Boehringer Ingelheim Investigational Site</name>
      <address>
        <city>Beijing</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>1288.18.86004 Boehringer Ingelheim Investigational Site</name>
      <address>
        <city>Beijing</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>1288.18.86046 Boehringer Ingelheim Investigational Site</name>
      <address>
        <city>Beijing</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>1288.18.86019 Boehringer Ingelheim Investigational Site</name>
      <address>
        <city>Changchun</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>1288.18.86020 Boehringer Ingelheim Investigational Site</name>
      <address>
        <city>Changchun</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>1288.18.86028 Boehringer Ingelheim Investigational Site</name>
      <address>
        <city>Changsha</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>1288.18.86029 Boehringer Ingelheim Investigational Site</name>
      <address>
        <city>Changsha</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>1288.18.86050 Boehringer Ingelheim Investigational Site</name>
      <address>
        <city>Changsha</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>1288.18.86045 Boehringer Ingelheim Investigational Site</name>
      <address>
        <city>Chengdu</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>1288.18.86042 Boehringer Ingelheim Investigational Site</name>
      <address>
        <city>Chongqing</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>1288.18.86023 Boehringer Ingelheim Investigational Site</name>
      <address>
        <city>Dalian</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>1288.18.86009 Boehringer Ingelheim Investigational Site</name>
      <address>
        <city>Guangzhou</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>1288.18.86010 Boehringer Ingelheim Investigational Site</name>
      <address>
        <city>Guangzhou</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>1288.18.86012 Boehringer Ingelheim Investigational Site</name>
      <address>
        <city>Guangzhou</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>1288.18.86047 Boehringer Ingelheim Investigational Site</name>
      <address>
        <city>Haerbin</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>1288.18.86032 Boehringer Ingelheim Investigational Site</name>
      <address>
        <city>Hefei</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>1288.18.86016 Boehringer Ingelheim Investigational Site</name>
      <address>
        <city>Hengshui</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>1288.18.86017 Boehringer Ingelheim Investigational Site</name>
      <address>
        <city>Jinan</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>1288.18.86026 Boehringer Ingelheim Investigational Site</name>
      <address>
        <city>Lanzhou</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>1288.18.86034 Boehringer Ingelheim Investigational Site</name>
      <address>
        <city>Nan Ning</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>1288.18.86039 Boehringer Ingelheim Investigational Site</name>
      <address>
        <city>Nanchang</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>1288.18.86035 Boehringer Ingelheim Investigational Site</name>
      <address>
        <city>Nanjing</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>1288.18.86036 Boehringer Ingelheim Investigational Site</name>
      <address>
        <city>Nanjing</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>1288.18.86006 Boehringer Ingelheim Investigational Site</name>
      <address>
        <city>Shanghai</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>1288.18.86007 Boehringer Ingelheim Investigational Site</name>
      <address>
        <city>Shanghai</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>1288.18.86008 Boehringer Ingelheim Investigational Site</name>
      <address>
        <city>Shanghai</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>1288.18.86013 Boehringer Ingelheim Investigational Site</name>
      <address>
        <city>Shantou</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>1288.18.86022 Boehringer Ingelheim Investigational Site</name>
      <address>
        <city>Shenyang</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>1288.18.86014 Boehringer Ingelheim Investigational Site</name>
      <address>
        <city>Shijiazhuang</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>1288.18.86015 Boehringer Ingelheim Investigational Site</name>
      <address>
        <city>Shijiazhuang</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>1288.18.86038 Boehringer Ingelheim Investigational Site</name>
      <address>
        <city>Suzhou</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>1288.18.86049 Boehringer Ingelheim Investigational Site</name>
      <address>
        <city>Wuhan</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>1288.18.86033 Boehringer Ingelheim Investigational Site</name>
      <address>
        <city>Wuhu</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>1288.18.86024 Boehringer Ingelheim Investigational Site</name>
      <address>
        <city>Xi'An</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>1288.18.86025 Boehringer Ingelheim Investigational Site</name>
      <address>
        <city>Xi'An</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>1288.18.86030 Boehringer Ingelheim Investigational Site</name>
      <address>
        <city>Yueyang</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>1288.18.60004 Boehringer Ingelheim Investigational Site</name>
      <address>
        <city>Kelantan</city>
        <country>Malaysia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>1288.18.60002 Boehringer Ingelheim Investigational Site</name>
      <address>
        <city>Melaka</city>
        <country>Malaysia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>1288.18.60005 Boehringer Ingelheim Investigational Site</name>
      <address>
        <city>Negeri Sembilan</city>
        <country>Malaysia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>1288.18.60007 Boehringer Ingelheim Investigational Site</name>
      <address>
        <city>Negeri Sembilan</city>
        <country>Malaysia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>1288.18.60001 Boehringer Ingelheim Investigational Site</name>
      <address>
        <city>Perak</city>
        <country>Malaysia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>1288.18.60006 Boehringer Ingelheim Investigational Site</name>
      <address>
        <city>Perak</city>
        <country>Malaysia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>1288.18.60008 Boehringer Ingelheim Investigational Site</name>
      <address>
        <city>Putrajaya</city>
        <country>Malaysia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>1288.18.60003 Boehringer Ingelheim Investigational Site</name>
      <address>
        <city>Selangor</city>
        <country>Malaysia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>1288.18.63003 Boehringer Ingelheim Investigational Site</name>
      <address>
        <city>Cebu City</city>
        <country>Philippines</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>1288.18.63007 Boehringer Ingelheim Investigational Site</name>
      <address>
        <city>Cebu</city>
        <country>Philippines</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>1288.18.63002 Boehringer Ingelheim Investigational Site</name>
      <address>
        <city>Makati City</city>
        <country>Philippines</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>1288.18.63001 Boehringer Ingelheim Investigational Site</name>
      <address>
        <city>Manila</city>
        <country>Philippines</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>1288.18.63008 Boehringer Ingelheim Investigational Site</name>
      <address>
        <city>Quezon City</city>
        <country>Philippines</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>1288.18.63006 Boehringer Ingelheim Investigational Site</name>
      <address>
        <city>Surigao</city>
        <country>Philippines</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>1288.18.63005 Boehringer Ingelheim Investigational Site</name>
      <address>
        <city>Tagum City</city>
        <country>Philippines</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>1288.18.84003 Boehringer Ingelheim Investigational Site</name>
      <address>
        <city>Hanoi</city>
        <country>Vietnam</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>1288.18.84001 Boehringer Ingelheim Investigational Site</name>
      <address>
        <city>Ho Chi Minh City</city>
        <country>Vietnam</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>1288.18.84002 Boehringer Ingelheim Investigational Site</name>
      <address>
        <city>Ho Chi Minh City</city>
        <country>Vietnam</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
    <country>Malaysia</country>
    <country>Philippines</country>
    <country>Vietnam</country>
  </location_countries>
  <link>
    <url>http://trials.boehringer-ingelheim.com/</url>
    <description>Related Info</description>
  </link>
  <verification_date>April 2015</verification_date>
  <study_first_submitted>October 16, 2012</study_first_submitted>
  <study_first_submitted_qc>October 16, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 17, 2012</study_first_posted>
  <results_first_submitted>April 8, 2015</results_first_submitted>
  <results_first_submitted_qc>April 8, 2015</results_first_submitted_qc>
  <results_first_posted type="Estimate">April 24, 2015</results_first_posted>
  <last_update_submitted>April 8, 2015</last_update_submitted>
  <last_update_submitted_qc>April 8, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">April 24, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Diabetes Mellitus, Type 2</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Metformin</mesh_term>
    <mesh_term>Linagliptin</mesh_term>
  </intervention_browse>

  <clinical_results>

    <participant_flow>
      <pre_assignment_details>After 2-weeks placebo run-in in the main group, 730 of 733 randomised patients were treated in a double-blind fashion for 24 weeks. In the additional parallel group (APG), all of 143 randomised patients with HbA1c &gt;=11% were treated for 24 weeks (the first 12 weeks were double-blind). There was a 1-week follow-up period after treatment.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Main: Linagliptin 5mg QD</title>
          <description>Main Group: Patients received linagliptin 5mg once daily (QD), administered oral as tablet.</description>
        </group>
        <group group_id="P2">
          <title>Main: Metformin 500mg BID</title>
          <description>Main Group: Patients received metformin 500mg twice daily (BID), administered oral as tablet.</description>
        </group>
        <group group_id="P3">
          <title>Main: Metformin 1000mg BID</title>
          <description>Main Group: Patients received metformin 1000mg twice daily (BID), administered oral as tablet.</description>
        </group>
        <group group_id="P4">
          <title>Main: Linagliptin 2.5mg / Metformin 500mg BID</title>
          <description>Main Group: Patients received linagliptin 2.5mg and metformin 500mg twice daily (BID), administered oral as fixed dose combination (FDC) tablet.</description>
        </group>
        <group group_id="P5">
          <title>Main: Linagliptin 2.5mg / Metformin 1000mg BID</title>
          <description>Main Group: Patients received linagliptin 2.5mg and metformin 1000mg twice daily (BID), administered oral as fixed dose combination (FDC) tablet.</description>
        </group>
        <group group_id="P6">
          <title>APG: Linagliptin 5mg QD</title>
          <description>Additional parallel group (APG): Patients received linagliptin 5mg once daily (QD), administered oral as tablet.&#xD;
(Data up to week 12)</description>
        </group>
        <group group_id="P7">
          <title>APG: Linagliptin 2.5mg / Metformin 1000mg BID</title>
          <description>Additional parallel group (APG): Patients received linagliptin 2.5mg and metformin 1000mg twice daily (BID), administered oral as fixed dose combination (FDC) tablet.&#xD;
(Data up to week 12)</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="147"/>
                <participants group_id="P2" count="145"/>
                <participants group_id="P3" count="144"/>
                <participants group_id="P4" count="147"/>
                <participants group_id="P5" count="147"/>
                <participants group_id="P6" count="71"/>
                <participants group_id="P7" count="72"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="130"/>
                <participants group_id="P2" count="137"/>
                <participants group_id="P3" count="127"/>
                <participants group_id="P4" count="137"/>
                <participants group_id="P5" count="131"/>
                <participants group_id="P6" count="64"/>
                <participants group_id="P7" count="65"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="17"/>
                <participants group_id="P2" count="8"/>
                <participants group_id="P3" count="17"/>
                <participants group_id="P4" count="10"/>
                <participants group_id="P5" count="16"/>
                <participants group_id="P6" count="7"/>
                <participants group_id="P7" count="7"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="4"/>
                <participants group_id="P3" count="9"/>
                <participants group_id="P4" count="2"/>
                <participants group_id="P5" count="7"/>
                <participants group_id="P6" count="3"/>
                <participants group_id="P7" count="5"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lack of Efficacy</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="1"/>
                <participants group_id="P7" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Non compliance with protocol</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="2"/>
                <participants group_id="P3" count="1"/>
                <participants group_id="P4" count="3"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="2"/>
                <participants group_id="P4" count="2"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Refused to continue trial medication</title>
              <participants_list>
                <participants group_id="P1" count="8"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="4"/>
                <participants group_id="P4" count="2"/>
                <participants group_id="P5" count="8"/>
                <participants group_id="P6" count="1"/>
                <participants group_id="P7" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Other Reason</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="1"/>
                <participants group_id="P4" count="1"/>
                <participants group_id="P5" count="1"/>
                <participants group_id="P6" count="2"/>
                <participants group_id="P7" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Treated set (TS): all patients treated with at least 1 dose of study medication</population>
      <group_list>
        <group group_id="B1">
          <title>Main: Linagliptin 5mg QD</title>
          <description>Main Group: Patients received linagliptin 5mg QD, administered oral as tablet.</description>
        </group>
        <group group_id="B2">
          <title>Main: Metformin 500mg BID</title>
          <description>Main Group: Patients received metformin 500mg BID, administered oral as tablet.</description>
        </group>
        <group group_id="B3">
          <title>Main: Metformin 1000mg BID</title>
          <description>Main Group: Patients received metformin 1000mg BID, administered oral as tablet.</description>
        </group>
        <group group_id="B4">
          <title>Main: Linagliptin 2.5mg / Metformin 500mg BID</title>
          <description>Main Group: Patients received linagliptin 2.5mg and metformin 500mg BID, administered oral as fixed dose combination (FDC) tablet.</description>
        </group>
        <group group_id="B5">
          <title>Main: Linagliptin 2.5mg / Metformin 1000mg BID</title>
          <description>Main Group: Patients received linagliptin 2.5mg and metformin 1000mg BID, administered oral as fixed dose combination (FDC) tablet.</description>
        </group>
        <group group_id="B6">
          <title>APG: Linagliptin 5mg QD</title>
          <description>Additional parallel group (APG): Patients received linagliptin 5mg QD, administered oral as tablet.&#xD;
(Data up to week 12)</description>
        </group>
        <group group_id="B7">
          <title>APG: Linagliptin 2.5mg / Metformin 1000mg BID</title>
          <description>Additional parallel group (APG): Patients received linagliptin 2.5mg and metformin 1000mg BID, administered oral as fixed dose combination (FDC) tablet.&#xD;
(Data up to week 12)</description>
        </group>
        <group group_id="B8">
          <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="147"/>
            <count group_id="B2" value="145"/>
            <count group_id="B3" value="144"/>
            <count group_id="B4" value="147"/>
            <count group_id="B5" value="147"/>
            <count group_id="B6" value="71"/>
            <count group_id="B7" value="72"/>
            <count group_id="B8" value="873"/>
          </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="50.8" spread="10.5"/>
                    <measurement group_id="B2" value="52.1" spread="9.6"/>
                    <measurement group_id="B3" value="51.4" spread="10.4"/>
                    <measurement group_id="B4" value="51.4" spread="10.2"/>
                    <measurement group_id="B5" value="50.7" spread="9.4"/>
                    <measurement group_id="B6" value="49.5" spread="11.6"/>
                    <measurement group_id="B7" value="49.9" spread="11.7"/>
                    <measurement group_id="B8" value="51.0" spread="10.3"/>
                  </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="71"/>
                    <measurement group_id="B2" value="54"/>
                    <measurement group_id="B3" value="53"/>
                    <measurement group_id="B4" value="55"/>
                    <measurement group_id="B5" value="60"/>
                    <measurement group_id="B6" value="23"/>
                    <measurement group_id="B7" value="32"/>
                    <measurement group_id="B8" value="348"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="76"/>
                    <measurement group_id="B2" value="91"/>
                    <measurement group_id="B3" value="91"/>
                    <measurement group_id="B4" value="92"/>
                    <measurement group_id="B5" value="87"/>
                    <measurement group_id="B6" value="48"/>
                    <measurement group_id="B7" value="40"/>
                    <measurement group_id="B8" value="525"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>The Change From Baseline in HbA1c After 24 Weeks of Treatment in Main Group</title>
        <description>The change from baseline in HbA1c after 24 weeks of treatment in main group.&#xD;
The mean was adjusted by baseline HbA1c and treatment group.</description>
        <time_frame>Baseline and week 24</time_frame>
        <population>Full analysis set (FAS): all randomised and treated patients who had a baseline and at least 1 on-treatment HbA1c value As the imputation rule for missing data the last observation carried forward (LOCF) was used.</population>
        <group_list>
          <group group_id="O1">
            <title>Main: Linagliptin 5mg QD</title>
            <description>Main Group: Patients received linagliptin 5mg QD, administered oral as tablet.</description>
          </group>
          <group group_id="O2">
            <title>Main: Metformin 500mg BID</title>
            <description>Main Group: Patients received metformin 500mg BID, administered oral as tablet.</description>
          </group>
          <group group_id="O3">
            <title>Main: Metformin 1000mg BID</title>
            <description>Main Group: Patients received metformin 1000mg BID, administered oral as tablet.</description>
          </group>
          <group group_id="O4">
            <title>Main: Linagliptin 2.5mg / Metformin 500mg BID</title>
            <description>Main Group: Patients received linagliptin 2.5mg and metformin 500mg BID, administered oral as fixed dose combination (FDC) tablet.</description>
          </group>
          <group group_id="O5">
            <title>Main: Linagliptin 2.5mg / Metformin 1000mg BID</title>
            <description>Main Group: Patients received linagliptin 2.5mg and metformin 1000mg BID, administered oral as fixed dose combination (FDC) tablet.</description>
          </group>
        </group_list>
        <measure>
          <title>The Change From Baseline in HbA1c After 24 Weeks of Treatment in Main Group</title>
          <description>The change from baseline in HbA1c after 24 weeks of treatment in main group.&#xD;
The mean was adjusted by baseline HbA1c and treatment group.</description>
          <population>Full analysis set (FAS): all randomised and treated patients who had a baseline and at least 1 on-treatment HbA1c value As the imputation rule for missing data the last observation carried forward (LOCF) was used.</population>
          <units>percentage</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="141"/>
                <count group_id="O2" value="144"/>
                <count group_id="O3" value="133"/>
                <count group_id="O4" value="142"/>
                <count group_id="O5" value="141"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.29" spread="0.08"/>
                    <measurement group_id="O2" value="-1.64" spread="0.08"/>
                    <measurement group_id="O3" value="-2.07" spread="0.08"/>
                    <measurement group_id="O4" value="-2.15" spread="0.08"/>
                    <measurement group_id="O5" value="-2.29" spread="0.08"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
              <group_id>O5</group_id>
            </group_id_list>
            <groups_desc>The model includes treatment as a fixed effect and baseline HbA1c as a linear covariate.&#xD;
The null and alternative hypotheses were tested in a hierarchical sequence. The next null hypothesis was tested in a confirmatory way only if all prior null-hypotheses were rejected. 'Greater effect' refers to a greater reduction in HbA1c.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.0587</p_value>
            <method>ANCOVA</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-0.22</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>-0.45</ci_lower_limit>
            <ci_upper_limit>0.01</ci_upper_limit>
            <estimate_desc>The adjusted mean difference was calculated as the adjusted mean of 'Main: Linagliptin 2.5mg / Metformin 1000mg BID' minus 'Main: Metformin 1000mg BID'.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O5</group_id>
            </group_id_list>
            <groups_desc>The model includes treatment as a fixed effect and baseline HbA1c as a linear covariate.&#xD;
The null and alternative hypotheses were tested in a hierarchical sequence. The next null hypothesis was tested in a confirmatory way only if all prior null-hypotheses were rejected. 'Greater effect' refers to a greater reduction in HbA1c.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>&lt;0.0001</p_value>
            <method>ANCOVA</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-1.00</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.11</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.23</ci_lower_limit>
            <ci_upper_limit>-0.78</ci_upper_limit>
            <estimate_desc>The adjusted mean difference was calculated as the adjusted mean of 'Main: Linagliptin 2.5mg / Metformin 1000mg BID' minus 'Main: Linagliptin 5mg QD'.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>The model includes treatment as a fixed effect and baseline HbA1c as a linear covariate.&#xD;
The null and alternative hypotheses were tested in a hierarchical sequence. The next null hypothesis was tested in a confirmatory way only if all prior null-hypotheses were rejected. 'Greater effect' refers to a greater reduction in HbA1c.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>&lt;0.0001</p_value>
            <method>ANCOVA</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-0.51</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.11</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.73</ci_lower_limit>
            <ci_upper_limit>-0.29</ci_upper_limit>
            <estimate_desc>The adjusted mean difference was calculated as the adjusted mean of 'Main: Linagliptin 2.5mg / Metformin 500mg BID' minus 'Main: Metformin 500mg BID'.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>The model includes treatment as a fixed effect and baseline HbA1c as a linear covariate.&#xD;
The null and alternative hypotheses were tested in a hierarchical sequence. The next null hypothesis was tested in a confirmatory way only if all prior null-hypotheses were rejected. 'Greater effect' refers to a greater reduction in HbA1c.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>&lt;0.0001</p_value>
            <method>ANCOVA</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-0.87</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.11</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.09</ci_lower_limit>
            <ci_upper_limit>-0.64</ci_upper_limit>
            <estimate_desc>The adjusted mean difference was calculated as the adjusted mean of 'Main: Linagliptin 2.5mg / Metformin 500mg BID' minus 'Main: Linagliptin 5mg QD'.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>The Occurrence of Treat to Target Efficacy Response in Terms of HbA1c &lt; 7.0 % After 24 Weeks of Treatment in Main Group</title>
        <description>The occurrence of treat to target efficacy response in terms of HbA1c &lt; 7.0 % after 24 weeks of treatment in main group.</description>
        <time_frame>Week 24 (after first drug administration)</time_frame>
        <population>FAS - non-completers were considered as nonresponders (NCF)</population>
        <group_list>
          <group group_id="O1">
            <title>Main: Linagliptin 5mg QD</title>
            <description>Main Group: Patients received linagliptin 5mg QD, administered oral as tablet.</description>
          </group>
          <group group_id="O2">
            <title>Main: Metformin 500mg BID</title>
            <description>Main Group: Patients received metformin 500mg BID, administered oral as tablet.</description>
          </group>
          <group group_id="O3">
            <title>Main: Metformin 1000mg BID</title>
            <description>Main Group: Patients received metformin 1000mg BID, administered oral as tablet.</description>
          </group>
          <group group_id="O4">
            <title>Main: Linagliptin 2.5mg / Metformin 500mg BID</title>
            <description>Main Group: Patients received linagliptin 2.5mg and metformin 500mg BID, administered oral as fixed dose combination (FDC) tablet.</description>
          </group>
          <group group_id="O5">
            <title>Main: Linagliptin 2.5mg / Metformin 1000mg BID</title>
            <description>Main Group: Patients received linagliptin 2.5mg and metformin 1000mg BID, administered oral as fixed dose combination (FDC) tablet.</description>
          </group>
        </group_list>
        <measure>
          <title>The Occurrence of Treat to Target Efficacy Response in Terms of HbA1c &lt; 7.0 % After 24 Weeks of Treatment in Main Group</title>
          <description>The occurrence of treat to target efficacy response in terms of HbA1c &lt; 7.0 % after 24 weeks of treatment in main group.</description>
          <population>FAS - non-completers were considered as nonresponders (NCF)</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="140"/>
                <count group_id="O2" value="144"/>
                <count group_id="O3" value="129"/>
                <count group_id="O4" value="140"/>
                <count group_id="O5" value="140"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="43.6" lower_limit="35.2" upper_limit="52.2"/>
                    <measurement group_id="O2" value="50.0" lower_limit="41.6" upper_limit="58.4"/>
                    <measurement group_id="O3" value="69.0" lower_limit="60.3" upper_limit="76.8"/>
                    <measurement group_id="O4" value="72.1" lower_limit="63.9" upper_limit="79.4"/>
                    <measurement group_id="O5" value="77.1" lower_limit="69.3" upper_limit="83.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
              <group_id>O5</group_id>
            </group_id_list>
            <groups_desc>Comparison of 'Main: Linagliptin 2.5mg / Metformin 1000mg BID' / 'Main: Metformin 1000mg BID'.&#xD;
The logistic regression includes treatment and continuous baseline HbA1c.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.0771</p_value>
            <method>Regression, Logistic</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>1.673</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.487</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.946</ci_lower_limit>
            <ci_upper_limit>2.961</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O5</group_id>
            </group_id_list>
            <groups_desc>Comparison of 'Main: Linagliptin 2.5mg / Metformin 1000mg BID' / 'Main: Linagliptin 5mg QD'.&#xD;
The logistic regression includes treatment and continuous baseline HbA1c.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>&lt;0.0001</p_value>
            <method>Regression, Logistic</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>5.489</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>1.543</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>3.164</ci_lower_limit>
            <ci_upper_limit>9.522</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Comparison of 'Main: Linagliptin 2.5mg / Metformin 500mg BID' / 'Main: Metformin 500mg BID'.&#xD;
The logistic regression includes treatment and continuous baseline HbA1c.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>&lt;0.0001</p_value>
            <method>Regression, Logistic</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>2.829</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.753</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>1.678</ci_lower_limit>
            <ci_upper_limit>4.767</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Comparison of 'Main: Linagliptin 2.5mg / Metformin 500mg BID' / 'Main: Linagliptin 5mg QD'.&#xD;
The logistic regression includes treatment and continuous baseline HbA1c.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>&lt;0.0001</p_value>
            <method>Regression, Logistic</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>3.818</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>1.023</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>2.259</ci_lower_limit>
            <ci_upper_limit>6.454</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>The Occurrence of Treat to Target Efficacy Response in Terms of HbA1c &lt; 7.0 % After 12 Weeks of Treatment in APG</title>
        <description>The occurrence of treat to target efficacy response in terms of HbA1c &lt; 7.0 % after 12 weeks of treatment in APG.</description>
        <time_frame>Week 12 (after first drug administration)</time_frame>
        <population>FAS (NCF)</population>
        <group_list>
          <group group_id="O1">
            <title>APG: Linagliptin 5mg QD</title>
            <description>Additional parallel group (APG): Patients received linagliptin 5mg QD, administered oral as tablet.&#xD;
(Data up to week 12)</description>
          </group>
          <group group_id="O2">
            <title>APG: Linagliptin 2.5mg / Metformin 1000mg BID</title>
            <description>Additional parallel group (APG): Patients received linagliptin 2.5mg and metformin 1000mg BID, administered oral as fixed dose combination (FDC) tablet.&#xD;
(Data up to week 12)</description>
          </group>
        </group_list>
        <measure>
          <title>The Occurrence of Treat to Target Efficacy Response in Terms of HbA1c &lt; 7.0 % After 12 Weeks of Treatment in APG</title>
          <description>The occurrence of treat to target efficacy response in terms of HbA1c &lt; 7.0 % after 12 weeks of treatment in APG.</description>
          <population>FAS (NCF)</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="70"/>
                <count group_id="O2" value="68"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="27.1" lower_limit="17.2" upper_limit="39.1"/>
                    <measurement group_id="O2" value="58.8" lower_limit="46.2" upper_limit="70.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Comparison of 'APG: Linagliptin 2.5mg / Metformin 1000mg BID' / 'APG: Linagliptin 5mg QD'.&#xD;
The logistic regression includes treatment and continuous baseline HbA1c.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.0001</p_value>
            <method>Regression, Logistic</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>4.169</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>1.565</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>1.997</ci_lower_limit>
            <ci_upper_limit>8.701</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>The Occurrence of Treat to Target Efficacy Response in Terms of HbA1c &lt; 6.5% After 24 Weeks of Treatment in Main Group</title>
        <description>The occurrence of treat to target efficacy response in terms of HbA1c &lt; 6.5% after 24 weeks of treatment in main group.</description>
        <time_frame>Week 24 (after first drug administration)</time_frame>
        <population>FAS (NCF)</population>
        <group_list>
          <group group_id="O1">
            <title>Main: Linagliptin 5mg QD</title>
            <description>Main Group: Patients received linagliptin 5mg QD, administered oral as tablet.</description>
          </group>
          <group group_id="O2">
            <title>Main: Metformin 500mg BID</title>
            <description>Main Group: Patients received metformin 500mg BID, administered oral as tablet.</description>
          </group>
          <group group_id="O3">
            <title>Main: Metformin 1000mg BID</title>
            <description>Main Group: Patients received metformin 1000mg BID, administered oral as tablet.</description>
          </group>
          <group group_id="O4">
            <title>Main: Linagliptin 2.5mg / Metformin 500mg BID</title>
            <description>Main Group: Patients received linagliptin 2.5mg and metformin 500mg BID, administered oral as fixed dose combination (FDC) tablet.</description>
          </group>
          <group group_id="O5">
            <title>Main: Linagliptin 2.5mg / Metformin 1000mg BID</title>
            <description>Main Group: Patients received linagliptin 2.5mg and metformin 1000mg BID, administered oral as fixed dose combination (FDC) tablet.</description>
          </group>
        </group_list>
        <measure>
          <title>The Occurrence of Treat to Target Efficacy Response in Terms of HbA1c &lt; 6.5% After 24 Weeks of Treatment in Main Group</title>
          <description>The occurrence of treat to target efficacy response in terms of HbA1c &lt; 6.5% after 24 weeks of treatment in main group.</description>
          <population>FAS (NCF)</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="141"/>
                <count group_id="O2" value="144"/>
                <count group_id="O3" value="133"/>
                <count group_id="O4" value="142"/>
                <count group_id="O5" value="141"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="23.4" lower_limit="16.7" upper_limit="31.3"/>
                    <measurement group_id="O2" value="34.7" lower_limit="27.0" upper_limit="43.1"/>
                    <measurement group_id="O3" value="50.4" lower_limit="41.6" upper_limit="59.2"/>
                    <measurement group_id="O4" value="56.3" lower_limit="47.8" upper_limit="64.6"/>
                    <measurement group_id="O5" value="60.3" lower_limit="51.7" upper_limit="68.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
              <group_id>O5</group_id>
            </group_id_list>
            <groups_desc>Comparison of 'Main: Linagliptin 2.5mg / Metformin 1000mg BID' / 'Main: Metformin 1000mg BID'.&#xD;
The logistic regression includes treatment and continuous baseline HbA1c.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.0480</p_value>
            <method>Regression, Logistic</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>1.661</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.426</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>1.004</ci_lower_limit>
            <ci_upper_limit>2.746</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O5</group_id>
            </group_id_list>
            <groups_desc>Comparison of 'Main: Linagliptin 2.5mg / Metformin 1000mg BID' / 'Main: Linagliptin 5mg QD'.&#xD;
The logistic regression includes treatment and continuous baseline HbA1c.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>&lt;0.0001</p_value>
            <method>Regression, Logistic</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>5.923</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>1.632</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>3.452</ci_lower_limit>
            <ci_upper_limit>10.164</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Comparison of 'Main: Linagliptin 2.5mg / Metformin 500mg BID' / 'Main: Metformin 500mg BID'.&#xD;
The logistic regression includes treatment and continuous baseline HbA1c.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.0002</p_value>
            <method>Regression, Logistic</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>2.574</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.655</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>1.563</ci_lower_limit>
            <ci_upper_limit>4.239</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Comparison of 'Main: Linagliptin 2.5mg / Metformin 500mg BID' / 'Main: Linagliptin 5mg QD'.&#xD;
The logistic regression includes treatment and continuous baseline HbA1c.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>&lt;0.0001</p_value>
            <method>Regression, Logistic</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>4.682</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>1.270</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>2.751</ci_lower_limit>
            <ci_upper_limit>7.968</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>The Occurrence of Treat to Target Efficacy Response in Terms of HbA1c &lt; 6.5% After 12 Weeks of Treatment in APG</title>
        <description>The occurrence of treat to target efficacy response in terms of HbA1c &lt; 6.5% after 12 weeks of treatment in APG.</description>
        <time_frame>Week 12 (after first drug administration)</time_frame>
        <population>FAS (NCF)</population>
        <group_list>
          <group group_id="O1">
            <title>APG: Linagliptin 5mg QD</title>
            <description>Additional parallel group (APG): Patients received linagliptin 5mg QD, administered oral as tablet.&#xD;
(Data up to week 12)</description>
          </group>
          <group group_id="O2">
            <title>APG: Linagliptin 2.5mg / Metformin 1000mg BID</title>
            <description>Additional parallel group (APG): Patients received linagliptin 2.5mg and metformin 1000mg BID, administered oral as fixed dose combination (FDC) tablet.&#xD;
(Data up to week 12)</description>
          </group>
        </group_list>
        <measure>
          <title>The Occurrence of Treat to Target Efficacy Response in Terms of HbA1c &lt; 6.5% After 12 Weeks of Treatment in APG</title>
          <description>The occurrence of treat to target efficacy response in terms of HbA1c &lt; 6.5% after 12 weeks of treatment in APG.</description>
          <population>FAS (NCF)</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="70"/>
                <count group_id="O2" value="68"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15.7" lower_limit="8.1" upper_limit="26.4"/>
                    <measurement group_id="O2" value="36.8" lower_limit="25.4" upper_limit="49.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Comparison of 'APG: Linagliptin 2.5mg / Metformin 1000mg BID' / 'APG: Linagliptin 5mg QD'.&#xD;
The logistic regression includes treatment and continuous baseline HbA1c.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.0062</p_value>
            <method>Regression, Logistic</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>3.135</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>1.310</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>1.383</ci_lower_limit>
            <ci_upper_limit>7.110</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>The Change From Baseline in HbA1c After 24 Weeks of Treatment in Main Group - FAS (OC)</title>
        <description>The change from baseline in HbA1c after 24 weeks of treatment in main group. Only subjects from the FAS with measured HbA1c values (observed cases [OC]) were considered.&#xD;
The mean was adjusted by treatment, baseline HbA1c, week and treatment*week.&#xD;
The sensitivity analysis was added as the primary analysis failed with borderline results.</description>
        <time_frame>Baseline and week 24</time_frame>
        <population>FAS (OC): subjects from the FAS with measured HbA1c values (observed cases [OC]) were considered</population>
        <group_list>
          <group group_id="O1">
            <title>Main: Linagliptin 5mg QD</title>
            <description>Main Group: Patients received linagliptin 5mg QD, administered oral as tablet.</description>
          </group>
          <group group_id="O2">
            <title>Main: Metformin 500mg BID</title>
            <description>Main Group: Patients received metformin 500mg BID, administered oral as tablet.</description>
          </group>
          <group group_id="O3">
            <title>Main: Metformin 1000mg BID</title>
            <description>Main Group: Patients received metformin 1000mg BID, administered oral as tablet.</description>
          </group>
          <group group_id="O4">
            <title>Main: Linagliptin 2.5mg / Metformin 500mg BID</title>
            <description>Main Group: Patients received linagliptin 2.5mg and metformin 500mg BID, administered oral as fixed dose combination (FDC) tablet.</description>
          </group>
          <group group_id="O5">
            <title>Main: Linagliptin 2.5mg / Metformin 1000mg BID</title>
            <description>Main Group: Patients received linagliptin 2.5mg and metformin 1000mg BID, administered oral as fixed dose combination (FDC) tablet.</description>
          </group>
        </group_list>
        <measure>
          <title>The Change From Baseline in HbA1c After 24 Weeks of Treatment in Main Group - FAS (OC)</title>
          <description>The change from baseline in HbA1c after 24 weeks of treatment in main group. Only subjects from the FAS with measured HbA1c values (observed cases [OC]) were considered.&#xD;
The mean was adjusted by treatment, baseline HbA1c, week and treatment*week.&#xD;
The sensitivity analysis was added as the primary analysis failed with borderline results.</description>
          <population>FAS (OC): subjects from the FAS with measured HbA1c values (observed cases [OC]) were considered</population>
          <units>percentage</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="125"/>
                <count group_id="O2" value="133"/>
                <count group_id="O3" value="127"/>
                <count group_id="O4" value="135"/>
                <count group_id="O5" value="128"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.34" spread="0.08"/>
                    <measurement group_id="O2" value="-1.68" spread="0.08"/>
                    <measurement group_id="O3" value="-2.08" spread="0.08"/>
                    <measurement group_id="O4" value="-2.16" spread="0.08"/>
                    <measurement group_id="O5" value="-2.38" spread="0.08"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
              <group_id>O5</group_id>
            </group_id_list>
            <groups_desc>Sensitivity analysis: Mixed Model for repeated measurements&#xD;
The model includes baseline HbA1c as a linear covariate; visit, treatment and visit by treatment interaction as fixed classification effects and patient as a random effect with unstructured covariance structure to model within-patients errors.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.0109</p_value>
            <method>ANCOVA</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-0.30</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>-0.53</ci_lower_limit>
            <ci_upper_limit>-0.07</ci_upper_limit>
            <estimate_desc>The adjusted mean difference was calculated as the adjusted mean of 'Main: Linagliptin 2.5mg / Metformin 1000mg BID' minus 'Main: Metformin 1000mg BID'.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O5</group_id>
            </group_id_list>
            <groups_desc>Sensitivity analysis: Mixed Model for repeated measurements&#xD;
The model includes baseline HbA1c as a linear covariate; visit, treatment and visit by treatment interaction as fixed classification effects and patient as a random effect with unstructured covariance structure to model within-patients errors.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>&lt;0.0001</p_value>
            <method>ANCOVA</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-1.04</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>-1.27</ci_lower_limit>
            <ci_upper_limit>-0.81</ci_upper_limit>
            <estimate_desc>The adjusted mean difference was calculated as the adjusted mean of 'Main: Linagliptin 2.5mg / Metformin 1000mg BID' minus 'Main: Linagliptin 5mg QD'.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Sensitivity analysis: Mixed Model for repeated measurements&#xD;
The model includes baseline HbA1c as a linear covariate; visit, treatment and visit by treatment interaction as fixed classification effects and patient as a random effect with unstructured covariance structure to model within-patients errors.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>&lt;0.0001</p_value>
            <method>ANCOVA</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-0.47</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>-0.70</ci_lower_limit>
            <ci_upper_limit>-0.24</ci_upper_limit>
            <estimate_desc>The adjusted mean difference was calculated as the adjusted mean of 'Main: Linagliptin 2.5mg / Metformin 500mg BID ' minus 'Main: Metformin 500mg BID' .</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Sensitivity analysis: Mixed Model for repeated measurements&#xD;
The model includes baseline HbA1c as a linear covariate; visit, treatment and visit by treatment interaction as fixed classification effects and patient as a random effect with unstructured covariance structure to model within-patients errors.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>&lt;0.0001</p_value>
            <method>ANCOVA</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-0.81</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>-1.04</ci_lower_limit>
            <ci_upper_limit>-0.58</ci_upper_limit>
            <estimate_desc>The adjusted mean difference was calculated as the adjusted mean of 'Main: Linagliptin 2.5mg / Metformin 500mg BID' minus 'Main: Linagliptin 5mg QD'.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>The Change From Baseline in HbA1c After 12 Weeks of Treatment in APG</title>
        <description>The change from baseline in HbA1c after 12 weeks of treatment in additional parallel group (APG)&#xD;
The mean was adjusted by baseline HbA1c and treatment group.</description>
        <time_frame>Baseline and week 12</time_frame>
        <population>FAS (LOCF)</population>
        <group_list>
          <group group_id="O1">
            <title>APG: Linagliptin 5mg QD</title>
            <description>Additional parallel group (APG): Patients received linagliptin 5mg QD, administered oral as tablet.&#xD;
(Data up to week 12)</description>
          </group>
          <group group_id="O2">
            <title>APG: Linagliptin 2.5mg / Metformin 1000mg BID</title>
            <description>Additional parallel group (APG): Patients received linagliptin 2.5mg and metformin 1000mg BID, administered oral as fixed dose combination (FDC) tablet.&#xD;
(Data up to week 12)</description>
          </group>
        </group_list>
        <measure>
          <title>The Change From Baseline in HbA1c After 12 Weeks of Treatment in APG</title>
          <description>The change from baseline in HbA1c after 12 weeks of treatment in additional parallel group (APG)&#xD;
The mean was adjusted by baseline HbA1c and treatment group.</description>
          <population>FAS (LOCF)</population>
          <units>percentage</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="70"/>
                <count group_id="O2" value="68"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-3.46" spread="0.22"/>
                    <measurement group_id="O2" value="-4.71" spread="0.22"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>The treatment effect of the 'APG: Linagliptin 2.5mg / Metformin 1000mg BID' was compared with 'APG: Linagliptin 5mg QD'.&#xD;
The model includes treatment as a fixed effect and baseline HbA1c as a linear covariate.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.0001</p_value>
            <method>ANCOVA</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-1.25</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.32</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.87</ci_lower_limit>
            <ci_upper_limit>-0.63</ci_upper_limit>
            <estimate_desc>The adjusted mean difference was calculated as the adjusted mean of 'APG: Linagliptin 2.5mg / Metformin 1000mg BID' minus 'APG: Linagliptin 5mg QD'.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>The Occurrence of Relative Efficacy Response in Main Group</title>
        <description>The occurrence of relative efficacy response (HbA1c lowering by at least 0.5% after 24 weeks of treatment) in main group</description>
        <time_frame>From baseline until week 24</time_frame>
        <population>FAS (NCF)</population>
        <group_list>
          <group group_id="O1">
            <title>Main: Linagliptin 5mg QD</title>
            <description>Main Group: Patients received linagliptin 5mg QD, administered oral as tablet.</description>
          </group>
          <group group_id="O2">
            <title>Main: Metformin 500mg BID</title>
            <description>Main Group: Patients received metformin 500mg BID, administered oral as tablet.</description>
          </group>
          <group group_id="O3">
            <title>Main: Metformin 1000mg BID</title>
            <description>Main Group: Patients received metformin 1000mg BID, administered oral as tablet.</description>
          </group>
          <group group_id="O4">
            <title>Main: Linagliptin 2.5mg / Metformin 500mg BID</title>
            <description>Main Group: Patients received linagliptin 2.5mg and metformin 500mg BID, administered oral as fixed dose combination (FDC) tablet.</description>
          </group>
          <group group_id="O5">
            <title>Main: Linagliptin 2.5mg / Metformin 1000mg BID</title>
            <description>Main Group: Patients received linagliptin 2.5mg and metformin 1000mg BID, administered oral as fixed dose combination (FDC) tablet.</description>
          </group>
        </group_list>
        <measure>
          <title>The Occurrence of Relative Efficacy Response in Main Group</title>
          <description>The occurrence of relative efficacy response (HbA1c lowering by at least 0.5% after 24 weeks of treatment) in main group</description>
          <population>FAS (NCF)</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="141"/>
                <count group_id="O2" value="144"/>
                <count group_id="O3" value="133"/>
                <count group_id="O4" value="142"/>
                <count group_id="O5" value="141"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="73.0" lower_limit="64.9" upper_limit="80.2"/>
                    <measurement group_id="O2" value="80.6" lower_limit="73.1" upper_limit="86.7"/>
                    <measurement group_id="O3" value="89.5" lower_limit="83.0" upper_limit="94.1"/>
                    <measurement group_id="O4" value="93.0" lower_limit="87.4" upper_limit="96.6"/>
                    <measurement group_id="O5" value="89.4" lower_limit="83.1" upper_limit="93.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
              <group_id>O5</group_id>
            </group_id_list>
            <groups_desc>Comparison of 'Main: Linagliptin 2.5mg / Metformin 1000mg BID' / 'Main: Metformin 1000mg BID'.&#xD;
The logistic regression includes treatment and continuous baseline HbA1c.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.9705</p_value>
            <method>Regression, Logistic</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>0.986</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.387</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.456</ci_lower_limit>
            <ci_upper_limit>2.130</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O5</group_id>
            </group_id_list>
            <groups_desc>Comparison of 'Main: Linagliptin 2.5mg / Metformin 1000mg BID' / 'Main: Linagliptin 5mg QD'.&#xD;
The logistic regression includes treatment and continuous baseline HbA1c.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.0007</p_value>
            <method>Regression, Logistic</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>3.093</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>1.029</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>1.612</ci_lower_limit>
            <ci_upper_limit>5.938</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Comparison of 'Main: Linagliptin 2.5mg / Metformin 500mg BID' / 'Main: Metformin 500mg BID'.&#xD;
The logistic regression includes treatment and continuous baseline HbA1c.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.0029</p_value>
            <method>Regression, Logistic</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>3.190</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>1.243</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>1.486</ci_lower_limit>
            <ci_upper_limit>6.849</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Comparison of 'Main: Linagliptin 2.5mg / Metformin 500mg BID' / 'Main: Linagliptin 5mg QD'.&#xD;
The logistic regression includes treatment and continuous baseline HbA1c.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>&lt;0.0001</p_value>
            <method>Regression, Logistic</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>4.871</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>1.846</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>2.318</ci_lower_limit>
            <ci_upper_limit>10.238</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>The Occurrence of Relative Efficacy Response in APG</title>
        <description>The Occurrence of Relative Efficacy Response (HbA1c Lowering by at Least 0.5% After 12 Weeks of Treatment) in APG</description>
        <time_frame>From baseline until week 12</time_frame>
        <population>FAS (NCF)</population>
        <group_list>
          <group group_id="O1">
            <title>APG: Linagliptin 5mg QD</title>
            <description>Additional parallel group (APG): Patients received linagliptin 5mg QD, administered oral as tablet.&#xD;
(Data up to week 12)</description>
          </group>
          <group group_id="O2">
            <title>APG: Linagliptin 2.5mg / Metformin 1000mg BID</title>
            <description>Additional parallel group (APG): Patients received linagliptin 2.5mg and metformin 1000mg BID, administered oral as fixed dose combination (FDC) tablet.&#xD;
(Data up to week 12)</description>
          </group>
        </group_list>
        <measure>
          <title>The Occurrence of Relative Efficacy Response in APG</title>
          <description>The Occurrence of Relative Efficacy Response (HbA1c Lowering by at Least 0.5% After 12 Weeks of Treatment) in APG</description>
          <population>FAS (NCF)</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="70"/>
                <count group_id="O2" value="68"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="84.3" lower_limit="73.6" upper_limit="91.9"/>
                    <measurement group_id="O2" value="91.2" lower_limit="81.8" upper_limit="96.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Comparison of 'APG: Linagliptin 2.5mg / Metformin 1000mg BID' / 'APG: Linagliptin 5mg QD'.&#xD;
The logistic regression includes treatment and continuous baseline HbA1c.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.2523</p_value>
            <method>Regression, Logistic</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>1.865</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>1.015</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.642</ci_lower_limit>
            <ci_upper_limit>5.420</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>The Change in Fasting Plasma Glucose (FPG) From Baseline After 24 Weeks of Treatment in Main Group</title>
        <description>The change in fasting plasma glucose (FPG) from baseline after 24 weeks of treatment in main group.&#xD;
Adjusted mean: The model includes continuous baseline HbA1c, continuous baseline FPG and treatment group.</description>
        <time_frame>Baseline and week 24</time_frame>
        <population>FAS (LOCF)</population>
        <group_list>
          <group group_id="O1">
            <title>Main: Linagliptin 5mg QD</title>
            <description>Main Group: Patients received linagliptin 5mg QD, administered oral as tablet.</description>
          </group>
          <group group_id="O2">
            <title>Main: Metformin 500mg BID</title>
            <description>Main Group: Patients received metformin 500mg BID, administered oral as tablet.</description>
          </group>
          <group group_id="O3">
            <title>Main: Metformin 1000mg BID</title>
            <description>Main Group: Patients received metformin 1000mg BID, administered oral as tablet.</description>
          </group>
          <group group_id="O4">
            <title>Main: Linagliptin 2.5mg / Metformin 500mg BID</title>
            <description>Main Group: Patients received linagliptin 2.5mg and metformin 500mg BID, administered oral as fixed dose combination (FDC) tablet.</description>
          </group>
          <group group_id="O5">
            <title>Main: Linagliptin 2.5mg / Metformin 1000mg BID</title>
            <description>Main Group: Patients received linagliptin 2.5mg and metformin 1000mg BID, administered oral as fixed dose combination (FDC) tablet.</description>
          </group>
        </group_list>
        <measure>
          <title>The Change in Fasting Plasma Glucose (FPG) From Baseline After 24 Weeks of Treatment in Main Group</title>
          <description>The change in fasting plasma glucose (FPG) from baseline after 24 weeks of treatment in main group.&#xD;
Adjusted mean: The model includes continuous baseline HbA1c, continuous baseline FPG and treatment group.</description>
          <population>FAS (LOCF)</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="140"/>
                <count group_id="O2" value="144"/>
                <count group_id="O3" value="133"/>
                <count group_id="O4" value="142"/>
                <count group_id="O5" value="140"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-15.03" spread="2.25"/>
                    <measurement group_id="O2" value="-29.87" spread="2.23"/>
                    <measurement group_id="O3" value="-42.07" spread="2.31"/>
                    <measurement group_id="O4" value="-39.33" spread="2.24"/>
                    <measurement group_id="O5" value="-47.44" spread="2.26"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
              <group_id>O5</group_id>
            </group_id_list>
            <groups_desc>The model includes continuous baseline HbA1c, continuous baseline FPG and treatment group.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.0971</p_value>
            <method>ANCOVA</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-5.37</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>3.23</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-11.72</ci_lower_limit>
            <ci_upper_limit>0.98</ci_upper_limit>
            <estimate_desc>The adjusted mean difference was calculated as the adjusted mean of 'Main: Linagliptin 2.5mg / Metformin 1000mg BID' minus 'Main: Metformin 1000mg BID'.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O5</group_id>
            </group_id_list>
            <groups_desc>The model includes continuous baseline HbA1c, continuous baseline FPG and treatment group.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>&lt;0.0001</p_value>
            <method>ANCOVA</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-32.42</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>3.19</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-38.67</ci_lower_limit>
            <ci_upper_limit>-26.16</ci_upper_limit>
            <estimate_desc>The adjusted mean difference was calculated as the adjusted mean of 'Main: Linagliptin 2.5mg / Metformin 1000mg BID' minus 'Main: Linagliptin 5mg QD'.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>The model includes continuous baseline HbA1c, continuous baseline FPG and treatment group.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.0028</p_value>
            <method>ANCOVA</method>
            <param_type>Median Difference (Net)</param_type>
            <param_value>-9.47</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>3.16</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-15.66</ci_lower_limit>
            <ci_upper_limit>-3.27</ci_upper_limit>
            <estimate_desc>The adjusted mean difference was calculated as the adjusted mean of 'Main: Linagliptin 2.5mg / Metformin 500mg BID' minus 'Main: Metformin 500mg BID'.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>The model includes continuous baseline HbA1c, continuous baseline FPG and treatment group.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>&lt;0.0001</p_value>
            <method>ANCOVA</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-24.31</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>3.17</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-30.54</ci_lower_limit>
            <ci_upper_limit>-18.08</ci_upper_limit>
            <estimate_desc>The adjusted mean difference was calculated as the adjusted mean of 'Main: Linagliptin 2.5mg / Metformin 500mg BID' minus 'Main: Linagliptin 5mg QD'.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>The Change in Fasting Plasma Glucose (FPG) From Baseline After 12 Weeks of Treatment in APG</title>
        <description>The Change in Fasting Plasma Glucose (FPG) From Baseline After 12 Weeks of Treatment in APG.&#xD;
Adjusted mean: The model includes continuous baseline HbA1c, continuous baseline FPG and treatment group.</description>
        <time_frame>Baseline and week 12</time_frame>
        <population>FAS (LOCF)</population>
        <group_list>
          <group group_id="O1">
            <title>APG: Linagliptin 5mg QD</title>
            <description>Additional parallel group (APG): Patients received linagliptin 5mg QD, administered oral as tablet.&#xD;
(Data up to week 12)</description>
          </group>
          <group group_id="O2">
            <title>APG: Linagliptin 2.5mg / Metformin 1000mg BID</title>
            <description>Additional parallel group (APG): Patients received linagliptin 2.5mg and metformin 1000mg BID, administered oral as fixed dose combination (FDC) tablet.&#xD;
(Data up to week 12)</description>
          </group>
        </group_list>
        <measure>
          <title>The Change in Fasting Plasma Glucose (FPG) From Baseline After 12 Weeks of Treatment in APG</title>
          <description>The Change in Fasting Plasma Glucose (FPG) From Baseline After 12 Weeks of Treatment in APG.&#xD;
Adjusted mean: The model includes continuous baseline HbA1c, continuous baseline FPG and treatment group.</description>
          <population>FAS (LOCF)</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="66"/>
                <count group_id="O2" value="67"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-56.70" spread="6.53"/>
                    <measurement group_id="O2" value="-91.92" spread="6.48"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>The model includes continuous baseline HbA1c, continuous baseline FPG and treatment group.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.0002</p_value>
            <method>ANCOVA</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-35.21</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>9.23</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-53.48</ci_lower_limit>
            <ci_upper_limit>-16.95</ci_upper_limit>
            <estimate_desc>The adjusted mean difference was calculated as the adjusted mean of 'APG: Linagliptin 2.5mg / Metformin 1000mg BID' minus 'APG: Linagliptin 5mg QD'.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>The Frequency of Patients With Use of Rescue Therapy During 24 Week Treatment Period in Main Group</title>
        <description>The frequency of patients with use of rescue therapy during 24 week treatment period in main group.&#xD;
For this analysis the main group contrast 'Metformin 1000mg BID, Linagliptin 2.5mg / Metformin 1000mg BID' could not be analysed due to lack of events in the Metformin 1000mg BID group.</description>
        <time_frame>From baseline until week 24</time_frame>
        <population>FAS</population>
        <group_list>
          <group group_id="O1">
            <title>Main: Linagliptin 5mg QD</title>
            <description>Main Group: Patients received linagliptin 5mg QD, administered oral as tablet.</description>
          </group>
          <group group_id="O2">
            <title>Main: Metformin 500mg BID</title>
            <description>Main Group: Patients received metformin 500mg BID, administered oral as tablet.</description>
          </group>
          <group group_id="O3">
            <title>Main: Metformin 1000mg BID</title>
            <description>Main Group: Patients received metformin 1000mg BID, administered oral as tablet.</description>
          </group>
          <group group_id="O4">
            <title>Main: Linagliptin 2.5mg / Metformin 500mg BID</title>
            <description>Main Group: Patients received linagliptin 2.5mg and metformin 500mg BID, administered oral as fixed dose combination (FDC) tablet.</description>
          </group>
          <group group_id="O5">
            <title>Main: Linagliptin 2.5mg / Metformin 1000mg BID</title>
            <description>Main Group: Patients received linagliptin 2.5mg and metformin 1000mg BID, administered oral as fixed dose combination (FDC) tablet.</description>
          </group>
        </group_list>
        <measure>
          <title>The Frequency of Patients With Use of Rescue Therapy During 24 Week Treatment Period in Main Group</title>
          <description>The frequency of patients with use of rescue therapy during 24 week treatment period in main group.&#xD;
For this analysis the main group contrast 'Metformin 1000mg BID, Linagliptin 2.5mg / Metformin 1000mg BID' could not be analysed due to lack of events in the Metformin 1000mg BID group.</description>
          <population>FAS</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="141"/>
                <count group_id="O2" value="144"/>
                <count group_id="O3" value="133"/>
                <count group_id="O4" value="142"/>
                <count group_id="O5" value="141"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.1" lower_limit="3.5" upper_limit="12.7"/>
                    <measurement group_id="O2" value="2.1" lower_limit="0.4" upper_limit="6.0"/>
                    <measurement group_id="O3" value="0.0" lower_limit="0.0" upper_limit="2.7"/>
                    <measurement group_id="O4" value="1.4" lower_limit="0.2" upper_limit="5.0"/>
                    <measurement group_id="O5" value="2.1" lower_limit="0.4" upper_limit="6.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O5</group_id>
            </group_id_list>
            <groups_desc>Comparison of 'Main: Linagliptin 2.5mg / Metformin 1000mg BID' / 'Main: Linagliptin 5mg QD'.&#xD;
The logistic regression includes treatment and continuous baseline HbA1c. The validity of the model is questionable as there is possibly a quasi-complete separation of data points, the results shown are based on the last maximum likelihood iteration.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.0271</p_value>
            <method>Regression, Logistic</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>0.209</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.148</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.052</ci_lower_limit>
            <ci_upper_limit>0.838</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Comparison of 'Main: Linagliptin 2.5mg / Metformin 500mg BID' / 'Main: Metformin 500mg BID'.&#xD;
The logistic regression includes treatment and continuous baseline HbA1c. The validity of the model is questionable as there is possibly a quasi-complete separation of data points, the results shown are based on the last maximum likelihood iteration.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.9699</p_value>
            <method>Regression, Logistic</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>0.965</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.916</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.150</ci_lower_limit>
            <ci_upper_limit>6.202</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Comparison of 'Main: Linagliptin 2.5mg / Metformin 500mg BID' / 'Main: Linagliptin 5mg QD'.&#xD;
The logistic regression includes treatment and continuous baseline HbA1c. The validity of the model is questionable as there is possibly a quasi-complete separation of data points, the results shown are based on the last maximum likelihood iteration.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.0343</p_value>
            <method>Regression, Logistic</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>0.183</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.147</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.038</ci_lower_limit>
            <ci_upper_limit>0.882</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>The Frequency of Patients With Use of Rescue Therapy During 12 Week Treatment Period in APG</title>
        <description>The Frequency of Patients With Use of Rescue Therapy During 12 Week Treatment Period in APG.</description>
        <time_frame>From baseline until week 12</time_frame>
        <population>FAS</population>
        <group_list>
          <group group_id="O1">
            <title>APG: Linagliptin 5mg QD</title>
            <description>Additional parallel group (APG): Patients received linagliptin 5mg QD, administered oral as tablet.&#xD;
(Data up to week 12)</description>
          </group>
          <group group_id="O2">
            <title>APG: Linagliptin 2.5mg / Metformin 1000mg BID</title>
            <description>Additional parallel group (APG): Patients received linagliptin 2.5mg and metformin 1000mg BID, administered oral as fixed dose combination (FDC) tablet.&#xD;
(Data up to week 12)</description>
          </group>
        </group_list>
        <measure>
          <title>The Frequency of Patients With Use of Rescue Therapy During 12 Week Treatment Period in APG</title>
          <description>The Frequency of Patients With Use of Rescue Therapy During 12 Week Treatment Period in APG.</description>
          <population>FAS</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="70"/>
                <count group_id="O2" value="68"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10.0" lower_limit="4.1" upper_limit="19.5"/>
                    <measurement group_id="O2" value="1.5" lower_limit="0.0" upper_limit="7.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Comparison of 'APG: Linagliptin 2.5mg / Metformin 1000mg BID' / 'APG: Linagliptin 5mg QD'.&#xD;
The logistic regression includes treatment and continuous baseline HbA1c.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.0474</p_value>
            <method>Regression, Logistic</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>0.114</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.125</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.013</ci_lower_limit>
            <ci_upper_limit>0.976</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>From first drug administration (week 1) until end of treatment, up to 24 weeks</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Main: Linagliptin 5mg QD</title>
          <description>Main Group: Patients once daily received linagliptin 5mg QD, administered oral as tablet.</description>
        </group>
        <group group_id="E2">
          <title>Main: Metformin 500mg BID</title>
          <description>Main Group: Patients twice daily received metformin 500mg BID, administered oral as tablet.</description>
        </group>
        <group group_id="E3">
          <title>Main: Metformin 1000mg BID</title>
          <description>Main Group: Patients twice daily received metformin 1000mg BID, administered oral as tablet.</description>
        </group>
        <group group_id="E4">
          <title>Main: Linagliptin 2.5mg / Metformin 500mg BID</title>
          <description>Main Group: Patients twice daily received linagliptin 2.5mg and metformin 500mg BID, administered oral as fixed dose combination (FDC) tablet.</description>
        </group>
        <group group_id="E5">
          <title>Main: Linagliptin 2.5mg / Metformin 1000mg BID</title>
          <description>Main Group: Patients twice daily received linagliptin 2.5mg and metformin 1000mg BID, administered oral as fixed dose combination (FDC) tablet.</description>
        </group>
        <group group_id="E6">
          <title>APG: Linagliptin 5mg QD up to Week 12</title>
          <description>Additional parallel group (APG): Patients once daily received linagliptin 5mg QD, administered oral as tablet.&#xD;
(Data up to week 12)</description>
        </group>
        <group group_id="E7">
          <title>APG: Linagliptin 2.5mg / Metformin 1000mg BID up to Week 12</title>
          <description>Additional parallel group (APG): Patients twice daily received linagliptin 2.5mg and metformin 1000mg BID, administered oral as fixed dose combination (FDC) tablet.&#xD;
(Data up to week 12)</description>
        </group>
        <group group_id="E8">
          <title>APG: Linagliptin 5mg After Week 12</title>
          <description>Additional parallel group (APG): Patients once daily received linagliptin 5mg QD, administered oral as tablet. Data from week 12 to week 24</description>
        </group>
        <group group_id="E9">
          <title>APG: Linagliptin 5mg - Linagliptin 2.5mg / Met After Week 12</title>
          <description>Additional parallel group (APG): Patients who received linagliptin 5mg QD, administered oral as tablet during the first 12 weeks and switched to linagliptin 2.5mg and metformin 1000mg (met) BID, administered oral as fixed dose combination (FDC) tablet from week 12 to week 24. Data from week 12 to week 24.</description>
        </group>
        <group group_id="E10">
          <title>APG: Linagliptin 2.5mg / Metformin 1000mg After Week 12</title>
          <description>Additional parallel group (APG): Patients twice daily received linagliptin 2.5mg and metformin 1000mg BID, administered oral as fixed dose combination (FDC) tablet.&#xD;
Data from week 12 to week 24.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MEDDRA 17.0</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="147"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="145"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="144"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="147"/>
                <counts group_id="E5" subjects_affected="4" subjects_at_risk="147"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="71"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="72"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="31"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="65"/>
              </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="147"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="145"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="144"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="147"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="147"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="71"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="72"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="65"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Acute coronary syndrome</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="147"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="145"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="144"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="147"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="147"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="71"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="72"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="65"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Ear and labyrinth disorders</title>
            <event_list>
              <event>
                <sub_title>Otosclerosis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="147"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="145"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="144"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="147"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="147"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="71"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="72"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="65"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Gastric ulcer</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="147"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="145"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="144"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="147"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="147"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="71"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="72"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="65"/>
              </event>
              <event>
                <sub_title>Gastritis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="147"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="145"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="144"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="147"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="147"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="71"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="72"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="31"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="65"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Paronychia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="147"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="145"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="144"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="147"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="147"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="71"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="72"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="65"/>
              </event>
              <event>
                <sub_title>Pharyngotonsillitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="147"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="145"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="144"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="147"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="147"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="71"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="72"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="65"/>
              </event>
              <event>
                <sub_title>Pneumonia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="147"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="145"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="144"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="147"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="147"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="71"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="72"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="65"/>
              </event>
              <event>
                <sub_title>Septic shock</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="147"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="145"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="144"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="147"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="147"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="71"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="72"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="65"/>
              </event>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="147"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="145"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="144"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="147"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="147"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="71"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="72"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="65"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Clavicle fracture</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="147"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="145"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="144"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="147"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="147"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="71"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="72"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="65"/>
              </event>
              <event>
                <sub_title>Contusion</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="147"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="145"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="144"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="147"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="147"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="71"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="72"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="65"/>
              </event>
              <event>
                <sub_title>Foot fracture</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="147"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="145"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="144"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="147"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="147"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="71"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="72"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="65"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Dehydration</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="147"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="145"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="144"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="147"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="147"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="71"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="72"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="65"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Pituitary tumour</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="147"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="145"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="144"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="147"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="147"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="71"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="72"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="65"/>
              </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="0" subjects_at_risk="147"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="145"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="144"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="147"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="147"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="71"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="72"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="65"/>
              </event>
              <event>
                <sub_title>Lacunar infarction</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="147"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="145"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="144"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="147"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="147"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="71"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="72"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="65"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Renal failure acute</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="147"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="145"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="144"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="147"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="147"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="71"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="72"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="65"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Reproductive system and breast disorders</title>
            <event_list>
              <event>
                <sub_title>Breast disorder</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="147"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="145"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="144"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="147"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="147"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="71"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="72"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="65"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MEDDRA 17.0</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="30" subjects_at_risk="147"/>
                <counts group_id="E2" subjects_affected="31" subjects_at_risk="145"/>
                <counts group_id="E3" subjects_affected="42" subjects_at_risk="144"/>
                <counts group_id="E4" subjects_affected="32" subjects_at_risk="147"/>
                <counts group_id="E5" subjects_affected="41" subjects_at_risk="147"/>
                <counts group_id="E6" subjects_affected="20" subjects_at_risk="71"/>
                <counts group_id="E7" subjects_affected="15" subjects_at_risk="72"/>
                <counts group_id="E8" subjects_affected="2" subjects_at_risk="33"/>
                <counts group_id="E9" subjects_affected="9" subjects_at_risk="31"/>
                <counts group_id="E10" subjects_affected="9" subjects_at_risk="65"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="147"/>
                <counts group_id="E2" subjects_affected="8" subjects_at_risk="145"/>
                <counts group_id="E3" subjects_affected="16" subjects_at_risk="144"/>
                <counts group_id="E4" subjects_affected="7" subjects_at_risk="147"/>
                <counts group_id="E5" subjects_affected="14" subjects_at_risk="147"/>
                <counts group_id="E6" subjects_affected="2" subjects_at_risk="71"/>
                <counts group_id="E7" subjects_affected="4" subjects_at_risk="72"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="33"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="31"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="65"/>
              </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="6" subjects_at_risk="147"/>
                <counts group_id="E2" subjects_affected="6" subjects_at_risk="145"/>
                <counts group_id="E3" subjects_affected="14" subjects_at_risk="144"/>
                <counts group_id="E4" subjects_affected="12" subjects_at_risk="147"/>
                <counts group_id="E5" subjects_affected="11" subjects_at_risk="147"/>
                <counts group_id="E6" subjects_affected="2" subjects_at_risk="71"/>
                <counts group_id="E7" subjects_affected="4" subjects_at_risk="72"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="31"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="65"/>
              </event>
              <event>
                <sub_title>Nasopharyngitis</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="147"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="145"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="144"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="147"/>
                <counts group_id="E5" subjects_affected="4" subjects_at_risk="147"/>
                <counts group_id="E6" subjects_affected="4" subjects_at_risk="71"/>
                <counts group_id="E7" subjects_affected="2" subjects_at_risk="72"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="65"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Hyperglycaemia</sub_title>
                <counts group_id="E1" subjects_affected="7" subjects_at_risk="147"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="145"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="144"/>
                <counts group_id="E4" subjects_affected="4" subjects_at_risk="147"/>
                <counts group_id="E5" subjects_affected="2" subjects_at_risk="147"/>
                <counts group_id="E6" subjects_affected="12" subjects_at_risk="71"/>
                <counts group_id="E7" subjects_affected="2" subjects_at_risk="72"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E9" subjects_affected="2" subjects_at_risk="31"/>
                <counts group_id="E10" subjects_affected="2" subjects_at_risk="65"/>
              </event>
              <event>
                <sub_title>Hyperuricaemia</sub_title>
                <counts group_id="E1" subjects_affected="11" subjects_at_risk="147"/>
                <counts group_id="E2" subjects_affected="13" subjects_at_risk="145"/>
                <counts group_id="E3" subjects_affected="13" subjects_at_risk="144"/>
                <counts group_id="E4" subjects_affected="8" subjects_at_risk="147"/>
                <counts group_id="E5" subjects_affected="11" subjects_at_risk="147"/>
                <counts group_id="E6" subjects_affected="4" subjects_at_risk="71"/>
                <counts group_id="E7" subjects_affected="4" subjects_at_risk="72"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="33"/>
                <counts group_id="E9" subjects_affected="6" subjects_at_risk="31"/>
                <counts group_id="E10" subjects_affected="4" subjects_at_risk="65"/>
              </event>
              <event>
                <sub_title>Dyslipidaemia</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="147"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="145"/>
                <counts group_id="E3" subjects_affected="4" subjects_at_risk="144"/>
                <counts group_id="E4" subjects_affected="5" subjects_at_risk="147"/>
                <counts group_id="E5" subjects_affected="10" subjects_at_risk="147"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="71"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="72"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="65"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="147"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="145"/>
                <counts group_id="E3" subjects_affected="7" subjects_at_risk="144"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="147"/>
                <counts group_id="E5" subjects_affected="6" subjects_at_risk="147"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="71"/>
                <counts group_id="E7" subjects_affected="2" subjects_at_risk="72"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E9" subjects_affected="2" subjects_at_risk="31"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="65"/>
              </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>Other - 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 Pharmaceuticals</organization>
      <phone>1-800-243-0127</phone>
      <email>clintriage.rdg@boehringer-ingelheim.com</email>
    </point_of_contact>
  </clinical_results>
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01708902
org study id: 1288.18
nct id: NCT01708902
lead sponsor: 
collaborator: 
Reduced factorial design study with 24 week randomized treatment of initial combination
      therapy with linagliptin and metformin in T2DM patients
allocation: Randomized
intervention model: Factorial Assignment
primary purpose: Treatment
masking: Double
measure: The Change From Baseline in HbA1c After 24 Weeks of Treatment in Main Group
time frame: Baseline and week 24
description: The change from baseline in HbA1c after 24 weeks of treatment in main group.
The mean was adjusted by baseline HbA1c and treatment group.
measure: The Change From Baseline in HbA1c After 24 Weeks of Treatment in Main Group - FAS (OC)
time frame: Baseline and week 24
description: The change from baseline in HbA1c after 24 weeks of treatment in main group. Only subjects from the FAS with measured HbA1c values (observed cases [OC]) were considered.
The mean was adjusted by treatment, baseline HbA1c, week and treatment*week.
The sensitivity analysis was added as the primary analysis failed with borderline results.
measure: The Change From Baseline in HbA1c After 12 Weeks of Treatment in APG
time frame: Baseline and week 12
description: The change from baseline in HbA1c after 12 weeks of treatment in additional parallel group (APG)
The mean was adjusted by baseline HbA1c and treatment group.
measure: The Occurrence of Treat to Target Efficacy Response in Terms of HbA1c < 7.0 % After 24 Weeks of Treatment in Main Group
time frame: Week 24 (after first drug administration)
description: The occurrence of treat to target efficacy response in terms of HbA1c < 7.0 % after 24 weeks of treatment in main group.
measure: The Occurrence of Treat to Target Efficacy Response in Terms of HbA1c < 7.0 % After 12 Weeks of Treatment in APG
time frame: Week 12 (after first drug administration)
description: The occurrence of treat to target efficacy response in terms of HbA1c < 7.0 % after 12 weeks of treatment in APG.
measure: The Occurrence of Treat to Target Efficacy Response in Terms of HbA1c < 6.5% After 24 Weeks of Treatment in Main Group
time frame: Week 24 (after first drug administration)
description: The occurrence of treat to target efficacy response in terms of HbA1c < 6.5% after 24 weeks of treatment in main group.
measure: The Occurrence of Treat to Target Efficacy Response in Terms of HbA1c < 6.5% After 12 Weeks of Treatment in APG
time frame: Week 12 (after first drug administration)
description: The occurrence of treat to target efficacy response in terms of HbA1c < 6.5% after 12 weeks of treatment in APG.
measure: The Occurrence of Relative Efficacy Response in Main Group
time frame: From baseline until week 24
description: The occurrence of relative efficacy response (HbA1c lowering by at least 0.5% after 24 weeks of treatment) in main group
measure: The Occurrence of Relative Efficacy Response in APG
time frame: From baseline until week 12
description: The Occurrence of Relative Efficacy Response (HbA1c Lowering by at Least 0.5% After 12 Weeks of Treatment) in APG
measure: The Change in Fasting Plasma Glucose (FPG) From Baseline After 24 Weeks of Treatment in Main Group
time frame: Baseline and week 24
description: The change in fasting plasma glucose (FPG) from baseline after 24 weeks of treatment in main group.
Adjusted mean: The model includes continuous baseline HbA1c, continuous baseline FPG and treatment group.
measure: The Change in Fasting Plasma Glucose (FPG) From Baseline After 12 Weeks of Treatment in APG
time frame: Baseline and week 12
description: The Change in Fasting Plasma Glucose (FPG) From Baseline After 12 Weeks of Treatment in APG.
Adjusted mean: The model includes continuous baseline HbA1c, continuous baseline FPG and treatment group.
measure: The Frequency of Patients With Use of Rescue Therapy During 24 Week Treatment Period in Main Group
time frame: From baseline until week 24
description: The frequency of patients with use of rescue therapy during 24 week treatment period in main group.
For this analysis the main group contrast 'Metformin 1000mg BID, Linagliptin 2.5mg / Metformin 1000mg BID' could not be analysed due to lack of events in the Metformin 1000mg BID group.
measure: The Frequency of Patients With Use of Rescue Therapy During 12 Week Treatment Period in APG
time frame: From baseline until week 12
description: The Frequency of Patients With Use of Rescue Therapy During 12 Week Treatment Period in APG.
arm group label: linagliptin2.5mg / metformin500mg BID
arm group type: Experimental
description: patient to receive a tablet containing linagliptin 2.5mg and metformin 500mg BID
arm group label: linagliptin2.5mg / metformin1000mg BID
arm group type: Experimental
description: patient to receive a tablet containing linagliptin 2.5mg and metformin 1000mg BID
arm group label: metformin 500mg BID
arm group type: Active Comparator
description: patient to receive a tablet containing metformin 500mg BID
arm group label: metformin 1000mg BID
arm group type: Active Comparator
description: patient to receive a tablet containing metformin 1000mg BID
arm group label: linagliptin 5 mg QD
arm group type: Active Comparator
description: patient to receive a tablet containing linagliptin 5mg once daily
intervention type: Drug
intervention name: linagliptin2.5mg/metformin1000mg
description: linagliptin2.5mg/metformin1000mg BID
arm group label: metformin 1000mg BID
intervention type: Drug
intervention name: linagliptin2.5mg/metformin1000mg
description: linagliptin2.5mg/metformin1000mg BID
arm group label: linagliptin 5 mg QD
intervention type: Drug
intervention name: linagliptin 5mg
description: linagliptin 5mg once daily
arm group label: linagliptin2.5mg / metformin500mg BID
intervention type: Drug
intervention name: Metformin 500mg
description: Metformin 500mg BID
arm group label: linagliptin2.5mg / metformin500mg BID
intervention type: Drug
intervention name: linagliptin2.5mg/metformin500mg
description: linagliptin2.5mg/metformin500mg BID
arm group label: metformin 500mg BID
intervention type: Drug
intervention name: linagliptin2.5mg/metformin500mg
description: linagliptin2.5mg/metformin500mg BID
arm group label: linagliptin 5 mg QD
intervention type: Drug
intervention name: linagliptin 5mg
description: linagliptin 5mg once daily
arm group label: linagliptin2.5mg / metformin1000mg BID
intervention type: Drug
intervention name: Metformin 1000mg
description: Metformin 1000mg BID
arm group label: linagliptin2.5mg / metformin1000mg BID
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Boehringer Ingelheim
role: Study Chair
affiliation: Boehringer Ingelheim
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country: China
country: Malaysia
country: Philippines
country: Vietnam
url: http://trials.boehringer-ingelheim.com/
description: Related Info
responsible party type: Sponsor
mesh term: Diabetes Mellitus, Type 2
mesh term: Metformin
mesh term: Linagliptin
participant flow: 
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outcome list: 
reported events: 
certain agreements: 
point of contact: 