<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/NCT02240680</url>
  </required_header>
  <id_info>
    <org_study_id>1218.149</org_study_id>
    <secondary_id>2014-000904-88</secondary_id>
    <nct_id>NCT02240680</nct_id>
  </id_info>
  <brief_title>Linagliptin as Add on to Basal Insulin in the Elderly</brief_title>
  <official_title>A 24 Week Randomized, Double-blind, Placebo-controlled, Parallel Group, Efficacy and Safety Trial of Once Daily Linagliptin, 5 Milligrams Orally, as Add on to Basal Insulin in Elderly Type 2 Diabetes Mellitus 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>
      To investigate the efficacy, safety, and tolerability of linagliptin 5 milligrams once a day&#xD;
      compared to placebo as as add-on therapy for 24 weeks to stable basal insulin treatment in&#xD;
      elderly patients, 60 years of age and older, with Type 2 Diabetes Mellitus and insufficient&#xD;
      glycaemic control.Stable background therapy of metformin and/or alpha-glucosidase inhibitors&#xD;
      is also allowed.&#xD;
&#xD;
      In addition, this trial will assess if linagliptin reduces the risk of hypoglycaemia when&#xD;
      added to background basal insulin therapy. The treatment duration of this trial (24 weeks)&#xD;
      will enable assessment of the clinically relevant endpoint of a decrease in glycosylated&#xD;
      Haemoglobin, a well-accepted measurement of chronic glycaemic control.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 23, 2014</start_date>
  <completion_date type="Actual">April 25, 2017</completion_date>
  <primary_completion_date type="Actual">April 18, 2017</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change From Baseline in Hemoglobin A1c (HbA1c) After 24 Weeks of Treatment.</measure>
    <time_frame>Baseline and Week 24</time_frame>
    <description>This outcome has measured difference between HbA1c values from baseline to 24 weeks post treatment. The term 'baseline' refers to the last observation prior to the administration of any randomised study medication. HbA1c is a form of hemoglobin, a blood pigment that carries oxygen, which is bound to glucose. The term HbA1c also refers to glycated hemoglobin. High levels of HbA1c (Normal range is less than 6%) indicate poorer control of diabetes than level in normal range.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Percentage of Patients Experiencing at Least One Hypoglycaemia Accompanied by a Prespecified Glucose Value.</measure>
    <time_frame>24 weeks</time_frame>
    <description>Hypoglycaemia accompanied by a prespecified glucose value is defined as any investigator reported hypoglycaemia (event or AE) with a reported blood glucose level of less than 54 milligram/deciLitre (3.0 millimole/Litre) or any investigator reported symptomatic hypoglycaemic AE with a reported blood glucose level of less or equal 70 milligram/deciLitre (3.9millimole/Litre) or any severe hypoglycaemic AE. Severe hypoglycaemia is an event that requires the assistance of another person to actively administer carbohydrates or glucagon because the patient is unable to take the substance on his or her own. The confidence intervals mentioned in measure of dispersion are exact 95% confidence interval by Clopper and Pearson. The percentage of patients with at least one hypoglycaemia accompanied by a glucose value less than 54mg/dL alone has also represented separately according American Diabetes Association definition of clinically significant hypoglycaemia.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Patients With HbA1c&lt;8.0%</measure>
    <time_frame>24 weeks</time_frame>
    <description>This is the percentage of patients with HbA1c on treatment &lt;8.0% after 24 weeks of treatment. The confidence intervals mentioned in measure of dispersion are exact 95% CI by Clopper and Pearson.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Patients With HbA1c on Treatment &lt;7.0%</measure>
    <time_frame>24 weeks</time_frame>
    <description>This is the percentage of patients with HbA1c on treatment &lt;7.0% after 24 weeks of treatment. The confidence intervals mentioned in measure of dispersion are exact 95% CI by Clopper and Pearson.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Patients With HbA1c Lowering by at Least 0.5%.</measure>
    <time_frame>24 weeks</time_frame>
    <description>The percentage of patients who attained lowering of HbA1c by ≥0.5% from baseline after 24 weeks of treatment were analysed. The confidence intervals mentioned in measure of dispersion are exact 95% CI by Clopper and Pearson.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Fasting Plasma Glucose (FPG)</measure>
    <time_frame>Baseline and Week 24</time_frame>
    <description>This outcome has measured difference between FPG values from baseline to 24 weeks post treatment. The term 'baseline' refers to the last observation prior to the administration of any randomised study medication</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">302</enrollment>
  <condition>Diabetes Mellitus, Type 2</condition>
  <arm_group>
    <arm_group_label>linagliptin 5 mg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>patient to receive a tablet of linagliptin 5 mg each day</description>
  </arm_group>
  <arm_group>
    <arm_group_label>placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>patient to receive a tablet of placebo matching linagliptin 5 mg</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>placebo</intervention_name>
    <description>placebo matching linagliptin 5 mg</description>
    <arm_group_label>placebo</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>linagliptin</intervention_name>
    <description>5 mg once a day</description>
    <arm_group_label>linagliptin 5 mg</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion criteria:&#xD;
&#xD;
          -  Patients must sign and date an Informed Consent consistent with International&#xD;
             Conference on Harmonisation and Good Clinical Practice guidelines and local&#xD;
             regulations prior to any evaluation and participation in the trial.&#xD;
&#xD;
          -  Male and female patients with a clinical diagnosis of Type 2 Diabetes Mellitus, at the&#xD;
             time of Informed Consent, who are:&#xD;
&#xD;
          -  60 years of age or older at informed consent or Screen Visit,&#xD;
&#xD;
          -  taking stable doses of basal or biosimilar basal insulin [strictly inclusive of:&#xD;
             insulin neutral protamine Hagedorn and isophane insulin; Humalog Basal (a suspension&#xD;
             of insulin lispro protamine); insulin degludec; insulin detemir; and insulin glargine]&#xD;
             for at least 4 weeks prior to randomisation (Visit 3) with dose adjustments up to a&#xD;
             maximum of plus or minus 20% of baseline being allowed,&#xD;
&#xD;
          -  may or may not be taking metformin immediate release or extended release [if the&#xD;
             patient is taking metformin, stable dose must be maintained for at least twelve weeks&#xD;
             without dose adjustments prior to randomisation (Visit 3)], and&#xD;
&#xD;
          -  may or may not be taking alpha-glucosidase inhibitors [acarbose, miglitol, and&#xD;
             voglibose; if the patient is taking alpha-glucosidase inhibitors, stable dose must be&#xD;
             maintained for at least twelve weeks without dose adjustments prior to randomisation&#xD;
             (Visit 3)].&#xD;
&#xD;
          -  Patients must have an glycosylated Haemoglobin of 7.0% (53 millimoles per mole) to&#xD;
             10.0% (86 millimoles per mole) at the first visit (Screen).&#xD;
&#xD;
          -  Patients must have a Body Mass Index of 45 kilogram/meter squared or less at the&#xD;
             Screen Visit.&#xD;
&#xD;
          -  In the investigator's opinion, patients must be reliable, compliant, and agree to&#xD;
             cooperate with all planned future trial evaluations as explained in detail during the&#xD;
             informed consent process and to be able to perform them.&#xD;
&#xD;
        Exclusion criteria:&#xD;
&#xD;
          -  Impaired cognitive ability as supported by the Saint Louis University Mental Status&#xD;
             Examination, additional assessment if necessary, and verified by the investigator at&#xD;
             the Screen Visit.&#xD;
&#xD;
          -  Depressed mood as supported by a score of 10 or more on the Patient Health&#xD;
             Questionnaire at the Screen Visit.&#xD;
&#xD;
          -  Type 1 Diabetes Mellitus as determined by past medical records and history.&#xD;
&#xD;
          -  Acute coronary syndrome (non-ST Elevation Myocardial Infarction, ST Elevation&#xD;
             Myocardial Infarction, and/or unstable angina pectoris), stroke or transient ischemic&#xD;
             attack within 3 months prior to Screen Visit.&#xD;
&#xD;
          -  Indication of liver disease determined during Screen and/or Run-In Period, defined by&#xD;
             a serum level above 3 times the upper limit of normal in any of the following: alanine&#xD;
             aminotransferase, aspartate aminotransferase, or alkaline phosphatase.&#xD;
&#xD;
          -  Bariatric, gastric bypass, and other gastrointestinal procedures or surgeries&#xD;
             (including all types of gastric banding, restriction, and/or LapBand) with the&#xD;
             objective of promoting weight loss within the past two years at Screen Visit.&#xD;
&#xD;
          -  Medical history of cancer (except for resected non-invasive basal or squamous cell&#xD;
             carcinoma) and/or treatment for cancer within the last 5 years.&#xD;
&#xD;
          -  Blood dyscrasias or any disorders causing hemolysis or unstable red blood cells&#xD;
             (malaria, babesiosis, haemolytic anaemia).&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>60 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Boehringer Ingelheim</last_name>
    <role>Study Chair</role>
    <affiliation>Boehringer Ingelheim</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Syed Research Consultants, LLC</name>
      <address>
        <city>Sheffield</city>
        <state>Alabama</state>
        <zip>35660</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Precision Research Institute, LLC</name>
      <address>
        <city>Chula Vista</city>
        <state>California</state>
        <zip>91910</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Aurora Care Clinic, LLC</name>
      <address>
        <city>Costa Mesa</city>
        <state>California</state>
        <zip>92627</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Prime Care Clinical Research</name>
      <address>
        <city>Laguna Hills</city>
        <state>California</state>
        <zip>92653</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Torrance Clinical Research Institute Inc.</name>
      <address>
        <city>Lomita</city>
        <state>California</state>
        <zip>90717</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Internal Medicine of the Rockies</name>
      <address>
        <city>Colorado Springs</city>
        <state>Colorado</state>
        <zip>80910</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cohen Medical Research Associates, LLC</name>
      <address>
        <city>Delray Beach</city>
        <state>Florida</state>
        <zip>33446</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Riverside Clinical Research</name>
      <address>
        <city>Edgewater</city>
        <state>Florida</state>
        <zip>32132</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Research of Hollywood</name>
      <address>
        <city>Hollywood</city>
        <state>Florida</state>
        <zip>33024</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>East Coast Institute for Research LLC at NE FL Endo &amp; Diabetes</name>
      <address>
        <city>Jacksonville</city>
        <state>Florida</state>
        <zip>32204</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Solutions Through Advanced Research, Inc.</name>
      <address>
        <city>Jacksonville</city>
        <state>Florida</state>
        <zip>32258</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Panax Clinical Research</name>
      <address>
        <city>Miami Lakes</city>
        <state>Florida</state>
        <zip>33014</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Baptist Diabetes Associates, PA</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33156</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>International Research Associates</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33183</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>South Florida Research Solutions, LLC</name>
      <address>
        <city>Pembroke Pines</city>
        <state>Florida</state>
        <zip>33026</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Georgia Clinical Research, LLC</name>
      <address>
        <city>Snellville</city>
        <state>Georgia</state>
        <zip>30078</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Midwest Endocrinology</name>
      <address>
        <city>Crystal Lake</city>
        <state>Illinois</state>
        <zip>60012</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>American Health Network</name>
      <address>
        <city>Avon</city>
        <state>Indiana</state>
        <zip>46123</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Accent Clinical Trials</name>
      <address>
        <city>Las Vegas</city>
        <state>Nevada</state>
        <zip>89052</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Research of South Nevada</name>
      <address>
        <city>Las Vegas</city>
        <state>Nevada</state>
        <zip>89121</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Manhattan Medical Research Practice PLLC</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10016</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Family Practice Center of Wadsworth, Inc.</name>
      <address>
        <city>Wadsworth</city>
        <state>Ohio</state>
        <zip>44281</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Research Associates of Central Pennsylvania</name>
      <address>
        <city>Altoona</city>
        <state>Pennsylvania</state>
        <zip>16602</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fleetwood Clinical Research</name>
      <address>
        <city>Fleetwood</city>
        <state>Pennsylvania</state>
        <zip>19522</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Preferred Primary Care Phys</name>
      <address>
        <city>Uniontown</city>
        <state>Pennsylvania</state>
        <zip>15401</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>TLM Medical Services, LLC</name>
      <address>
        <city>Columbia</city>
        <state>South Carolina</state>
        <zip>29204</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Advanced Research Associates</name>
      <address>
        <city>Hodges</city>
        <state>South Carolina</state>
        <zip>29653</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Holston Medical Group</name>
      <address>
        <city>Kingsport</city>
        <state>Tennessee</state>
        <zip>37660</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Arlington Family Research Center, Inc.</name>
      <address>
        <city>Arlington</city>
        <state>Texas</state>
        <zip>76012</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Renaissance Clinical Research and Hypertension of Texas</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75234</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Diabetes and Thyroid Center of Fort Worth</name>
      <address>
        <city>Fort Worth</city>
        <state>Texas</state>
        <zip>76132</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Houston Clinical Research Associates</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77090</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Science Advancing Medicine Clinical Research Center</name>
      <address>
        <city>San Antonio</city>
        <state>Texas</state>
        <zip>78229</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Office of Dr. Val R. Hansen</name>
      <address>
        <city>Bountiful</city>
        <state>Utah</state>
        <zip>84010</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Millennium Clinical Trials LLC</name>
      <address>
        <city>Arlington</city>
        <state>Virginia</state>
        <zip>22203</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>York Clinical Research, LLC</name>
      <address>
        <city>Norfolk</city>
        <state>Virginia</state>
        <zip>23510</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Rowan Research, Inc.</name>
      <address>
        <city>Spokane</city>
        <state>Washington</state>
        <zip>99218</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Family Medical Clinic</name>
      <address>
        <city>Milwaukee</city>
        <state>Wisconsin</state>
        <zip>53216</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>AIM Centre</name>
      <address>
        <city>Merewether</city>
        <state>New South Wales</state>
        <zip>2291</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Royal Brisbane &amp; Women's Hospital-Endocrinology</name>
      <address>
        <city>Herston</city>
        <state>Queensland</state>
        <zip>4029</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>ECRU Maroondah</name>
      <address>
        <city>East Ringwood</city>
        <state>Victoria</state>
        <zip>3135</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ham - PRAC Mortelmans</name>
      <address>
        <city>Oostham</city>
        <zip>3945</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CEQUIN</name>
      <address>
        <city>Armenia</city>
        <zip>630004</zip>
        <country>Colombia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dexa Diabetes Servicios Médicos Ltda</name>
      <address>
        <city>Bogotá</city>
        <zip>110221</zip>
        <country>Colombia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CAFAM Caja de Compensación Familiar</name>
      <address>
        <city>Bogotá</city>
        <zip>111211</zip>
        <country>Colombia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Asociacion IPS Medicos Internistas de Caldas</name>
      <address>
        <city>Manizales</city>
        <zip>170004</zip>
        <country>Colombia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Pablo Tobón Uribe</name>
      <address>
        <city>Medellín</city>
        <zip>050034</zip>
        <country>Colombia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Aalborg Sygehus Syd</name>
      <address>
        <city>Aalborg</city>
        <zip>9100</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sydvestjyst Sygehus Esbjerg, Endokrinologisk afdeling</name>
      <address>
        <city>Esbjerg</city>
        <zip>6700</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Frederiksberg Hospital, Endokrinologisk afd.</name>
      <address>
        <city>Frederiksberg</city>
        <zip>2000</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Gentofte University Hospital</name>
      <address>
        <city>Hellerup</city>
        <zip>2900</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kolding Sygehus</name>
      <address>
        <city>Kolding</city>
        <zip>6000</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Bispebjerg Hospital</name>
      <address>
        <city>København NV</city>
        <zip>2400</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Køge Sygehus</name>
      <address>
        <city>Køge</city>
        <zip>4600</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Roskilde Sygehus</name>
      <address>
        <city>Roskilde</city>
        <zip>4000</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Keravan terveyskeskus</name>
      <address>
        <city>Kerava</city>
        <zip>04200</zip>
        <country>Finland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Terveystalo Oulu, Diapolis</name>
      <address>
        <city>Oulu</city>
        <zip>FI-90100</zip>
        <country>Finland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Lääkärikeskus Aava, Turku</name>
      <address>
        <city>Turku</city>
        <zip>20520</zip>
        <country>Finland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>TYKS</name>
      <address>
        <city>Turku</city>
        <zip>FI-20520</zip>
        <country>Finland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Gemeinschaftspraxis, Asslar</name>
      <address>
        <city>Asslar</city>
        <zip>35614</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>ikfe - Institut für klinische Forschung und Entwicklung Berlin GmbH</name>
      <address>
        <city>Berlin</city>
        <zip>10115</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Diabetologische Schwerpunktpraxis, Bosenheim</name>
      <address>
        <city>Bosenheim</city>
        <zip>55545</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dünnwaldpraxis, Köln</name>
      <address>
        <city>Koeln</city>
        <zip>51069</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Praxis Dr. Naudts, Rodgau</name>
      <address>
        <city>Rodgau</city>
        <zip>63110</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Praxis Dr. Braun, Unterschneidheim</name>
      <address>
        <city>Unterschneidheim</city>
        <zip>73485</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>&quot;Korgialeneio-Benakeio&quot; Hellenic Red Cross Hospital</name>
      <address>
        <city>Athens</city>
        <zip>115 26</zip>
        <country>Greece</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>General Hospital of Athens &quot;G. Gennimatas&quot;</name>
      <address>
        <city>Athens</city>
        <zip>11527</zip>
        <country>Greece</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Univ. Gen. Hosp. of Ioannina</name>
      <address>
        <city>Ioannina</city>
        <zip>45500</zip>
        <country>Greece</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>General Hospital of Attiki &quot;KAT-EKA&quot;</name>
      <address>
        <city>Kifisia</city>
        <zip>14561</zip>
        <country>Greece</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>General Hospital of Nikaia</name>
      <address>
        <city>Nikaia</city>
        <zip>18454</zip>
        <country>Greece</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>General Hospital of Thessaloniki &quot;G. Papanikolaou&quot;</name>
      <address>
        <city>Thessaloniki</city>
        <zip>57010</zip>
        <country>Greece</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Connolly Hospital Blanchardstown</name>
      <address>
        <city>Dublin</city>
        <zip>Dublin 15</zip>
        <country>Ireland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Daishinkai Medical Corporation Ookuma Hospital</name>
      <address>
        <city>Aichi, Nagoya</city>
        <zip>462-0825</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Matsuyama Shimin Hospital</name>
      <address>
        <city>Ehime, Matsuyama</city>
        <zip>790-0067</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Iryohojin Kikuchi Naika Clinic</name>
      <address>
        <city>Gunma, Maebashi</city>
        <zip>370-3573</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nakamura Digestive Organ Internal Medicine Clinic</name>
      <address>
        <city>Hokkaido, Bibai</city>
        <zip>072-0012</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Iida Medical Clinic</name>
      <address>
        <city>Hokkaido, Hakodate</city>
        <zip>042-0942</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Jiyugaoka Yamada Clinic</name>
      <address>
        <city>Hokkaido, Obihiro</city>
        <zip>080-0848</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Shinkotoni family Clinic</name>
      <address>
        <city>Hokkaido, Sapporo</city>
        <zip>001-0912</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Yoshida Memorial Hospital</name>
      <address>
        <city>Hokkaido, Sapporo</city>
        <zip>003-0026</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Teine Keijinkai Clinic</name>
      <address>
        <city>Hokkaido, Sapporo</city>
        <zip>006-0811</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Japan Community Health Care Organization Hokkaido Hospital</name>
      <address>
        <city>Hokkaido, Sapporo</city>
        <zip>062-8618</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Itabashi Diabetic medicine and Dermatology Clinic</name>
      <address>
        <city>Ibaraki, Koga</city>
        <zip>306-0232</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nakakinen Clinic</name>
      <address>
        <city>Ibaraki, Naka</city>
        <zip>311-0113</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Takai Naika Clinic</name>
      <address>
        <city>Kanagawa, Kamakura</city>
        <zip>247-0056</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kaneshiro DIAB Clinic, Kanagawa, I.M.</name>
      <address>
        <city>Kanagawa, Sagamihara</city>
        <zip>252-0302</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Asahi Med. clinic, Kanagawa, I.M.</name>
      <address>
        <city>Kanagawa, Yokohama</city>
        <zip>221-0802</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ishikawa Med. Clinic, Kanagawa, I.M.</name>
      <address>
        <city>Kanagawa, Yokohama</city>
        <zip>241-0821</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>National Hospital Organization Yokohama Medical Center</name>
      <address>
        <city>Kanagawa, Yokohama</city>
        <zip>245-8575</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Okayama Saiseikai General Hospital Outpatient Center</name>
      <address>
        <city>Okayama, Okayama</city>
        <zip>700-8511</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>AMC Nishi-umeda Clinic</name>
      <address>
        <city>Osaka, Osaka</city>
        <zip>530-0001</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nissay Hospital Nippon Life Saiseikai Public Interest Incorporated Foundation</name>
      <address>
        <city>Osaka, Osaka</city>
        <zip>550-0012</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>OCROM Clinic</name>
      <address>
        <city>Osaka, Suita</city>
        <zip>565-0853</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Saga Memorial Hospital</name>
      <address>
        <city>Saga, Saga</city>
        <zip>849-0917</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Asano Clinic</name>
      <address>
        <city>Saitama, Kawagoe</city>
        <zip>350-0851</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hamamatsu Rosai Hospital</name>
      <address>
        <city>Shizuoka, Hamamatsu</city>
        <zip>430-8525</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kuriyama Clinic</name>
      <address>
        <city>Tokyo, Adachi-ku</city>
        <zip>121-0064</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Institute for Adult Deseases, Asahi Life Foundation</name>
      <address>
        <city>Tokyo, Chuo-ku</city>
        <zip>103-0002</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tokyo-Eki Center-building Clinic</name>
      <address>
        <city>Tokyo, Chuo-ku</city>
        <zip>103-0027</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tokyo Center Clinic</name>
      <address>
        <city>Tokyo, Chuo-ku</city>
        <zip>103-0028</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>AGE Makita Medical Clinic</name>
      <address>
        <city>Tokyo, Chuo-ku</city>
        <zip>104-0061</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kobayashi Internal Medicine Clinic</name>
      <address>
        <city>Tokyo, Koto-ku</city>
        <zip>135-0011</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kunitachi Naika Clinic</name>
      <address>
        <city>Tokyo, Kunitachi</city>
        <zip>186-0002</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Japanese Red Cross Medical Center</name>
      <address>
        <city>Tokyo, Shibuya-ku</city>
        <zip>150-8935</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigación en Salud y Metabolismo S.C.</name>
      <address>
        <city>Chihuahua</city>
        <zip>31217</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centro de At. e Inv.en Fact.de riesgo cardiovasc.Omega, S.C.</name>
      <address>
        <city>Mexico</city>
        <zip>06400</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CAIMED</name>
      <address>
        <city>Mexico</city>
        <zip>06760</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinstile S.A. de C.V.</name>
      <address>
        <city>México</city>
        <zip>06700</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CEDOPEC-Ctro Esp en Diab, Obesidad y Prev de Enf Cardiovasc</name>
      <address>
        <city>México</city>
        <zip>C.P. 11650</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Asociación Mexicana para la Investigacion Clínica, A.C(AMIC)</name>
      <address>
        <city>Pachuca</city>
        <zip>42070</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>South Pacific Clinical Trials</name>
      <address>
        <city>Auckland, New Zealand</city>
        <zip>0610</zip>
        <country>New Zealand</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Middlemore Clinical Trials</name>
      <address>
        <city>Auckland</city>
        <zip>2025</zip>
        <country>New Zealand</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Christchurch Hospital</name>
      <address>
        <city>Christchurch</city>
        <zip>8011</zip>
        <country>New Zealand</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medicome Sp. z o.o.</name>
      <address>
        <city>Oswiecim</city>
        <zip>32-600</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Omedica Centrum Medyczne</name>
      <address>
        <city>Poznan</city>
        <zip>60-111</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>NBR Polska</name>
      <address>
        <city>Warszawa</city>
        <zip>00-465</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nicodiab SRL, Bucharest</name>
      <address>
        <city>Bucharest</city>
        <zip>010507</zip>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Pelican Impex SRL, Cabinet Nr. 15</name>
      <address>
        <city>Oradea</city>
        <zip>410469</zip>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mediab SRL</name>
      <address>
        <city>Tirgu Mures</city>
        <zip>540142</zip>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>TREAD Research</name>
      <address>
        <city>Cape Town</city>
        <zip>7500</zip>
        <country>South Africa</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tiervlei Trial Centre</name>
      <address>
        <city>Cape Town</city>
        <zip>7530</zip>
        <country>South Africa</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Paarl Research Centre</name>
      <address>
        <city>Cape Town</city>
        <zip>7646</zip>
        <country>South Africa</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Soweto Clinical Trials Centre</name>
      <address>
        <city>Johannesburg</city>
        <zip>1818</zip>
        <country>South Africa</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>LCS Clinical Research Unit</name>
      <address>
        <city>Johannesburg</city>
        <zip>2021</zip>
        <country>South Africa</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Resego Health Services</name>
      <address>
        <city>Johannesburg</city>
        <zip>2189</zip>
        <country>South Africa</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Zinakekele Medical Centre</name>
      <address>
        <city>KwaMhlanga</city>
        <zip>1022</zip>
        <country>South Africa</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mzansi Ethical Research Centre</name>
      <address>
        <city>Middleburg</city>
        <zip>1055</zip>
        <country>South Africa</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>VX Pharma (Pty) Ltd Pretoria</name>
      <address>
        <city>Pretoria</city>
        <zip>0087</zip>
        <country>South Africa</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital A Coruña</name>
      <address>
        <city>A Coruña</city>
        <zip>15003</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Instituto de Ciencias Médicas</name>
      <address>
        <city>Alicante</city>
        <zip>03004</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Quiron. I.C.U.</name>
      <address>
        <city>Barcelona</city>
        <zip>08023</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>C.A.P. Sardenya</name>
      <address>
        <city>Barcelona</city>
        <zip>08025</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CAP Les Corts</name>
      <address>
        <city>Barcelona</city>
        <zip>08028</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CAP Canet de Mar</name>
      <address>
        <city>Canet de Mar</city>
        <zip>08360</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Virgen de la Victoria</name>
      <address>
        <city>Malaga</city>
        <zip>29010</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Nuestra Señora de Valme</name>
      <address>
        <city>Sevilla</city>
        <zip>41014</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Clínico de Valencia</name>
      <address>
        <city>Valencia</city>
        <zip>46010</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CAP El Remei</name>
      <address>
        <city>Vic</city>
        <zip>08500</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Haven Surgery</name>
      <address>
        <city>Burnhope</city>
        <zip>DH7 0BD</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>South Axholme Practice</name>
      <address>
        <city>Doncaster</city>
        <zip>DN9 2HY</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fowey Clinical Research Company Ltd</name>
      <address>
        <city>Fowey</city>
        <zip>PL23 1DT</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Oak Tree Surgery</name>
      <address>
        <city>Liskeard</city>
        <zip>PL14 3XA</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St. Mary's Hospital, Vectasearch Clinic, Newport</name>
      <address>
        <city>Newport</city>
        <zip>PO309 5TG</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mounts Bay Medical Ltd</name>
      <address>
        <city>Penzance</city>
        <zip>TR19 7HX</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Rame Medical, Penntorr Health</name>
      <address>
        <city>Torpoint</city>
        <zip>PL11 2TB</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Australia</country>
    <country>Belgium</country>
    <country>Colombia</country>
    <country>Denmark</country>
    <country>Finland</country>
    <country>Germany</country>
    <country>Greece</country>
    <country>Ireland</country>
    <country>Japan</country>
    <country>Mexico</country>
    <country>New Zealand</country>
    <country>Poland</country>
    <country>Romania</country>
    <country>South Africa</country>
    <country>Spain</country>
    <country>United Kingdom</country>
    <country>United States</country>
  </location_countries>
  <verification_date>May 2018</verification_date>
  <study_first_submitted>September 15, 2014</study_first_submitted>
  <study_first_submitted_qc>September 15, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 16, 2014</study_first_posted>
  <results_first_submitted>April 17, 2018</results_first_submitted>
  <results_first_submitted_qc>June 1, 2018</results_first_submitted_qc>
  <results_first_posted type="Actual">July 3, 2018</results_first_posted>
  <last_update_submitted>June 1, 2018</last_update_submitted>
  <last_update_submitted_qc>June 1, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">July 3, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Diabetes Mellitus</mesh_term>
    <mesh_term>Diabetes Mellitus, Type 2</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Linagliptin</mesh_term>
  </intervention_browse>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>October 16, 2015</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/80/NCT02240680/Prot_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>November 9, 2016</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/80/NCT02240680/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>This was randomised, double blinded, placebo controlled, parallel study. Total 525 patients with type 2 diabetes mellitus (T2DM) and insufficient glycaemic control were screened. 302 patients were randomised into two groups. The trial was extended to 52 weeks for Japanese patients. 102 patients were identified and observed for the extended period.</recruitment_details>
      <pre_assignment_details>All patients were screened for eligibility to participate in the trial. Subjects attended specialist sites which would then ensure that they (the subject) met all strictly implemented inclusion/exclusion criteria. Subjects were not to be randomised to trial treatment if any one of the specific entry criteria were violated.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Placebo (Up to 24 Weeks)</title>
          <description>Patients were orally administered with Placebo tablets (matching Linagliptin) once daily up to 24 weeks</description>
        </group>
        <group group_id="P2">
          <title>Linagliptin 5 Milligram (Up to 24 Weeks)</title>
          <description>Patients were orally administered with Linagliptin 5 milligram film-coated tablets once daily up to 24 weeks.</description>
        </group>
        <group group_id="P3">
          <title>Placebo (Up to 52 Weeks)</title>
          <description>Only Japanese patients were orally administered with Placebo tablets (matching Linagliptin) once daily up to 52 weeks</description>
        </group>
        <group group_id="P4">
          <title>Linagliptin 5 Milligram (Up to 52 Weeks)</title>
          <description>Only Japanese patients were orally administered with Linagliptin 5 milligram film-coated tablets once daily up to 52 weeks</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study (Up to 24 Weeks)</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="151"/>
                <participants group_id="P2" count="151"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="136"/>
                <participants group_id="P2" count="143"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="15"/>
                <participants group_id="P2" count="8"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="6"/>
                <participants group_id="P2" count="6"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Protocol Violation</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</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_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Other than specified</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
        <period>
          <title>Japanese Patients (Up to 52 Weeks)</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="50"/>
                <participants group_id="P4" count="52"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="42"/>
                <participants group_id="P4" count="45"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="8"/>
                <participants group_id="P4" 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="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="6"/>
                <participants group_id="P4" count="7"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Protocol Violation</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="1"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="1"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Treated set (TS): It includes all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.</population>
      <group_list>
        <group group_id="B1">
          <title>Placebo (Up to 24 Weeks)</title>
          <description>Patients were orally administered with Placebo tablets (matching Linagliptin) once daily up to 24 weeks</description>
        </group>
        <group group_id="B2">
          <title>Linagliptin 5 Milligram (Up to 24 Weeks)</title>
          <description>Patients were orally administered with Linagliptin 5 milligram film-coated tablets once daily up to 24 weeks.</description>
        </group>
        <group group_id="B3">
          <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="151"/>
            <count group_id="B2" value="151"/>
            <count group_id="B3" value="302"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <description>Data of age collected for all included patients in the study.</description>
          <population>Treated set (TS): includes all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.</population>
          <units>Years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="151"/>
                    <count group_id="B2" value="151"/>
                    <count group_id="B3" value="302"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="72.5" spread="5.6"/>
                    <measurement group_id="B2" value="72.3" spread="5.1"/>
                    <measurement group_id="B3" value="72.4" spread="5.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <description>Data of Gender collected of all patients included in the study.</description>
          <population>Treated set (TS): includes all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="151"/>
                    <count group_id="B2" value="151"/>
                    <count group_id="B3" value="302"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="60"/>
                    <measurement group_id="B2" value="59"/>
                    <measurement group_id="B3" value="119"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="91"/>
                    <measurement group_id="B2" value="92"/>
                    <measurement group_id="B3" value="183"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <description>Data for Ethnicity of patients collected under protocol for all included patients in the study.</description>
          <population>Treated set (TS): includes all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="151"/>
                    <count group_id="B2" value="151"/>
                    <count group_id="B3" value="302"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="19"/>
                    <measurement group_id="B2" value="15"/>
                    <measurement group_id="B3" value="34"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="132"/>
                    <measurement group_id="B2" value="136"/>
                    <measurement group_id="B3" value="268"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <description>Data for Race of patients collected under protocol for all included patients in the study.</description>
          <population>Treated set (TS): It includes all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="151"/>
                    <count group_id="B2" value="151"/>
                    <count group_id="B3" value="302"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="11"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="52"/>
                    <measurement group_id="B2" value="52"/>
                    <measurement group_id="B3" value="104"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                    <measurement group_id="B2" value="8"/>
                    <measurement group_id="B3" value="18"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="81"/>
                    <measurement group_id="B2" value="84"/>
                    <measurement group_id="B3" value="165"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Hemoglobin A1c (HbA1c) at baseline</title>
          <description>HbA1c values measured at baseline in percent. HbA1c is a form of hemoglobin, a blood pigment that carries oxygen, which is bound to glucose. The term HbA1c also refers to glycated hemoglobin. High levels of HbA1c (Normal range is less than 6%) indicate poorer control of diabetes than level in normal range.</description>
          <population>Full analysis set (FAS): Includes all patients randomised in the Treated Set who had a baseline and at least one on-treatment HbA1c value.</population>
          <units>Percentage of HbA1c (%)</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="147"/>
                    <count group_id="B2" value="149"/>
                    <count group_id="B3" value="296"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="8.1" spread="0.7"/>
                    <measurement group_id="B2" value="8.2" spread="0.8"/>
                    <measurement group_id="B3" value="8.2" spread="0.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Change From Baseline in Hemoglobin A1c (HbA1c) After 24 Weeks of Treatment.</title>
        <description>This outcome has measured difference between HbA1c values from baseline to 24 weeks post treatment. The term 'baseline' refers to the last observation prior to the administration of any randomised study medication. HbA1c is a form of hemoglobin, a blood pigment that carries oxygen, which is bound to glucose. The term HbA1c also refers to glycated hemoglobin. High levels of HbA1c (Normal range is less than 6%) indicate poorer control of diabetes than level in normal range.</description>
        <time_frame>Baseline and Week 24</time_frame>
        <population>Full analysis set observed cases (FAS (OC)): Includes all patients randomised in the Treated Set who had a baseline and at least one on-treatment HbA1c value. These analyses used available data as observed while patients were on treatment. All values collected after a patient started rescue medication were excluded from the analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo (Up to 24 Weeks)</title>
            <description>Patients were orally administered with Placebo tablets (matching Linagliptin) once daily up to 24 weeks</description>
          </group>
          <group group_id="O2">
            <title>Linagliptin 5 Milligram (Up to 24 Weeks)</title>
            <description>Patients were orally administered with Linagliptin 5 milligram film-coated tablets once daily up to 24 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Hemoglobin A1c (HbA1c) After 24 Weeks of Treatment.</title>
          <description>This outcome has measured difference between HbA1c values from baseline to 24 weeks post treatment. The term 'baseline' refers to the last observation prior to the administration of any randomised study medication. HbA1c is a form of hemoglobin, a blood pigment that carries oxygen, which is bound to glucose. The term HbA1c also refers to glycated hemoglobin. High levels of HbA1c (Normal range is less than 6%) indicate poorer control of diabetes than level in normal range.</description>
          <population>Full analysis set observed cases (FAS (OC)): Includes all patients randomised in the Treated Set who had a baseline and at least one on-treatment HbA1c value. These analyses used available data as observed while patients were on treatment. All values collected after a patient started rescue medication were excluded from the analysis.</population>
          <units>Percentage (%) of HbA1c</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="147"/>
                <count group_id="O2" value="149"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.38" spread="0.07"/>
                    <measurement group_id="O2" value="-1.01" spread="0.06"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt; 0.0001</p_value>
            <method>Mixed Models Analysis</method>
            <method_desc>Mixed model repeated measures(MMRM) included treatment, week and interaction as fixed effects, baseline HbA1c, daily basal insulin dose as covariates</method_desc>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-0.63</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.09</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.81</ci_lower_limit>
            <ci_upper_limit>-0.46</ci_upper_limit>
            <estimate_desc>Adjusted mean of all differences between HbA1c at baseline and after 24 weeks. It is based on all patients in the model (not only patients with a baseline and week 24 measurement).</estimate_desc>
            <other_analysis_desc>MMRM including fixed effects treatment , week and treatment by week interaction linear covariates baseline HbA1c , baseline daily basal insulin and baseline HbA1c by week interaction and random effect for patient. Within-patient errors are modelled by unstructured covariance matrix. Adjusted mean is based on all patients in the model (not only patients with a baseline and week 24 measurement).</other_analysis_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Patients Experiencing at Least One Hypoglycaemia Accompanied by a Prespecified Glucose Value.</title>
        <description>Hypoglycaemia accompanied by a prespecified glucose value is defined as any investigator reported hypoglycaemia (event or AE) with a reported blood glucose level of less than 54 milligram/deciLitre (3.0 millimole/Litre) or any investigator reported symptomatic hypoglycaemic AE with a reported blood glucose level of less or equal 70 milligram/deciLitre (3.9millimole/Litre) or any severe hypoglycaemic AE. Severe hypoglycaemia is an event that requires the assistance of another person to actively administer carbohydrates or glucagon because the patient is unable to take the substance on his or her own. The confidence intervals mentioned in measure of dispersion are exact 95% confidence interval by Clopper and Pearson. The percentage of patients with at least one hypoglycaemia accompanied by a glucose value less than 54mg/dL alone has also represented separately according American Diabetes Association definition of clinically significant hypoglycaemia.</description>
        <time_frame>24 weeks</time_frame>
        <population>Full analysis set observed cases (FAS (OC)): Includes all patients randomised in the Treated Set who had a baseline and at least one on-treatment HbA1c value. These analyses used available data as observed while patients were on treatment. All values collected after a patient started rescue medication were excluded from the analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo (Up to 24 Weeks)</title>
            <description>Patients were orally administered with Placebo tablets (matching Linagliptin) once daily up to 24 weeks</description>
          </group>
          <group group_id="O2">
            <title>Linagliptin 5 Milligram (Up to 24 Weeks)</title>
            <description>Patients were orally administered with Linagliptin 5 milligram film-coated tablets once daily up to 24 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Patients Experiencing at Least One Hypoglycaemia Accompanied by a Prespecified Glucose Value.</title>
          <description>Hypoglycaemia accompanied by a prespecified glucose value is defined as any investigator reported hypoglycaemia (event or AE) with a reported blood glucose level of less than 54 milligram/deciLitre (3.0 millimole/Litre) or any investigator reported symptomatic hypoglycaemic AE with a reported blood glucose level of less or equal 70 milligram/deciLitre (3.9millimole/Litre) or any severe hypoglycaemic AE. Severe hypoglycaemia is an event that requires the assistance of another person to actively administer carbohydrates or glucagon because the patient is unable to take the substance on his or her own. The confidence intervals mentioned in measure of dispersion are exact 95% confidence interval by Clopper and Pearson. The percentage of patients with at least one hypoglycaemia accompanied by a glucose value less than 54mg/dL alone has also represented separately according American Diabetes Association definition of clinically significant hypoglycaemia.</description>
          <population>Full analysis set observed cases (FAS (OC)): Includes all patients randomised in the Treated Set who had a baseline and at least one on-treatment HbA1c value. These analyses used available data as observed while patients were on treatment. All values collected after a patient started rescue medication were excluded from the analysis.</population>
          <units>Percentage of patients (%)</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="147"/>
                <count group_id="O2" value="149"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Prespecified glucose value</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="23.8" lower_limit="17.2" upper_limit="31.5"/>
                    <measurement group_id="O2" value="30.9" lower_limit="23.6" upper_limit="39.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Glucose value &lt;54 mg/dL</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15.0" lower_limit="9.6" upper_limit="21.8"/>
                    <measurement group_id="O2" value="16.8" lower_limit="11.2" upper_limit="23.8"/>
                  </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>For any hypoglycemia event accompanied by prespecified glucose value</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.1594</p_value>
            <method>Regression, Logistic</method>
            <method_desc>A logistic regression model with treatment as fixed effect and baseline HbA1c and baseline daily basal insulin dose as linear covariates was applied.</method_desc>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>1.464</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.397</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.861</ci_lower_limit>
            <ci_upper_limit>2.491</ci_upper_limit>
            <estimate_desc>The dispersion value standard error of the mean is actually standard error for odds ratio.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>For glucose value &lt; 54mg/dL according American Diabetes Association definition of clinically significant hypoglycaemia</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.6720</p_value>
            <method>Regression, Logistic</method>
            <method_desc>A logistic regression model with treatment as fixed effect and baseline HbA1c and baseline daily basal insulin dose as linear covariates was applied.</method_desc>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>1.149</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.377</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.604</ci_lower_limit>
            <ci_upper_limit>2.188</ci_upper_limit>
            <estimate_desc>The dispersion value standard error of the mean is actually standard error for odds ratio.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Patients With HbA1c&lt;8.0%</title>
        <description>This is the percentage of patients with HbA1c on treatment &lt;8.0% after 24 weeks of treatment. The confidence intervals mentioned in measure of dispersion are exact 95% CI by Clopper and Pearson.</description>
        <time_frame>24 weeks</time_frame>
        <population>Full analysis set (Non-completers considered failure)(FAS (NCF)): Includes all patients randomised in the Treated Set who had a baseline and at least one on-treatment HbA1c value. This analyses regarded missing values for binary efficacy endpoints as failure.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo (Up to 24 Weeks)</title>
            <description>Patients were orally administered with Placebo tablets (matching Linagliptin) once daily up to 24 weeks</description>
          </group>
          <group group_id="O2">
            <title>Linagliptin 5 Milligram (Up to 24 Weeks)</title>
            <description>Patients were orally administered with Linagliptin 5 milligram film-coated tablets once daily up to 24 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Patients With HbA1c&lt;8.0%</title>
          <description>This is the percentage of patients with HbA1c on treatment &lt;8.0% after 24 weeks of treatment. The confidence intervals mentioned in measure of dispersion are exact 95% CI by Clopper and Pearson.</description>
          <population>Full analysis set (Non-completers considered failure)(FAS (NCF)): Includes all patients randomised in the Treated Set who had a baseline and at least one on-treatment HbA1c value. This analyses regarded missing values for binary efficacy endpoints as failure.</population>
          <units>Percentage of patients (%)</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="147"/>
                <count group_id="O2" value="149"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="40.2" lower_limit="29.9" upper_limit="51.3"/>
                    <measurement group_id="O2" value="70.1" lower_limit="59.4" upper_limit="79.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>&lt; 0.0001</p_value>
            <method>Regression, Logistic</method>
            <method_desc>A logistic regression model with treatment as fixed effect and baseline HbA1c and baseline daily basal insulin dose as linear covariates was applied.</method_desc>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>5.018</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>1.818</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>2.468</ci_lower_limit>
            <ci_upper_limit>10.206</ci_upper_limit>
            <estimate_desc>The dispersion value standard error of the mean is actually standard error of odds ratio</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Patients With HbA1c on Treatment &lt;7.0%</title>
        <description>This is the percentage of patients with HbA1c on treatment &lt;7.0% after 24 weeks of treatment. The confidence intervals mentioned in measure of dispersion are exact 95% CI by Clopper and Pearson.</description>
        <time_frame>24 weeks</time_frame>
        <population>Full analysis set non-completers considered failure (FAS (NCF)): Includes all patients randomised in the treated set who had a baseline and at least one on-treatment HbA1c value. This analyses regarded missing values for binary efficacy endpoints as failure.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo (Up to 24 Weeks)</title>
            <description>Patients were orally administered with Placebo tablets (matching Linagliptin) once daily up to 24 weeks</description>
          </group>
          <group group_id="O2">
            <title>Linagliptin 5 Milligram (Up to 24 Weeks)</title>
            <description>Patients were orally administered with Linagliptin 5 milligram film-coated tablets once daily up to 24 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Patients With HbA1c on Treatment &lt;7.0%</title>
          <description>This is the percentage of patients with HbA1c on treatment &lt;7.0% after 24 weeks of treatment. The confidence intervals mentioned in measure of dispersion are exact 95% CI by Clopper and Pearson.</description>
          <population>Full analysis set non-completers considered failure (FAS (NCF)): Includes all patients randomised in the treated set who had a baseline and at least one on-treatment HbA1c value. This analyses regarded missing values for binary efficacy endpoints as failure.</population>
          <units>Percentage of Patients (%)</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="147"/>
                <count group_id="O2" value="149"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="14.6" lower_limit="9.3" upper_limit="21.4"/>
                    <measurement group_id="O2" value="37.8" lower_limit="29.8" upper_limit="46.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>&lt; 0.0001</p_value>
            <method>Regression, Logistic</method>
            <method_desc>A logistic regression model with treatment as fixed effect and baseline HbA1c and baseline daily basal insulin dose as linear covariates was applied.</method_desc>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>4.689</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>1.519</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>2.485</ci_lower_limit>
            <ci_upper_limit>8.848</ci_upper_limit>
            <estimate_desc>The dispersion value standard error of the mean is actually standard error of odds ratio</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Patients With HbA1c Lowering by at Least 0.5%.</title>
        <description>The percentage of patients who attained lowering of HbA1c by ≥0.5% from baseline after 24 weeks of treatment were analysed. The confidence intervals mentioned in measure of dispersion are exact 95% CI by Clopper and Pearson.</description>
        <time_frame>24 weeks</time_frame>
        <population>Full analysis set non-completers considered failure (FAS (NCF)): Includes all patients randomised in the treated set who had a baseline and at least one on-treatment HbA1c value. This analyses regarded missing values for binary efficacy endpoints as failure.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo (Up to 24 Weeks)</title>
            <description>Patients were orally administered with Placebo tablets (matching Linagliptin) once daily up to 24 weeks</description>
          </group>
          <group group_id="O2">
            <title>Linagliptin 5 Milligram (Up to 24 Weeks)</title>
            <description>Patients were orally administered with Linagliptin 5 milligram film-coated tablets once daily up to 24 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Patients With HbA1c Lowering by at Least 0.5%.</title>
          <description>The percentage of patients who attained lowering of HbA1c by ≥0.5% from baseline after 24 weeks of treatment were analysed. The confidence intervals mentioned in measure of dispersion are exact 95% CI by Clopper and Pearson.</description>
          <population>Full analysis set non-completers considered failure (FAS (NCF)): Includes all patients randomised in the treated set who had a baseline and at least one on-treatment HbA1c value. This analyses regarded missing values for binary efficacy endpoints as failure.</population>
          <units>Percentage of patients (%)</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="147"/>
                <count group_id="O2" value="149"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="37.4" lower_limit="29.6" upper_limit="45.8"/>
                    <measurement group_id="O2" value="69.1" lower_limit="61.0" upper_limit="76.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>&lt; 0.0001</p_value>
            <method>Regression, Logistic</method>
            <method_desc>A logistic regression model with treatment as fixed effect and baseline HbA1c and baseline daily basal insulin dose as linear covariates was applied.</method_desc>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>3.731</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.920</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>2.302</ci_lower_limit>
            <ci_upper_limit>6.048</ci_upper_limit>
            <estimate_desc>The dispersion value standard error of the mean is actually standard error of odds ratio</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Fasting Plasma Glucose (FPG)</title>
        <description>This outcome has measured difference between FPG values from baseline to 24 weeks post treatment. The term 'baseline' refers to the last observation prior to the administration of any randomised study medication</description>
        <time_frame>Baseline and Week 24</time_frame>
        <population>Full analysis set observed cases (FAS (OC)): Includes all patients randomised in the Treated Set who had a baseline and at least one on-treatment HbA1c value. These analyses used available data as observed while patients were on treatment. All values collected after a patient started rescue medication were excluded from the analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo (Up to 24 Weeks)</title>
            <description>Patients were orally administered with Placebo tablets (matching Linagliptin) once daily up to 24 weeks</description>
          </group>
          <group group_id="O2">
            <title>Linagliptin 5 Milligram (Up to 24 Weeks)</title>
            <description>Patients were orally administered with Linagliptin 5 milligram film-coated tablets once daily up to 24 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Fasting Plasma Glucose (FPG)</title>
          <description>This outcome has measured difference between FPG values from baseline to 24 weeks post treatment. The term 'baseline' refers to the last observation prior to the administration of any randomised study medication</description>
          <population>Full analysis set observed cases (FAS (OC)): Includes all patients randomised in the Treated Set who had a baseline and at least one on-treatment HbA1c value. These analyses used available data as observed while patients were on treatment. All values collected after a patient started rescue medication were excluded from the analysis.</population>
          <units>milligram/decilitre</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="147"/>
                <count group_id="O2" value="149"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.2" spread="3.6"/>
                    <measurement group_id="O2" value="-11.3" spread="3.3"/>
                  </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>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0178</p_value>
            <method>Mixed Models Analysis</method>
            <method_desc>Mixed model repeated measures(MMRM) included treatment, week and interaction as fixed effects, baseline HbA1c, FPG, daily insulin dose as covariates</method_desc>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-11.5</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>4.8</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-21.0</ci_lower_limit>
            <ci_upper_limit>-2.0</ci_upper_limit>
            <estimate_desc>Adjusted mean of all differences between HbA1c at baseline and after 24 weeks. It is based on all patients in the model (not only patients with a baseline and week 24 measurement).</estimate_desc>
            <other_analysis_desc>MMRM including fixed effects treatment, week and treatment by week interaction, linear covariates baseline HbA1c, baseline daily basal insulin, baseline FPG and baseline FPG by week interaction and random effect for patient. Within-patient errors are modelled by unstructured covariance matrix. Adjusted mean is based on all patients in the model (not only patients with a baseline and week 24 measurement).</other_analysis_desc>
          </analysis>
        </analysis_list>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>The adverse events were reported by overall population from first drug administration up to treatment period of 24 weeks, until 7 days after last drug administration. The adverse events were reported by Japanese population from first drug administration up to treatment period of 52 weeks, until 7 days after last drug administration.</time_frame>
      <desc>An AE was defined as any untoward medical occurrence, including an exacerbation of a preexisting condition, in a patient in a clinical investigation who received a pharmaceutical product. A treated set (TS) was used for analysis of adverse events. TS includes all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.</desc>
      <group_list>
        <group group_id="E1">
          <title>Placebo (Up to 24 Weeks)</title>
          <description>Patients were orally administered with Placebo tablets (matching Linagliptin) once daily up to 24 weeks</description>
        </group>
        <group group_id="E2">
          <title>Linagliptin 5 mg (Up to 24 Weeks)</title>
          <description>Patients were orally administered with Linagliptin 5 mg film-coated tablets once daily up to 24 weeks.</description>
        </group>
        <group group_id="E3">
          <title>Placebo (Up to 52 Weeks)</title>
          <description>Japanese patients were orally administered with Placebo tablets (matching Linagliptin) once daily up to 52 weeks</description>
        </group>
        <group group_id="E4">
          <title>Linagliptin 5mg (Up to 52 Weeks)</title>
          <description>Japanese patients were orally administered with Linagliptin 5 mg film-coated tablets once daily up to 52 weeks.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>20.0</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="151"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="151"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="21" subjects_at_risk="151"/>
                <counts group_id="E2" subjects_affected="19" subjects_at_risk="151"/>
                <counts group_id="E3" subjects_affected="7" subjects_at_risk="50"/>
                <counts group_id="E4" subjects_affected="13" subjects_at_risk="52"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Acute myocardial infarction</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="151"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="151"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Angina pectoris</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="151"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="151"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Angina unstable</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="151"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="151"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Arrhythmia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="151"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="151"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Atrial fibrillation</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="151"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="151"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Bradycardia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="151"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="151"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Cardiac arrest</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="151"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="151"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Cardiac failure congestive</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="151"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="151"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Coronary artery disease</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="151"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="151"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Coronary artery stenosis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="151"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="151"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="52"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Ear and labyrinth disorders</title>
            <event_list>
              <event>
                <sub_title>Vertigo positional</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="151"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="151"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="52"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Cataract</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="151"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="151"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Diabetic retinopathy</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="151"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="151"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Glaucoma</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="151"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="151"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="52"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Ascites</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="151"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="151"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Gastrooesophageal reflux disease</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="151"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="151"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Haemorrhoids</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="151"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="151"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Inguinal hernia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="151"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="151"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="52"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Chest pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="151"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="151"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="52"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>Cholecystitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="151"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="151"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Cholelithiasis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="151"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="151"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="52"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Bronchitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="151"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="151"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Erysipelas</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="151"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="151"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Klebsiella sepsis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="151"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="151"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Pneumonia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="151"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="151"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="151"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="151"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="52"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Fall</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="151"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="151"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Femoral neck fracture</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="151"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="151"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Joint dislocation</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="151"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="151"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Multiple fractures</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="151"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="151"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Rib fracture</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="151"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="151"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Spinal compression fracture</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="151"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="151"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="52"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Lipase increased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="151"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="151"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="52"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Hypoglycaemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="151"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="151"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="52"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Osteoarthritis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="151"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="151"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="52"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Breast cancer</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="151"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="151"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Colorectal cancer</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="151"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="151"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Enchondromatosis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="151"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="151"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Gastric cancer</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="151"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="151"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Lung neoplasm malignant</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="151"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="151"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Squamous cell carcinoma of skin</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="151"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="151"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="52"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Brain stem infarction</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="151"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="151"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Cerebral arteriosclerosis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="151"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="151"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Cerebral infarction</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="151"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="151"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="151"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="151"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Hypoxic-ischaemic encephalopathy</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="151"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="151"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Lumbar radiculopathy</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="151"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="151"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="52"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Acute kidney injury</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="151"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="151"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Haematuria</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="151"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="151"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Renal impairment</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="151"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="151"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="52"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Asthma</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="151"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="151"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Chronic obstructive pulmonary disease</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="151"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="151"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Cough</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="151"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="151"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Dyspnoea</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="151"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="151"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Pulmonary embolism</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="151"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="151"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="52"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Deep vein thrombosis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="151"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="151"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Intermittent claudication</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="151"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="151"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="52"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>20.0</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="58" subjects_at_risk="151"/>
                <counts group_id="E2" subjects_affected="72" subjects_at_risk="151"/>
                <counts group_id="E3" subjects_affected="19" subjects_at_risk="50"/>
                <counts group_id="E4" subjects_affected="37" subjects_at_risk="52"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Constipation</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="151"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="151"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Large intestine polyp</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="151"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="151"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="52"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Bronchitis</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="151"/>
                <counts group_id="E2" subjects_affected="7" subjects_at_risk="151"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E4" subjects_affected="5" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" subjects_affected="9" subjects_at_risk="151"/>
                <counts group_id="E2" subjects_affected="10" subjects_at_risk="151"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Viral upper respiratory tract infection</sub_title>
                <counts group_id="E1" subjects_affected="8" subjects_at_risk="151"/>
                <counts group_id="E2" subjects_affected="11" subjects_at_risk="151"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="50"/>
                <counts group_id="E4" subjects_affected="11" subjects_at_risk="52"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Hypoglycaemia</sub_title>
                <counts group_id="E1" subjects_affected="38" subjects_at_risk="151"/>
                <counts group_id="E2" subjects_affected="51" subjects_at_risk="151"/>
                <counts group_id="E3" subjects_affected="14" subjects_at_risk="50"/>
                <counts group_id="E4" subjects_affected="20" subjects_at_risk="52"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Back pain</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="151"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="151"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="50"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="52"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Reproductive system and breast disorders</title>
            <event_list>
              <event>
                <sub_title>Benign prostatic hyperplasia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="151"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="151"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="52"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI's intellectual property rights.</restrictive_agreement>
    </certain_agreements>
    <limitations_and_caveats>For patients in Japan, a local protocol amendment was introduced, and according to it the study was extended to 52 weeks for Japanese population only.</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Boehringer Ingelheim, Call Center</name_or_title>
      <organization>Boehringer Ingelheim</organization>
      <phone>1-800-243-0127</phone>
      <email>clintriage.rdg@boehringer-ingelheim.com</email>
    </point_of_contact>
  </clinical_results>
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02240680
org study id: 1218.149
secondary id: 2014-000904-88
nct id: NCT02240680
lead sponsor: 
collaborator: 
To investigate the efficacy, safety, and tolerability of linagliptin 5 milligrams once a day
      compared to placebo as as add-on therapy for 24 weeks to stable basal insulin treatment in
      elderly patients, 60 years of age and older, with Type 2 Diabetes Mellitus and insufficient
      glycaemic control.Stable background therapy of metformin and/or alpha-glucosidase inhibitors
      is also allowed.

      In addition, this trial will assess if linagliptin reduces the risk of hypoglycaemia when
      added to background basal insulin therapy. The treatment duration of this trial (24 weeks)
      will enable assessment of the clinically relevant endpoint of a decrease in glycosylated
      Haemoglobin, a well-accepted measurement of chronic glycaemic control.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Change From Baseline in Hemoglobin A1c (HbA1c) After 24 Weeks of Treatment.
time frame: Baseline and Week 24
description: This outcome has measured difference between HbA1c values from baseline to 24 weeks post treatment. The term 'baseline' refers to the last observation prior to the administration of any randomised study medication. HbA1c is a form of hemoglobin, a blood pigment that carries oxygen, which is bound to glucose. The term HbA1c also refers to glycated hemoglobin. High levels of HbA1c (Normal range is less than 6%) indicate poorer control of diabetes than level in normal range.
measure: Percentage of Patients Experiencing at Least One Hypoglycaemia Accompanied by a Prespecified Glucose Value.
time frame: 24 weeks
description: Hypoglycaemia accompanied by a prespecified glucose value is defined as any investigator reported hypoglycaemia (event or AE) with a reported blood glucose level of less than 54 milligram/deciLitre (3.0 millimole/Litre) or any investigator reported symptomatic hypoglycaemic AE with a reported blood glucose level of less or equal 70 milligram/deciLitre (3.9millimole/Litre) or any severe hypoglycaemic AE. Severe hypoglycaemia is an event that requires the assistance of another person to actively administer carbohydrates or glucagon because the patient is unable to take the substance on his or her own. The confidence intervals mentioned in measure of dispersion are exact 95% confidence interval by Clopper and Pearson. The percentage of patients with at least one hypoglycaemia accompanied by a glucose value less than 54mg/dL alone has also represented separately according American Diabetes Association definition of clinically significant hypoglycaemia.
measure: Percentage of Patients With HbA1c<8.0%
time frame: 24 weeks
description: This is the percentage of patients with HbA1c on treatment <8.0% after 24 weeks of treatment. The confidence intervals mentioned in measure of dispersion are exact 95% CI by Clopper and Pearson.
measure: Percentage of Patients With HbA1c on Treatment <7.0%
time frame: 24 weeks
description: This is the percentage of patients with HbA1c on treatment <7.0% after 24 weeks of treatment. The confidence intervals mentioned in measure of dispersion are exact 95% CI by Clopper and Pearson.
measure: Percentage of Patients With HbA1c Lowering by at Least 0.5%.
time frame: 24 weeks
description: The percentage of patients who attained lowering of HbA1c by ≥0.5% from baseline after 24 weeks of treatment were analysed. The confidence intervals mentioned in measure of dispersion are exact 95% CI by Clopper and Pearson.
measure: Change From Baseline in Fasting Plasma Glucose (FPG)
time frame: Baseline and Week 24
description: This outcome has measured difference between FPG values from baseline to 24 weeks post treatment. The term 'baseline' refers to the last observation prior to the administration of any randomised study medication
arm group label: linagliptin 5 mg
arm group type: Experimental
description: patient to receive a tablet of linagliptin 5 mg each day
arm group label: placebo
arm group type: Placebo Comparator
description: patient to receive a tablet of placebo matching linagliptin 5 mg
intervention type: Drug
intervention name: placebo
description: placebo matching linagliptin 5 mg
arm group label: placebo
intervention type: Drug
intervention name: linagliptin
description: 5 mg once a day
arm group label: linagliptin 5 mg
criteria: 
gender: All
minimum age: 60 Years
maximum age: N/A
healthy volunteers: No
last name: Boehringer Ingelheim
role: Study Chair
affiliation: Boehringer Ingelheim
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country: Australia
country: Belgium
country: Colombia
country: Denmark
country: Finland
country: Germany
country: Greece
country: Ireland
country: Japan
country: Mexico
country: New Zealand
country: Poland
country: Romania
country: South Africa
country: Spain
country: United Kingdom
country: United States
responsible party type: Sponsor
mesh term: Diabetes Mellitus
mesh term: Diabetes Mellitus, Type 2
mesh term: Linagliptin
provided document: 
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participant flow: 
baseline: 
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reported events: 
certain agreements: 
limitations and caveats: For patients in Japan, a local protocol amendment was introduced, and according to it the study was extended to 52 weeks for Japanese population only.
point of contact: 