<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/NCT02227875</url>
  </required_header>
  <id_info>
    <org_study_id>MYL-GAI-3002</org_study_id>
    <nct_id>NCT02227875</nct_id>
  </id_info>
  <brief_title>Non-inferiority Study to Compare the Efficacy and Safety of Mylan's Insulin Glargine With Lantus® in Type 2 Diabetes Mellitus Patients (INSTRIDE 2)</brief_title>
  <acronym>INSTRIDE 2</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 2 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;
      (both administered in combination with other anti-diabetic drugs) based on the change in&#xD;
      HbA1c from baseline to 24 weeks&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This trial is a multi-center, open-label, randomized, parallel group trial in patients with&#xD;
      T2DM comparing the efficacy and safety of Mylan's insulin glargine with that of Lantus®.&#xD;
      Patients with an established diagnosis of T2DM per ADA 2014 criteria and who satisfy the&#xD;
      selection criteria will be included in the trial. This will be followed by a 24-week&#xD;
      randomized, comparative, parallel-assignment treatment period with Mylan's insulin glargine&#xD;
      or Lantus® (in addition to other anti-diabetic drugs). After the treatment period, there will&#xD;
      be a follow-up visit; 4 weeks after the patient has been put back on approved medications.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>August 2014</start_date>
  <completion_date type="Actual">December 2015</completion_date>
  <primary_completion_date type="Actual">December 2015</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>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>Rate of Hypoglycemic Events Per 30 Days</measure>
    <time_frame>Baseline and up to 24 weeks</time_frame>
    <description>The change from baseline at 12 and 24 weeks is reported</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hypoglycemia Occurrence</measure>
    <time_frame>24 weeks</time_frame>
    <description>Overall hypoglycemic incidence during treatment period</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Total Insulin Antibody Percent Binding for Mylan's Insulin Glargine Assay Over Time</measure>
    <time_frame>Week 12 and week 24</time_frame>
    <description>Comparison of change from Baseline in Immunogenicity</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Total Insulin Antibody Percent Binding for Lantus Assay Over Time</measure>
    <time_frame>week 12 and week 24</time_frame>
    <description>Comparison of change from Baseline in Immunogenicity</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Cross-Reactive Insulin Antibody Percent Binding for Mylan's Insulin Glargine Assay Over Time</measure>
    <time_frame>week 12 and week 24</time_frame>
    <description>Comparison of change from Baseline in Immunogenicity</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Cross-Reactive Insulin Antibody Percent Binding for Lantus Assay Over Time</measure>
    <time_frame>Week 12 and week 24</time_frame>
    <description>Comparison of change from Baseline in Immunogenicity</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">560</enrollment>
  <condition>Type 2 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</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Lantus®</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>receive Lantus®</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Mylan's insulin glargine</intervention_name>
    <description>Patients who are randomized to receive Mylan's insulin glargine during the comparative phase will receive the same dose as the dose of Lantus® received during the screening period. The recommended starting dose of Mylan's insulin glargine or Lantus®, in patients with T2DM who are not currently treated with insulin is 10 units (or 0.2 Units/kg) once daily, which should subsequently be adjusted every week if essential.</description>
    <arm_group_label>Mylan's insulin Glargine</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Lantus®</intervention_name>
    <description>For patients who are randomized to receive Lantus® during the comparative phase the dose of Lantus® will be equal to the dose received during the screening period.</description>
    <arm_group_label>Lantus®</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with an established diagnosis of T2DM per ADA 2014 criteria who also fulfill&#xD;
             the following:&#xD;
&#xD;
               -  Diagnosis established 1 year prior to screening&#xD;
&#xD;
               -  Insulin-naïve OR&#xD;
&#xD;
               -  On Lantus® once daily at stable dose (±15% variation in dose) for at least 3&#xD;
                  months prior to screening&#xD;
&#xD;
          -  Body mass index (BMI) of 18.50 to 40.00 kg/m2 at screening (both values inclusive).&#xD;
&#xD;
          -  Stable weight, with no more than 5 kg gain or loss, in the 3 months prior to&#xD;
             screening; this information will be collected by patient interview during medical&#xD;
             history.&#xD;
&#xD;
          -  Hemoglobin ≥9.0 g/dL at screening&#xD;
&#xD;
          -  Glycosylated hemoglobin (HbA1c) of &lt;10.5% or between 7.5 to 10.5% for insulin naïve&#xD;
             patients at screening.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  History of hypersensitivity to any of the active or inactive ingredients of the&#xD;
             insulin/insulin analog 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, any insulin other than&#xD;
             Lantus® within the last 3 months prior to screening, or use of biosimilar insulin&#xD;
             glargine at any time prior to screening.&#xD;
&#xD;
          -  Patients requiring basal-bolus insulin therapy or who in the opinion of the&#xD;
             investigator require mealtime insulin in order to achieve glycemic control.&#xD;
&#xD;
          -  Regular use of immune-modulator 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 I)&#xD;
             as judged by the investigator.&#xD;
&#xD;
          -  History of ≥1 episode of hyperglycemic hyperosmolar coma 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;
&#xD;
          -  Receipt of another investigational drug in the 3 months prior to screening (or as per&#xD;
             local regulations), or if the screening visit is within 5 half-lives of another&#xD;
             investigational drug (whichever is longer), or scheduled to receive another&#xD;
             investigational drug during the current trial period.&#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>Chandler</city>
        <state>Arizona</state>
        <zip>85224</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <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>94904</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 Angeles</city>
        <state>California</state>
        <zip>90057</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>47304</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>Orange</city>
        <state>California</state>
        <zip>92868</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mylan Investigational Site</name>
      <address>
        <city>Palm Springs</city>
        <state>California</state>
        <zip>92262</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mylan Investigational Site</name>
      <address>
        <city>Spring Valley</city>
        <state>California</state>
        <zip>91978</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>West Hills</city>
        <state>California</state>
        <zip>91307</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>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>Pembroke Pines</city>
        <state>Florida</state>
        <zip>33028</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mylan Investigational Site</name>
      <address>
        <city>Port Charlotte</city>
        <state>Florida</state>
        <zip>33952</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>Winter Haven</city>
        <state>Florida</state>
        <zip>33880</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>Gainesville</city>
        <state>Georgia</state>
        <zip>30501</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>Chicago</city>
        <state>Illinois</state>
        <zip>60616</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>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>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>Augusta</city>
        <state>Kansas</state>
        <zip>67010</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>Wichita</city>
        <state>Kansas</state>
        <zip>67207</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mylan Investigational Site</name>
      <address>
        <city>Crestview Hills</city>
        <state>Kentucky</state>
        <zip>41017</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>Waltham</city>
        <state>Massachusetts</state>
        <zip>02453</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mylan Investigational Site</name>
      <address>
        <city>Kansas City</city>
        <state>Missouri</state>
        <zip>64114</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mylan Investigational Site</name>
      <address>
        <city>Saint Louis</city>
        <state>Missouri</state>
        <zip>63128</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>Lincoln</city>
        <state>Nebraska</state>
        <zip>68516</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>89119</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>Nashua</city>
        <state>New Hampshire</state>
        <zip>03063</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>Hartsdale</city>
        <state>New York</state>
        <zip>10530</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mylan Investigational Site</name>
      <address>
        <city>Smithtown</city>
        <state>New York</state>
        <zip>11787</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>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>Cary</city>
        <state>North Carolina</state>
        <zip>27513</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>28590</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>Cleveland</city>
        <state>Ohio</state>
        <zip>44122</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mylan Investigational Site</name>
      <address>
        <city>Columbus</city>
        <state>Ohio</state>
        <zip>43201</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>Charleston</city>
        <state>South Carolina</state>
        <zip>29407</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mylan Investigational Site</name>
      <address>
        <city>Greer</city>
        <state>South Carolina</state>
        <zip>29651</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mylan Investigational Site</name>
      <address>
        <city>Bristol</city>
        <state>Tennessee</state>
        <zip>34208</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mylan Investigational Site</name>
      <address>
        <city>Kingsport</city>
        <state>Tennessee</state>
        <zip>37660</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mylan Investigational Site</name>
      <address>
        <city>Memphis</city>
        <state>Tennessee</state>
        <zip>38119</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mylan Investigational Site</name>
      <address>
        <city>Austin</city>
        <state>Texas</state>
        <zip>78731</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mylan Investigational Site</name>
      <address>
        <city>Corpus Christi</city>
        <state>Texas</state>
        <zip>78404</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mylan Investigational Site</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75230</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mylan Investigational Site</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75231</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mylan Investigational Site</name>
      <address>
        <city>El Paso</city>
        <state>Texas</state>
        <zip>79925</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mylan Investigational Site</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77004</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mylan Investigational Site</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77095</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mylan Investigational Site</name>
      <address>
        <city>McKinney</city>
        <state>Texas</state>
        <zip>75070</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mylan Investigational Site</name>
      <address>
        <city>Round Rock</city>
        <state>Texas</state>
        <zip>78681</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mylan Investigational Site</name>
      <address>
        <city>San Antonio</city>
        <state>Texas</state>
        <zip>78258</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mylan Investigational Site</name>
      <address>
        <city>Spring</city>
        <state>Texas</state>
        <zip>77379</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mylan Investigational Site</name>
      <address>
        <city>Victoria</city>
        <state>Texas</state>
        <zip>77901</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mylan Investigational Site</name>
      <address>
        <city>Ogden</city>
        <state>Utah</state>
        <zip>84405</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mylan Investigational Site</name>
      <address>
        <city>Salt Lake City</city>
        <state>Utah</state>
        <zip>84102</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mylan Investigational Site</name>
      <address>
        <city>Salt Lake City</city>
        <state>Utah</state>
        <zip>84109</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mylan Investigational Site</name>
      <address>
        <city>Salt Lake City</city>
        <state>Utah</state>
        <zip>84121</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mylan Investigational Site</name>
      <address>
        <city>South Jordan</city>
        <state>Utah</state>
        <zip>84095</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mylan Investigational Site</name>
      <address>
        <city>Chesapeake</city>
        <state>Virginia</state>
        <zip>23321</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mylan Investigational Site</name>
      <address>
        <city>Manassas</city>
        <state>Virginia</state>
        <zip>20110</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mylan Investigational Site</name>
      <address>
        <city>Tacoma</city>
        <state>Washington</state>
        <zip>98405</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mylan Investigational Site</name>
      <address>
        <city>Vancouver</city>
        <state>Washington</state>
        <zip>98405</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mylan Investigational Site</name>
      <address>
        <city>Amman</city>
        <country>Jordan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mylan Investigational Site</name>
      <address>
        <city>Irbid</city>
        <country>Jordan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mylan Investigational Site</name>
      <address>
        <city>Seoul</city>
        <state>Gyeonggi-do</state>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mylan Investigational Site</name>
      <address>
        <city>Suwon-si</city>
        <state>Gyeonggi-do</state>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mylan Investigational Site</name>
      <address>
        <city>Seoul</city>
        <zip>110744</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mylan Investigational Site</name>
      <address>
        <city>Banska Bystrica</city>
        <country>Slovakia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mylan Investigational Site</name>
      <address>
        <city>Bardejov</city>
        <country>Slovakia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mylan Investigational Site</name>
      <address>
        <city>Bratislava</city>
        <country>Slovakia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mylan Investigational Site</name>
      <address>
        <city>Dolny Kubin</city>
        <country>Slovakia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mylan Investigational Site</name>
      <address>
        <city>Kosice</city>
        <country>Slovakia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mylan Investigational Site</name>
      <address>
        <city>Levice</city>
        <country>Slovakia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mylan Investigational Site</name>
      <address>
        <city>Sabinov</city>
        <country>Slovakia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mylan Investigational Site</name>
      <address>
        <city>Sahy</city>
        <country>Slovakia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mylan Investigational Site</name>
      <address>
        <city>Stropkov</city>
        <country>Slovakia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mylan Investigational Site</name>
      <address>
        <city>Sturovo</city>
        <country>Slovakia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mylan Investigational Site</name>
      <address>
        <city>Trebisov</city>
        <country>Slovakia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mylan Investigational Site</name>
      <address>
        <city>Trencin</city>
        <country>Slovakia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mylan Investigational Site</name>
      <address>
        <city>Zilina</city>
        <country>Slovakia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mylan Investigational Site</name>
      <address>
        <city>Johannesburg</city>
        <state>Gauteng</state>
        <country>South Africa</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mylan Investigational Site</name>
      <address>
        <city>Durban</city>
        <state>KwaZulu-Natal</state>
        <country>South Africa</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mylan Investigational Site</name>
      <address>
        <city>Cape Town</city>
        <state>Western Cape</state>
        <zip>7646</zip>
        <country>South Africa</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mylan Investigational Site</name>
      <address>
        <city>Cape Town</city>
        <state>Western Cape</state>
        <country>South Africa</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mylan Investigational Site</name>
      <address>
        <city>Worcester</city>
        <state>Western Cape</state>
        <country>South Africa</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mylan Investigational Site</name>
      <address>
        <city>Bloemfontein</city>
        <country>South Africa</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mylan Investigational Site</name>
      <address>
        <city>Kaohsiung</city>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mylan Investigational Site</name>
      <address>
        <city>Taipei</city>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Jordan</country>
    <country>Korea, Republic of</country>
    <country>Slovakia</country>
    <country>South Africa</country>
    <country>Taiwan</country>
    <country>United States</country>
  </location_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>July 30, 2020</results_first_submitted_qc>
  <results_first_posted type="Actual">August 13, 2020</results_first_posted>
  <disposition_first_submitted>March 3, 2017</disposition_first_submitted>
  <disposition_first_submitted_qc>March 3, 2017</disposition_first_submitted_qc>
  <disposition_first_posted type="Actual">March 6, 2017</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 2</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&#xD;
Mylan's insulin glargine: Patients who are randomized to receive Mylan's insulin glargine during the comparative phase will receive the same dose as the dose of Lantus® received during the screening period. The recommended starting dose of Mylan's insulin glargine or Lantus®, in patients with T2DM who are not currently treated with insulin is 10 units (or 0.2 Units/kg) once daily, which should subsequently be adjusted every week if essential.</description>
        </group>
        <group group_id="P2">
          <title>Lantus®</title>
          <description>receive Lantus®&#xD;
Lantus®: For patients who are randomized to receive Lantus® during the comparative phase the dose of Lantus® will be equal to the dose received during the screening period.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="277"/>
                <participants group_id="P2" count="283"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="240"/>
                <participants group_id="P2" count="250"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="37"/>
                <participants group_id="P2" count="33"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Protocol Violation</title>
              <participants_list>
                <participants group_id="P1" count="10"/>
                <participants group_id="P2" count="7"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Other</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="3"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Physician Decision</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="12"/>
                <participants group_id="P2" count="13"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="10"/>
                <participants group_id="P2" count="10"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Recruitment details:&#xD;
Gender: male or female;&#xD;
Age: 18-65 years, inclusive;&#xD;
Body mass index (BMI): 18.5-40.0 kg/m2, inclusive</population>
      <group_list>
        <group group_id="B1">
          <title>Mylan's Insulin Glargine</title>
          <description>receive Mylan's insulin Glargine&#xD;
Mylan's insulin glargine: Patients who are randomized to receive Mylan's insulin glargine during the comparative phase will receive the same dose as the dose of Lantus® received during the screening period. The recommended starting dose of Mylan's insulin glargine or Lantus®, in patients with T2DM who are not currently treated with insulin is 10 units (or 0.2 Units/kg) once daily, which should subsequently be adjusted every week if essential.</description>
        </group>
        <group group_id="B2">
          <title>Lantus®</title>
          <description>receive Lantus®&#xD;
Lantus®: For patients who are randomized to receive Lantus® during the comparative phase the dose of Lantus® will be equal to the dose received during the screening period.</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="277"/>
            <count group_id="B2" value="283"/>
            <count group_id="B3" value="560"/>
          </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="267"/>
                    <measurement group_id="B2" value="267"/>
                    <measurement group_id="B3" value="534"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                    <measurement group_id="B2" value="16"/>
                    <measurement group_id="B3" value="26"/>
                  </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="55" spread="7.91"/>
                    <measurement group_id="B2" value="55.1" spread="7.5"/>
                    <measurement group_id="B3" value="55.1" spread="7.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="130"/>
                    <measurement group_id="B2" value="118"/>
                    <measurement group_id="B3" value="248"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="147"/>
                    <measurement group_id="B2" value="165"/>
                    <measurement group_id="B3" value="312"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>South Korea</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="225"/>
                    <measurement group_id="B2" value="228"/>
                    <measurement group_id="B3" value="453"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Taiwan</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>South Africa</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="12"/>
                    <measurement group_id="B2" value="15"/>
                    <measurement group_id="B3" value="27"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Slovakia</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="34"/>
                    <measurement group_id="B2" value="33"/>
                    <measurement group_id="B3" value="67"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Jordan</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="5"/>
                  </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>
        <population>Intent-to-Treat Population</population>
        <group_list>
          <group group_id="O1">
            <title>Mylan's Insulin Glargine</title>
            <description>receive Mylan's insulin Glargine&#xD;
Mylan's insulin glargine: Patients who are randomized to receive Mylan's insulin glargine during the comparative phase will receive the same dose as the dose of Lantus® received during the screening period. The recommended starting dose of Mylan's insulin glargine or Lantus®, in patients with T2DM who are not currently treated with insulin is 10 units (or 0.2 Units/kg) once daily, which should subsequently be adjusted every week if essential.</description>
          </group>
          <group group_id="O2">
            <title>Lantus®</title>
            <description>receive Lantus®&#xD;
Lantus®: For patients who are randomized to receive Lantus® during the comparative phase the dose of Lantus® will be equal to the dose received during the screening period.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in HbA1c From Baseline to 24 Weeks</title>
          <population>Intent-to-Treat Population</population>
          <units>percent</units>
          <param>Least Squares Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="274"/>
                <count group_id="O2" value="278"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.6" lower_limit="-0.779" upper_limit="-0.414"/>
                    <measurement group_id="O2" value="-0.66" lower_limit="-0.837" upper_limit="-0.475"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Non-Inferiority</non_inferiority_type>
            <non_inferiority_desc>Mixed-Effect Model for Repeated Measures</non_inferiority_desc>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>0.06</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.08</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.098</ci_lower_limit>
            <ci_upper_limit>0.218</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Rate of Hypoglycemic Events Per 30 Days</title>
        <description>The change from baseline at 12 and 24 weeks is reported</description>
        <time_frame>Baseline and up to 24 weeks</time_frame>
        <population>Safety Population</population>
        <group_list>
          <group group_id="O1">
            <title>Mylan's Insulin Glargine</title>
            <description>receive Mylan's insulin Glargine&#xD;
Mylan's insulin glargine: Patients who are randomized to receive Mylan's insulin glargine during the comparative phase will receive the same dose as the dose of Lantus® received during the screening period. The recommended starting dose of Mylan's insulin glargine or Lantus®, in patients with T2DM who are not currently treated with insulin is 10 units (or 0.2 Units/kg) once daily, which should subsequently be adjusted every week if essential.</description>
          </group>
          <group group_id="O2">
            <title>Lantus®</title>
            <description>receive Lantus®&#xD;
Lantus®: For patients who are randomized to receive Lantus® during the comparative phase the dose of Lantus® will be equal to the dose received during the screening period.</description>
          </group>
        </group_list>
        <measure>
          <title>Rate of Hypoglycemic Events Per 30 Days</title>
          <description>The change from baseline at 12 and 24 weeks is reported</description>
          <population>Safety Population</population>
          <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="276"/>
                <count group_id="O2" value="282"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>week 12</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.341" spread="1.8963"/>
                    <measurement group_id="O2" value="0.24" spread="2.0551"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>week 24</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.057" spread="0.919"/>
                    <measurement group_id="O2" value="-0.102" spread="1.6791"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Hypoglycemia Occurrence</title>
        <description>Overall hypoglycemic incidence during treatment period</description>
        <time_frame>24 weeks</time_frame>
        <population>Safety Population</population>
        <group_list>
          <group group_id="O1">
            <title>Mylan's Insulin Glargine</title>
            <description>receive Mylan's insulin Glargine&#xD;
Mylan's insulin glargine: Patients who are randomized to receive Mylan's insulin glargine during the comparative phase will receive the same dose as the dose of Lantus® received during the screening period. The recommended starting dose of Mylan's insulin glargine or Lantus®, in patients with T2DM who are not currently treated with insulin is 10 units (or 0.2 Units/kg) once daily, which should subsequently be adjusted every week if essential.</description>
          </group>
          <group group_id="O2">
            <title>Lantus®</title>
            <description>receive Lantus®&#xD;
Lantus®: For patients who are randomized to receive Lantus® during the comparative phase the dose of Lantus® will be equal to the dose received during the screening period.</description>
          </group>
        </group_list>
        <measure>
          <title>Hypoglycemia Occurrence</title>
          <description>Overall hypoglycemic incidence during treatment period</description>
          <population>Safety Population</population>
          <units>number of events</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="276"/>
                <count group_id="O2" value="282"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Any hypoglycemic event</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="130"/>
                    <measurement group_id="O2" value="136"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Severe Hypoglycemia</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Documented Symptomatic Hypoglycemia</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="75"/>
                    <measurement group_id="O2" value="76"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Asymptomatic Hypoglycemia</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="85"/>
                    <measurement group_id="O2" value="92"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Probable Symptomatic Hypoglycemia</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7"/>
                    <measurement group_id="O2" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Relative Hypoglycemia</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="20"/>
                    <measurement group_id="O2" value="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Unknown</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="29"/>
                    <measurement group_id="O2" value="25"/>
                  </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>
        <description>Comparison of change from Baseline in Immunogenicity</description>
        <time_frame>Week 12 and week 24</time_frame>
        <population>Safety Population</population>
        <group_list>
          <group group_id="O1">
            <title>Mylan's Insulin Glargine</title>
            <description>receive Mylan's insulin Glargine&#xD;
Mylan's insulin glargine: Patients who are randomized to receive Mylan's insulin glargine during the comparative phase will receive the same dose as the dose of Lantus® received during the screening period. The recommended starting dose of Mylan's insulin glargine or Lantus®, in patients with T2DM who are not currently treated with insulin is 10 units (or 0.2 Units/kg) once daily, which should subsequently be adjusted every week if essential.</description>
          </group>
          <group group_id="O2">
            <title>Lantus®</title>
            <description>receive Lantus®&#xD;
Lantus®: For patients who are randomized to receive Lantus® during the comparative phase the dose of Lantus® will be equal to the dose received during the screening period.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Total Insulin Antibody Percent Binding for Mylan's Insulin Glargine Assay Over Time</title>
          <description>Comparison of change from Baseline in Immunogenicity</description>
          <population>Safety Population</population>
          <units>percentage of specific binding (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="276"/>
                <count group_id="O2" value="282"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>week 12</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.9238" spread="12.54369"/>
                    <measurement group_id="O2" value="0.6585" spread="8.05473"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>week 24</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.7802" spread="9.64745"/>
                    <measurement group_id="O2" value="0.7838" spread="8.15086"/>
                  </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>
        <description>Comparison of change from Baseline in Immunogenicity</description>
        <time_frame>week 12 and week 24</time_frame>
        <population>Safety Population</population>
        <group_list>
          <group group_id="O1">
            <title>Mylan's Insulin Glargine</title>
            <description>receive Mylan's insulin Glargine&#xD;
Mylan's insulin glargine: Patients who are randomized to receive Mylan's insulin glargine during the comparative phase will receive the same dose as the dose of Lantus® received during the screening period. The recommended starting dose of Mylan's insulin glargine or Lantus®, in patients with T2DM who are not currently treated with insulin is 10 units (or 0.2 Units/kg) once daily, which should subsequently be adjusted every week if essential.</description>
          </group>
          <group group_id="O2">
            <title>Lantus®</title>
            <description>receive Lantus®&#xD;
Lantus®: For patients who are randomized to receive Lantus® during the comparative phase the dose of Lantus® will be equal to the dose received during the screening period.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Total Insulin Antibody Percent Binding for Lantus Assay Over Time</title>
          <description>Comparison of change from Baseline in Immunogenicity</description>
          <population>Safety Population</population>
          <units>percentage of 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="276"/>
                <count group_id="O2" value="282"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>week 12</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.787" spread="11.67578"/>
                    <measurement group_id="O2" value="0.6462" spread="7.56375"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>week 24</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.6866" spread="9.57132"/>
                    <measurement group_id="O2" value="0.8212" spread="8.1084"/>
                  </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>
        <description>Comparison of change from Baseline in Immunogenicity</description>
        <time_frame>week 12 and week 24</time_frame>
        <population>Safety Population</population>
        <group_list>
          <group group_id="O1">
            <title>Mylan's Insulin Glargine</title>
            <description>receive Mylan's insulin Glargine&#xD;
Mylan's insulin glargine: Patients who are randomized to receive Mylan's insulin glargine during the comparative phase will receive the same dose as the dose of Lantus® received during the screening period. The recommended starting dose of Mylan's insulin glargine or Lantus®, in patients with T2DM who are not currently treated with insulin is 10 units (or 0.2 Units/kg) once daily, which should subsequently be adjusted every week if essential.</description>
          </group>
          <group group_id="O2">
            <title>Lantus®</title>
            <description>receive Lantus®&#xD;
Lantus®: For patients who are randomized to receive Lantus® during the comparative phase the dose of Lantus® will be equal to the dose received during the screening period.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Cross-Reactive Insulin Antibody Percent Binding for Mylan's Insulin Glargine Assay Over Time</title>
          <description>Comparison of change from Baseline in Immunogenicity</description>
          <population>Safety Population</population>
          <units>percentage of 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="276"/>
                <count group_id="O2" value="282"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>week 12</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.7488" spread="11.68129"/>
                    <measurement group_id="O2" value="0.5116" spread="7.25175"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>week 24</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.6301" spread="9.11098"/>
                    <measurement group_id="O2" value="0.7524" spread="7.93317"/>
                  </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>
        <description>Comparison of change from Baseline in Immunogenicity</description>
        <time_frame>Week 12 and week 24</time_frame>
        <population>Safety Population</population>
        <group_list>
          <group group_id="O1">
            <title>Mylan's Insulin Glargine</title>
            <description>receive Mylan's insulin Glargine&#xD;
Mylan's insulin glargine: Patients who are randomized to receive Mylan's insulin glargine during the comparative phase will receive the same dose as the dose of Lantus® received during the screening period. The recommended starting dose of Mylan's insulin glargine or Lantus®, in patients with T2DM who are not currently treated with insulin is 10 units (or 0.2 Units/kg) once daily, which should subsequently be adjusted every week if essential.</description>
          </group>
          <group group_id="O2">
            <title>Lantus®</title>
            <description>receive Lantus®&#xD;
Lantus®: For patients who are randomized to receive Lantus® during the comparative phase the dose of Lantus® will be equal to the dose received during the screening period.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Cross-Reactive Insulin Antibody Percent Binding for Lantus Assay Over Time</title>
          <description>Comparison of change from Baseline in Immunogenicity</description>
          <population>Safety Population</population>
          <units>percentage of 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="276"/>
                <count group_id="O2" value="282"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>week 12</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.5994" spread="10.64782"/>
                    <measurement group_id="O2" value="0.5014" spread="6.72058"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>week 24</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.5648" spread="9.04243"/>
                    <measurement group_id="O2" value="0.8361" spread="7.96308"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>24 weeks</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Mylan's Insulin Glargine</title>
          <description>receive Mylan's insulin Glargine&#xD;
Mylan's insulin glargine: Patients who are randomized to receive Mylan's insulin glargine during the comparative phase will receive the same dose as the dose of Lantus® received during the screening period. The recommended starting dose of Mylan's insulin glargine or Lantus®, in patients with T2DM who are not currently treated with insulin is 10 units (or 0.2 Units/kg) once daily, which should subsequently be adjusted every week if essential.</description>
        </group>
        <group group_id="E2">
          <title>Lantus®</title>
          <description>receive Lantus®&#xD;
Lantus®: For patients who are randomized to receive Lantus® during the comparative phase the dose of Lantus® will be equal to the dose received during the screening period.</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="0" subjects_at_risk="276"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="282"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="8" subjects_at_risk="276"/>
                <counts group_id="E2" subjects_affected="9" subjects_at_risk="282"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Eye haemorrhage</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="276"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="282"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Gastric ulcer</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="276"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="282"/>
              </event>
              <event>
                <sub_title>Pancreatitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="276"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="282"/>
              </event>
              <event>
                <sub_title>Pancreatitis acute</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="276"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="282"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Non-cardiac chest pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="276"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="282"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Bronchitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="276"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="282"/>
              </event>
              <event>
                <sub_title>Meningitis viral</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="276"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="282"/>
              </event>
              <event>
                <sub_title>Paraspinal abscess</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="276"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="282"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Helicobacter test positive</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="276"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="282"/>
              </event>
              <event>
                <sub_title>Hepatic enzyme increased</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="276"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="282"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Dehydration</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="276"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="282"/>
              </event>
              <event>
                <sub_title>Hyperosmolar hyperglycaemic state</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="276"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="282"/>
              </event>
              <event>
                <sub_title>Hypoglycaemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="276"/>
                <counts group_id="E2" events="2" subjects_affected="1" subjects_at_risk="282"/>
              </event>
              <event>
                <sub_title>Lactic acidosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="276"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="282"/>
              </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="1" subjects_affected="1" subjects_at_risk="276"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="282"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Endometrial adenocarcinoma</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="276"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="282"/>
              </event>
              <event>
                <sub_title>Squamous cell carcinoma of skin</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="276"/>
                <counts group_id="E2" events="2" subjects_affected="1" subjects_at_risk="282"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Cerebrovascular accident</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="276"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="282"/>
              </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="0" subjects_affected="0" subjects_at_risk="276"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="282"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Asthma</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="276"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="282"/>
              </event>
              <event>
                <sub_title>Chronic obstructive pulmonary</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="276"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="282"/>
              </event>
              <event>
                <sub_title>Hypoxia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="276"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="282"/>
              </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="177" subjects_at_risk="276"/>
                <counts group_id="E2" subjects_affected="164" subjects_at_risk="282"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" events="6" subjects_affected="6" subjects_at_risk="276"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="282"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="276"/>
                <counts group_id="E2" events="5" subjects_affected="5" subjects_at_risk="282"/>
              </event>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="276"/>
                <counts group_id="E2" events="10" subjects_affected="5" subjects_at_risk="282"/>
              </event>
              <event>
                <sub_title>Abdominal pain</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="276"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="282"/>
              </event>
              <event>
                <sub_title>Constipation</sub_title>
                <counts group_id="E1" events="5" subjects_affected="3" subjects_at_risk="276"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="282"/>
              </event>
              <event>
                <sub_title>Dyspepsia</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="276"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="282"/>
              </event>
              <event>
                <sub_title>Gastrooesophageal reflux disease</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="276"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="282"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="276"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="282"/>
              </event>
              <event>
                <sub_title>Injection site pain</sub_title>
                <counts group_id="E1" events="4" subjects_affected="3" subjects_at_risk="276"/>
                <counts group_id="E2" events="3" subjects_affected="2" subjects_at_risk="282"/>
              </event>
              <event>
                <sub_title>Oedema peripheral</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="276"/>
                <counts group_id="E2" events="6" subjects_affected="6" subjects_at_risk="282"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Immune system disorders</title>
            <event_list>
              <event>
                <sub_title>Seasonal allergy</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="276"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="282"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Upper respiratory tract infection</sub_title>
                <counts group_id="E1" events="19" subjects_affected="17" subjects_at_risk="276"/>
                <counts group_id="E2" events="15" subjects_affected="15" subjects_at_risk="282"/>
              </event>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" events="13" subjects_affected="12" subjects_at_risk="276"/>
                <counts group_id="E2" events="8" subjects_affected="8" subjects_at_risk="282"/>
              </event>
              <event>
                <sub_title>Nasopharyngitis</sub_title>
                <counts group_id="E1" events="11" subjects_affected="10" subjects_at_risk="276"/>
                <counts group_id="E2" events="14" subjects_affected="13" subjects_at_risk="282"/>
              </event>
              <event>
                <sub_title>Sinusitis</sub_title>
                <counts group_id="E1" events="9" subjects_affected="8" subjects_at_risk="276"/>
                <counts group_id="E2" events="5" subjects_affected="4" subjects_at_risk="282"/>
              </event>
              <event>
                <sub_title>Influenza</sub_title>
                <counts group_id="E1" events="7" subjects_affected="6" subjects_at_risk="276"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="282"/>
              </event>
              <event>
                <sub_title>Bronchitis</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="276"/>
                <counts group_id="E2" events="7" subjects_affected="7" subjects_at_risk="282"/>
              </event>
              <event>
                <sub_title>Gastroenteritis</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="276"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="282"/>
              </event>
              <event>
                <sub_title>Pharyngitis</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="276"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="282"/>
              </event>
              <event>
                <sub_title>Pneumonia</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="276"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="282"/>
              </event>
              <event>
                <sub_title>Vulvovaginal mycotic infection</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="276"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="282"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Contusion</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="276"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="282"/>
              </event>
              <event>
                <sub_title>Laceration</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="276"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="282"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Lipase increased</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="276"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="282"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Hypoglycemia</sub_title>
                <counts group_id="E1" events="330" subjects_affected="75" subjects_at_risk="276"/>
                <counts group_id="E2" events="282" subjects_affected="66" subjects_at_risk="282"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Back pain</sub_title>
                <counts group_id="E1" events="7" subjects_affected="7" subjects_at_risk="276"/>
                <counts group_id="E2" events="6" subjects_affected="6" subjects_at_risk="282"/>
              </event>
              <event>
                <sub_title>Pain in extremity</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="276"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="282"/>
              </event>
              <event>
                <sub_title>Arthralgia</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="276"/>
                <counts group_id="E2" events="7" subjects_affected="5" subjects_at_risk="282"/>
              </event>
              <event>
                <sub_title>Musculoskeletal pain</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="276"/>
                <counts group_id="E2" events="5" subjects_affected="5" subjects_at_risk="282"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" events="9" subjects_affected="8" subjects_at_risk="276"/>
                <counts group_id="E2" events="11" subjects_affected="10" subjects_at_risk="282"/>
              </event>
              <event>
                <sub_title>Tremor</sub_title>
                <counts group_id="E1" events="9" subjects_affected="6" subjects_at_risk="276"/>
                <counts group_id="E2" events="3" subjects_affected="1" subjects_at_risk="282"/>
              </event>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="276"/>
                <counts group_id="E2" events="8" subjects_affected="7" subjects_at_risk="282"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Nephrolithiasis</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="276"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="282"/>
              </event>
              <event>
                <sub_title>Dysuria</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="276"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="282"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Oropharyngeal pain</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="276"/>
                <counts group_id="E2" events="5" subjects_affected="5" subjects_at_risk="282"/>
              </event>
              <event>
                <sub_title>Cough</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="276"/>
                <counts group_id="E2" events="10" subjects_affected="10" subjects_at_risk="282"/>
              </event>
              <event>
                <sub_title>Respiratory tract congestion</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="276"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="282"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Rash</sub_title>
                <counts group_id="E1" events="3" subjects_affected="2" subjects_at_risk="276"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="282"/>
              </event>
              <event>
                <sub_title>Pruritus</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="276"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="282"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Hypertension</sub_title>
                <counts group_id="E1" events="6" subjects_affected="6" subjects_at_risk="276"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="282"/>
              </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>Keri L. Vaughan, Director Global Clinical Operations, General Medicine</name_or_title>
      <organization>Mylan, Inc.</organization>
      <email>keri.vaughan@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/NCT02227875
org study id: MYL-GAI-3002
nct id: NCT02227875
lead sponsor: 
collaborator: 
has dmc: No
To test whether Mylan's insulin glargine once daily is non-inferior to Lantus® once daily
      (both administered in combination with other anti-diabetic drugs) based on the change in
      HbA1c from baseline to 24 weeks
This trial is a multi-center, open-label, randomized, parallel group trial in patients with
      T2DM comparing the efficacy and safety of Mylan's insulin glargine with that of Lantus®.
      Patients with an established diagnosis of T2DM per ADA 2014 criteria and who satisfy the
      selection criteria will be included in the trial. This will be followed by a 24-week
      randomized, comparative, parallel-assignment treatment period with Mylan's insulin glargine
      or Lantus® (in addition to other anti-diabetic drugs). After the treatment period, there will
      be a follow-up visit; 4 weeks after the patient has been put back on approved medications.
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: Rate of Hypoglycemic Events Per 30 Days
time frame: Baseline and up to 24 weeks
description: The change from baseline at 12 and 24 weeks is reported
measure: Hypoglycemia Occurrence
time frame: 24 weeks
description: Overall hypoglycemic incidence during treatment period
measure: Change in Total Insulin Antibody Percent Binding for Mylan's Insulin Glargine Assay Over Time
time frame: Week 12 and week 24
description: Comparison of change from Baseline in Immunogenicity
measure: Change in Total Insulin Antibody Percent Binding for Lantus Assay Over Time
time frame: week 12 and week 24
description: Comparison of change from Baseline in Immunogenicity
measure: Change in Cross-Reactive Insulin Antibody Percent Binding for Mylan's Insulin Glargine Assay Over Time
time frame: week 12 and week 24
description: Comparison of change from Baseline in Immunogenicity
measure: Change in Cross-Reactive Insulin Antibody Percent Binding for Lantus Assay Over Time
time frame: Week 12 and week 24
description: Comparison of change from Baseline in Immunogenicity
arm group label: Mylan's insulin Glargine
arm group type: Experimental
description: receive Mylan's insulin Glargine
arm group label: Lantus®
arm group type: Active Comparator
description: receive Lantus®
intervention type: Drug
intervention name: Mylan's insulin glargine
description: Patients who are randomized to receive Mylan's insulin glargine during the comparative phase will receive the same dose as the dose of Lantus® received during the screening period. The recommended starting dose of Mylan's insulin glargine or Lantus®, in patients with T2DM who are not currently treated with insulin is 10 units (or 0.2 Units/kg) once daily, which should subsequently be adjusted every week if essential.
arm group label: Mylan's insulin Glargine
intervention type: Drug
intervention name: Lantus®
description: For patients who are randomized to receive Lantus® during the comparative phase the dose of Lantus® will be equal to the dose received during the screening period.
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: Jordan
country: Korea, Republic of
country: Slovakia
country: South Africa
country: Taiwan
country: United States
responsible party type: Sponsor
mesh term: Diabetes Mellitus
mesh term: Diabetes Mellitus, Type 2
mesh term: Insulin Glargine
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certain agreements: 
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