<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/NCT02227862</url>
  </required_header>
  <id_info>
    <org_study_id>MYL-GAI-3001</org_study_id>
    <nct_id>NCT02227862</nct_id>
  </id_info>
  <brief_title>Non-inferiority Study to Compare the Efficacy and Safety of Mylan's Insulin Glargine With Lantus® in Type 1 Diabetes Mellitus Patients (INSTRIDE 1)</brief_title>
  <acronym>INSTRIDE 1</acronym>
  <official_title>An Open-Label, Randomized, Multi-Center, Parallel-Group Clinical Trial Comparing the Efficacy and Safety of Mylan's Insulin Glargine With Lantus® in Type 1 Diabetes Mellitus Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Mylan Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Mylan GmbH</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Viatris Inc.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      To test whether Mylan's insulin glargine once daily is non-inferior to Lantus® once daily&#xD;
      (based on change in HbA1c from baseline to 24 weeks) when administered in combination with&#xD;
      mealtime insulin lispro.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This trial is a multicenter, open-label, randomized, parallel-group trial in patients with&#xD;
      Type 1 Diabetes Mellitus (T1DM) comparing the efficacy and safety of Mylan's insulin glargine&#xD;
      with that of Lantus®.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 2014</start_date>
  <completion_date type="Actual">July 2016</completion_date>
  <primary_completion_date type="Actual">July 2016</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in HbA1c From Baseline to 24 Weeks</measure>
    <time_frame>24 weeks</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Summary of Actual and Change From Baseline in HbA1c</measure>
    <time_frame>24 and 52 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in FPG Over Time</measure>
    <time_frame>24 and 52 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in 8-point SMBG Profile Over Time</measure>
    <time_frame>24 and 52 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Total Daily Insulin Dose Per Unit Body Weight From Baseline Over Time</measure>
    <time_frame>24 and 52 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of Hypoglycemic Events Per 30 Days Over Time</measure>
    <time_frame>24 and 52 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hypoglycemia Occurrence</measure>
    <time_frame>52 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Occurrence of Local and Systematic Reactions</measure>
    <time_frame>52 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Total Insulin Antibody Percent Binding for Mylan's Insulin Glargine Assay Over Time</measure>
    <time_frame>24 and 52 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Total Insulin Antibody Percent Binding for Lantus Assay Over Time</measure>
    <time_frame>24 and 52 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Cross-reactive Insulin Antibody Percent Binding for Mylan's Insulin Glargine Assay Over Time</measure>
    <time_frame>24 and 52 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Cross-reactive Insulin Antibody Percent Binding for Lantus Assay Over Time</measure>
    <time_frame>24 and 52 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of Patients With HbA1c &lt; 7%</measure>
    <time_frame>24 and 52 weeks</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">558</enrollment>
  <condition>Type 1 Diabetes</condition>
  <arm_group>
    <arm_group_label>Mylan's Insulin Glargine</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Receive Mylan's Insulin Glargine plus insulin lispro.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Lantus®</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Receive Lantus® plus insulin lispro</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Mylan's insulin glargine</intervention_name>
    <description>All patients will be shifted from their current mealtime insulin to insulin lispro at the start of the run-in period, and will continue on this for the complete trial. During the 6 week run-in period the doses of Lantus® and insulin lispro will be titrated (if required) to ensure diabetes control. After the run-in period, patients will be randomized to receive either Mylan's insulin glargine (in place of Lantus®), or to continue on Lantus®. During the period from 12 to 24 weeks dose titration will be kept to a minimum.</description>
    <arm_group_label>Mylan's Insulin Glargine</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Lantus®</intervention_name>
    <description>All patients will be shifted from their current mealtime insulin to insulin lispro at the start of the run-in period; and will continue on this for the complete trial. During the 6week run-in period the doses of Lantus® and insulin lispro will be titrated (if required) to ensure diabetes control. After the run-in period, patients will be randomized to receive either Mylan's insulin glargine (in place of Lantus®), or to continue on Lantus®. During the period from 12 to 24 weeks dose titration will be kept to a minimum.</description>
    <arm_group_label>Lantus®</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with an established diagnosis of T1DM per ADA 2014 criteria&#xD;
&#xD;
          -  Body mass index (BMI) of 18.5 to 35 kg/m2 at screening (both values inclusive).&#xD;
&#xD;
          -  Glycosylated hemoglobin (HbA1c) ≤9.5% at screening.&#xD;
&#xD;
          -  Hemoglobin ≥9.0 g/dL at screening.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  History of hypersensitivity to any of the active or inactive ingredients of the&#xD;
             insulin/insulin analogue preparations used in the trial, OR history of significant&#xD;
             allergic drug reactions.&#xD;
&#xD;
          -  History of use of animal insulin within the last 3 years or use of biosimilar insulin&#xD;
             glargine at any time prior.&#xD;
&#xD;
          -  History of use of a regular immunomodulator therapy in the 1 year prior to screening.&#xD;
&#xD;
          -  History of ≥2 episodes of severe hypoglycemia within the 6 months before screening or&#xD;
             history of hypoglycemia unawareness (a sample questionnaire is provided in Appendix&#xD;
             I), as judged by the investigator.&#xD;
&#xD;
          -  History of ≥1 episodes of diabetic ketoacidosis or emergency room visits for&#xD;
             uncontrolled diabetes leading to hospitalization within the 6 months prior to&#xD;
             screening.&#xD;
&#xD;
          -  Serological evidence of human immunodeficiency virus (HIV), hepatitis B (HbSAg) or&#xD;
             hepatitis C (HCVAb) antibodies at screening.&#xD;
&#xD;
          -  History of drug or alcohol dependence or abuse during the 1 year prior to screening.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Thomas Blevins, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Texas Diabetes &amp; Endocrinology</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Mylan Investigational Site</name>
      <address>
        <city>Bell Gardens</city>
        <state>California</state>
        <zip>90201</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mylan Investigational Site</name>
      <address>
        <city>Fresno</city>
        <state>California</state>
        <zip>93720</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mylan Investigational Site</name>
      <address>
        <city>Greenbrae</city>
        <state>California</state>
        <zip>93720</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mylan Investigational Site</name>
      <address>
        <city>La Jolla</city>
        <state>California</state>
        <zip>92037</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mylan Investigational Site</name>
      <address>
        <city>La Mesa</city>
        <state>California</state>
        <zip>91942</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mylan Investigational Site</name>
      <address>
        <city>Long Beach</city>
        <state>California</state>
        <zip>90807</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mylan Investigational Site</name>
      <address>
        <city>Los Gatos</city>
        <state>California</state>
        <zip>95032</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mylan Investigational Site</name>
      <address>
        <city>Mission Hills</city>
        <state>California</state>
        <zip>91345</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mylan Investigational Site</name>
      <address>
        <city>National City</city>
        <state>California</state>
        <zip>91950</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mylan Investigational Site</name>
      <address>
        <city>Northridge</city>
        <state>California</state>
        <zip>91324</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mylan Investigational Site</name>
      <address>
        <city>Tustin</city>
        <state>California</state>
        <zip>92780</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mylan Investigational Site</name>
      <address>
        <city>Walnut Creek</city>
        <state>California</state>
        <zip>94598</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mylan Investigational Site</name>
      <address>
        <city>Bradenton</city>
        <state>Florida</state>
        <zip>34208</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mylan Investigational Site</name>
      <address>
        <city>Cooper City</city>
        <state>Florida</state>
        <zip>33024</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mylan Investigational Site</name>
      <address>
        <city>Hialeah</city>
        <state>Florida</state>
        <zip>33012</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mylan Investigational Site</name>
      <address>
        <city>Hollywood</city>
        <state>Florida</state>
        <zip>33021</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mylan Investigational Site</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33142</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mylan Investigational Site</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33156</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mylan Investigational Site</name>
      <address>
        <city>New Port Richey</city>
        <state>Florida</state>
        <zip>34652</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mylan Investigational Site</name>
      <address>
        <city>Palm Harbor</city>
        <state>Florida</state>
        <zip>34684</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mylan Investigational Site</name>
      <address>
        <city>West Palm Beach</city>
        <state>Florida</state>
        <zip>33401</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mylan Investigational Site</name>
      <address>
        <city>Atlanta</city>
        <state>Georgia</state>
        <zip>30318</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mylan Investigational Site</name>
      <address>
        <city>Columbus</city>
        <state>Georgia</state>
        <zip>31904</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mylan Investigational Site</name>
      <address>
        <city>Honolulu</city>
        <state>Hawaii</state>
        <zip>96814</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mylan Investigational Site</name>
      <address>
        <city>Idaho Falls</city>
        <state>Idaho</state>
        <zip>83404</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mylan Investigational Site</name>
      <address>
        <city>Crystal Lake</city>
        <state>Illinois</state>
        <zip>60012</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mylan Investigational Site</name>
      <address>
        <city>LaGrange</city>
        <state>Illinois</state>
        <zip>60525</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mylan Investigational Site</name>
      <address>
        <city>Springfield</city>
        <state>Illinois</state>
        <zip>62704</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mylan Investigational Site</name>
      <address>
        <city>Anderson</city>
        <state>Indiana</state>
        <zip>46011</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mylan Investigational Site</name>
      <address>
        <city>Muncie</city>
        <state>Indiana</state>
        <zip>47304</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mylan Investigational Site</name>
      <address>
        <city>Council Bluffs</city>
        <state>Iowa</state>
        <zip>51501</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mylan Investigational Site</name>
      <address>
        <city>Des Moines</city>
        <state>Iowa</state>
        <zip>50314</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mylan Investigational Site</name>
      <address>
        <city>Overland Park</city>
        <state>Kansas</state>
        <zip>66210</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mylan Investigational Site</name>
      <address>
        <city>Topeka</city>
        <state>Kansas</state>
        <zip>66606</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mylan Investigational Site</name>
      <address>
        <city>Lexington</city>
        <state>Kentucky</state>
        <zip>40503</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mylan Investigational Site</name>
      <address>
        <city>Billings</city>
        <state>Montana</state>
        <zip>59101</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mylan Investigational Site</name>
      <address>
        <city>Omaha</city>
        <state>Nebraska</state>
        <zip>68114</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mylan Investigational Site</name>
      <address>
        <city>Omaha</city>
        <state>Nebraska</state>
        <zip>68131</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mylan Investigational Site</name>
      <address>
        <city>Las Vegas</city>
        <state>Nevada</state>
        <zip>89128</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mylan Investigational Site</name>
      <address>
        <city>Albany</city>
        <state>New York</state>
        <zip>12206</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mylan Investigational Site</name>
      <address>
        <city>Mineola</city>
        <state>New York</state>
        <zip>11501</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mylan Investigational Site</name>
      <address>
        <city>Staten Island</city>
        <state>New York</state>
        <zip>10301</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mylan Investigational Site</name>
      <address>
        <city>Syracuse</city>
        <state>New York</state>
        <zip>13210</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mylan Investigational Site</name>
      <address>
        <city>Asheville</city>
        <state>North Carolina</state>
        <zip>28803</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mylan Investigational Site</name>
      <address>
        <city>Burlington</city>
        <state>North Carolina</state>
        <zip>27215</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mylan Investigational Site</name>
      <address>
        <city>Greensboro</city>
        <state>North Carolina</state>
        <zip>27408</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mylan Investigational Site</name>
      <address>
        <city>Greenville</city>
        <state>North Carolina</state>
        <zip>27834</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mylan Investigational Site</name>
      <address>
        <city>Hickory</city>
        <state>North Carolina</state>
        <zip>28601</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mylan Investigational Site</name>
      <address>
        <city>Morehead City</city>
        <state>North Carolina</state>
        <zip>28557</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mylan Investigational Site</name>
      <address>
        <city>Wilmington</city>
        <state>North Carolina</state>
        <zip>28401</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mylan Investigational Site</name>
      <address>
        <city>Cincinnati</city>
        <state>Ohio</state>
        <zip>45236</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mylan Investigational Site</name>
      <address>
        <city>Mentor</city>
        <state>Ohio</state>
        <zip>44060</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mylan Investigational Site</name>
      <address>
        <city>Bend</city>
        <state>Oregon</state>
        <zip>97701</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mylan Investigational Site</name>
      <address>
        <city>Corvallis</city>
        <state>Oregon</state>
        <zip>97330</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mylan Investigational Site</name>
      <address>
        <city>Chattanooga</city>
        <state>Tennessee</state>
        <zip>37411</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
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  <location>
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  <location>
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  <location>
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  <location>
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  <location>
    <facility>
      <name>Mylan Investigational Site</name>
      <address>
        <city>Skalica</city>
        <zip>90901</zip>
        <country>Slovakia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mylan Investigational Site</name>
      <address>
        <city>Sturovo</city>
        <zip>943 01</zip>
        <country>Slovakia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mylan Investigational Site</name>
      <address>
        <city>Trebisov</city>
        <zip>07501</zip>
        <country>Slovakia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mylan Investigational Site</name>
      <address>
        <city>Zilina</city>
        <zip>01001</zip>
        <country>Slovakia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mylan Investigational Site</name>
      <address>
        <city>Bloemfontein</city>
        <state>Free State</state>
        <zip>9301</zip>
        <country>South Africa</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mylan Investigational Site</name>
      <address>
        <city>Johannesburg</city>
        <state>Gauteng</state>
        <zip>1501</zip>
        <country>South Africa</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mylan Investigational Site</name>
      <address>
        <city>Johannesburg</city>
        <state>Gauteng</state>
        <zip>1619</zip>
        <country>South Africa</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mylan Investigational Site</name>
      <address>
        <city>Johannesburg</city>
        <state>Gauteng</state>
        <zip>2198</zip>
        <country>South Africa</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mylan Investigational Site</name>
      <address>
        <city>Krugersdorp</city>
        <state>Gauteng</state>
        <zip>1739</zip>
        <country>South Africa</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mylan Investigational Site</name>
      <address>
        <city>Pretoria</city>
        <state>Gauteng</state>
        <zip>0002</zip>
        <country>South Africa</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mylan Investigational Site</name>
      <address>
        <city>Durban</city>
        <state>KwaZulu-Natal</state>
        <zip>4091</zip>
        <country>South Africa</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mylan Investigational Site</name>
      <address>
        <city>Cape Town</city>
        <state>Western Cape</state>
        <zip>7570</zip>
        <country>South Africa</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mylan Investigational Site</name>
      <address>
        <city>Cape Town</city>
        <state>Western Cape</state>
        <zip>7580</zip>
        <country>South Africa</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mylan Investigational Site</name>
      <address>
        <city>Cape Town</city>
        <state>Western Cape</state>
        <zip>7708</zip>
        <country>South Africa</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mylan Investigational Site</name>
      <address>
        <city>Plymouth</city>
        <state>Devon</state>
        <zip>PL6 8DH</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mylan Investigational Site</name>
      <address>
        <city>Leicester</city>
        <state>Leicestershire</state>
        <zip>LE5 4PW</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mylan Investigational Site</name>
      <address>
        <city>Swansea</city>
        <zip>SA6 6NL</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
    <country>Czechia</country>
    <country>Estonia</country>
    <country>Germany</country>
    <country>Hungary</country>
    <country>Latvia</country>
    <country>Romania</country>
    <country>Slovakia</country>
    <country>South Africa</country>
    <country>United Kingdom</country>
    <country>United States</country>
  </location_countries>
  <removed_countries>
    <country>Czech Republic</country>
  </removed_countries>
  <verification_date>March 2022</verification_date>
  <study_first_submitted>August 26, 2014</study_first_submitted>
  <study_first_submitted_qc>August 26, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 28, 2014</study_first_posted>
  <results_first_submitted>February 24, 2020</results_first_submitted>
  <results_first_submitted_qc>February 24, 2020</results_first_submitted_qc>
  <results_first_posted type="Actual">March 9, 2020</results_first_posted>
  <disposition_first_submitted>February 26, 2018</disposition_first_submitted>
  <disposition_first_submitted_qc>February 26, 2018</disposition_first_submitted_qc>
  <disposition_first_posted type="Actual">February 28, 2018</disposition_first_posted>
  <last_update_submitted>March 1, 2022</last_update_submitted>
  <last_update_submitted_qc>March 1, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">March 3, 2022</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 1</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Insulin Glargine</mesh_term>
  </intervention_browse>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Mylan's Insulin Glargine</title>
          <description>Receive Mylan's Insulin Glargine plus insulin lispro.&#xD;
Mylan's insulin glargine: All patients will be shifted from their current mealtime insulin to insulin lispro at the start of the run-in period, and will continue on this for the complete trial. During the 6 week run-in period the doses of Lantus® and insulin lispro will be titrated (if required) to ensure diabetes control. After the run-in period, patients will be randomized to receive either Mylan's insulin glargine (in place of Lantus®), or to continue on Lantus®. During the period from 12 to 24 weeks dose titration will be kept to a minimum.</description>
        </group>
        <group group_id="P2">
          <title>Lantus®</title>
          <description>Receive Lantus® plus insulin lispro&#xD;
Lantus®: All patients will be shifted from their current mealtime insulin to insulin lispro at the start of the run-in period; and will continue on this for the complete trial. During the 6week run-in period the doses of Lantus® and insulin lispro will be titrated (if required) to ensure diabetes control. After the run-in period, patients will be randomized to receive either Mylan's insulin glargine (in place of Lantus®), or to continue on Lantus®. During the period from 12 to 24 weeks dose titration will be kept to a minimum.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="280"/>
                <participants group_id="P2" count="278"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Week 24</title>
              <participants_list>
                <participants group_id="P1" count="269"/>
                <participants group_id="P2" count="263"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="261"/>
                <participants group_id="P2" count="256"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="19"/>
                <participants group_id="P2" count="22"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Protocol Violation</title>
              <participants_list>
                <participants group_id="P1" count="7"/>
                <participants group_id="P2" count="9"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Other</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
                <participants group_id="P2" count="3"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="7"/>
                <participants group_id="P2" count="6"/>
              </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="2"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Mylan's Insulin Glargine</title>
          <description>Receive Mylan's Insulin Glargine plus insulin lispro.&#xD;
Mylan's insulin glargine: All patients will be shifted from their current mealtime insulin to insulin lispro at the start of the run-in period, and will continue on this for the complete trial. During the 6 week run-in period the doses of Lantus® and insulin lispro will be titrated (if required) to ensure diabetes control. After the run-in period, patients will be randomized to receive either Mylan's insulin glargine (in place of Lantus®), or to continue on Lantus®. During the period from 12 to 24 weeks dose titration will be kept to a minimum.</description>
        </group>
        <group group_id="B2">
          <title>Lantus®</title>
          <description>Receive Lantus® plus insulin lispro&#xD;
Lantus®: All patients will be shifted from their current mealtime insulin to insulin lispro at the start of the run-in period; and will continue on this for the complete trial. During the 6week run-in period the doses of Lantus® and insulin lispro will be titrated (if required) to ensure diabetes control. After the run-in period, patients will be randomized to receive either Mylan's insulin glargine (in place of Lantus®), or to continue on Lantus®. During the period from 12 to 24 weeks dose titration will be kept to a minimum.</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="280"/>
            <count group_id="B2" value="278"/>
            <count group_id="B3" value="558"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</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>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="275"/>
                    <measurement group_id="B2" value="272"/>
                    <measurement group_id="B3" value="547"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="42" spread="12.03"/>
                    <measurement group_id="B2" value="42.2" spread="11.97"/>
                    <measurement group_id="B3" value="42.1" spread="11.99"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="116"/>
                    <measurement group_id="B2" value="106"/>
                    <measurement group_id="B3" value="222"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="164"/>
                    <measurement group_id="B2" value="172"/>
                    <measurement group_id="B3" value="336"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Asian</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Black</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Caucasian</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="263"/>
                    <measurement group_id="B2" value="265"/>
                    <measurement group_id="B3" value="528"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hispanic</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Other</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Europe</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="145"/>
                    <measurement group_id="B2" value="145"/>
                    <measurement group_id="B3" value="290"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>North America</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="126"/>
                    <measurement group_id="B2" value="126"/>
                    <measurement group_id="B3" value="252"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>South Africa</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                    <measurement group_id="B2" value="7"/>
                    <measurement group_id="B3" value="16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Insulin History</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Yes</title>
                  <measurement_list>
                    <measurement group_id="B1" value="280"/>
                    <measurement group_id="B2" value="277"/>
                    <measurement group_id="B3" value="557"/>
                  </measurement_list>
                </category>
                <category>
                  <title>No</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_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Dosing Time</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Morning</title>
                  <measurement_list>
                    <measurement group_id="B1" value="38"/>
                    <measurement group_id="B2" value="40"/>
                    <measurement group_id="B3" value="78"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Evening</title>
                  <measurement_list>
                    <measurement group_id="B1" value="242"/>
                    <measurement group_id="B2" value="238"/>
                    <measurement group_id="B3" value="480"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Body Mass Index (BMI)</title>
          <units>kg/m2</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="26.435" spread="3.7058"/>
                    <measurement group_id="B2" value="26.636" spread="4.2022"/>
                    <measurement group_id="B3" value="26.535" spread="3.9586"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Duration of Diabetes</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="18.685" spread="11.7771"/>
                    <measurement group_id="B2" value="19.697" spread="11.2868"/>
                    <measurement group_id="B3" value="19.206" spread="11.5411"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Baseline fasting plasma glucose</title>
          <units>mg/dL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="167.4" spread="68.43"/>
                    <measurement group_id="B2" value="163.9" spread="61.61"/>
                    <measurement group_id="B3" value="165.6" spread="65.09"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Baseline HbA1c</title>
          <units>percent</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="7.37" spread="0.869"/>
                    <measurement group_id="B2" value="7.39" spread="0.843"/>
                    <measurement group_id="B3" value="7.38" spread="0.855"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Baseline fasting C-peptide</title>
          <units>mmol/L</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0.298" spread="0.2291"/>
                    <measurement group_id="B2" value="0.291" spread="0.2508"/>
                    <measurement group_id="B3" value="0.295" spread="0.2395"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Change in HbA1c From Baseline to 24 Weeks</title>
        <time_frame>24 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Mylan's Insulin Glargine</title>
            <description>Receive Mylan's Insulin Glargine plus insulin lispro.&#xD;
Mylan's insulin glargine: All patients will be shifted from their current mealtime insulin to insulin lispro at the start of the run-in period, and will continue on this for the complete trial. During the 6 week run-in period the doses of Lantus® and insulin lispro will be titrated (if required) to ensure diabetes control. After the run-in period, patients will be randomized to receive either Mylan's insulin glargine (in place of Lantus®), or to continue on Lantus®. During the period from 12 to 24 weeks dose titration will be kept to a minimum.</description>
          </group>
          <group group_id="O2">
            <title>Lantus®</title>
            <description>Receive Lantus® plus insulin lispro&#xD;
Lantus®: All patients will be shifted from their current mealtime insulin to insulin lispro at the start of the run-in period; and will continue on this for the complete trial. During the 6week run-in period the doses of Lantus® and insulin lispro will be titrated (if required) to ensure diabetes control. After the run-in period, patients will be randomized to receive either Mylan's insulin glargine (in place of Lantus®), or to continue on Lantus®. During the period from 12 to 24 weeks dose titration will be kept to a minimum.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in HbA1c From Baseline to 24 Weeks</title>
          <units>percent</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="280"/>
                <count group_id="O2" value="277"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.14" spread="0.054"/>
                    <measurement group_id="O2" value="0.11" spread="0.054"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Summary of Actual and Change From Baseline in HbA1c</title>
        <time_frame>24 and 52 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Mylan's Insulin Glargine</title>
            <description>Receive Mylan's Insulin Glargine plus insulin lispro.&#xD;
Mylan's insulin glargine: All patients will be shifted from their current mealtime insulin to insulin lispro at the start of the run-in period, and will continue on this for the complete trial. During the 6 week run-in period the doses of Lantus® and insulin lispro will be titrated (if required) to ensure diabetes control. After the run-in period, patients will be randomized to receive either Mylan's insulin glargine (in place of Lantus®), or to continue on Lantus®. During the period from 12 to 24 weeks dose titration will be kept to a minimum.</description>
          </group>
          <group group_id="O2">
            <title>Lantus®</title>
            <description>Receive Lantus® plus insulin lispro&#xD;
Lantus®: All patients will be shifted from their current mealtime insulin to insulin lispro at the start of the run-in period; and will continue on this for the complete trial. During the 6week run-in period the doses of Lantus® and insulin lispro will be titrated (if required) to ensure diabetes control. After the run-in period, patients will be randomized to receive either Mylan's insulin glargine (in place of Lantus®), or to continue on Lantus®. During the period from 12 to 24 weeks dose titration will be kept to a minimum.</description>
          </group>
        </group_list>
        <measure>
          <title>Summary of Actual and Change From Baseline in HbA1c</title>
          <units>percent</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="280"/>
                <count group_id="O2" value="277"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>week 24</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.12" spread="0.599"/>
                    <measurement group_id="O2" value="0.09" spread="0.526"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>week 52</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.2" spread="0.633"/>
                    <measurement group_id="O2" value="0.25" spread="0.595"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in FPG Over Time</title>
        <time_frame>24 and 52 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Mylan's Insulin Glargine</title>
            <description>Receive Mylan's Insulin Glargine plus insulin lispro.&#xD;
Mylan's insulin glargine: All patients will be shifted from their current mealtime insulin to insulin lispro at the start of the run-in period, and will continue on this for the complete trial. During the 6 week run-in period the doses of Lantus® and insulin lispro will be titrated (if required) to ensure diabetes control. After the run-in period, patients will be randomized to receive either Mylan's insulin glargine (in place of Lantus®), or to continue on Lantus®. During the period from 12 to 24 weeks dose titration will be kept to a minimum.</description>
          </group>
          <group group_id="O2">
            <title>Lantus®</title>
            <description>Receive Lantus® plus insulin lispro&#xD;
Lantus®: All patients will be shifted from their current mealtime insulin to insulin lispro at the start of the run-in period; and will continue on this for the complete trial. During the 6week run-in period the doses of Lantus® and insulin lispro will be titrated (if required) to ensure diabetes control. After the run-in period, patients will be randomized to receive either Mylan's insulin glargine (in place of Lantus®), or to continue on Lantus®. During the period from 12 to 24 weeks dose titration will be kept to a minimum.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in FPG Over Time</title>
          <units>mmol/L</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="280"/>
                <count group_id="O2" value="277"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>week 24</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.81" spread="4.485"/>
                    <measurement group_id="O2" value="0.09" spread="4.507"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>week 52</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.23" spread="4.281"/>
                    <measurement group_id="O2" value="0.43" spread="4.455"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in 8-point SMBG Profile Over Time</title>
        <time_frame>24 and 52 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Mylan's Insulin Glargine</title>
            <description>Receive Mylan's Insulin Glargine plus insulin lispro.&#xD;
Mylan's insulin glargine: All patients will be shifted from their current mealtime insulin to insulin lispro at the start of the run-in period, and will continue on this for the complete trial. During the 6 week run-in period the doses of Lantus® and insulin lispro will be titrated (if required) to ensure diabetes control. After the run-in period, patients will be randomized to receive either Mylan's insulin glargine (in place of Lantus®), or to continue on Lantus®. During the period from 12 to 24 weeks dose titration will be kept to a minimum.</description>
          </group>
          <group group_id="O2">
            <title>Lantus®</title>
            <description>Receive Lantus® plus insulin lispro&#xD;
Lantus®: All patients will be shifted from their current mealtime insulin to insulin lispro at the start of the run-in period; and will continue on this for the complete trial. During the 6week run-in period the doses of Lantus® and insulin lispro will be titrated (if required) to ensure diabetes control. After the run-in period, patients will be randomized to receive either Mylan's insulin glargine (in place of Lantus®), or to continue on Lantus®. During the period from 12 to 24 weeks dose titration will be kept to a minimum.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in 8-point SMBG Profile Over Time</title>
          <units>mmol/L</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="280"/>
                <count group_id="O2" value="277"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>week 24</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.038" spread="2.3751"/>
                    <measurement group_id="O2" value="-0.095" spread="1.5012"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>week 52</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.082" spread="1.5032"/>
                    <measurement group_id="O2" value="-0.082" spread="1.5267"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Total Daily Insulin Dose Per Unit Body Weight From Baseline Over Time</title>
        <time_frame>24 and 52 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Mylan's Insulin Glargine</title>
            <description>Receive Mylan's Insulin Glargine plus insulin lispro.&#xD;
Mylan's insulin glargine: All patients will be shifted from their current mealtime insulin to insulin lispro at the start of the run-in period, and will continue on this for the complete trial. During the 6 week run-in period the doses of Lantus® and insulin lispro will be titrated (if required) to ensure diabetes control. After the run-in period, patients will be randomized to receive either Mylan's insulin glargine (in place of Lantus®), or to continue on Lantus®. During the period from 12 to 24 weeks dose titration will be kept to a minimum.</description>
          </group>
          <group group_id="O2">
            <title>Lantus®</title>
            <description>Receive Lantus® plus insulin lispro&#xD;
Lantus®: All patients will be shifted from their current mealtime insulin to insulin lispro at the start of the run-in period; and will continue on this for the complete trial. During the 6week run-in period the doses of Lantus® and insulin lispro will be titrated (if required) to ensure diabetes control. After the run-in period, patients will be randomized to receive either Mylan's insulin glargine (in place of Lantus®), or to continue on Lantus®. During the period from 12 to 24 weeks dose titration will be kept to a minimum.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Total Daily Insulin Dose Per Unit Body Weight From Baseline Over Time</title>
          <units>U/Kg</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="280"/>
                <count group_id="O2" value="277"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>week 24</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0203" spread="0.09962"/>
                    <measurement group_id="O2" value="0.0127" spread="0.10871"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>week 52</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0278" spread="0.1044"/>
                    <measurement group_id="O2" value="0.0138" spread="0.11372"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Rate of Hypoglycemic Events Per 30 Days Over Time</title>
        <time_frame>24 and 52 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Mylan's Insulin Glargine</title>
            <description>Receive Mylan's Insulin Glargine plus insulin lispro.&#xD;
Mylan's insulin glargine: All patients will be shifted from their current mealtime insulin to insulin lispro at the start of the run-in period, and will continue on this for the complete trial. During the 6 week run-in period the doses of Lantus® and insulin lispro will be titrated (if required) to ensure diabetes control. After the run-in period, patients will be randomized to receive either Mylan's insulin glargine (in place of Lantus®), or to continue on Lantus®. During the period from 12 to 24 weeks dose titration will be kept to a minimum.</description>
          </group>
          <group group_id="O2">
            <title>Lantus®</title>
            <description>Receive Lantus® plus insulin lispro&#xD;
Lantus®: All patients will be shifted from their current mealtime insulin to insulin lispro at the start of the run-in period; and will continue on this for the complete trial. During the 6week run-in period the doses of Lantus® and insulin lispro will be titrated (if required) to ensure diabetes control. After the run-in period, patients will be randomized to receive either Mylan's insulin glargine (in place of Lantus®), or to continue on Lantus®. During the period from 12 to 24 weeks dose titration will be kept to a minimum.</description>
          </group>
        </group_list>
        <measure>
          <title>Rate of Hypoglycemic Events Per 30 Days Over Time</title>
          <units>Episodes/30 Days</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="280"/>
                <count group_id="O2" value="278"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>week 24</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-5.162" spread="9.0724"/>
                    <measurement group_id="O2" value="-4.93" spread="8.3815"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>week 52</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-6.241" spread="9.214"/>
                    <measurement group_id="O2" value="-5.765" spread="8.3658"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Hypoglycemia Occurrence</title>
        <time_frame>52 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Mylan's Insulin Glargine</title>
            <description>Receive Mylan's Insulin Glargine plus insulin lispro.&#xD;
Mylan's insulin glargine: All patients will be shifted from their current mealtime insulin to insulin lispro at the start of the run-in period, and will continue on this for the complete trial. During the 6 week run-in period the doses of Lantus® and insulin lispro will be titrated (if required) to ensure diabetes control. After the run-in period, patients will be randomized to receive either Mylan's insulin glargine (in place of Lantus®), or to continue on Lantus®. During the period from 12 to 24 weeks dose titration will be kept to a minimum.</description>
          </group>
          <group group_id="O2">
            <title>Lantus®</title>
            <description>Receive Lantus® plus insulin lispro&#xD;
Lantus®: All patients will be shifted from their current mealtime insulin to insulin lispro at the start of the run-in period; and will continue on this for the complete trial. During the 6week run-in period the doses of Lantus® and insulin lispro will be titrated (if required) to ensure diabetes control. After the run-in period, patients will be randomized to receive either Mylan's insulin glargine (in place of Lantus®), or to continue on Lantus®. During the period from 12 to 24 weeks dose titration will be kept to a minimum.</description>
          </group>
        </group_list>
        <measure>
          <title>Hypoglycemia Occurrence</title>
          <units>Number of patients</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="280"/>
                <count group_id="O2" value="278"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Any hypoglycemic event</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="273"/>
                    <measurement group_id="O2" value="269"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Severe hypoglycemia</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11"/>
                    <measurement group_id="O2" value="13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Documented symptomatic hypoglycemia</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="249"/>
                    <measurement group_id="O2" value="249"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Asymptomatic hypoglycemia</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="246"/>
                    <measurement group_id="O2" value="243"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Probable symptomatic hypoglycemia</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="37"/>
                    <measurement group_id="O2" value="36"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Relative hypoglycemia</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="35"/>
                    <measurement group_id="O2" value="44"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Other hypoglycemia</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="19"/>
                    <measurement group_id="O2" value="19"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Unknown</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="77"/>
                    <measurement group_id="O2" value="71"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Occurrence of Local and Systematic Reactions</title>
        <time_frame>52 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Mylan's Insulin Glargine</title>
            <description>Receive Mylan's Insulin Glargine plus insulin lispro.&#xD;
Mylan's insulin glargine: All patients will be shifted from their current mealtime insulin to insulin lispro at the start of the run-in period, and will continue on this for the complete trial. During the 6 week run-in period the doses of Lantus® and insulin lispro will be titrated (if required) to ensure diabetes control. After the run-in period, patients will be randomized to receive either Mylan's insulin glargine (in place of Lantus®), or to continue on Lantus®. During the period from 12 to 24 weeks dose titration will be kept to a minimum.</description>
          </group>
          <group group_id="O2">
            <title>Lantus®</title>
            <description>Receive Lantus® plus insulin lispro&#xD;
Lantus®: All patients will be shifted from their current mealtime insulin to insulin lispro at the start of the run-in period; and will continue on this for the complete trial. During the 6week run-in period the doses of Lantus® and insulin lispro will be titrated (if required) to ensure diabetes control. After the run-in period, patients will be randomized to receive either Mylan's insulin glargine (in place of Lantus®), or to continue on Lantus®. During the period from 12 to 24 weeks dose titration will be kept to a minimum.</description>
          </group>
        </group_list>
        <measure>
          <title>Occurrence of Local and Systematic Reactions</title>
          <units>Number of patients</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="280"/>
                <count group_id="O2" value="278"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Local</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Systemic</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Total Insulin Antibody Percent Binding for Mylan's Insulin Glargine Assay Over Time</title>
        <time_frame>24 and 52 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Mylan's Insulin Glargine</title>
            <description>Receive Mylan's Insulin Glargine plus insulin lispro.&#xD;
Mylan's insulin glargine: All patients will be shifted from their current mealtime insulin to insulin lispro at the start of the run-in period, and will continue on this for the complete trial. During the 6 week run-in period the doses of Lantus® and insulin lispro will be titrated (if required) to ensure diabetes control. After the run-in period, patients will be randomized to receive either Mylan's insulin glargine (in place of Lantus®), or to continue on Lantus®. During the period from 12 to 24 weeks dose titration will be kept to a minimum.</description>
          </group>
          <group group_id="O2">
            <title>Lantus®</title>
            <description>Receive Lantus® plus insulin lispro&#xD;
Lantus®: All patients will be shifted from their current mealtime insulin to insulin lispro at the start of the run-in period; and will continue on this for the complete trial. During the 6week run-in period the doses of Lantus® and insulin lispro will be titrated (if required) to ensure diabetes control. After the run-in period, patients will be randomized to receive either Mylan's insulin glargine (in place of Lantus®), or to continue on Lantus®. During the period from 12 to 24 weeks dose titration will be kept to a minimum.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Total Insulin Antibody Percent Binding for Mylan's Insulin Glargine Assay Over Time</title>
          <units>%SB</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="280"/>
                <count group_id="O2" value="278"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>week 24</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.3063" spread="7.22075"/>
                    <measurement group_id="O2" value="0.3592" spread="7.16624"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>week 52</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.9591" spread="8.51754"/>
                    <measurement group_id="O2" value="-1.0634" spread="8.42794"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Total Insulin Antibody Percent Binding for Lantus Assay Over Time</title>
        <time_frame>24 and 52 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Mylan's Insulin Glargine</title>
            <description>Receive Mylan's Insulin Glargine plus insulin lispro.&#xD;
Mylan's insulin glargine: All patients will be shifted from their current mealtime insulin to insulin lispro at the start of the run-in period, and will continue on this for the complete trial. During the 6 week run-in period the doses of Lantus® and insulin lispro will be titrated (if required) to ensure diabetes control. After the run-in period, patients will be randomized to receive either Mylan's insulin glargine (in place of Lantus®), or to continue on Lantus®. During the period from 12 to 24 weeks dose titration will be kept to a minimum.</description>
          </group>
          <group group_id="O2">
            <title>Lantus®</title>
            <description>Receive Lantus® plus insulin lispro&#xD;
Lantus®: All patients will be shifted from their current mealtime insulin to insulin lispro at the start of the run-in period; and will continue on this for the complete trial. During the 6week run-in period the doses of Lantus® and insulin lispro will be titrated (if required) to ensure diabetes control. After the run-in period, patients will be randomized to receive either Mylan's insulin glargine (in place of Lantus®), or to continue on Lantus®. During the period from 12 to 24 weeks dose titration will be kept to a minimum.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Total Insulin Antibody Percent Binding for Lantus Assay Over Time</title>
          <units>%SB</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="280"/>
                <count group_id="O2" value="278"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>week 24</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.215" spread="7.3298"/>
                    <measurement group_id="O2" value="0.157" spread="7.411"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>week 52</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.896" spread="8.5610"/>
                    <measurement group_id="O2" value="-1.233" spread="8.623"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Cross-reactive Insulin Antibody Percent Binding for Mylan's Insulin Glargine Assay Over Time</title>
        <time_frame>24 and 52 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Mylan's Insulin Glargine</title>
            <description>Receive Mylan's Insulin Glargine plus insulin lispro.&#xD;
Mylan's insulin glargine: All patients will be shifted from their current mealtime insulin to insulin lispro at the start of the run-in period, and will continue on this for the complete trial. During the 6 week run-in period the doses of Lantus® and insulin lispro will be titrated (if required) to ensure diabetes control. After the run-in period, patients will be randomized to receive either Mylan's insulin glargine (in place of Lantus®), or to continue on Lantus®. During the period from 12 to 24 weeks dose titration will be kept to a minimum.</description>
          </group>
          <group group_id="O2">
            <title>Lantus®</title>
            <description>Receive Lantus® plus insulin lispro&#xD;
Lantus®: All patients will be shifted from their current mealtime insulin to insulin lispro at the start of the run-in period; and will continue on this for the complete trial. During the 6week run-in period the doses of Lantus® and insulin lispro will be titrated (if required) to ensure diabetes control. After the run-in period, patients will be randomized to receive either Mylan's insulin glargine (in place of Lantus®), or to continue on Lantus®. During the period from 12 to 24 weeks dose titration will be kept to a minimum.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Cross-reactive Insulin Antibody Percent Binding for Mylan's Insulin Glargine Assay Over Time</title>
          <units>%SB</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="280"/>
                <count group_id="O2" value="278"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>week 24</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.363" spread="7.1081"/>
                    <measurement group_id="O2" value="0.27" spread="7.1204"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>week 52</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.132" spread="8.3911"/>
                    <measurement group_id="O2" value="-1.21" spread="8.4096"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Cross-reactive Insulin Antibody Percent Binding for Lantus Assay Over Time</title>
        <time_frame>24 and 52 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Mylan's Insulin Glargine</title>
            <description>Receive Mylan's Insulin Glargine plus insulin lispro.&#xD;
Mylan's insulin glargine: All patients will be shifted from their current mealtime insulin to insulin lispro at the start of the run-in period, and will continue on this for the complete trial. During the 6 week run-in period the doses of Lantus® and insulin lispro will be titrated (if required) to ensure diabetes control. After the run-in period, patients will be randomized to receive either Mylan's insulin glargine (in place of Lantus®), or to continue on Lantus®. During the period from 12 to 24 weeks dose titration will be kept to a minimum.</description>
          </group>
          <group group_id="O2">
            <title>Lantus®</title>
            <description>Receive Lantus® plus insulin lispro&#xD;
Lantus®: All patients will be shifted from their current mealtime insulin to insulin lispro at the start of the run-in period; and will continue on this for the complete trial. During the 6week run-in period the doses of Lantus® and insulin lispro will be titrated (if required) to ensure diabetes control. After the run-in period, patients will be randomized to receive either Mylan's insulin glargine (in place of Lantus®), or to continue on Lantus®. During the period from 12 to 24 weeks dose titration will be kept to a minimum.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Cross-reactive Insulin Antibody Percent Binding for Lantus Assay Over Time</title>
          <units>%SB</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="280"/>
                <count group_id="O2" value="278"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>week 24</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.265" spread="7.2543"/>
                    <measurement group_id="O2" value="0.055" spread="7.3985"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>week 52</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.060" spread="8.4414"/>
                    <measurement group_id="O2" value="-1.367" spread="8.6848"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Proportion of Patients With HbA1c &lt; 7%</title>
        <time_frame>24 and 52 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Mylan's Insulin Glargine</title>
            <description>Receive Mylan's Insulin Glargine plus insulin lispro.&#xD;
Mylan's insulin glargine: All patients will be shifted from their current mealtime insulin to insulin lispro at the start of the run-in period, and will continue on this for the complete trial. During the 6 week run-in period the doses of Lantus® and insulin lispro will be titrated (if required) to ensure diabetes control. After the run-in period, patients will be randomized to receive either Mylan's insulin glargine (in place of Lantus®), or to continue on Lantus®. During the period from 12 to 24 weeks dose titration will be kept to a minimum.</description>
          </group>
          <group group_id="O2">
            <title>Lantus®</title>
            <description>Receive Lantus® plus insulin lispro&#xD;
Lantus®: All patients will be shifted from their current mealtime insulin to insulin lispro at the start of the run-in period; and will continue on this for the complete trial. During the 6week run-in period the doses of Lantus® and insulin lispro will be titrated (if required) to ensure diabetes control. After the run-in period, patients will be randomized to receive either Mylan's insulin glargine (in place of Lantus®), or to continue on Lantus®. During the period from 12 to 24 weeks dose titration will be kept to a minimum.</description>
          </group>
        </group_list>
        <measure>
          <title>Proportion of Patients With HbA1c &lt; 7%</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="280"/>
                <count group_id="O2" value="277"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>week 24</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="73"/>
                    <measurement group_id="O2" value="84"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>week 52</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="65"/>
                    <measurement group_id="O2" value="61"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>56 Weeks</time_frame>
      <desc>After Week 52, all the patients resumed treatment as per local standard of care. A safety follow up visit was done at Week 56.</desc>
      <group_list>
        <group group_id="E1">
          <title>Mylan's Insulin Glargine</title>
          <description>Receive Mylan's Insulin Glargine plus insulin lispro.&#xD;
Mylan's insulin glargine: All patients will be shifted from their current mealtime insulin to insulin lispro at the start of the run-in period, and will continue on this for the complete trial. During the 6 week run-in period the doses of Lantus® and insulin lispro will be titrated (if required) to ensure diabetes control. After the run-in period, patients will be randomized to receive either Mylan's insulin glargine (in place of Lantus®), or to continue on Lantus®. During the period from 12 to 24 weeks dose titration will be kept to a minimum.</description>
        </group>
        <group group_id="E2">
          <title>Lantus®</title>
          <description>Receive Lantus® plus insulin lispro&#xD;
Lantus®: All patients will be shifted from their current mealtime insulin to insulin lispro at the start of the run-in period; and will continue on this for the complete trial. During the 6week run-in period the doses of Lantus® and insulin lispro will be titrated (if required) to ensure diabetes control. After the run-in period, patients will be randomized to receive either Mylan's insulin glargine (in place of Lantus®), or to continue on Lantus®. During the period from 12 to 24 weeks dose titration will be kept to a minimum.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA 18.1</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="280"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="278"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="18" subjects_at_risk="280"/>
                <counts group_id="E2" subjects_affected="22" subjects_at_risk="278"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Atrial fibrillation</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="280"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="278"/>
              </event>
              <event>
                <sub_title>Coronary artery disease</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="280"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="278"/>
              </event>
              <event>
                <sub_title>Myocardial infarction</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="280"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="278"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Endocrine disorders</title>
            <event_list>
              <event>
                <sub_title>Goitre</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="280"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="278"/>
              </event>
              <event>
                <sub_title>Hypothyroidism</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="280"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="278"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Retinal artery occlusion</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="280"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="278"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Death</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="280"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="278"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Cellulitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="280"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="278"/>
              </event>
              <event>
                <sub_title>Diverticulitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="280"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="278"/>
              </event>
              <event>
                <sub_title>Haematoma infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="280"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="278"/>
              </event>
              <event>
                <sub_title>Pharyngitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="280"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="278"/>
              </event>
              <event>
                <sub_title>Pneumonia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="280"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="278"/>
              </event>
              <event>
                <sub_title>Pyelonephritis acute</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="280"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="278"/>
              </event>
              <event>
                <sub_title>Urosepsis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="280"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="278"/>
              </event>
              <event>
                <sub_title>Viral rash</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="280"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="278"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Femoral neck fracture</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="280"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="278"/>
              </event>
              <event>
                <sub_title>Femur fracture</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="280"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="278"/>
              </event>
              <event>
                <sub_title>Lower limb fracture</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="280"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="278"/>
              </event>
              <event>
                <sub_title>Postoperative respiratory distress</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="280"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="278"/>
              </event>
              <event>
                <sub_title>Scapula fracture</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="280"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="278"/>
              </event>
              <event>
                <sub_title>Upper limb fracture</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="280"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="278"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Hypoglycaemia</sub_title>
                <counts group_id="E1" events="7" subjects_affected="7" subjects_at_risk="280"/>
                <counts group_id="E2" events="10" subjects_affected="10" subjects_at_risk="278"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Cervical spinal stenosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="280"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="278"/>
              </event>
              <event>
                <sub_title>Osteochondrosis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="280"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="278"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Malignant oligodendroglioma</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="280"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="278"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Epilepsy</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="280"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="278"/>
              </event>
              <event>
                <sub_title>Generalized tonic-clonic seizure</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="280"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="278"/>
              </event>
              <event>
                <sub_title>Hypoglycaemic seizure</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="280"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="278"/>
              </event>
              <event>
                <sub_title>Ischaemic stroke</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="280"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="278"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Psychotic disorder</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="280"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="278"/>
              </event>
              <event>
                <sub_title>Depression</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="280"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="278"/>
              </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" events="2" subjects_affected="2" subjects_at_risk="280"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="278"/>
              </event>
              <event>
                <sub_title>Glomerulonephritis minimal lesion</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="280"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="278"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Pleural effusion</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="280"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="278"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Skin ulcer</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="280"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="278"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Hypertension</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="280"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="278"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>1</frequency_threshold>
        <default_vocab>MedDRA 18.1</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="225" subjects_at_risk="225"/>
                <counts group_id="E2" subjects_affected="239" subjects_at_risk="239"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Tachycardia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="225"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="239"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Diabetic retinopathy</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="225"/>
                <counts group_id="E2" events="5" subjects_affected="5" subjects_at_risk="239"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" events="10" subjects_affected="10" subjects_at_risk="225"/>
                <counts group_id="E2" events="8" subjects_affected="6" subjects_at_risk="239"/>
              </event>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" events="12" subjects_affected="11" subjects_at_risk="225"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="239"/>
              </event>
              <event>
                <sub_title>Toothache</sub_title>
                <counts group_id="E1" events="7" subjects_affected="4" subjects_at_risk="225"/>
                <counts group_id="E2" events="5" subjects_affected="5" subjects_at_risk="239"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" events="7" subjects_affected="6" subjects_at_risk="225"/>
                <counts group_id="E2" events="3" subjects_affected="2" subjects_at_risk="239"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Pyrexia</sub_title>
                <counts group_id="E1" events="6" subjects_affected="5" subjects_at_risk="225"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="239"/>
              </event>
              <event>
                <sub_title>Oedema peripheral</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="225"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="239"/>
              </event>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="225"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="239"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Immune system disorders</title>
            <event_list>
              <event>
                <sub_title>Seasonal allergy</sub_title>
                <counts group_id="E1" events="4" subjects_affected="2" subjects_at_risk="225"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="239"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Nasopharyngitis</sub_title>
                <counts group_id="E1" events="37" subjects_affected="25" subjects_at_risk="225"/>
                <counts group_id="E2" events="58" subjects_affected="39" subjects_at_risk="239"/>
              </event>
              <event>
                <sub_title>Upper respiratory tract infection</sub_title>
                <counts group_id="E1" events="38" subjects_affected="27" subjects_at_risk="225"/>
                <counts group_id="E2" events="44" subjects_affected="33" subjects_at_risk="239"/>
              </event>
              <event>
                <sub_title>Influenza</sub_title>
                <counts group_id="E1" events="12" subjects_affected="12" subjects_at_risk="225"/>
                <counts group_id="E2" events="14" subjects_affected="12" subjects_at_risk="239"/>
              </event>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" events="13" subjects_affected="9" subjects_at_risk="225"/>
                <counts group_id="E2" events="11" subjects_affected="10" subjects_at_risk="239"/>
              </event>
              <event>
                <sub_title>Bronchitis</sub_title>
                <counts group_id="E1" events="9" subjects_affected="9" subjects_at_risk="225"/>
                <counts group_id="E2" events="8" subjects_affected="8" subjects_at_risk="239"/>
              </event>
              <event>
                <sub_title>Gastroenteritis</sub_title>
                <counts group_id="E1" events="10" subjects_affected="10" subjects_at_risk="225"/>
                <counts group_id="E2" events="6" subjects_affected="6" subjects_at_risk="239"/>
              </event>
              <event>
                <sub_title>Sinusitis</sub_title>
                <counts group_id="E1" events="10" subjects_affected="8" subjects_at_risk="225"/>
                <counts group_id="E2" events="8" subjects_affected="8" subjects_at_risk="239"/>
              </event>
              <event>
                <sub_title>Gastroenteritis viral</sub_title>
                <counts group_id="E1" events="6" subjects_affected="6" subjects_at_risk="225"/>
                <counts group_id="E2" events="7" subjects_affected="7" subjects_at_risk="239"/>
              </event>
              <event>
                <sub_title>Viral infection</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="225"/>
                <counts group_id="E2" events="6" subjects_affected="6" subjects_at_risk="239"/>
              </event>
              <event>
                <sub_title>Pharyngitis</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="225"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="239"/>
              </event>
              <event>
                <sub_title>Fungal infection</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="225"/>
                <counts group_id="E2" events="4" subjects_affected="3" subjects_at_risk="239"/>
              </event>
              <event>
                <sub_title>Pharyngitis streptococcal</sub_title>
                <counts group_id="E1" events="6" subjects_affected="4" subjects_at_risk="225"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="239"/>
              </event>
              <event>
                <sub_title>Rhinitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="225"/>
                <counts group_id="E2" events="5" subjects_affected="5" subjects_at_risk="239"/>
              </event>
              <event>
                <sub_title>Respiratory tract infection</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="225"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="239"/>
              </event>
              <event>
                <sub_title>Onychomycosis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="225"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="239"/>
              </event>
              <event>
                <sub_title>Respiratory tract infection viral</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="225"/>
                <counts group_id="E2" events="4" subjects_affected="3" subjects_at_risk="239"/>
              </event>
              <event>
                <sub_title>Tonsilitis</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="225"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="239"/>
              </event>
              <event>
                <sub_title>Vulvovaginal mycotic infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="225"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="239"/>
              </event>
              <event>
                <sub_title>Viral upper respiratory tract infection</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="225"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="239"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Ligament sprain</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="225"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="239"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Blood creatine phosphokinase increased</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="225"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="239"/>
              </event>
              <event>
                <sub_title>Blood pressure increased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="225"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="239"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Hypoglycaemia</sub_title>
                <counts group_id="E1" events="3045" subjects_affected="154" subjects_at_risk="225"/>
                <counts group_id="E2" events="3184" subjects_affected="170" subjects_at_risk="239"/>
              </event>
              <event>
                <sub_title>Hyperglycaemia</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="225"/>
                <counts group_id="E2" events="6" subjects_affected="5" subjects_at_risk="239"/>
              </event>
              <event>
                <sub_title>Hyperlipidaemia</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="225"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="239"/>
              </event>
              <event>
                <sub_title>Hyperkalaemia</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="225"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="239"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Arthralgia</sub_title>
                <counts group_id="E1" events="13" subjects_affected="9" subjects_at_risk="225"/>
                <counts group_id="E2" events="4" subjects_affected="2" subjects_at_risk="239"/>
              </event>
              <event>
                <sub_title>Back pain</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="225"/>
                <counts group_id="E2" events="7" subjects_affected="6" subjects_at_risk="239"/>
              </event>
              <event>
                <sub_title>Muscle spasms</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="225"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="239"/>
              </event>
              <event>
                <sub_title>Osteoarthritis</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="225"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="239"/>
              </event>
              <event>
                <sub_title>Trigger finger</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="225"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="239"/>
              </event>
              <event>
                <sub_title>Musculoskeletal pain</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="225"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="239"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="225"/>
                <counts group_id="E2" events="20" subjects_affected="14" subjects_at_risk="239"/>
              </event>
              <event>
                <sub_title>Carpal tunnel syndrome</sub_title>
                <counts group_id="E1" events="5" subjects_affected="4" subjects_at_risk="225"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="239"/>
              </event>
              <event>
                <sub_title>Diabetic neuropathy</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="225"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="239"/>
              </event>
              <event>
                <sub_title>Neuropathy peripheral</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="225"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="239"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Depression</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="225"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="239"/>
              </event>
              <event>
                <sub_title>Anxiety</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="225"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="239"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Microalbuminuria</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="225"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="239"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Cough</sub_title>
                <counts group_id="E1" events="6" subjects_affected="6" subjects_at_risk="225"/>
                <counts group_id="E2" events="5" subjects_affected="5" subjects_at_risk="239"/>
              </event>
              <event>
                <sub_title>Oropharyngeal pain</sub_title>
                <counts group_id="E1" events="6" subjects_affected="6" subjects_at_risk="225"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="239"/>
              </event>
              <event>
                <sub_title>Sinus congestion</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="225"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="239"/>
              </event>
              <event>
                <sub_title>Asthma</sub_title>
                <counts group_id="E1" events="6" subjects_affected="5" subjects_at_risk="225"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="239"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Dermatitis contact</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="225"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="239"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Hypertension</sub_title>
                <counts group_id="E1" events="9" subjects_affected="9" subjects_at_risk="225"/>
                <counts group_id="E2" events="6" subjects_affected="6" subjects_at_risk="239"/>
              </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>The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>David Gillogly, Head of Global Clinical Operations</name_or_title>
      <organization>Mylan Inc.</organization>
      <phone>+1 (724) 4856581</phone>
      <email>david.gillogly@mylan.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/NCT02227862
org study id: MYL-GAI-3001
nct id: NCT02227862
lead sponsor: 
collaborator: 
has dmc: No
To test whether Mylan's insulin glargine once daily is non-inferior to Lantus® once daily
      (based on change in HbA1c from baseline to 24 weeks) when administered in combination with
      mealtime insulin lispro.
This trial is a multicenter, open-label, randomized, parallel-group trial in patients with
      Type 1 Diabetes Mellitus (T1DM) comparing the efficacy and safety of Mylan's insulin glargine
      with that of Lantus®.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Change in HbA1c From Baseline to 24 Weeks
time frame: 24 weeks
measure: Summary of Actual and Change From Baseline in HbA1c
time frame: 24 and 52 weeks
measure: Change From Baseline in FPG Over Time
time frame: 24 and 52 weeks
measure: Change From Baseline in 8-point SMBG Profile Over Time
time frame: 24 and 52 weeks
measure: Change in Total Daily Insulin Dose Per Unit Body Weight From Baseline Over Time
time frame: 24 and 52 weeks
measure: Rate of Hypoglycemic Events Per 30 Days Over Time
time frame: 24 and 52 weeks
measure: Hypoglycemia Occurrence
time frame: 52 weeks
measure: Occurrence of Local and Systematic Reactions
time frame: 52 weeks
measure: Change in Total Insulin Antibody Percent Binding for Mylan's Insulin Glargine Assay Over Time
time frame: 24 and 52 weeks
measure: Change in Total Insulin Antibody Percent Binding for Lantus Assay Over Time
time frame: 24 and 52 weeks
measure: Change in Cross-reactive Insulin Antibody Percent Binding for Mylan's Insulin Glargine Assay Over Time
time frame: 24 and 52 weeks
measure: Change in Cross-reactive Insulin Antibody Percent Binding for Lantus Assay Over Time
time frame: 24 and 52 weeks
measure: Proportion of Patients With HbA1c < 7%
time frame: 24 and 52 weeks
arm group label: Mylan's Insulin Glargine
arm group type: Experimental
description: Receive Mylan's Insulin Glargine plus insulin lispro.
arm group label: Lantus®
arm group type: Active Comparator
description: Receive Lantus® plus insulin lispro
intervention type: Drug
intervention name: Mylan's insulin glargine
description: All patients will be shifted from their current mealtime insulin to insulin lispro at the start of the run-in period, and will continue on this for the complete trial. During the 6 week run-in period the doses of Lantus® and insulin lispro will be titrated (if required) to ensure diabetes control. After the run-in period, patients will be randomized to receive either Mylan's insulin glargine (in place of Lantus®), or to continue on Lantus®. During the period from 12 to 24 weeks dose titration will be kept to a minimum.
arm group label: Mylan's Insulin Glargine
intervention type: Drug
intervention name: Lantus®
description: All patients will be shifted from their current mealtime insulin to insulin lispro at the start of the run-in period; and will continue on this for the complete trial. During the 6week run-in period the doses of Lantus® and insulin lispro will be titrated (if required) to ensure diabetes control. After the run-in period, patients will be randomized to receive either Mylan's insulin glargine (in place of Lantus®), or to continue on Lantus®. During the period from 12 to 24 weeks dose titration will be kept to a minimum.
arm group label: Lantus®
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Thomas Blevins, MD
role: Principal Investigator
affiliation: Texas Diabetes & Endocrinology
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country: Canada
country: Czechia
country: Estonia
country: Germany
country: Hungary
country: Latvia
country: Romania
country: Slovakia
country: South Africa
country: United Kingdom
country: United States
country: Czech Republic
responsible party type: Sponsor
mesh term: Diabetes Mellitus
mesh term: Diabetes Mellitus, Type 1
mesh term: Insulin Glargine
participant flow: 
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certain agreements: 
point of contact: 