<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/NCT01683266</url>
  </required_header>
  <id_info>
    <org_study_id>EFC12456</org_study_id>
    <secondary_id>2012-001524-35</secondary_id>
    <secondary_id>U1111-1128-5517</secondary_id>
    <nct_id>NCT01683266</nct_id>
  </id_info>
  <brief_title>Comparison of a New Formulation of Insulin Glargine With Lantus in Patients With Type 1 Diabetes Mellitus</brief_title>
  <acronym>EDITION IV</acronym>
  <official_title>A 6-Month, Multicenter, Randomized, Open-label, Parallel-group Study Comparing the Efficacy and Safety of a New Formulation of Insulin Glargine and Lantus® Injected in the Morning or Evening in Patients With Type 1 Diabetes Mellitus With a 6-month Safety Extension Period</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Sanofi</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Sanofi</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Primary Objective:&#xD;
&#xD;
        -  To compare the efficacy of a new formulation of insulin glargine and Lantus (overall,&#xD;
           regardless the injection time) in terms of change of HbA1c from baseline to endpoint&#xD;
           (scheduled Month 6) in participants with type 1 diabetes mellitus&#xD;
&#xD;
      Secondary Objective:&#xD;
&#xD;
        -  To compare HOE901-U300 and Lantus when given in the morning or in the evening in terms&#xD;
           of:&#xD;
&#xD;
        -  Change of HbA1c from baseline to endpoint (scheduled Month 6)&#xD;
&#xD;
        -  Change from baseline to endpoint (Month 6) in fasting plasma glucose (FPG), plasma&#xD;
           glucose prior to injection of study drug, plasma glucose at 03:00 hours, mean plasma&#xD;
           glucose (8-point profiles), glucose variability, treatment satisfaction and health&#xD;
           related quality of life in participants with Type 1 Diabetes Mellitus (T1DM)&#xD;
&#xD;
        -  Reaching target HbA1c values and controlled plasma glucose (all and reaching target&#xD;
           without hypoglycemia)&#xD;
&#xD;
        -  Frequency of occurrence and diurnal distribution of hypoglycemia by category of&#xD;
           hypoglycemia (symptomatic, asymptomatic, nocturnal, severe, probable and relative)&#xD;
&#xD;
        -  Safety and tolerability of HOE901-U300 including development of anti-insulin antibody&#xD;
           (AIAs) during the 12-month study period&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The maximum study duration was up to approximately 54 weeks per participants:&#xD;
&#xD;
        -  Up to 2-week screening period&#xD;
&#xD;
        -  6-month open-label comparative efficacy and safety treatment period&#xD;
&#xD;
        -  6-month open-label comparative safety extension period&#xD;
&#xD;
        -  48-hour post-treatment safety follow-up period&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>September 2012</start_date>
  <completion_date type="Actual">March 2014</completion_date>
  <primary_completion_date type="Actual">September 2013</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 Month 6 Endpoint</measure>
    <time_frame>Baseline, Month 6</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With HbA1c &lt;7% at Month 6 Endpoint</measure>
    <time_frame>Month 6</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With HbA1c Less Than or Equal to 6.5% at Month 6 Endpoint</measure>
    <time_frame>Month 6</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change In Average Pre-Injection Self-Monitored Plasma Glucose (SMPG) From Baseline Month 6 Endpoint</measure>
    <time_frame>Baseline, Month 6</time_frame>
    <description>Pre-injection SMPG was measured within 30 minutes prior to the injection of the study drug. Average was assessed by the mean of at least 3 SMPG calculated over the 7 days preceding the assessment visit.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Variability of Pre-injection SMPG From Baseline to Month 6 Endpoint</measure>
    <time_frame>Baseline, Month 6</time_frame>
    <description>Pre-injection SMPG was measured within 30 minutes prior to the injection of the study drug. Variability was assessed by the mean of coefficient of variation calculated as 100 multiplied by (standard deviation/mean) over at least 3 SMPG measured during the 7 days preceding the assessment visit.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Fasting Plasma Glucose From Baseline to Month 6 Endpoint</measure>
    <time_frame>Baseline, Month 6</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With Fasting Plasma Glucose (FPG) &lt;5.6 mmol/L (100 mg/dL) At Month 6</measure>
    <time_frame>Month 6</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With FPG &lt;7.2 mmol/L (130 mg/dL) at Month 6 Endpoint</measure>
    <time_frame>Month 6</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in 8--Point SMPG Profiles Per Time Point From Baseline to Month 6 Endpoint</measure>
    <time_frame>Baseline, Month 6</time_frame>
    <description>Change in each time-point of 8-point SMPG profile: 03:00 hours (clock time) at night; before and 2 hours after breakfast; before and 2 hours after lunch; before and 2 hours after dinner; and at bedtime.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Daily Average Total Insulin Dose From Baseline to Month 6 Endpoint</measure>
    <time_frame>Baseline, Month 6</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Total Treatment Satisfaction Score Using The Diabetes Treatment Satisfaction Questionnaire (DTSQs) From Baseline to Month 6 Endpoint</measure>
    <time_frame>Baseline, Month 6</time_frame>
    <description>DTSQ is a validated measure to assess how satisfied participants with diabetes are with their treatment and how they perceive hyper- and hypoglycemia. It consists of 8 questions which are answered on a Likert scale from 0 to 6. DTSQ treatment satisfaction score is the sum of question 1 and 4-8 scores and ranges between 0 and 36, where higher scores indicate more treatment satisfaction.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With Hypoglycemia (All and Nocturnal) Events From Baseline to Month 12</measure>
    <time_frame>Up to Month 12</time_frame>
    <description>Hypoglycemia events were Severe hypoglycemia (an event that required assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions); Documented symptomatic hypoglycemia (typical symptoms of hypoglycemia with plasma glucose level of &lt;=3.9 mmol/L [70 mg/dL]); Asymptomatic hypoglycemia (no typical symptoms of hypoglycemia but plasma glucose level &lt;=3.9 mmol/L); Probable symptomatic hypoglycemia (an event during which symptoms of hypoglycemia were not accompanied by a plasma glucose determination, but was presumably caused by a plasma glucose level &lt;=3.9 mmol/L, symptoms treated with oral carbohydrate without a test of plasma glucose); Relative hypoglycemia (an event during which the person with diabetes reported any of the typical symptoms of hypoglycemia, and interpreted the symptoms as indicative of hypoglycemia, but plasma glucose level &gt;3.9 mmol/L); Severe and/or confirmed a hypoglycemia (plasma glucose &lt;=3.9 mmol/L).</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">549</enrollment>
  <condition>Type 1 Diabetes Mellitus</condition>
  <arm_group>
    <arm_group_label>HOE901-U300</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>HOE901-U300 (new insulin glargine 300 units per milliliter [U/mL]) subcutaneous (SC) injection once daily in morning or evening for 12 months on top of mealtime insulin analogue. Dose titration seeking fasting plasma glucose 4.4-5.6 millimole per liter (mmol/L) (80 - 100 milligram per deciliter [mg/dL]).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Lantus</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Lantus (HOE901-U100, insulin glargine 100 U/mL) SC injection once daily in morning or evening for 12 months on top of mealtime insulin analogue. Dose titration seeking fasting plasma glucose 4.4-5.6 mmol/L (80 - 100 mg/dL).</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>HOE901-U300 (Insulin glargine new formulation)</intervention_name>
    <arm_group_label>HOE901-U300</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Lantus (Insulin glargine)</intervention_name>
    <arm_group_label>Lantus</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion criteria:&#xD;
&#xD;
          -  Adult participants with type 1 diabetes mellitus&#xD;
&#xD;
        Exclusion criteria:&#xD;
&#xD;
          -  HbA1c less than (&lt;) 7.0% (53 mmol/mol) or greater than (&gt;) 10% (86 mmol/mol) at&#xD;
             screening&#xD;
&#xD;
          -  Less than 1 year on any basal plus mealtime insulin and self-monitoring of blood&#xD;
             glucose before screening visit&#xD;
&#xD;
          -  Participants not on stable insulin dose (+/-20 percent total basal insulin dose) in&#xD;
             the last 30 days prior to screening visit&#xD;
&#xD;
          -  Participants using pre-mix insulins, human regular insulin as mealtime insulin and/or&#xD;
             any glucose-lowering drugs other than basal insulin and mealtime analogue insulin in&#xD;
             the last 3 months before screening visit&#xD;
&#xD;
          -  Use of an insulin pump in the last 6 months before screening visit and no plan to&#xD;
             switch to insulin pump in the next 12 months&#xD;
&#xD;
          -  Not willing to inject insulin glargine as assigned by the randomization process once&#xD;
             daily in the morning or evening;&#xD;
&#xD;
          -  Severe hypoglycemia resulting in coma/seizures, and/or hospitalization for diabetic&#xD;
             ketoacidosis in the last 6 months before screening visit&#xD;
&#xD;
          -  Unstable proliferative diabetic retinopathy or any other rapidly progressive diabetic&#xD;
             retinopathy or macular edema likely to require treatment (example laser, surgical&#xD;
             treatment or injectable drugs) during the study period&#xD;
&#xD;
        The above information is not intended to contain all considerations relevant to a&#xD;
        participant's potential participation in a clinical trial.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Clinical Sciences &amp; Operations</last_name>
    <role>Study Director</role>
    <affiliation>Sanofi</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Investigational Site Number 840156</name>
      <address>
        <city>Chandler</city>
        <state>Arizona</state>
        <zip>85224</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 840177</name>
      <address>
        <city>Little Rock</city>
        <state>Arkansas</state>
        <zip>72205</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 840430</name>
      <address>
        <city>Bell Gardens</city>
        <state>California</state>
        <zip>90201</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 840131</name>
      <address>
        <city>Escondido</city>
        <state>California</state>
        <zip>92025</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 840140</name>
      <address>
        <city>Fresno</city>
        <state>California</state>
        <zip>93720</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 840107</name>
      <address>
        <city>Greenbrae</city>
        <state>California</state>
        <zip>94904</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 840149</name>
      <address>
        <city>Huntington Beach</city>
        <state>California</state>
        <zip>92648</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 840120</name>
      <address>
        <city>La Jolla</city>
        <state>California</state>
        <zip>92037</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 840123</name>
      <address>
        <city>La Mesa</city>
        <state>California</state>
        <zip>91942</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 840159</name>
      <address>
        <city>La Mesa</city>
        <state>California</state>
        <zip>91942</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 840114</name>
      <address>
        <city>Long Beach</city>
        <state>California</state>
        <zip>90806</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 840189</name>
      <address>
        <city>Mission Hills</city>
        <state>California</state>
        <zip>91345</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 840105</name>
      <address>
        <city>Temecula</city>
        <state>California</state>
        <zip>92591</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 840155</name>
      <address>
        <city>Tustin</city>
        <state>California</state>
        <zip>92780</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 840115</name>
      <address>
        <city>Walnut Creek</city>
        <state>California</state>
        <zip>94598</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 840160</name>
      <address>
        <city>Denver</city>
        <state>Colorado</state>
        <zip>80239</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 840188</name>
      <address>
        <city>Denver</city>
        <state>Colorado</state>
        <zip>80262</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 840196</name>
      <address>
        <city>New Haven</city>
        <state>Connecticut</state>
        <zip>06520</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 840113</name>
      <address>
        <city>Bradenton</city>
        <state>Florida</state>
        <zip>34208</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 840102</name>
      <address>
        <city>Hialeah</city>
        <state>Florida</state>
        <zip>33012</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 840134</name>
      <address>
        <city>Hollywood</city>
        <state>Florida</state>
        <zip>33021</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 840185</name>
      <address>
        <city>Jacksonville</city>
        <state>Florida</state>
        <zip>32216</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 840116</name>
      <address>
        <city>Jacksonville</city>
        <state>Florida</state>
        <zip>32258</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 840126</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33144</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 840179</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33176</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 840117</name>
      <address>
        <city>New Port Richey</city>
        <state>Florida</state>
        <zip>34652</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 840174</name>
      <address>
        <city>Orlando</city>
        <state>Florida</state>
        <zip>32806</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 840110</name>
      <address>
        <city>Oviedo</city>
        <state>Florida</state>
        <zip>32765</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 840178</name>
      <address>
        <city>Palm Harbor</city>
        <state>Florida</state>
        <zip>34684</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 840181</name>
      <address>
        <city>Tampa</city>
        <state>Florida</state>
        <zip>33613</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 840420</name>
      <address>
        <city>West Palm Beach</city>
        <state>Florida</state>
        <zip>33401</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 840195</name>
      <address>
        <city>Atlanta</city>
        <state>Georgia</state>
        <zip>30318</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 840124</name>
      <address>
        <city>Honolulu</city>
        <state>Hawaii</state>
        <zip>96814</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 840167</name>
      <address>
        <city>Idaho Falls</city>
        <state>Idaho</state>
        <zip>83404</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 840163</name>
      <address>
        <city>Nampa</city>
        <state>Idaho</state>
        <zip>83686</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 840162</name>
      <address>
        <city>Springfield</city>
        <state>Illinois</state>
        <zip>62704</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 840172</name>
      <address>
        <city>Avon</city>
        <state>Indiana</state>
        <zip>46123</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 840197</name>
      <address>
        <city>Indianapolis</city>
        <state>Indiana</state>
        <zip>46202</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 840108</name>
      <address>
        <city>Des Moines</city>
        <state>Iowa</state>
        <zip>50314</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 840407</name>
      <address>
        <city>Iowa City</city>
        <state>Iowa</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 840170</name>
      <address>
        <city>Topeka</city>
        <state>Kansas</state>
        <zip>66606</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 840421</name>
      <address>
        <city>Lexington</city>
        <state>Kentucky</state>
        <zip>40503</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 840426</name>
      <address>
        <city>Metairie</city>
        <state>Louisiana</state>
        <zip>70006</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 840104</name>
      <address>
        <city>Baltimore</city>
        <state>Maryland</state>
        <zip>21237</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 840180</name>
      <address>
        <city>Rockville</city>
        <state>Maryland</state>
        <zip>20852</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 840137</name>
      <address>
        <city>Haverhill</city>
        <state>Massachusetts</state>
        <zip>1830</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 840408</name>
      <address>
        <city>Detroit</city>
        <state>Michigan</state>
        <zip>48202</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 840153</name>
      <address>
        <city>Madison Heights</city>
        <state>Michigan</state>
        <zip>48071</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 840171</name>
      <address>
        <city>St Louis Park</city>
        <state>Minnesota</state>
        <zip>55416</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 840184</name>
      <address>
        <city>St Louis</city>
        <state>Missouri</state>
        <zip>63110</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 840106</name>
      <address>
        <city>Omaha</city>
        <state>Nebraska</state>
        <zip>68131</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 840145</name>
      <address>
        <city>Omaha</city>
        <state>Nebraska</state>
        <zip>68131</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 840139</name>
      <address>
        <city>Las Vegas</city>
        <state>Nevada</state>
        <zip>89148</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 840151</name>
      <address>
        <city>Albuquerque</city>
        <state>New Mexico</state>
        <zip>87106</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 840191</name>
      <address>
        <city>New Hyde Park</city>
        <state>New York</state>
        <zip>11042</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 840173</name>
      <address>
        <city>Syracuse</city>
        <state>New York</state>
        <zip>13210</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 840133</name>
      <address>
        <city>Asheville</city>
        <state>North Carolina</state>
        <zip>28803</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 840175</name>
      <address>
        <city>Chapel Hill</city>
        <state>North Carolina</state>
        <zip>27599-7295</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 840161</name>
      <address>
        <city>Morganton</city>
        <state>North Carolina</state>
        <zip>28655</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 840169</name>
      <address>
        <city>Mentor</city>
        <state>Ohio</state>
        <zip>44060</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 840119</name>
      <address>
        <city>Norman</city>
        <state>Oklahoma</state>
        <zip>73069</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 840112</name>
      <address>
        <city>Bend</city>
        <state>Oregon</state>
        <zip>97701</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 840136</name>
      <address>
        <city>Greer</city>
        <state>South Carolina</state>
        <zip>29651</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 840122</name>
      <address>
        <city>Dakota Dunes</city>
        <state>South Dakota</state>
        <zip>57049</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 840144</name>
      <address>
        <city>Chattanooga</city>
        <state>Tennessee</state>
        <zip>37404</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 840187</name>
      <address>
        <city>Nashville</city>
        <state>Tennessee</state>
        <zip>37232</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 840109</name>
      <address>
        <city>Austin</city>
        <state>Texas</state>
        <zip>78731</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 840157</name>
      <address>
        <city>Austin</city>
        <state>Texas</state>
        <zip>78731</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 840150</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75230</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 840412</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75231</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 840130</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 840141</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77095</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 840166</name>
      <address>
        <city>San Antonio</city>
        <state>Texas</state>
        <zip>78229</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 840101</name>
      <address>
        <city>Murray</city>
        <state>Utah</state>
        <zip>84123</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 840125</name>
      <address>
        <city>Burke</city>
        <state>Virginia</state>
        <zip>22015</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 840427</name>
      <address>
        <city>Chesapeake</city>
        <state>Virginia</state>
        <zip>23321</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 840103</name>
      <address>
        <city>Manassas</city>
        <state>Virginia</state>
        <zip>20110</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 840132</name>
      <address>
        <city>Renton</city>
        <state>Washington</state>
        <zip>98055</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 840403</name>
      <address>
        <city>Seattle</city>
        <state>Washington</state>
        <zip>98195</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 840402</name>
      <address>
        <city>Spokane</city>
        <state>Washington</state>
        <zip>99220</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 840127</name>
      <address>
        <city>Tacoma</city>
        <state>Washington</state>
        <zip>98415-0299</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 840411</name>
      <address>
        <city>Milwaukee</city>
        <state>Wisconsin</state>
        <zip>53209-0996</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 124110</name>
      <address>
        <city>Coquitlam</city>
        <zip>V3K 3P4</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 124104</name>
      <address>
        <city>Laval</city>
        <zip>H7T 2P5</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 124108</name>
      <address>
        <city>Mirabel</city>
        <zip>J7J 2K8</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 124109</name>
      <address>
        <city>Montreal</city>
        <zip>H1Y 3L1</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 124105</name>
      <address>
        <city>Thornhill</city>
        <zip>L4J 8L7</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 124101</name>
      <address>
        <city>Toronto</city>
        <zip>M4R 2G4</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 203102</name>
      <address>
        <city>Brno</city>
        <zip>62500</zip>
        <country>Czech Republic</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 203104</name>
      <address>
        <city>Praha 10</city>
        <zip>10034</zip>
        <country>Czech Republic</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 203103</name>
      <address>
        <city>Praha 8</city>
        <zip>18100</zip>
        <country>Czech Republic</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 208103</name>
      <address>
        <city>Esbjerg</city>
        <zip>6700</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 208105</name>
      <address>
        <city>Gentofte</city>
        <zip>2900</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 208104</name>
      <address>
        <city>København Nv</city>
        <zip>2400</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 208107</name>
      <address>
        <city>Køge</city>
        <zip>4600</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 208102</name>
      <address>
        <city>Ålborg</city>
        <zip>9100</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 233104</name>
      <address>
        <city>Pärnu</city>
        <zip>80018</zip>
        <country>Estonia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 233105</name>
      <address>
        <city>Tallinn</city>
        <zip>13419</zip>
        <country>Estonia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 233106</name>
      <address>
        <city>Tartu</city>
        <zip>50406</zip>
        <country>Estonia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 233101</name>
      <address>
        <city>Tartu</city>
        <zip>50410</zip>
        <country>Estonia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 233103</name>
      <address>
        <city>Viljandimaa</city>
        <zip>71024</zip>
        <country>Estonia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 246102</name>
      <address>
        <city>Kokkola</city>
        <zip>67100</zip>
        <country>Finland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 246101</name>
      <address>
        <city>Kuopio</city>
        <zip>70210</zip>
        <country>Finland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 246106</name>
      <address>
        <city>Loimaa</city>
        <zip>32200</zip>
        <country>Finland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 246105</name>
      <address>
        <city>Oulu</city>
        <zip>90100</zip>
        <country>Finland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 246103</name>
      <address>
        <city>Tampere</city>
        <zip>33100</zip>
        <country>Finland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 348103</name>
      <address>
        <city>Budapest</city>
        <zip>1036</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 348108</name>
      <address>
        <city>Budapest</city>
        <zip>1083</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 348107</name>
      <address>
        <city>Budapest</city>
        <zip>1088</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 348106</name>
      <address>
        <city>Debrecen</city>
        <zip>4031</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 348102</name>
      <address>
        <city>Gyula</city>
        <zip>5700</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 348101</name>
      <address>
        <city>Urhida</city>
        <zip>8142</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 392110</name>
      <address>
        <city>Aisai-Shi</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 392105</name>
      <address>
        <city>Ise-Shi</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 392104</name>
      <address>
        <city>Karatsu-Shi</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 392111</name>
      <address>
        <city>Kitakyushu-Shi</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 392112</name>
      <address>
        <city>Matsumoto-Shi</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 392108</name>
      <address>
        <city>Matumoto</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 392103</name>
      <address>
        <city>Midori-Shi</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 392107</name>
      <address>
        <city>Mito-Shi</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 392101</name>
      <address>
        <city>Sakai-Shi</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 392102</name>
      <address>
        <city>Tomishiro</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 392106</name>
      <address>
        <city>Yamagata-Shi</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 428106</name>
      <address>
        <city>Limbazi</city>
        <zip>LV-4001</zip>
        <country>Latvia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 428103</name>
      <address>
        <city>Riga</city>
        <zip>LV-1002</zip>
        <country>Latvia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 428105</name>
      <address>
        <city>Riga</city>
        <zip>LV-1050</zip>
        <country>Latvia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 428102</name>
      <address>
        <city>Sigulda</city>
        <zip>LV-2150</zip>
        <country>Latvia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 428101</name>
      <address>
        <city>Ventspils</city>
        <zip>LV-3601</zip>
        <country>Latvia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 528101</name>
      <address>
        <city>Almere</city>
        <zip>1311 RL</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 528103</name>
      <address>
        <city>Beek</city>
        <zip>6191 JW</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 528105</name>
      <address>
        <city>Nijmegen</city>
        <zip>6525 GA</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 528104</name>
      <address>
        <city>Venlo</city>
        <zip>5912 BL</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 528102</name>
      <address>
        <city>Zwijndrecht</city>
        <zip>3331 LZ</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 840602</name>
      <address>
        <city>Ponce</city>
        <zip>00717</zip>
        <country>Puerto Rico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 642107</name>
      <address>
        <city>Bacau</city>
        <zip>600164</zip>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 642103</name>
      <address>
        <city>Brasov</city>
        <zip>500365</zip>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 642109</name>
      <address>
        <city>Oradea</city>
        <zip>410169</zip>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 642106</name>
      <address>
        <city>Resita</city>
        <zip>320076</zip>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 642104</name>
      <address>
        <city>Sibiu</city>
        <zip>550371</zip>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 642101</name>
      <address>
        <city>Targu Mures</city>
        <zip>540142</zip>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 642102</name>
      <address>
        <city>Targu Mures</city>
        <zip>540142</zip>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 642105</name>
      <address>
        <city>Timisoara</city>
        <zip>300133</zip>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 642108</name>
      <address>
        <city>Timisoara</city>
        <zip>300456</zip>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 752103</name>
      <address>
        <city>Goteborg</city>
        <zip>41345</zip>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 752105</name>
      <address>
        <city>Kristianstad</city>
        <zip>29185</zip>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 752101</name>
      <address>
        <city>Stockholm</city>
        <zip>11526</zip>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 752104</name>
      <address>
        <city>Vällingby</city>
        <zip>16268</zip>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
    <country>Czech Republic</country>
    <country>Denmark</country>
    <country>Estonia</country>
    <country>Finland</country>
    <country>Hungary</country>
    <country>Japan</country>
    <country>Latvia</country>
    <country>Netherlands</country>
    <country>Puerto Rico</country>
    <country>Romania</country>
    <country>Sweden</country>
    <country>United States</country>
  </location_countries>
  <verification_date>May 2015</verification_date>
  <study_first_submitted>September 7, 2012</study_first_submitted>
  <study_first_submitted_qc>September 10, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 11, 2012</study_first_posted>
  <results_first_submitted>March 24, 2015</results_first_submitted>
  <results_first_submitted_qc>April 22, 2015</results_first_submitted_qc>
  <results_first_posted type="Estimate">April 23, 2015</results_first_posted>
  <disposition_first_submitted>November 14, 2014</disposition_first_submitted>
  <disposition_first_submitted_qc>November 14, 2014</disposition_first_submitted_qc>
  <disposition_first_posted type="Estimate">November 26, 2014</disposition_first_posted>
  <last_update_submitted>May 28, 2015</last_update_submitted>
  <last_update_submitted_qc>May 28, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">June 24, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Diabetes Mellitus</mesh_term>
    <mesh_term>Diabetes Mellitus, Type 1</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Insulin</mesh_term>
    <mesh_term>Insulin, Globin Zinc</mesh_term>
    <mesh_term>Insulin Glargine</mesh_term>
  </intervention_browse>

  <clinical_results>

    <participant_flow>
      <recruitment_details>A total of 846 participants were screened, of whom 297 participants were screen failure and 549 participants were randomized.</recruitment_details>
      <group_list>
        <group group_id="P1">
          <title>HOE901--U300</title>
          <description>HOE901-U300 (new insulin glargine 300 units per milliliter [U/mL]) subcutaneous (SC) injection once daily in morning or evening for 12 months on top of mealtime insulin analogue.</description>
        </group>
        <group group_id="P2">
          <title>Lantus</title>
          <description>Lantus (HOE901-U100, insulin glargine 100 U/mL) SC injection once daily in morning or evening for 12 months on top of mealtime insulin analogue.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="274"/>
                <participants group_id="P2" count="275"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Modified Intent-to-Treat Population</title>
              <participants_list>
                <participants group_id="P1" count="273">Participants who received at least 1 dose of drug, had both baseline, at least 1 post-baseline data</participants>
                <participants group_id="P2" count="273">Participants who received at least 1 dose of drug, had both baseline, at least 1 post-baseline data</participants>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="219"/>
                <participants group_id="P2" count="225"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="55"/>
                <participants group_id="P2" count="50"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="5"/>
                <participants group_id="P2" count="4"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lack of Efficacy</title>
              <participants_list>
                <participants group_id="P1" count="5"/>
                <participants group_id="P2" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Protocol Violation</title>
              <participants_list>
                <participants group_id="P1" count="13"/>
                <participants group_id="P2" count="6"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Personal Reason</title>
              <participants_list>
                <participants group_id="P1" count="17"/>
                <participants group_id="P2" count="25"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Selection Criterion / Protocol Violation</title>
              <participants_list>
                <participants group_id="P1" count="7"/>
                <participants group_id="P2" count="5"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="5"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Site Closure / Site Withdrawal</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="3"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Nonserious Hypoglycemia</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="3"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Perceived Lack of Efficacy</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Possibly Hypoglycemia</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Serious Adverse Event of Hypoglycemia</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Randomized population: all screened participants (who originally met inclusion criteria and signed informed consent) allocated to a treatment group and recorded in Interactive Voice/Web Response System (IVRS/IWRS) database, regardless of whether treatment was used or not. Participants were analyzed in treatment group to which they were randomized.</population>
      <group_list>
        <group group_id="B1">
          <title>HOE901--U300</title>
          <description>HOE901-U300 SC injection once daily in morning or evening for 12 months on top of mealtime insulin.</description>
        </group>
        <group group_id="B2">
          <title>Lantus</title>
          <description>Lantus SC injection once daily in morning or evening for 12 months on top of mealtime insulin.</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="274"/>
            <count group_id="B2" value="275"/>
            <count group_id="B3" value="549"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="46.4" spread="13.9"/>
                    <measurement group_id="B2" value="48.2" spread="13.4"/>
                    <measurement group_id="B3" value="47.3" spread="13.7"/>
                  </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="125"/>
                    <measurement group_id="B2" value="111"/>
                    <measurement group_id="B3" value="236"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="149"/>
                    <measurement group_id="B2" value="164"/>
                    <measurement group_id="B3" value="313"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Body Mass Index (BMI)</title>
          <units>kilogram per square meter (kg/m^2)</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="27.6" spread="5.5"/>
                    <measurement group_id="B2" value="27.6" spread="4.7"/>
                    <measurement group_id="B3" value="27.6" spread="5.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Duration of Diabetes</title>
          <description>Number of participants analyzed for this baseline characteristics = 274 and 272 for each reporting group, respectively.</description>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="20.5" spread="12.7"/>
                    <measurement group_id="B2" value="21.4" spread="13.1"/>
                    <measurement group_id="B3" value="21.0" spread="12.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Glycated Hemoglobin (HbA1c)</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>Less Than (&lt;) 8%</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="105"/>
                    <measurement group_id="B2" value="105"/>
                    <measurement group_id="B3" value="210"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Greater Than or Equal to (&gt;=) 8%</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="169"/>
                    <measurement group_id="B2" value="170"/>
                    <measurement group_id="B3" value="339"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Basal Insulin Daily Dose</title>
          <description>Number of participants analyzed for this baseline characteristics = 201 and 210 for each reporting group, respectively.</description>
          <units>units per kilogram (U/kg)</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0.381" spread="0.173"/>
                    <measurement group_id="B2" value="0.372" spread="0.152"/>
                    <measurement group_id="B3" value="0.376" spread="0.162"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Total Insulin Daily Dose</title>
          <description>Number of participants analyzed for this baseline characteristics = 195 and 198 for each reporting group, respectively.</description>
          <units>U/kg</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0.714" spread="0.278"/>
                    <measurement group_id="B2" value="0.724" spread="0.245"/>
                    <measurement group_id="B3" value="0.719" spread="0.262"/>
                  </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 Month 6 Endpoint</title>
        <time_frame>Baseline, Month 6</time_frame>
        <population>Modified Intent-to-Treat (mITT) population: all randomized participants who received at least (&gt;=)1 dose, had baseline and &gt;=1 post-baseline assessment of any efficacy variable, irrespective of compliance. Number of participants analyzed = participants with baseline and Month 6 HbA1c assessment.</population>
        <group_list>
          <group group_id="O1">
            <title>HOE901--U300</title>
            <description>HOE901-U300 SC injection once daily in morning or evening for 12 months on top of mealtime insulin.</description>
          </group>
          <group group_id="O2">
            <title>Lantus</title>
            <description>Lantus SC injection once daily in morning or evening for 12 months on top of mealtime insulin.</description>
          </group>
        </group_list>
        <measure>
          <title>Change In HbA1c From Baseline to Month 6 Endpoint</title>
          <population>Modified Intent-to-Treat (mITT) population: all randomized participants who received at least (&gt;=)1 dose, had baseline and &gt;=1 post-baseline assessment of any efficacy variable, irrespective of compliance. Number of participants analyzed = participants with baseline and Month 6 HbA1c assessment.</population>
          <units>percentage of hemoglobin</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="225"/>
                <count group_id="O2" value="229"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.40" spread="0.051"/>
                    <measurement group_id="O2" value="-0.44" spread="0.051"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Analysis was performed using mixed model for repeated measurements (MMRM) with treatment groups, strata of screening HbA1c (&lt;8.0, &gt;=8.0%), geographical region (Non-Japan; Japan), visit and visit-by-treatment groups interaction as fixed categorical effects; baseline HbA1c and baseline HbA1c-by-visit interaction as continuous fixed covariates.</groups_desc>
            <non_inferiority_type>Non-Inferiority or Equivalence</non_inferiority_type>
            <non_inferiority_desc>Stepwise closed testing approach was used to assess non-inferiority and superiority sequentially:&#xD;
Non-inferiority of HOE901-U300 vs Lantus: Upper bound of two-sided 95% confidence interval (CI) of difference between HOE901-U300 and Lantus on mITT population is &lt;0.4%.&#xD;
Superiority (only if non-inferiority has been demonstrated): Upper bound of two-sided 95% CI for difference in mean change in HbA1c from baseline to endpoint between HOE901-U300 and Lantus on mITT population is &lt;0.</non_inferiority_desc>
            <param_type>Least Squares (LS) Mean difference</param_type>
            <param_value>0.04</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.072</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>0.185</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With HbA1c &lt;7% at Month 6 Endpoint</title>
        <time_frame>Month 6</time_frame>
        <population>mITT Population.</population>
        <group_list>
          <group group_id="O1">
            <title>HOE901--U300</title>
            <description>HOE901-U300 SC injection once daily in morning or evening for 12 months on top of mealtime insulin.</description>
          </group>
          <group group_id="O2">
            <title>Lantus</title>
            <description>Lantus SC injection once daily in morning or evening for 12 months on top of mealtime insulin.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With HbA1c &lt;7% at Month 6 Endpoint</title>
          <population>mITT Population.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="273"/>
                <count group_id="O2" value="273"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16.8"/>
                    <measurement group_id="O2" value="15.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With HbA1c Less Than or Equal to 6.5% at Month 6 Endpoint</title>
        <time_frame>Month 6</time_frame>
        <population>mITT Population.</population>
        <group_list>
          <group group_id="O1">
            <title>HOE901--U300</title>
            <description>HOE901-U300 SC injection once daily in morning or evening for 12 months on top of mealtime insulin.</description>
          </group>
          <group group_id="O2">
            <title>Lantus</title>
            <description>Lantus SC injection once daily in morning or evening for 12 months on top of mealtime insulin.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With HbA1c Less Than or Equal to 6.5% at Month 6 Endpoint</title>
          <population>mITT Population.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="273"/>
                <count group_id="O2" value="273"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.1"/>
                    <measurement group_id="O2" value="5.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change In Average Pre-Injection Self-Monitored Plasma Glucose (SMPG) From Baseline Month 6 Endpoint</title>
        <description>Pre-injection SMPG was measured within 30 minutes prior to the injection of the study drug. Average was assessed by the mean of at least 3 SMPG calculated over the 7 days preceding the assessment visit.</description>
        <time_frame>Baseline, Month 6</time_frame>
        <population>mITT population. Number of participants analyzed = participants with baseline and Month 6 pre-injection SMPG assessment.</population>
        <group_list>
          <group group_id="O1">
            <title>HOE901--U300</title>
            <description>HOE901-U300 SC injection once daily in morning or evening for 12 months on top of mealtime insulin.</description>
          </group>
          <group group_id="O2">
            <title>Lantus</title>
            <description>Lantus SC injection once daily in morning or evening for 12 months on top of mealtime insulin.</description>
          </group>
        </group_list>
        <measure>
          <title>Change In Average Pre-Injection Self-Monitored Plasma Glucose (SMPG) From Baseline Month 6 Endpoint</title>
          <description>Pre-injection SMPG was measured within 30 minutes prior to the injection of the study drug. Average was assessed by the mean of at least 3 SMPG calculated over the 7 days preceding the assessment visit.</description>
          <population>mITT population. Number of participants analyzed = participants with baseline and Month 6 pre-injection SMPG assessment.</population>
          <units>millimole per liter (mmol/L)</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="117"/>
                <count group_id="O2" value="105"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.16" spread="0.223"/>
                    <measurement group_id="O2" value="-0.82" spread="0.233"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Change in pre-injection SMPG was analyzed using MMRM model with treatment groups, strata of screening HbA1c (&lt;8.0, &gt;=8.0%), geographical region (Non-Japan; Japan), visit and visit-by-treatment groups interaction as fixed categorical effects; pre-injection SMPG value and pre-injection SMPG value-by-visit interaction as continuous fixed covariates.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>LS Mean difference</param_type>
            <param_value>-0.35</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.322</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.982</ci_lower_limit>
            <ci_upper_limit>0.287</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Variability of Pre-injection SMPG From Baseline to Month 6 Endpoint</title>
        <description>Pre-injection SMPG was measured within 30 minutes prior to the injection of the study drug. Variability was assessed by the mean of coefficient of variation calculated as 100 multiplied by (standard deviation/mean) over at least 3 SMPG measured during the 7 days preceding the assessment visit.</description>
        <time_frame>Baseline, Month 6</time_frame>
        <population>mITT population. Number of participants analyzed = participants with baseline and Month 6 pre-injection SMPG assessment.</population>
        <group_list>
          <group group_id="O1">
            <title>HOE901--U300</title>
            <description>HOE901-U300 SC injection once daily in morning or evening for 12 months on top of mealtime insulin.</description>
          </group>
          <group group_id="O2">
            <title>Lantus</title>
            <description>Lantus SC injection once daily in morning or evening for 12 months on top of mealtime insulin.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Variability of Pre-injection SMPG From Baseline to Month 6 Endpoint</title>
          <description>Pre-injection SMPG was measured within 30 minutes prior to the injection of the study drug. Variability was assessed by the mean of coefficient of variation calculated as 100 multiplied by (standard deviation/mean) over at least 3 SMPG measured during the 7 days preceding the assessment visit.</description>
          <population>mITT population. Number of participants analyzed = participants with baseline and Month 6 pre-injection SMPG assessment.</population>
          <units>percentage of mean</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="117"/>
                <count group_id="O2" value="105"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-3.03" spread="1.573"/>
                    <measurement group_id="O2" value="-1.76" spread="1.651"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Fasting Plasma Glucose From Baseline to Month 6 Endpoint</title>
        <time_frame>Baseline, Month 6</time_frame>
        <population>mITT Population. Number of participants analyzed = participants with baseline and Month 6 FPG assessment.</population>
        <group_list>
          <group group_id="O1">
            <title>HOE901--U300</title>
            <description>HOE901-U300 SC injection once daily in morning or evening for 12 months on top of mealtime insulin.</description>
          </group>
          <group group_id="O2">
            <title>Lantus</title>
            <description>Lantus SC injection once daily in morning or evening for 12 months on top of mealtime insulin.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Fasting Plasma Glucose From Baseline to Month 6 Endpoint</title>
          <population>mITT Population. Number of participants analyzed = participants with baseline and Month 6 FPG assessment.</population>
          <units>mmol/L</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="213"/>
                <count group_id="O2" value="216"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.95" spread="0.263"/>
                    <measurement group_id="O2" value="-1.14" spread="0.260"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With Fasting Plasma Glucose (FPG) &lt;5.6 mmol/L (100 mg/dL) At Month 6</title>
        <time_frame>Month 6</time_frame>
        <population>mITT Population.</population>
        <group_list>
          <group group_id="O1">
            <title>HOE901--U300</title>
            <description>HOE901-U300 SC injection once daily in morning or evening for 12 months on top of mealtime insulin.</description>
          </group>
          <group group_id="O2">
            <title>Lantus</title>
            <description>Lantus SC injection once daily in morning or evening for 12 months on top of mealtime insulin.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Fasting Plasma Glucose (FPG) &lt;5.6 mmol/L (100 mg/dL) At Month 6</title>
          <population>mITT Population.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="273"/>
                <count group_id="O2" value="273"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9.9"/>
                    <measurement group_id="O2" value="12.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With FPG &lt;7.2 mmol/L (130 mg/dL) at Month 6 Endpoint</title>
        <time_frame>Month 6</time_frame>
        <population>mITT Population. Number of participants analyzed = participants with baseline and Month 6 FPG assessment.</population>
        <group_list>
          <group group_id="O1">
            <title>HOE901--U300</title>
            <description>HOE901-U300 SC injection once daily in morning or evening for 12 months on top of mealtime insulin.</description>
          </group>
          <group group_id="O2">
            <title>Lantus</title>
            <description>Lantus SC injection once daily in morning or evening for 12 months on top of mealtime insulin.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With FPG &lt;7.2 mmol/L (130 mg/dL) at Month 6 Endpoint</title>
          <population>mITT Population. Number of participants analyzed = participants with baseline and Month 6 FPG assessment.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="273"/>
                <count group_id="O2" value="273"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="25.3"/>
                    <measurement group_id="O2" value="25.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in 8--Point SMPG Profiles Per Time Point From Baseline to Month 6 Endpoint</title>
        <description>Change in each time-point of 8-point SMPG profile: 03:00 hours (clock time) at night; before and 2 hours after breakfast; before and 2 hours after lunch; before and 2 hours after dinner; and at bedtime.</description>
        <time_frame>Baseline, Month 6</time_frame>
        <population>mITT Population. Here, n = participants with Baseline and Month 6 8-point SMPG assessment separately for each analysed time point.</population>
        <group_list>
          <group group_id="O1">
            <title>HOE901--U300</title>
            <description>HOE901-U300 SC injection once daily in morning or evening for 12 months on top of mealtime insulin.</description>
          </group>
          <group group_id="O2">
            <title>Lantus</title>
            <description>Lantus SC injection once daily in morning or evening for 12 months on top of mealtime insulin.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in 8--Point SMPG Profiles Per Time Point From Baseline to Month 6 Endpoint</title>
          <description>Change in each time-point of 8-point SMPG profile: 03:00 hours (clock time) at night; before and 2 hours after breakfast; before and 2 hours after lunch; before and 2 hours after dinner; and at bedtime.</description>
          <population>mITT Population. Here, n = participants with Baseline and Month 6 8-point SMPG assessment separately for each analysed time point.</population>
          <units>mmol/L</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="273"/>
                <count group_id="O2" value="273"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>03:00 at Night (n= 156, 159)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.47" spread="4.56"/>
                    <measurement group_id="O2" value="-0.67" spread="4.98"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Pre--Breakfast (n= 166, 167)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.86" spread="5.30"/>
                    <measurement group_id="O2" value="-0.07" spread="5.20"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>2 Hours After Breakfast (n= 152, 156)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.62" spread="4.75"/>
                    <measurement group_id="O2" value="-1.18" spread="5.66"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Pre--Lunch (n= 166, 166)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.95" spread="4.53"/>
                    <measurement group_id="O2" value="-0.93" spread="4.76"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>2 Hours After Lunch (n= 163,163)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.13" spread="5.20"/>
                    <measurement group_id="O2" value="-1.43" spread="5.37"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Pre--Dinner (n= 165,166)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.56" spread="6.00"/>
                    <measurement group_id="O2" value="-1.74" spread="5.28"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>2 Hours After Dinner (n= 154,152)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.93" spread="5.27"/>
                    <measurement group_id="O2" value="-1.19" spread="5.51"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Bedtime (n= 141,146)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.80" spread="5.39"/>
                    <measurement group_id="O2" value="-1.91" spread="5.10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Daily Average Total Insulin Dose From Baseline to Month 6 Endpoint</title>
        <time_frame>Baseline, Month 6</time_frame>
        <population>mITT Population. Number of participants analyzed = participants with Baseline and Month 6 daily average total insulin dose assessment.</population>
        <group_list>
          <group group_id="O1">
            <title>HOE901--U300</title>
            <description>HOE901-U300 SC injection once daily in morning or evening for 12 months on top of mealtime insulin.</description>
          </group>
          <group group_id="O2">
            <title>Lantus</title>
            <description>Lantus SC injection once daily in morning or evening for 12 months on top of mealtime insulin.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Daily Average Total Insulin Dose From Baseline to Month 6 Endpoint</title>
          <population>mITT Population. Number of participants analyzed = participants with Baseline and Month 6 daily average total insulin dose assessment.</population>
          <units>U/kg</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="173"/>
                <count group_id="O2" value="158"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.19" spread="0.22"/>
                    <measurement group_id="O2" value="0.10" spread="0.16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Total Treatment Satisfaction Score Using The Diabetes Treatment Satisfaction Questionnaire (DTSQs) From Baseline to Month 6 Endpoint</title>
        <description>DTSQ is a validated measure to assess how satisfied participants with diabetes are with their treatment and how they perceive hyper- and hypoglycemia. It consists of 8 questions which are answered on a Likert scale from 0 to 6. DTSQ treatment satisfaction score is the sum of question 1 and 4-8 scores and ranges between 0 and 36, where higher scores indicate more treatment satisfaction.</description>
        <time_frame>Baseline, Month 6</time_frame>
        <population>mITT Population. Number of participants analyzed = participants with Baseline and Month 6 DTSQ assessment.</population>
        <group_list>
          <group group_id="O1">
            <title>HOE901--U300</title>
            <description>HOE901-U300 SC injection once daily in morning or evening for 12 months on top of mealtime insulin.</description>
          </group>
          <group group_id="O2">
            <title>Lantus</title>
            <description>Lantus SC injection once daily in morning or evening for 12 months on top of mealtime insulin.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Total Treatment Satisfaction Score Using The Diabetes Treatment Satisfaction Questionnaire (DTSQs) From Baseline to Month 6 Endpoint</title>
          <description>DTSQ is a validated measure to assess how satisfied participants with diabetes are with their treatment and how they perceive hyper- and hypoglycemia. It consists of 8 questions which are answered on a Likert scale from 0 to 6. DTSQ treatment satisfaction score is the sum of question 1 and 4-8 scores and ranges between 0 and 36, where higher scores indicate more treatment satisfaction.</description>
          <population>mITT Population. Number of participants analyzed = participants with Baseline and Month 6 DTSQ assessment.</population>
          <units>units on a scale</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="212"/>
                <count group_id="O2" value="206"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.00" spread="0.331"/>
                    <measurement group_id="O2" value="1.41" spread="0.334"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With Hypoglycemia (All and Nocturnal) Events From Baseline to Month 12</title>
        <description>Hypoglycemia events were Severe hypoglycemia (an event that required assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions); Documented symptomatic hypoglycemia (typical symptoms of hypoglycemia with plasma glucose level of &lt;=3.9 mmol/L [70 mg/dL]); Asymptomatic hypoglycemia (no typical symptoms of hypoglycemia but plasma glucose level &lt;=3.9 mmol/L); Probable symptomatic hypoglycemia (an event during which symptoms of hypoglycemia were not accompanied by a plasma glucose determination, but was presumably caused by a plasma glucose level &lt;=3.9 mmol/L, symptoms treated with oral carbohydrate without a test of plasma glucose); Relative hypoglycemia (an event during which the person with diabetes reported any of the typical symptoms of hypoglycemia, and interpreted the symptoms as indicative of hypoglycemia, but plasma glucose level &gt;3.9 mmol/L); Severe and/or confirmed a hypoglycemia (plasma glucose &lt;=3.9 mmol/L).</description>
        <time_frame>Up to Month 12</time_frame>
        <population>Safety population: all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. In the event of participants having received treatments different from those assigned according to the randomization schedule, safety analyses were conducted according to treatment received.</population>
        <group_list>
          <group group_id="O1">
            <title>HOE901--U300</title>
            <description>HOE901-U300 SC injection once daily in morning or evening for 12 months on top of mealtime insulin.</description>
          </group>
          <group group_id="O2">
            <title>Lantus</title>
            <description>Lantus SC injection once daily in morning or evening for 12 months on top of mealtime insulin.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Hypoglycemia (All and Nocturnal) Events From Baseline to Month 12</title>
          <description>Hypoglycemia events were Severe hypoglycemia (an event that required assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions); Documented symptomatic hypoglycemia (typical symptoms of hypoglycemia with plasma glucose level of &lt;=3.9 mmol/L [70 mg/dL]); Asymptomatic hypoglycemia (no typical symptoms of hypoglycemia but plasma glucose level &lt;=3.9 mmol/L); Probable symptomatic hypoglycemia (an event during which symptoms of hypoglycemia were not accompanied by a plasma glucose determination, but was presumably caused by a plasma glucose level &lt;=3.9 mmol/L, symptoms treated with oral carbohydrate without a test of plasma glucose); Relative hypoglycemia (an event during which the person with diabetes reported any of the typical symptoms of hypoglycemia, and interpreted the symptoms as indicative of hypoglycemia, but plasma glucose level &gt;3.9 mmol/L); Severe and/or confirmed a hypoglycemia (plasma glucose &lt;=3.9 mmol/L).</description>
          <population>Safety population: all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. In the event of participants having received treatments different from those assigned according to the randomization schedule, safety analyses were conducted according to treatment received.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="274"/>
                <count group_id="O2" value="275"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Any Hypoglycemia Event: All Hypoglycemia</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="95.3"/>
                    <measurement group_id="O2" value="94.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Severe Hypoglycemia: All Hypoglycemia</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9.1"/>
                    <measurement group_id="O2" value="11.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Documented Symptomatic: All Hypoglycemia</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="87.6"/>
                    <measurement group_id="O2" value="86.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Asymptomatic: All Hypoglycemia</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="76.6"/>
                    <measurement group_id="O2" value="81.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Probable Symptomatic: All Hypoglycemia</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11.3"/>
                    <measurement group_id="O2" value="15.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Relative: All Hypoglycemia</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="14.6"/>
                    <measurement group_id="O2" value="9.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Severe and/or Confirmed: All Hypoglycemia</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="94.9"/>
                    <measurement group_id="O2" value="94.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Any Hypoglycemia Event: Nocturnal Hypoglycemia</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="73.4"/>
                    <measurement group_id="O2" value="74.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Severe Hypoglycemia: Nocturnal Hypoglycemia</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.3"/>
                    <measurement group_id="O2" value="3.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Documented Symptomatic: Nocturnal Hypoglycemia</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="64.2"/>
                    <measurement group_id="O2" value="63.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Asymptomatic: Nocturnal Hypoglycemia</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="35.0"/>
                    <measurement group_id="O2" value="38.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Probable Symptomatic: Nocturnal Hypoglycemia</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.1"/>
                    <measurement group_id="O2" value="6.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Relative: Nocturnal Hypoglycemia</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.0"/>
                    <measurement group_id="O2" value="5.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Severe and/or Confirmed: Nocturnal Hypoglycemia</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="72.6"/>
                    <measurement group_id="O2" value="74.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>All Adverse Events (AE) were collected from signature of informed consent form up to study completion regardless of seriousness or relationship to study drug.</time_frame>
      <desc>Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (as the time from first injection of IMP up to 2 days after the last injection of IMP). Analysis was done on safety population.</desc>
      <group_list>
        <group group_id="E1">
          <title>HOE901--U300</title>
          <description>HOE901-U300 SC injection once daily in morning or evening for 12 months on top of mealtime insulin.</description>
        </group>
        <group group_id="E2">
          <title>Lantus</title>
          <description>Lantus SC injection once daily in morning or evening for 12 months on top of mealtime insulin.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDra 17.0</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="27" subjects_at_risk="274"/>
                <counts group_id="E2" subjects_affected="26" subjects_at_risk="275"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Angina pectoris</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="274"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="275"/>
              </event>
              <event>
                <sub_title>Atrioventricular block complete</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="274"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="275"/>
              </event>
              <event>
                <sub_title>Coronary artery disease</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="274"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="275"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Ileus</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="274"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="275"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Non-cardiac chest pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="274"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="275"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Immune system disorders</title>
            <event_list>
              <event>
                <sub_title>Hypersensitivity</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="274"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="275"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Appendicitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="274"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="275"/>
              </event>
              <event>
                <sub_title>Cellulitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="274"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="275"/>
              </event>
              <event>
                <sub_title>Chronic tonsillitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="274"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="275"/>
              </event>
              <event>
                <sub_title>Erysipelas</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="274"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="275"/>
              </event>
              <event>
                <sub_title>H1N1 influenza</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="274"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="275"/>
              </event>
              <event>
                <sub_title>Pyelonephritis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="274"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="275"/>
              </event>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="274"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="275"/>
              </event>
              <event>
                <sub_title>Viral infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="274"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="275"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Accidental overdose</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="274"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="275"/>
              </event>
              <event>
                <sub_title>Brain contusion</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="274"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="275"/>
              </event>
              <event>
                <sub_title>Comminuted fracture</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="274"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="275"/>
              </event>
              <event>
                <sub_title>Fall</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="274"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="275"/>
              </event>
              <event>
                <sub_title>Joint dislocation</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="274"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="275"/>
              </event>
              <event>
                <sub_title>Open fracture</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="274"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="275"/>
              </event>
              <event>
                <sub_title>Overdose</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="274"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="275"/>
              </event>
              <event>
                <sub_title>Patella fracture</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="274"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="275"/>
              </event>
              <event>
                <sub_title>Pelvic fracture</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="274"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="275"/>
              </event>
              <event>
                <sub_title>Rib fracture</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="274"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="275"/>
              </event>
              <event>
                <sub_title>Road traffic accident</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="274"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="275"/>
              </event>
              <event>
                <sub_title>Spinal compression fracture</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="274"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="275"/>
              </event>
              <event>
                <sub_title>Subdural haematoma</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="274"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="275"/>
              </event>
              <event>
                <sub_title>Tendon rupture</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="274"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="275"/>
              </event>
              <event>
                <sub_title>Thoracic vertebral fracture</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="274"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="275"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Diabetic ketoacidosis</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="274"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="275"/>
              </event>
              <event>
                <sub_title>Hypoglycaemia</sub_title>
                <counts group_id="E1" subjects_affected="16" subjects_at_risk="274"/>
                <counts group_id="E2" subjects_affected="13" subjects_at_risk="275"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Dupuytren's contracture</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="274"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="275"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Malignant melanoma</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="274"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="275"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Aphasia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="274"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="275"/>
              </event>
              <event>
                <sub_title>Convulsion</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="274"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="275"/>
              </event>
              <event>
                <sub_title>Diabetic neuropathy</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="274"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="275"/>
              </event>
              <event>
                <sub_title>Hypoglycaemic seizure</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="274"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="275"/>
              </event>
              <event>
                <sub_title>Hypoglycaemic unconsciousness</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="274"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="275"/>
              </event>
              <event>
                <sub_title>Loss of consciousness</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="274"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="275"/>
              </event>
              <event>
                <sub_title>Syncope</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="274"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="275"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Renal failure acute</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="274"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="275"/>
              </event>
              <event>
                <sub_title>Urinary retention</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="274"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="275"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Diabetic foot</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="274"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="275"/>
              </event>
              <event>
                <sub_title>Urticaria</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="274"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="275"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Femoral artery occlusion</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="274"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="275"/>
              </event>
              <event>
                <sub_title>Hypertension</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="274"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="275"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDra 17.0</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="113" subjects_at_risk="274"/>
                <counts group_id="E2" subjects_affected="86" subjects_at_risk="275"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Influenza</sub_title>
                <counts group_id="E1" subjects_affected="16" subjects_at_risk="274"/>
                <counts group_id="E2" subjects_affected="14" subjects_at_risk="275"/>
              </event>
              <event>
                <sub_title>Nasopharyngitis</sub_title>
                <counts group_id="E1" subjects_affected="43" subjects_at_risk="274"/>
                <counts group_id="E2" subjects_affected="35" subjects_at_risk="275"/>
              </event>
              <event>
                <sub_title>Sinusitis</sub_title>
                <counts group_id="E1" subjects_affected="14" subjects_at_risk="274"/>
                <counts group_id="E2" subjects_affected="11" subjects_at_risk="275"/>
              </event>
              <event>
                <sub_title>Upper respiratory tract infection</sub_title>
                <counts group_id="E1" subjects_affected="38" subjects_at_risk="274"/>
                <counts group_id="E2" subjects_affected="26" subjects_at_risk="275"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Back pain</sub_title>
                <counts group_id="E1" subjects_affected="14" subjects_at_risk="274"/>
                <counts group_id="E2" subjects_affected="7" subjects_at_risk="275"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" subjects_affected="17" subjects_at_risk="274"/>
                <counts group_id="E2" subjects_affected="13" subjects_at_risk="275"/>
              </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>If no publication has occurred within 12 months of the completion of the study, the Investigator shall have the right to publish/present independently the results of the study. The Investigator shall provide the Sponsor with a copy of any such presentation/publication for comment at least 30 days before any presentation/submission for publication. If requested by the Sponsor, any presentation/submission shall be delayed up to 90 days, to allow the Sponsor to preserve its proprietary rights.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Trial Transparency Team</name_or_title>
      <organization>Sanofi</organization>
      <email>Contact--US@sanofi.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/NCT01683266
org study id: EFC12456
secondary id: 2012-001524-35
secondary id: U1111-1128-5517
nct id: NCT01683266
lead sponsor: 
has dmc: No
Primary Objective:

        -  To compare the efficacy of a new formulation of insulin glargine and Lantus (overall,
           regardless the injection time) in terms of change of HbA1c from baseline to endpoint
           (scheduled Month 6) in participants with type 1 diabetes mellitus

      Secondary Objective:

        -  To compare HOE901-U300 and Lantus when given in the morning or in the evening in terms
           of:

        -  Change of HbA1c from baseline to endpoint (scheduled Month 6)

        -  Change from baseline to endpoint (Month 6) in fasting plasma glucose (FPG), plasma
           glucose prior to injection of study drug, plasma glucose at 03:00 hours, mean plasma
           glucose (8-point profiles), glucose variability, treatment satisfaction and health
           related quality of life in participants with Type 1 Diabetes Mellitus (T1DM)

        -  Reaching target HbA1c values and controlled plasma glucose (all and reaching target
           without hypoglycemia)

        -  Frequency of occurrence and diurnal distribution of hypoglycemia by category of
           hypoglycemia (symptomatic, asymptomatic, nocturnal, severe, probable and relative)

        -  Safety and tolerability of HOE901-U300 including development of anti-insulin antibody
           (AIAs) during the 12-month study period
The maximum study duration was up to approximately 54 weeks per participants:

        -  Up to 2-week screening period

        -  6-month open-label comparative efficacy and safety treatment period

        -  6-month open-label comparative safety extension period

        -  48-hour post-treatment safety follow-up period
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Change In HbA1c From Baseline to Month 6 Endpoint
time frame: Baseline, Month 6
measure: Percentage of Participants With HbA1c <7% at Month 6 Endpoint
time frame: Month 6
measure: Percentage of Participants With HbA1c Less Than or Equal to 6.5% at Month 6 Endpoint
time frame: Month 6
measure: Change In Average Pre-Injection Self-Monitored Plasma Glucose (SMPG) From Baseline Month 6 Endpoint
time frame: Baseline, Month 6
description: Pre-injection SMPG was measured within 30 minutes prior to the injection of the study drug. Average was assessed by the mean of at least 3 SMPG calculated over the 7 days preceding the assessment visit.
measure: Change in Variability of Pre-injection SMPG From Baseline to Month 6 Endpoint
time frame: Baseline, Month 6
description: Pre-injection SMPG was measured within 30 minutes prior to the injection of the study drug. Variability was assessed by the mean of coefficient of variation calculated as 100 multiplied by (standard deviation/mean) over at least 3 SMPG measured during the 7 days preceding the assessment visit.
measure: Change in Fasting Plasma Glucose From Baseline to Month 6 Endpoint
time frame: Baseline, Month 6
measure: Percentage of Participants With Fasting Plasma Glucose (FPG) <5.6 mmol/L (100 mg/dL) At Month 6
time frame: Month 6
measure: Percentage of Participants With FPG <7.2 mmol/L (130 mg/dL) at Month 6 Endpoint
time frame: Month 6
measure: Change in 8--Point SMPG Profiles Per Time Point From Baseline to Month 6 Endpoint
time frame: Baseline, Month 6
description: Change in each time-point of 8-point SMPG profile: 03:00 hours (clock time) at night; before and 2 hours after breakfast; before and 2 hours after lunch; before and 2 hours after dinner; and at bedtime.
measure: Change in Daily Average Total Insulin Dose From Baseline to Month 6 Endpoint
time frame: Baseline, Month 6
measure: Change in Total Treatment Satisfaction Score Using The Diabetes Treatment Satisfaction Questionnaire (DTSQs) From Baseline to Month 6 Endpoint
time frame: Baseline, Month 6
description: DTSQ is a validated measure to assess how satisfied participants with diabetes are with their treatment and how they perceive hyper- and hypoglycemia. It consists of 8 questions which are answered on a Likert scale from 0 to 6. DTSQ treatment satisfaction score is the sum of question 1 and 4-8 scores and ranges between 0 and 36, where higher scores indicate more treatment satisfaction.
measure: Percentage of Participants With Hypoglycemia (All and Nocturnal) Events From Baseline to Month 12
time frame: Up to Month 12
description: Hypoglycemia events were Severe hypoglycemia (an event that required assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions); Documented symptomatic hypoglycemia (typical symptoms of hypoglycemia with plasma glucose level of <=3.9 mmol/L [70 mg/dL]); Asymptomatic hypoglycemia (no typical symptoms of hypoglycemia but plasma glucose level <=3.9 mmol/L); Probable symptomatic hypoglycemia (an event during which symptoms of hypoglycemia were not accompanied by a plasma glucose determination, but was presumably caused by a plasma glucose level <=3.9 mmol/L, symptoms treated with oral carbohydrate without a test of plasma glucose); Relative hypoglycemia (an event during which the person with diabetes reported any of the typical symptoms of hypoglycemia, and interpreted the symptoms as indicative of hypoglycemia, but plasma glucose level >3.9 mmol/L); Severe and/or confirmed a hypoglycemia (plasma glucose <=3.9 mmol/L).
arm group label: HOE901-U300
arm group type: Experimental
description: HOE901-U300 (new insulin glargine 300 units per milliliter [U/mL]) subcutaneous (SC) injection once daily in morning or evening for 12 months on top of mealtime insulin analogue. Dose titration seeking fasting plasma glucose 4.4-5.6 millimole per liter (mmol/L) (80 - 100 milligram per deciliter [mg/dL]).
arm group label: Lantus
arm group type: Active Comparator
description: Lantus (HOE901-U100, insulin glargine 100 U/mL) SC injection once daily in morning or evening for 12 months on top of mealtime insulin analogue. Dose titration seeking fasting plasma glucose 4.4-5.6 mmol/L (80 - 100 mg/dL).
intervention type: Drug
intervention name: HOE901-U300 (Insulin glargine new formulation)
arm group label: HOE901-U300
intervention type: Drug
intervention name: Lantus (Insulin glargine)
arm group label: Lantus
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Clinical Sciences & Operations
role: Study Director
affiliation: Sanofi
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country: Canada
country: Czech Republic
country: Denmark
country: Estonia
country: Finland
country: Hungary
country: Japan
country: Latvia
country: Netherlands
country: Puerto Rico
country: Romania
country: Sweden
country: United States
responsible party type: Sponsor
mesh term: Diabetes Mellitus
mesh term: Diabetes Mellitus, Type 1
mesh term: Insulin
mesh term: Insulin, Globin Zinc
mesh term: Insulin Glargine
participant flow: 
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outcome list: 
reported events: 
certain agreements: 
point of contact: 