<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/NCT01676220</url>
  </required_header>
  <id_info>
    <org_study_id>EFC12347</org_study_id>
    <secondary_id>2012-000146-35</secondary_id>
    <secondary_id>U1111-1124-5261</secondary_id>
    <nct_id>NCT01676220</nct_id>
  </id_info>
  <brief_title>Comparison of a New Formulation of Insulin Glargine With Lantus in Patients With Type 2 Diabetes on Non-insulin Antidiabetic Therapy</brief_title>
  <acronym>EDITION III</acronym>
  <official_title>6-Month, Multicenter, Randomized, Open-label, Parallel-group Study Comparing the Efficacy and Safety of a New Formulation of Insulin Glargine and Lantus® in Insulin-Naïve Patients With Type 2 Diabetes Mellitus Not Adequately Controlled With Non-Insulin Antihyperglycemic Drugs 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 in terms of&#xD;
      change of HbA1c from baseline to endpoint (scheduled at Month 6, Week 26) in participants&#xD;
      with type 2 diabetes mellitus&#xD;
&#xD;
      Secondary Objectives:&#xD;
&#xD;
      To compare a new formulation of insulin glargine and Lantus in terms of:&#xD;
&#xD;
      - occurrence of nocturnal hypoglycemia&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The maximum study duration was up to approximately 54 weeks per participant, consisting of:&#xD;
&#xD;
        -  Up to 2 week screening period; it can be exceptionally extended of up to one additional&#xD;
           week&#xD;
&#xD;
        -  6-month comparative efficacy and safety treatment period&#xD;
&#xD;
        -  6-month comparative safety extension period&#xD;
&#xD;
        -  2-day post-treatment safety follow-up period&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>August 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>
    <description>Only HbA1c measurements performed before initiation of rescue therapy were considered in the analysis. Month 6 Endpoint is either the observed value at Month 6 visit or value retrieved according to time windows.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With At Least One Severe and/or Confirmed Nocturnal Hypoglycemia From Start of Week 9 to Month 6</measure>
    <time_frame>Week 9 Up to Month 6</time_frame>
    <description>Nocturnal hypoglycemia was hypoglycemia that occurred between 00:00 and 05:59 hours (clock time), regardless the participant was awake or woke up because of the event. Severe hypoglycemia was an event that required assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions. Confirmed hypoglycemia was an event associated with plasma glucose less than or equal to (&lt;=) 3.9 millimoles per liter (mmol/L) (70 milligram per deciliter [mg/dL]). Only nocturnal hypoglycemia occurring before initiation of rescue therapy were considered in the analysis. Week 9 and Month 6 value correspond to the observed value at Week 9 and Month 6 visit respectively.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Preinjection Self-Monitored Plasma Glucose (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. Except for baseline value average of preinjection SMPG was assessed by the mean of at least 3 SMPG calculated over the 7 days preceding the assessment visit. Only preinjection SMPG measurements performed before initiation of rescue therapy were considered in the analysis. Month 6 Endpoint is either the observed value at Month 6 visit or value retrieved according to time windows.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Variability of Preinjection SMPG at Month 6 Endpoint</measure>
    <time_frame>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. Only preinjection SMPG measurements performed before initiation of rescue therapy were considered in the analysis. Month 6 Endpoint is either the observed value at Month 6 visit or value retrieved according to time windows.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With HbA1c &lt;7% at Month 6</measure>
    <time_frame>Month 6</time_frame>
    <description>Only HbA1c measurements performed before initiation of rescue therapy were considered in the analysis. Month 6 value corresponds to the observed value at Month 6 visit.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Fasting Plasma Glucose (FPG) From Baseline to Month 6 Endpoint</measure>
    <time_frame>Baseline, Month 6</time_frame>
    <description>Only FPG measurements performed before initiation of rescue therapy were considered in the analysis. Month 6 Endpoint is either the observed value at Month 6 visit or value retrieved according to time windows.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With FPG &lt;5.6 mmol/L (100 mg/dL) at Month 6</measure>
    <time_frame>Month 6</time_frame>
    <description>Only FPG measurements performed before initiation of rescue therapy were considered in the analysis. Month 6 value corresponds to the observed value at Month 6 visit.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in 8-Point SMPG Profiles Per Time Point From Baseline to Month 6</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. Only 8-point SMPG profiles measurements performed before initiation of rescue therapy were considered in the analysis. Month 6 value corresponds to the observed value at Month 6 visit.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in 24-hour Average 8-point SMPG Profile From Baseline to Month 6 Endpoint</measure>
    <time_frame>Baseline, Month 6</time_frame>
    <description>Change in 24-hour average of 8-point SMPG profile. 8-point SMPG was assessed at: 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. Only 24-hour average 8-point SMPG measurements performed before initiation of rescue therapy were considered in the analysis. Month 6 Endpoint is either the observed value at Month 6 visit or value retrieved according to time windows.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Variability of 24 Hour Average 8-point SMPG Profiles From Baseline to Month 6 Endpoint</measure>
    <time_frame>Baseline, Month 6</time_frame>
    <description>Variability is assessed by the mean of coefficient of variation calculated as 100 multiplied by (standard deviation/mean) over at least 5 measurements of the 8-point profiles. Only variability of 24-hour 8-point SMPG measurements performed before initiation of rescue therapy were considered in the analysis. Month 6 Endpoint is either the observed value at Month 6 visit or value retrieved according to time windows.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Daily Basal Insulin Dose From Baseline to Month 6</measure>
    <time_frame>Baseline, Month 6</time_frame>
    <description>Only insulin dose measurements performed before initiation of rescue therapy were considered in the analysis. Month 6 value corresponds to the observed value at Month 6 visit.</description>
  </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. Only DTSQ total score measurements performed before initiation of rescue therapy were considered in the analysis. Month 6 Endpoint is either the observed value at Month 6 visit or value retrieved according to time windows.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With Hypoglycemia (All and Nocturnal) Events From Baseline up to Month 12</measure>
    <time_frame>Up to 12 months</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">878</enrollment>
  <condition>Type 2 Diabetes Mellitus</condition>
  <arm_group>
    <arm_group_label>HOE901-U300</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Lantus</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>HOE901-U300 (new formulation of insulin glargine)</intervention_name>
    <description>HOE901-U300 (new insulin glargine 300 units per milliliter [U/mL]) subcutaneous (SC) injection once daily (evening) for 12 months on top of non-insulin antihyperglycemic drug(s). 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_label>HOE901-U300</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Lantus (insulin glargine)</intervention_name>
    <description>Lantus (HOE901-U100, insulin glargine 100 U/mL) SC injection once daily (evening) for 12 months on top of non-insulin antihyperglycemic drug(s). Dose titration seeking fasting plasma glucose 4.4-5.6 mmol/L (80 - 100 mg/dL).</description>
    <arm_group_label>Lantus</arm_group_label>
    <other_name>Lantus</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion criteria :&#xD;
&#xD;
          -  Adult participants with type 2 diabetes mellitus inadequately controlled with&#xD;
             non-insulin antihyperglycemic drug(s);&#xD;
&#xD;
          -  Signed written informed consent.&#xD;
&#xD;
        Exclusion criteria:&#xD;
&#xD;
          -  HbA1c less than (&lt;) 7.0% (&lt; 53 millimole per mole [mmol/mol]) or greater than (&gt;) 11%&#xD;
             (&gt; 97 mmol/mol)&#xD;
&#xD;
          -  History of type 2 diabetes mellitus for less than 1 year before screening&#xD;
&#xD;
          -  Less than 6 months before screening with non-insulin antihyperglycemic treatment&#xD;
&#xD;
          -  Change in dose of non-insulin antihyperglycemic treatment in the last 3 month before&#xD;
             screening&#xD;
&#xD;
          -  Initiation of new glucose-lowering medications and/or weight loss drug in the last 3&#xD;
             months before screening visit and/or initiation of Glucagon-like peptide-1 (GLP-1)&#xD;
             receptor agonist in the last 6 months before screening visit&#xD;
&#xD;
          -  Participants receiving only non-insulin antihyperglycemic drugs not approved for&#xD;
             combination with insulin according to local labeling/local treatment guidelines and/or&#xD;
             sulfonylurea or glinide (Note: non-insulin antihyperglycemic drugs not approved for&#xD;
             combination with insulin, sulfonylurea and glinide are to be discontinued at baseline)&#xD;
&#xD;
          -  Current or previous insulin use except for a maximum of 8 consecutive days (for&#xD;
             example, acute illness, surgery) during the last year prior to screening&#xD;
&#xD;
          -  Unstable proliferative diabetic retinopathy or any other rapidly progressive diabetic&#xD;
             retinopathy or macular edema likely to require treatment (for 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 840324</name>
      <address>
        <city>Montgomery</city>
        <state>Alabama</state>
        <zip>36109</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 840273</name>
      <address>
        <city>Chandler</city>
        <state>Arizona</state>
        <zip>85224</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 840217</name>
      <address>
        <city>Mesa</city>
        <state>Arizona</state>
        <zip>85206</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 840220</name>
      <address>
        <city>Peoria</city>
        <state>Arizona</state>
        <zip>85050</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 840211</name>
      <address>
        <city>Phoenix</city>
        <state>Arizona</state>
        <zip>85028</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 840207</name>
      <address>
        <city>Phoenix</city>
        <state>Arizona</state>
        <zip>85050</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 840264</name>
      <address>
        <city>Tempe</city>
        <state>Arizona</state>
        <zip>85282</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 840234</name>
      <address>
        <city>Tempe</city>
        <state>Arizona</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 840304</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 840347</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 840244</name>
      <address>
        <city>Escondido</city>
        <state>California</state>
        <zip>92025</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 840257</name>
      <address>
        <city>Fresno</city>
        <state>California</state>
        <zip>93720</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 840213</name>
      <address>
        <city>Greenbrae</city>
        <state>California</state>
        <zip>94904</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 840267</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 840230</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 840235</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 840274</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 840222</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 840243</name>
      <address>
        <city>Palm Springs</city>
        <state>California</state>
        <zip>92262</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 840250</name>
      <address>
        <city>Spring Valley</city>
        <state>California</state>
        <zip>91978</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 840209</name>
      <address>
        <city>Temecula</city>
        <state>California</state>
        <zip>92591</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 840297</name>
      <address>
        <city>Torrance</city>
        <state>California</state>
        <zip>90502</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 840272</name>
      <address>
        <city>Tustin</city>
        <state>California</state>
        <zip>92780</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 840223</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 840249</name>
      <address>
        <city>Colorado Springs</city>
        <state>Colorado</state>
        <zip>80907</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 840331</name>
      <address>
        <city>Denver</city>
        <state>Colorado</state>
        <zip>80212</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 840299</name>
      <address>
        <city>Boca Raton</city>
        <state>Florida</state>
        <zip>33432</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 840285</name>
      <address>
        <city>Boynton Beach</city>
        <state>Florida</state>
        <zip>33472</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 840221</name>
      <address>
        <city>Bradenton</city>
        <state>Florida</state>
        <zip>34208</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 840233</name>
      <address>
        <city>Clearwater</city>
        <state>Florida</state>
        <zip>33765</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 840212</name>
      <address>
        <city>Coral Gables</city>
        <state>Florida</state>
        <zip>33134</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 840266</name>
      <address>
        <city>Coral Gables</city>
        <state>Florida</state>
        <zip>33134</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 840204</name>
      <address>
        <city>Hialeah</city>
        <state>Florida</state>
        <zip>33012</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 840248</name>
      <address>
        <city>Hollywood</city>
        <state>Florida</state>
        <zip>33021</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 840226</name>
      <address>
        <city>Jacksonville</city>
        <state>Florida</state>
        <zip>32205</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 840318</name>
      <address>
        <city>Jacksonville</city>
        <state>Florida</state>
        <zip>32216</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 840224</name>
      <address>
        <city>Jacksonville</city>
        <state>Florida</state>
        <zip>32258</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 840337</name>
      <address>
        <city>Miami Beach</city>
        <state>Florida</state>
        <zip>33141</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 840228</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33144</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 840238</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33144</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 840302</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33176</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 840227</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 840303</name>
      <address>
        <city>North Miami Beach</city>
        <state>Florida</state>
        <zip>33162</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 840225</name>
      <address>
        <city>Ocala</city>
        <state>Florida</state>
        <zip>34471</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 840291</name>
      <address>
        <city>Orlando</city>
        <state>Florida</state>
        <zip>32804</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 840316</name>
      <address>
        <city>Orlando</city>
        <state>Florida</state>
        <zip>32806</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 840216</name>
      <address>
        <city>Oviedo</city>
        <state>Florida</state>
        <zip>32765</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 840332</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 840288</name>
      <address>
        <city>Pembroke Pines</city>
        <state>Florida</state>
        <zip>33028</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 840325</name>
      <address>
        <city>Port Charlotte</city>
        <state>Florida</state>
        <zip>33952</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 840309</name>
      <address>
        <city>St. Petersburg</city>
        <state>Florida</state>
        <zip>33716</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 840251</name>
      <address>
        <city>Tampa</city>
        <state>Florida</state>
        <zip>33603</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 840339</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 840245</name>
      <address>
        <city>Atlanta</city>
        <state>Georgia</state>
        <zip>30308</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 840323</name>
      <address>
        <city>Stockbridge</city>
        <state>Georgia</state>
        <zip>30281</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 840236</name>
      <address>
        <city>Honolulu</city>
        <state>Hawaii</state>
        <zip>96814</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 840283</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 840278</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60607</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 840320</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60612</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 840276</name>
      <address>
        <city>Springfield</city>
        <state>Illinois</state>
        <zip>62704</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 840314</name>
      <address>
        <city>Avon</city>
        <state>Indiana</state>
        <zip>46123</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 840317</name>
      <address>
        <city>Avon</city>
        <state>Indiana</state>
        <zip>46123</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 840214</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 840232</name>
      <address>
        <city>Overland Park</city>
        <state>Kansas</state>
        <zip>66210</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 840287</name>
      <address>
        <city>Topeka</city>
        <state>Kansas</state>
        <zip>66606</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 840344</name>
      <address>
        <city>Lexington</city>
        <state>Kentucky</state>
        <zip>40503</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 840231</name>
      <address>
        <city>Murray</city>
        <state>Kentucky</state>
        <zip>42003</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 840348</name>
      <address>
        <city>Metairie</city>
        <state>Louisiana</state>
        <zip>70006</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 840290</name>
      <address>
        <city>New Orleans</city>
        <state>Louisiana</state>
        <zip>70119</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 840208</name>
      <address>
        <city>Baltimore</city>
        <state>Maryland</state>
        <zip>21237</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 840301</name>
      <address>
        <city>Rockville</city>
        <state>Maryland</state>
        <zip>20852</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 840289</name>
      <address>
        <city>Fall River</city>
        <state>Massachusetts</state>
        <zip>02720</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 840253</name>
      <address>
        <city>Haverhill</city>
        <state>Massachusetts</state>
        <zip>1830</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 840270</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 840300</name>
      <address>
        <city>Omaha</city>
        <state>Nebraska</state>
        <zip>68105</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 840210</name>
      <address>
        <city>Omaha</city>
        <state>Nebraska</state>
        <zip>68131</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 840263</name>
      <address>
        <city>Omaha</city>
        <state>Nebraska</state>
        <zip>68131</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 840349</name>
      <address>
        <city>Las Vegas</city>
        <state>Nevada</state>
        <zip>89117</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 840201</name>
      <address>
        <city>Las Vegas</city>
        <state>Nevada</state>
        <zip>89119</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 840256</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 840306</name>
      <address>
        <city>Hamilton</city>
        <state>New Jersey</state>
        <zip>08619</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 840203</name>
      <address>
        <city>Sea Girt</city>
        <state>New Jersey</state>
        <zip>08750</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 840295</name>
      <address>
        <city>Sicklerville</city>
        <state>New Jersey</state>
        <zip>08081</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 840269</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 840310</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 840247</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 840296</name>
      <address>
        <city>Greensboro</city>
        <state>North Carolina</state>
        <zip>27408</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 840275</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 840330</name>
      <address>
        <city>Cleveland</city>
        <state>Ohio</state>
        <zip>44122</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 840307</name>
      <address>
        <city>Columbus</city>
        <state>Ohio</state>
        <zip>43213</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 840229</name>
      <address>
        <city>Norman</city>
        <state>Oklahoma</state>
        <zip>73069</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 840219</name>
      <address>
        <city>Bend</city>
        <state>Oregon</state>
        <zip>97701</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 840240</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19139</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 840308</name>
      <address>
        <city>Tipton</city>
        <state>Pennsylvania</state>
        <zip>16684</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 840252</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 840237</name>
      <address>
        <city>Spartanburg</city>
        <state>South Carolina</state>
        <zip>29303</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 840294</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 840260</name>
      <address>
        <city>Bristol</city>
        <state>Tennessee</state>
        <zip>37620</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 840262</name>
      <address>
        <city>Chattanooga</city>
        <state>Tennessee</state>
        <zip>37404</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 840342</name>
      <address>
        <city>Corpus Christi</city>
        <state>Texas</state>
        <zip>78404</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 840268</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75230</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 840292</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75230</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 840315</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75231</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 840242</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75246</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 840326</name>
      <address>
        <city>Edinburg</city>
        <state>Texas</state>
        <zip>78539</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 840338</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77002</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 840218</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77004</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 840328</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77074</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 840259</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77095</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 840327</name>
      <address>
        <city>Pearland</city>
        <state>Texas</state>
        <zip>77584</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 840282</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 840202</name>
      <address>
        <city>Murray</city>
        <state>Utah</state>
        <zip>84123</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 840343</name>
      <address>
        <city>Salt Lake City</city>
        <state>Utah</state>
        <zip>84107</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 840239</name>
      <address>
        <city>Burke</city>
        <state>Virginia</state>
        <zip>22015</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 840206</name>
      <address>
        <city>Manassas</city>
        <state>Virginia</state>
        <zip>20110</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 840246</name>
      <address>
        <city>Renton</city>
        <state>Washington</state>
        <zip>98055</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 840311</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 100205</name>
      <address>
        <city>Blagoevgrad</city>
        <zip>2700</zip>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 100203</name>
      <address>
        <city>Byala</city>
        <zip>7100</zip>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 100201</name>
      <address>
        <city>Plovdiv</city>
        <zip>4002</zip>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 100204</name>
      <address>
        <city>Plovdiv</city>
        <zip>4002</zip>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 100206</name>
      <address>
        <city>Sofia</city>
        <zip>1431</zip>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 124204</name>
      <address>
        <city>Brampton</city>
        <zip>L6R 3J5</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 124211</name>
      <address>
        <city>Etobicoke</city>
        <zip>M9R 4E1</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 124208</name>
      <address>
        <city>Laval</city>
        <zip>H7T 2P5</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 124214</name>
      <address>
        <city>London</city>
        <zip>N6A 5G6</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 124210</name>
      <address>
        <city>Montreal</city>
        <zip>H1Y 3L1</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 124218</name>
      <address>
        <city>Montreal</city>
        <zip>H4N 3C5</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 124206</name>
      <address>
        <city>Pointe-Claire</city>
        <zip>H9R 4S3</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 124219</name>
      <address>
        <city>Sherbrooke</city>
        <zip>J1H 1Z1</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 124201</name>
      <address>
        <city>Thornhill</city>
        <zip>L4J 8L7</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 124209</name>
      <address>
        <city>Thornhill</city>
        <zip>L4J 8L7</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 124212</name>
      <address>
        <city>Toronto</city>
        <zip>M9W 4L9</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 124216</name>
      <address>
        <city>Ville St-Laurent</city>
        <zip>H4T 1Z9</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 203201</name>
      <address>
        <city>Brno</city>
        <zip>62500</zip>
        <country>Czech Republic</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 203205</name>
      <address>
        <city>Brno</city>
        <zip>65691</zip>
        <country>Czech Republic</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 203204</name>
      <address>
        <city>Havirov</city>
        <zip>73601</zip>
        <country>Czech Republic</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 203203</name>
      <address>
        <city>Praha 10</city>
        <zip>10034</zip>
        <country>Czech Republic</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 203202</name>
      <address>
        <city>Praha 8</city>
        <zip>18100</zip>
        <country>Czech Republic</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 208203</name>
      <address>
        <city>Esbjerg</city>
        <zip>6700</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 208209</name>
      <address>
        <city>Hellerup</city>
        <zip>2900</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 208202</name>
      <address>
        <city>Herlev</city>
        <zip>2730</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 208206</name>
      <address>
        <city>Hvidovre</city>
        <zip>2650</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 208210</name>
      <address>
        <city>Kolding</city>
        <zip>6000</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 208207</name>
      <address>
        <city>København Nv</city>
        <zip>2400</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 208201</name>
      <address>
        <city>Odense C</city>
        <zip>5000</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 208204</name>
      <address>
        <city>Viborg</city>
        <zip>8800</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 208205</name>
      <address>
        <city>Ålborg</city>
        <zip>9100</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 233204</name>
      <address>
        <city>Tallinn</city>
        <zip>13419</zip>
        <country>Estonia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 233203</name>
      <address>
        <city>Tartu</city>
        <zip>50406</zip>
        <country>Estonia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 233205</name>
      <address>
        <city>Tartu</city>
        <zip>50410</zip>
        <country>Estonia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 246208</name>
      <address>
        <city>Helsinki</city>
        <zip>260</zip>
        <country>Finland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 246202</name>
      <address>
        <city>Kokkola</city>
        <zip>67100</zip>
        <country>Finland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 246207</name>
      <address>
        <city>Oulu</city>
        <zip>90100</zip>
        <country>Finland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 246206</name>
      <address>
        <city>Tampere</city>
        <zip>33100</zip>
        <country>Finland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 246205</name>
      <address>
        <city>Turku</city>
        <zip>20100</zip>
        <country>Finland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 348205</name>
      <address>
        <city>Balassagyarmat</city>
        <zip>2660</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 348201</name>
      <address>
        <city>Budapest</city>
        <zip>1036</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 348207</name>
      <address>
        <city>Budapest</city>
        <zip>1036</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 348212</name>
      <address>
        <city>Budapest</city>
        <zip>1083</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 348210</name>
      <address>
        <city>Budapest</city>
        <zip>1134</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 348202</name>
      <address>
        <city>Urhida</city>
        <zip>8142</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 392214</name>
      <address>
        <city>Fujimi</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 392215</name>
      <address>
        <city>Fujimi</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 392206</name>
      <address>
        <city>Ise-Shi</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 392217</name>
      <address>
        <city>Kitaazumi-Gun</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 392210</name>
      <address>
        <city>Matsumoto-Shi</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 392208</name>
      <address>
        <city>Matumoto</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 392205</name>
      <address>
        <city>Midori-Shi</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 392203</name>
      <address>
        <city>Mito-Shi</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 392216</name>
      <address>
        <city>Sakai</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 392213</name>
      <address>
        <city>Shimotsuke</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 392218</name>
      <address>
        <city>Shunan-Shi</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 392204</name>
      <address>
        <city>Yamagata-Shi</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 428206</name>
      <address>
        <city>Riga</city>
        <zip>1024</zip>
        <country>Latvia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 428203</name>
      <address>
        <city>Riga</city>
        <zip>LV-1002</zip>
        <country>Latvia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 428205</name>
      <address>
        <city>Riga</city>
        <zip>LV-1050</zip>
        <country>Latvia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 428202</name>
      <address>
        <city>Sigulda</city>
        <zip>LV-2150</zip>
        <country>Latvia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 428201</name>
      <address>
        <city>Ventspils</city>
        <zip>LV-3601</zip>
        <country>Latvia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 440203</name>
      <address>
        <city>Kaunas</city>
        <zip>48259</zip>
        <country>Lithuania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 440204</name>
      <address>
        <city>Kaunas</city>
        <zip>LT-49456</zip>
        <country>Lithuania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 440201</name>
      <address>
        <city>Klaipeda</city>
        <zip>LT-92253</zip>
        <country>Lithuania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 440202</name>
      <address>
        <city>Klaipeda</city>
        <zip>LT-92304</zip>
        <country>Lithuania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 440205</name>
      <address>
        <city>Vilnius</city>
        <zip>LT-08661</zip>
        <country>Lithuania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 528204</name>
      <address>
        <city>Almere</city>
        <zip>1311 RL</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 528209</name>
      <address>
        <city>Beek</city>
        <zip>6191 JW</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 528205</name>
      <address>
        <city>Breda</city>
        <zip>4811 SW</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 528207</name>
      <address>
        <city>Leiderdorp</city>
        <zip>2352 RA</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 528203</name>
      <address>
        <city>Rotterdam</city>
        <zip>3021 HC</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 528202</name>
      <address>
        <city>Velp</city>
        <zip>6883 ES</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 840709</name>
      <address>
        <city>Cagua</city>
        <zip>725</zip>
        <country>Puerto Rico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 840706</name>
      <address>
        <city>Carolina</city>
        <zip>987</zip>
        <country>Puerto Rico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 840704</name>
      <address>
        <city>San Juan</city>
        <zip>00917</zip>
        <country>Puerto Rico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 840710</name>
      <address>
        <city>San Juan</city>
        <zip>00917</zip>
        <country>Puerto Rico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 840703</name>
      <address>
        <city>San Juan</city>
        <zip>917</zip>
        <country>Puerto Rico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 840708</name>
      <address>
        <city>San Juan</city>
        <zip>926</zip>
        <country>Puerto Rico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 642208</name>
      <address>
        <city>Bacau</city>
        <zip>600164</zip>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 642212</name>
      <address>
        <city>Bucuresti</city>
        <zip>020359</zip>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 642201</name>
      <address>
        <city>Bucuresti</city>
        <zip>20475</zip>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 642202</name>
      <address>
        <city>Cluj-Napoca</city>
        <zip>400006</zip>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 642213</name>
      <address>
        <city>Oradea</city>
        <zip>410169</zip>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 642207</name>
      <address>
        <city>Resita</city>
        <zip>320076</zip>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 642205</name>
      <address>
        <city>Sibiu</city>
        <zip>550371</zip>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 642203</name>
      <address>
        <city>Targu Mures</city>
        <zip>540142</zip>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 642204</name>
      <address>
        <city>Targu Mures</city>
        <zip>540142</zip>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 642206</name>
      <address>
        <city>Timisoara</city>
        <zip>300133</zip>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 642209</name>
      <address>
        <city>Timisoara</city>
        <zip>300456</zip>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 703205</name>
      <address>
        <city>Banska Bystrica</city>
        <zip>97517</zip>
        <country>Slovakia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 703202</name>
      <address>
        <city>Bardejov</city>
        <zip>085 01</zip>
        <country>Slovakia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 703203</name>
      <address>
        <city>Bratislava</city>
        <zip>85101</zip>
        <country>Slovakia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 703201</name>
      <address>
        <city>Levice</city>
        <zip>93405</zip>
        <country>Slovakia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 703206</name>
      <address>
        <city>Levice</city>
        <zip>95401</zip>
        <country>Slovakia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 703207</name>
      <address>
        <city>Lucenec</city>
        <zip>98401</zip>
        <country>Slovakia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 752205</name>
      <address>
        <city>Kristianstad</city>
        <zip>29185</zip>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 752206</name>
      <address>
        <city>Malmö</city>
        <zip>211 52</zip>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 752201</name>
      <address>
        <city>Stockholm</city>
        <zip>11526</zip>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 752204</name>
      <address>
        <city>Vällingby</city>
        <zip>16268</zip>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Bulgaria</country>
    <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>Lithuania</country>
    <country>Netherlands</country>
    <country>Puerto Rico</country>
    <country>Romania</country>
    <country>Slovakia</country>
    <country>Sweden</country>
    <country>United States</country>
  </location_countries>
  <results_reference>
    <citation>Bolli GB, Riddle MC, Bergenstal RM, Ziemen M, Sestakauskas K, Goyeau H, Home PD; on behalf of the EDITION 3 study investigators. New insulin glargine 300 U/ml compared with glargine 100 U/ml in insulin-naive people with type 2 diabetes on oral glucose-lowering drugs: a randomized controlled trial (EDITION 3). Diabetes Obes Metab. 2015 Apr;17(4):386-94. doi: 10.1111/dom.12438. Epub 2015 Feb 12.</citation>
    <PMID>25641260</PMID>
  </results_reference>
  <verification_date>May 2015</verification_date>
  <study_first_submitted>August 28, 2012</study_first_submitted>
  <study_first_submitted_qc>August 28, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 30, 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 2</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 1396 participants were screened, of whom 518 participants were screen failure and 878 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 (evening) for 12 months in combination with non-insulin antihyperglycemic drug(s).</description>
        </group>
        <group group_id="P2">
          <title>Lantus (Insulin Glargine)</title>
          <description>Lantus (HOE901-U100, insulin glargine 100 U/mL) SC injection once daily (evening) for 12 months in combination with non-insulin antihyperglycemic drug(s).</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="439"/>
                <participants group_id="P2" count="439"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Treated</title>
              <participants_list>
                <participants group_id="P1" count="435"/>
                <participants group_id="P2" count="438"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Modified Intent-To-Treat Population</title>
              <participants_list>
                <participants group_id="P1" count="432">Participants who received at least 1 dose of drug, had both baseline, at least 1 post-baseline data</participants>
                <participants group_id="P2" count="430">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="337"/>
                <participants group_id="P2" count="314"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="102"/>
                <participants group_id="P2" count="125"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Randomized But Not Treated</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="10"/>
                <participants group_id="P2" count="8"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lack of Efficacy</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="5"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Protocol Violation</title>
              <participants_list>
                <participants group_id="P1" count="11"/>
                <participants group_id="P2" count="12"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Received Rescue Therapy</title>
              <participants_list>
                <participants group_id="P1" count="14"/>
                <participants group_id="P2" count="22"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Personal Reason</title>
              <participants_list>
                <participants group_id="P1" count="34"/>
                <participants group_id="P2" count="45"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="11"/>
                <participants group_id="P2" count="18"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Selection Criterion/Protocol Violation</title>
              <participants_list>
                <participants group_id="P1" count="9"/>
                <participants group_id="P2" count="9"/>
              </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="4"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Perceived Lack of Efficacy</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Non Serious Hypoglycemia</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>No More Need of Insulin</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
              </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 for 12 months in combination with non-insulin antihyperglycemic drug(s).</description>
        </group>
        <group group_id="B2">
          <title>Lantus</title>
          <description>Lantus SC injection once daily for 12 months in combination with non-insulin antihyperglycemic drug(s).</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="439"/>
            <count group_id="B2" value="439"/>
            <count group_id="B3" value="878"/>
          </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="58.2" spread="9.9"/>
                    <measurement group_id="B2" value="57.2" spread="10.3"/>
                    <measurement group_id="B3" value="57.7" spread="10.1"/>
                  </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="186"/>
                    <measurement group_id="B2" value="185"/>
                    <measurement group_id="B3" value="371"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="253"/>
                    <measurement group_id="B2" value="254"/>
                    <measurement group_id="B3" value="507"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Body Mass Index (BMI)</title>
          <units>kilogram per square meter</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="32.8" spread="6.9"/>
                    <measurement group_id="B2" value="33.2" spread="6.6"/>
                    <measurement group_id="B3" value="33.0" spread="6.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Duration of Diabetes</title>
          <description>Number of participants analyzed for this baseline characteristics = 435 and 436 in HOE901-U300 and Lantus arm, 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="10.11" spread="6.49"/>
                    <measurement group_id="B2" value="9.57" spread="6.22"/>
                    <measurement group_id="B3" value="9.84" spread="6.36"/>
                  </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 = 432 and 436 in HOE901-U300 and Lantus arm, 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="0.193" spread="0.027"/>
                    <measurement group_id="B2" value="0.193" spread="0.034"/>
                    <measurement group_id="B3" value="0.193" spread="0.031"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Glycated Hemoglobin A1c (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="141"/>
                    <measurement group_id="B2" value="142"/>
                    <measurement group_id="B3" value="283"/>
                  </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="298"/>
                    <measurement group_id="B2" value="297"/>
                    <measurement group_id="B3" value="595"/>
                  </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>
        <description>Only HbA1c measurements performed before initiation of rescue therapy were considered in the analysis. Month 6 Endpoint is either the observed value at Month 6 visit or value retrieved according to time windows.</description>
        <time_frame>Baseline, Month 6</time_frame>
        <population>Modified Intent-to-Treat (mITT) population:randomized participants who received at least 1 dose, had baseline and at least 1 post-baseline data of any efficacy variable, irrespective of compliance. Number of participants analyzed=participants included in mITT population with baseline and at least 1 post-baseline HbA1c data (Week 12 and/or Month 6).</population>
        <group_list>
          <group group_id="O1">
            <title>HOE901-U300</title>
            <description>HOE901-U300 SC injection once daily for 12 months in combination with non-insulin antihyperglycemic drug(s).</description>
          </group>
          <group group_id="O2">
            <title>Lantus</title>
            <description>Lantus SC injection once daily for 12 months in combination with non-insulin antihyperglycemic drug(s).</description>
          </group>
        </group_list>
        <measure>
          <title>Change in HbA1c From Baseline to Month 6 Endpoint</title>
          <description>Only HbA1c measurements performed before initiation of rescue therapy were considered in the analysis. Month 6 Endpoint is either the observed value at Month 6 visit or value retrieved according to time windows.</description>
          <population>Modified Intent-to-Treat (mITT) population:randomized participants who received at least 1 dose, had baseline and at least 1 post-baseline data of any efficacy variable, irrespective of compliance. Number of participants analyzed=participants included in mITT population with baseline and at least 1 post-baseline HbA1c data (Week 12 and/or Month 6).</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="402"/>
                <count group_id="O2" value="394"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.42" spread="0.047"/>
                    <measurement group_id="O2" value="-1.46" spread="0.048"/>
                  </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>0.067</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.090</ci_lower_limit>
            <ci_upper_limit>0.174</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With At Least One Severe and/or Confirmed Nocturnal Hypoglycemia From Start of Week 9 to Month 6</title>
        <description>Nocturnal hypoglycemia was hypoglycemia that occurred between 00:00 and 05:59 hours (clock time), regardless the participant was awake or woke up because of the event. Severe hypoglycemia was an event that required assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions. Confirmed hypoglycemia was an event associated with plasma glucose less than or equal to (&lt;=) 3.9 millimoles per liter (mmol/L) (70 milligram per deciliter [mg/dL]). Only nocturnal hypoglycemia occurring before initiation of rescue therapy were considered in the analysis. Week 9 and Month 6 value correspond to the observed value at Week 9 and Month 6 visit respectively.</description>
        <time_frame>Week 9 Up to Month 6</time_frame>
        <population>Modified intent-to-treat population.</population>
        <group_list>
          <group group_id="O1">
            <title>HOE901-U300</title>
            <description>HOE901-U300 SC injection once daily for 12 months in combination with non-insulin antihyperglycemic drug(s).</description>
          </group>
          <group group_id="O2">
            <title>Lantus</title>
            <description>Lantus SC injection once daily for 12 months in combination with non-insulin antihyperglycemic drug(s).</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With At Least One Severe and/or Confirmed Nocturnal Hypoglycemia From Start of Week 9 to Month 6</title>
          <description>Nocturnal hypoglycemia was hypoglycemia that occurred between 00:00 and 05:59 hours (clock time), regardless the participant was awake or woke up because of the event. Severe hypoglycemia was an event that required assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions. Confirmed hypoglycemia was an event associated with plasma glucose less than or equal to (&lt;=) 3.9 millimoles per liter (mmol/L) (70 milligram per deciliter [mg/dL]). Only nocturnal hypoglycemia occurring before initiation of rescue therapy were considered in the analysis. Week 9 and Month 6 value correspond to the observed value at Week 9 and Month 6 visit respectively.</description>
          <population>Modified intent-to-treat 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="432"/>
                <count group_id="O2" value="430"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15.5"/>
                    <measurement group_id="O2" value="17.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>A one-sided test (at alpha=0.025) for superiority of HOE901-U300 over Lantus was to be performed in case the non-inferiority of HOE901-U300 vs Lantus for the primary endpoint was demonstrated. Analysis was performed using Cochran-Mantel-Haenszel (CMH) method stratified by randomization strata of screening HbA1c (&lt;8.0, &gt;=8.0%), randomization strata of geographical region (Non-Japan; Japan).</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.4536</p_value>
            <method>Cochran-Mantel-Haenszel</method>
            <param_type>Risk Ratio (RR)</param_type>
            <param_value>0.89</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.66</ci_lower_limit>
            <ci_upper_limit>1.20</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Preinjection Self-Monitored Plasma Glucose (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. Except for baseline value average of preinjection SMPG was assessed by the mean of at least 3 SMPG calculated over the 7 days preceding the assessment visit. Only preinjection SMPG measurements performed before initiation of rescue therapy were considered in the analysis. Month 6 Endpoint is either the observed value at Month 6 visit or value retrieved according to time windows.</description>
        <time_frame>Baseline, Month 6</time_frame>
        <population>mITT population. Number of participants analyzed = participants included in the mITT population with baseline and at least one pre-injection SMPG assessment (Week 2, Week 4, Week 8, Week 12, Month 4 and/or Month 6)</population>
        <group_list>
          <group group_id="O1">
            <title>HOE901-U300</title>
            <description>HOE901-U300 SC injection once daily for 12 months in combination with non-insulin antihyperglycemic drug(s).</description>
          </group>
          <group group_id="O2">
            <title>Lantus</title>
            <description>Lantus SC injection once daily for 12 months in combination with non-insulin antihyperglycemic drug(s).</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Preinjection Self-Monitored Plasma Glucose (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. Except for baseline value average of preinjection SMPG was assessed by the mean of at least 3 SMPG calculated over the 7 days preceding the assessment visit. Only preinjection SMPG measurements performed before initiation of rescue therapy were considered in the analysis. Month 6 Endpoint is either the observed value at Month 6 visit or value retrieved according to time windows.</description>
          <population>mITT population. Number of participants analyzed = participants included in the mITT population with baseline and at least one pre-injection SMPG assessment (Week 2, Week 4, Week 8, Week 12, Month 4 and/or Month 6)</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="207"/>
                <count group_id="O2" value="222"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.16" spread="0.162"/>
                    <measurement group_id="O2" value="-2.33" spread="0.156"/>
                  </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; baseline preinjection SMPG value and baseline preinjection 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>0.17</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.224</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.275</ci_lower_limit>
            <ci_upper_limit>0.605</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Variability of Preinjection SMPG at 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. Only preinjection SMPG measurements performed before initiation of rescue therapy were considered in the analysis. Month 6 Endpoint is either the observed value at Month 6 visit or value retrieved according to time windows.</description>
        <time_frame>Month 6</time_frame>
        <population>mITT population. Number of participants analyzed = participants included in the mITT Population with at least one pre-injection SMPG variability assessment (Week 2, Week 4, Week 8, Week 12, Month 4 and/or Month 6).</population>
        <group_list>
          <group group_id="O1">
            <title>HOE901-U300</title>
            <description>HOE901-U300 SC injection once daily for 12 months in combination with non-insulin antihyperglycemic drug(s).</description>
          </group>
          <group group_id="O2">
            <title>Lantus</title>
            <description>Lantus SC injection once daily for 12 months in combination with non-insulin antihyperglycemic drug(s).</description>
          </group>
        </group_list>
        <measure>
          <title>Variability of Preinjection SMPG at 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. Only preinjection SMPG measurements performed before initiation of rescue therapy were considered in the analysis. Month 6 Endpoint is either the observed value at Month 6 visit or value retrieved according to time windows.</description>
          <population>mITT population. Number of participants analyzed = participants included in the mITT Population with at least one pre-injection SMPG variability assessment (Week 2, Week 4, Week 8, Week 12, Month 4 and/or Month 6).</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="422"/>
                <count group_id="O2" value="418"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="18.70" spread="0.502"/>
                    <measurement group_id="O2" value="18.33" spread="0.521"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With HbA1c &lt;7% at Month 6</title>
        <description>Only HbA1c measurements performed before initiation of rescue therapy were considered in the analysis. Month 6 value corresponds to the observed value at Month 6 visit.</description>
        <time_frame>Month 6</time_frame>
        <population>mITT Population. Participants without any available Month 6 HbA1C assessment were considered as failures (non-responders).</population>
        <group_list>
          <group group_id="O1">
            <title>HOE901-U300</title>
            <description>HOE901-U300 SC injection once daily for 12 months in combination with non-insulin antihyperglycemic drug(s).</description>
          </group>
          <group group_id="O2">
            <title>Lantus</title>
            <description>Lantus SC injection once daily for 12 months in combination with non-insulin antihyperglycemic drug(s).</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With HbA1c &lt;7% at Month 6</title>
          <description>Only HbA1c measurements performed before initiation of rescue therapy were considered in the analysis. Month 6 value corresponds to the observed value at Month 6 visit.</description>
          <population>mITT Population. Participants without any available Month 6 HbA1C assessment were considered as failures (non-responders).</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="432"/>
                <count group_id="O2" value="430"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="43.1"/>
                    <measurement group_id="O2" value="42.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Fasting Plasma Glucose (FPG) From Baseline to Month 6 Endpoint</title>
        <description>Only FPG measurements performed before initiation of rescue therapy were considered in the analysis. Month 6 Endpoint is either the observed value at Month 6 visit or value retrieved according to time windows.</description>
        <time_frame>Baseline, Month 6</time_frame>
        <population>mITT Population. Number of participants analyzed = participants included in the mITT population with baseline and at least one post-baseline FPG assessment (Week 12 and/or Month 6).</population>
        <group_list>
          <group group_id="O1">
            <title>HOE901-U300</title>
            <description>HOE901-U300 SC injection once daily for 12 months in combination with non-insulin antihyperglycemic drug(s).</description>
          </group>
          <group group_id="O2">
            <title>Lantus</title>
            <description>Lantus SC injection once daily for 12 months in combination with non-insulin antihyperglycemic drug(s).</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Fasting Plasma Glucose (FPG) From Baseline to Month 6 Endpoint</title>
          <description>Only FPG measurements performed before initiation of rescue therapy were considered in the analysis. Month 6 Endpoint is either the observed value at Month 6 visit or value retrieved according to time windows.</description>
          <population>mITT Population. Number of participants analyzed = participants included in the mITT population with baseline and at least one post-baseline FPG assessment (Week 12 and/or Month 6).</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="398"/>
                <count group_id="O2" value="387"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-3.41" spread="0.103"/>
                    <measurement group_id="O2" value="-3.80" spread="0.105"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With FPG &lt;5.6 mmol/L (100 mg/dL) at Month 6</title>
        <description>Only FPG measurements performed before initiation of rescue therapy were considered in the analysis. Month 6 value corresponds to the observed value at Month 6 visit.</description>
        <time_frame>Month 6</time_frame>
        <population>mITT Population. Participants without any available FPG assessment at Month 6 were considered as failures (non-responders).</population>
        <group_list>
          <group group_id="O1">
            <title>HOE901-U300</title>
            <description>HOE901-U300 SC injection once daily for 12 months in combination with non-insulin antihyperglycemic drug(s).</description>
          </group>
          <group group_id="O2">
            <title>Lantus</title>
            <description>Lantus SC injection once daily for 12 months in combination with non-insulin antihyperglycemic drug(s).</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With FPG &lt;5.6 mmol/L (100 mg/dL) at Month 6</title>
          <description>Only FPG measurements performed before initiation of rescue therapy were considered in the analysis. Month 6 value corresponds to the observed value at Month 6 visit.</description>
          <population>mITT Population. Participants without any available FPG assessment at Month 6 were considered as failures (non-responders).</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="432"/>
                <count group_id="O2" value="430"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="26.2"/>
                    <measurement group_id="O2" value="29.5"/>
                  </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</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. Only 8-point SMPG profiles measurements performed before initiation of rescue therapy were considered in the analysis. Month 6 value corresponds to the observed value at Month 6 visit.</description>
        <time_frame>Baseline, Month 6</time_frame>
        <population>mITT Population. Only participants from the mITT population with a value at baseline and at specified timepoint were analyzed (represented by n=X, X in the category titles).</population>
        <group_list>
          <group group_id="O1">
            <title>HOE901-U300</title>
            <description>HOE901-U300 SC injection once daily for 12 months in combination with non-insulin antihyperglycemic drug(s).</description>
          </group>
          <group group_id="O2">
            <title>Lantus</title>
            <description>Lantus SC injection once daily for 12 months in combination with non-insulin antihyperglycemic drug(s).</description>
          </group>
        </group_list>
        <measure>
          <title>Change in 8-Point SMPG Profiles Per Time Point From Baseline to Month 6</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. Only 8-point SMPG profiles measurements performed before initiation of rescue therapy were considered in the analysis. Month 6 value corresponds to the observed value at Month 6 visit.</description>
          <population>mITT Population. Only participants from the mITT population with a value at baseline and at specified timepoint were analyzed (represented by n=X, X in the category titles).</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="432"/>
                <count group_id="O2" value="430"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>03:00 at Night Plasma Glucose (n=281,277)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.63" spread="3.24"/>
                    <measurement group_id="O2" value="-3.01" spread="3.75"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Pre-Breakfast Plasma Glucose (n=292,286)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-3.28" spread="2.72"/>
                    <measurement group_id="O2" value="-3.72" spread="2.96"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>2 Hours After Breakfast Plasma Glucose (n=278,278)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-3.69" spread="3.65"/>
                    <measurement group_id="O2" value="-4.08" spread="4.03"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Pre-Lunch Plasma Glucose (n=289,281)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.58" spread="3.39"/>
                    <measurement group_id="O2" value="-3.39" spread="3.76"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>2 Hours After Lunch Plasma Glucose (n=280,269)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.19" spread="3.88"/>
                    <measurement group_id="O2" value="-3.13" spread="3.77"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Pre-Dinner Plasma Glucose (n=291,285)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.57" spread="3.49"/>
                    <measurement group_id="O2" value="-2.43" spread="3.79"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>2 Hours After Dinner Plasma Glucose (n=282,269)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.36" spread="3.89"/>
                    <measurement group_id="O2" value="-2.33" spread="4.03"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Bedtime Plasma Glucose (n=249,249)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.19" spread="3.75"/>
                    <measurement group_id="O2" value="-2.26" spread="3.66"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in 24-hour Average 8-point SMPG Profile From Baseline to Month 6 Endpoint</title>
        <description>Change in 24-hour average of 8-point SMPG profile. 8-point SMPG was assessed at: 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. Only 24-hour average 8-point SMPG measurements performed before initiation of rescue therapy were considered in the analysis. Month 6 Endpoint is either the observed value at Month 6 visit or value retrieved according to time windows.</description>
        <time_frame>Baseline, Month 6</time_frame>
        <population>mITT Population. Number of participants analyzed = participants included in the mITT population with baseline and at least one post-baseline 24-hour average 8-point SMPG assessment (Week 2, Week 4, Week 8, Week 12, Month 4 and/or Month 6).</population>
        <group_list>
          <group group_id="O1">
            <title>HOE901-U300</title>
            <description>HOE901-U300 SC injection once daily for 12 months on top of non-insulin antihyperglycemic drug(s).</description>
          </group>
          <group group_id="O2">
            <title>Lantus</title>
            <description>Lantus SC injection once daily for 12 months on top of non-insulin antihyperglycemic drug(s).</description>
          </group>
        </group_list>
        <measure>
          <title>Change in 24-hour Average 8-point SMPG Profile From Baseline to Month 6 Endpoint</title>
          <description>Change in 24-hour average of 8-point SMPG profile. 8-point SMPG was assessed at: 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. Only 24-hour average 8-point SMPG measurements performed before initiation of rescue therapy were considered in the analysis. Month 6 Endpoint is either the observed value at Month 6 visit or value retrieved according to time windows.</description>
          <population>mITT Population. Number of participants analyzed = participants included in the mITT population with baseline and at least one post-baseline 24-hour average 8-point SMPG assessment (Week 2, Week 4, Week 8, Week 12, Month 4 and/or Month 6).</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="381"/>
                <count group_id="O2" value="393"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.72" spread="0.088"/>
                    <measurement group_id="O2" value="-2.90" spread="0.089"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Variability of 24 Hour Average 8-point SMPG Profiles From Baseline to Month 6 Endpoint</title>
        <description>Variability is assessed by the mean of coefficient of variation calculated as 100 multiplied by (standard deviation/mean) over at least 5 measurements of the 8-point profiles. Only variability of 24-hour 8-point SMPG measurements performed before initiation of rescue therapy were considered in the analysis. Month 6 Endpoint is either the observed value at Month 6 visit or value retrieved according to time windows.</description>
        <time_frame>Baseline, Month 6</time_frame>
        <population>mITT Population. Number of participants analyzed = participants included in the mITT population with baseline and at least one post-baseline variability of 24-hour average 8-point SMPG assessment (Week 2, Week 4, Week 8, Week 12, Month 4 and/or Month 6).</population>
        <group_list>
          <group group_id="O1">
            <title>HOE901-U300</title>
            <description>HOE901-U300 SC injection once daily for 12 months in combination with non-insulin antihyperglycemic drug(s).</description>
          </group>
          <group group_id="O2">
            <title>Lantus</title>
            <description>Lantus SC injection once daily for 12 months in combination with non-insulin antihyperglycemic drug(s).</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Variability of 24 Hour Average 8-point SMPG Profiles From Baseline to Month 6 Endpoint</title>
          <description>Variability is assessed by the mean of coefficient of variation calculated as 100 multiplied by (standard deviation/mean) over at least 5 measurements of the 8-point profiles. Only variability of 24-hour 8-point SMPG measurements performed before initiation of rescue therapy were considered in the analysis. Month 6 Endpoint is either the observed value at Month 6 visit or value retrieved according to time windows.</description>
          <population>mITT Population. Number of participants analyzed = participants included in the mITT population with baseline and at least one post-baseline variability of 24-hour average 8-point SMPG assessment (Week 2, Week 4, Week 8, Week 12, Month 4 and/or Month 6).</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="381"/>
                <count group_id="O2" value="393"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.53" spread="0.643"/>
                    <measurement group_id="O2" value="1.41" spread="0.647"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Daily Basal Insulin Dose From Baseline to Month 6</title>
        <description>Only insulin dose measurements performed before initiation of rescue therapy were considered in the analysis. Month 6 value corresponds to the observed value at Month 6 visit.</description>
        <time_frame>Baseline, Month 6</time_frame>
        <population>mITT Population. Number of participants analyzed = participants included in the mITT population with Baseline and Month 6 basal insulin dose assessment.</population>
        <group_list>
          <group group_id="O1">
            <title>HOE901-U300</title>
            <description>HOE901-U300 SC injection once daily for 12 months in combination with non-insulin antihyperglycemic drug(s).</description>
          </group>
          <group group_id="O2">
            <title>Lantus</title>
            <description>Lantus SC injection once daily for 12 months in combination with non-insulin antihyperglycemic drug(s).</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Daily Basal Insulin Dose From Baseline to Month 6</title>
          <description>Only insulin dose measurements performed before initiation of rescue therapy were considered in the analysis. Month 6 value corresponds to the observed value at Month 6 visit.</description>
          <population>mITT Population. Number of participants analyzed = participants included in the mITT population with Baseline and Month 6 basal 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="362"/>
                <count group_id="O2" value="340"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.43" spread="0.29"/>
                    <measurement group_id="O2" value="0.34" spread="0.24"/>
                  </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. Only DTSQ total score measurements performed before initiation of rescue therapy were considered in the analysis. Month 6 Endpoint is either the observed value at Month 6 visit or value retrieved according to time windows.</description>
        <time_frame>Baseline, Month 6</time_frame>
        <population>mITT Population. Number of participants analyzed = participants included in the mITT population with Baseline and at least one post-baseline DTSQ assessment (Week 12 and/or Month 6).</population>
        <group_list>
          <group group_id="O1">
            <title>HOE901-U300</title>
            <description>HOE901-U300 SC injection once daily for 12 months in combination with non-insulin antihyperglycemic drug(s).</description>
          </group>
          <group group_id="O2">
            <title>Lantus</title>
            <description>Lantus SC injection once daily for 12 months in combination with non-insulin antihyperglycemic drug(s).</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. Only DTSQ total score measurements performed before initiation of rescue therapy were considered in the analysis. Month 6 Endpoint is either the observed value at Month 6 visit or value retrieved according to time windows.</description>
          <population>mITT Population. Number of participants analyzed = participants included in the mITT population with Baseline and at least one post-baseline DTSQ assessment (Week 12 and/or Month 6).</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="371"/>
                <count group_id="O2" value="367"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.89" spread="0.246"/>
                    <measurement group_id="O2" value="5.12" spread="0.251"/>
                  </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 up 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 12 months</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 for 12 months in combination with non-insulin antihyperglycemic drug(s).</description>
          </group>
          <group group_id="O2">
            <title>Lantus</title>
            <description>Lantus SC injection once daily for 12 months in combination with non-insulin antihyperglycemic drug(s).</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Hypoglycemia (All and Nocturnal) Events From Baseline up 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="435"/>
                <count group_id="O2" value="438"/>
              </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="58.9"/>
                    <measurement group_id="O2" value="63.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Severe Hypoglycemia: All Hypoglycemia</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.4"/>
                    <measurement group_id="O2" value="2.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Documented Symptomatic: All Hypoglycemia</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="39.1"/>
                    <measurement group_id="O2" value="44.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Asymptomatic: All Hypoglycemia</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="41.6"/>
                    <measurement group_id="O2" value="46.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Probable Symptomatic: All Hypoglycemia</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.2"/>
                    <measurement group_id="O2" value="3.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Relative: All Hypoglycemia</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10.6"/>
                    <measurement group_id="O2" value="11.6"/>
                  </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="56.3"/>
                    <measurement group_id="O2" value="61.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Any Hypoglycemia Event: Nocturnal Hypoglycemia</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="27.6"/>
                    <measurement group_id="O2" value="30.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Severe Hypoglycemia: Nocturnal Hypoglycemia</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0"/>
                    <measurement group_id="O2" value="0.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Documented Symptomatic: Nocturnal Hypoglycemia</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="18.6"/>
                    <measurement group_id="O2" value="20.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Asymptomatic: Nocturnal Hypoglycemia</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="13.3"/>
                    <measurement group_id="O2" value="16.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Probable Symptomatic: Nocturnal Hypoglycemia</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.7"/>
                    <measurement group_id="O2" value="0.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Relative: Nocturnal Hypoglycemia</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.4"/>
                    <measurement group_id="O2" value="3.2"/>
                  </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="25.3"/>
                    <measurement group_id="O2" value="29.5"/>
                  </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' (time from first injection of study drug up to 2 day after the last injection of study drug). Analysis was done on safety population.</desc>
      <group_list>
        <group group_id="E1">
          <title>HOE901-U300</title>
          <description>HOE901-U300 SC injection once daily for 12 months in combination with non-insulin antihyperglycemic drug(s).</description>
        </group>
        <group group_id="E2">
          <title>Lantus</title>
          <description>Lantus SC injection once daily for 12 months in combination with non-insulin antihyperglycemic drug(s).</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="35" subjects_at_risk="435"/>
                <counts group_id="E2" subjects_affected="39" subjects_at_risk="438"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Acute myocardial infarction</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="435"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="438"/>
              </event>
              <event>
                <sub_title>Angina pectoris</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="435"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="438"/>
              </event>
              <event>
                <sub_title>Angina unstable</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="435"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="438"/>
              </event>
              <event>
                <sub_title>Arteriosclerosis coronary artery</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="435"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="438"/>
              </event>
              <event>
                <sub_title>Atrial fibrillation</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="435"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="438"/>
              </event>
              <event>
                <sub_title>Cardiac failure congestive</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="435"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="438"/>
              </event>
              <event>
                <sub_title>Coronary artery disease</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="435"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="438"/>
              </event>
              <event>
                <sub_title>Myocardial infarction</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="435"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="438"/>
              </event>
              <event>
                <sub_title>Ventricular tachycardia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="435"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="438"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Endocrine disorders</title>
            <event_list>
              <event>
                <sub_title>Goitre</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="435"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="438"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Cataract</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="435"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="438"/>
              </event>
              <event>
                <sub_title>Retinal detachment</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="435"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="438"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal hernia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="435"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="438"/>
              </event>
              <event>
                <sub_title>Abdominal pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="435"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="438"/>
              </event>
              <event>
                <sub_title>Colitis ischaemic</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="435"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="438"/>
              </event>
              <event>
                <sub_title>Diverticulum intestinal</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="435"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="438"/>
              </event>
              <event>
                <sub_title>Duodenal ulcer</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="435"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="438"/>
              </event>
              <event>
                <sub_title>Gastric ulcer haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="435"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="438"/>
              </event>
              <event>
                <sub_title>Gastrointestinal haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="435"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="438"/>
              </event>
              <event>
                <sub_title>Haemorrhoids</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="435"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="438"/>
              </event>
              <event>
                <sub_title>Pancreatitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="435"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="438"/>
              </event>
              <event>
                <sub_title>Peptic ulcer</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="435"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="438"/>
              </event>
              <event>
                <sub_title>Small intestinal obstruction</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="435"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="438"/>
              </event>
              <event>
                <sub_title>Umbilical hernia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="435"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="438"/>
              </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="2" subjects_at_risk="435"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="438"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>Cholecystitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="435"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="438"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Cystitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="435"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="438"/>
              </event>
              <event>
                <sub_title>Diabetic foot infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="435"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="438"/>
              </event>
              <event>
                <sub_title>Diverticulitis</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="435"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="438"/>
              </event>
              <event>
                <sub_title>Liver abscess</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="435"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="438"/>
              </event>
              <event>
                <sub_title>Lobar pneumonia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="435"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="438"/>
              </event>
              <event>
                <sub_title>Lung infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="435"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="438"/>
              </event>
              <event>
                <sub_title>Pneumonia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="435"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="438"/>
              </event>
              <event>
                <sub_title>Postoperative wound infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="435"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="438"/>
              </event>
              <event>
                <sub_title>Pulmonary mycosis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="435"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="438"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Fall</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="435"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="438"/>
              </event>
              <event>
                <sub_title>Limb injury</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="435"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="438"/>
              </event>
              <event>
                <sub_title>Multiple injuries</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="435"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="438"/>
              </event>
              <event>
                <sub_title>Rib fracture</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="435"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="438"/>
              </event>
              <event>
                <sub_title>Road traffic accident</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="435"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="438"/>
              </event>
              <event>
                <sub_title>Upper limb fracture</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="435"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="438"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Alanine aminotransferase increased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="435"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="438"/>
              </event>
              <event>
                <sub_title>Blood bilirubin increased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="435"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="438"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Hypoglycaemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="435"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="438"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Arthritis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="435"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="438"/>
              </event>
              <event>
                <sub_title>Chondrocalcinosis pyrophosphate</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="435"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="438"/>
              </event>
              <event>
                <sub_title>Flank pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="435"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="438"/>
              </event>
              <event>
                <sub_title>Musculoskeletal chest pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="435"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="438"/>
              </event>
              <event>
                <sub_title>Osteoarthritis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="435"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="438"/>
              </event>
              <event>
                <sub_title>Pain in extremity</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="435"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="438"/>
              </event>
              <event>
                <sub_title>Spinal osteoarthritis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="435"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="438"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Basal cell carcinoma</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="435"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="438"/>
              </event>
              <event>
                <sub_title>Breast cancer</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="435"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="438"/>
              </event>
              <event>
                <sub_title>Prostate cancer</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="435"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="438"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Carotid artery aneurysm</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="435"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="438"/>
              </event>
              <event>
                <sub_title>Cerebral artery embolism</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="435"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="438"/>
              </event>
              <event>
                <sub_title>Cerebral infarction</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="435"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="438"/>
              </event>
              <event>
                <sub_title>Cerebrovascular accident</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="435"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="438"/>
              </event>
              <event>
                <sub_title>Convulsion</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="435"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="438"/>
              </event>
              <event>
                <sub_title>Hypoglycaemic unconsciousness</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="435"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="438"/>
              </event>
              <event>
                <sub_title>Ischaemic stroke</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="435"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="438"/>
              </event>
              <event>
                <sub_title>Syncope</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="435"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="438"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Haematuria</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="435"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="438"/>
              </event>
              <event>
                <sub_title>Nephrolithiasis</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="435"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="438"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Reproductive system and breast disorders</title>
            <event_list>
              <event>
                <sub_title>Benign prostatic hyperplasia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="435"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="438"/>
              </event>
              <event>
                <sub_title>Menorrhagia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="435"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="438"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Acute pulmonary oedema</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="435"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="438"/>
              </event>
              <event>
                <sub_title>Acute respiratory failure</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="435"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="438"/>
              </event>
              <event>
                <sub_title>Asthma</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="435"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="438"/>
              </event>
              <event>
                <sub_title>Chronic obstructive pulmonary disease</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="435"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="438"/>
              </event>
              <event>
                <sub_title>Dyspnoea</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="435"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="438"/>
              </event>
              <event>
                <sub_title>Interstitial lung disease</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="435"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="438"/>
              </event>
              <event>
                <sub_title>Sleep apnoea syndrome</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="435"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="438"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Surgical and medical procedures</title>
            <event_list>
              <event>
                <sub_title>Medical device removal</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="435"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="438"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Peripheral arterial occlusive disease</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="435"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="438"/>
              </event>
              <event>
                <sub_title>Varicose vein</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="435"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="438"/>
              </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="115" subjects_at_risk="435"/>
                <counts group_id="E2" subjects_affected="107" subjects_at_risk="438"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Nasopharyngitis</sub_title>
                <counts group_id="E1" subjects_affected="41" subjects_at_risk="435"/>
                <counts group_id="E2" subjects_affected="47" subjects_at_risk="438"/>
              </event>
              <event>
                <sub_title>Sinusitis</sub_title>
                <counts group_id="E1" subjects_affected="11" subjects_at_risk="435"/>
                <counts group_id="E2" subjects_affected="23" subjects_at_risk="438"/>
              </event>
              <event>
                <sub_title>Upper respiratory tract infection</sub_title>
                <counts group_id="E1" subjects_affected="45" subjects_at_risk="435"/>
                <counts group_id="E2" subjects_affected="34" subjects_at_risk="438"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" subjects_affected="36" subjects_at_risk="435"/>
                <counts group_id="E2" subjects_affected="22" subjects_at_risk="438"/>
              </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/NCT01676220
org study id: EFC12347
secondary id: 2012-000146-35
secondary id: U1111-1124-5261
nct id: NCT01676220
lead sponsor: 
has dmc: No
Primary Objective:

      To compare the efficacy of a new formulation of insulin glargine and Lantus in terms of
      change of HbA1c from baseline to endpoint (scheduled at Month 6, Week 26) in participants
      with type 2 diabetes mellitus

      Secondary Objectives:

      To compare a new formulation of insulin glargine and Lantus in terms of:

      - occurrence of nocturnal hypoglycemia
The maximum study duration was up to approximately 54 weeks per participant, consisting of:

        -  Up to 2 week screening period; it can be exceptionally extended of up to one additional
           week

        -  6-month comparative efficacy and safety treatment period

        -  6-month comparative safety extension period

        -  2-day 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
description: Only HbA1c measurements performed before initiation of rescue therapy were considered in the analysis. Month 6 Endpoint is either the observed value at Month 6 visit or value retrieved according to time windows.
measure: Percentage of Participants With At Least One Severe and/or Confirmed Nocturnal Hypoglycemia From Start of Week 9 to Month 6
time frame: Week 9 Up to Month 6
description: Nocturnal hypoglycemia was hypoglycemia that occurred between 00:00 and 05:59 hours (clock time), regardless the participant was awake or woke up because of the event. Severe hypoglycemia was an event that required assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions. Confirmed hypoglycemia was an event associated with plasma glucose less than or equal to (<=) 3.9 millimoles per liter (mmol/L) (70 milligram per deciliter [mg/dL]). Only nocturnal hypoglycemia occurring before initiation of rescue therapy were considered in the analysis. Week 9 and Month 6 value correspond to the observed value at Week 9 and Month 6 visit respectively.
measure: Change in Preinjection Self-Monitored Plasma Glucose (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. Except for baseline value average of preinjection SMPG was assessed by the mean of at least 3 SMPG calculated over the 7 days preceding the assessment visit. Only preinjection SMPG measurements performed before initiation of rescue therapy were considered in the analysis. Month 6 Endpoint is either the observed value at Month 6 visit or value retrieved according to time windows.
measure: Variability of Preinjection SMPG at Month 6 Endpoint
time frame: 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. Only preinjection SMPG measurements performed before initiation of rescue therapy were considered in the analysis. Month 6 Endpoint is either the observed value at Month 6 visit or value retrieved according to time windows.
measure: Percentage of Participants With HbA1c <7% at Month 6
time frame: Month 6
description: Only HbA1c measurements performed before initiation of rescue therapy were considered in the analysis. Month 6 value corresponds to the observed value at Month 6 visit.
measure: Change in Fasting Plasma Glucose (FPG) From Baseline to Month 6 Endpoint
time frame: Baseline, Month 6
description: Only FPG measurements performed before initiation of rescue therapy were considered in the analysis. Month 6 Endpoint is either the observed value at Month 6 visit or value retrieved according to time windows.
measure: Percentage of Participants With FPG <5.6 mmol/L (100 mg/dL) at Month 6
time frame: Month 6
description: Only FPG measurements performed before initiation of rescue therapy were considered in the analysis. Month 6 value corresponds to the observed value at Month 6 visit.
measure: Change in 8-Point SMPG Profiles Per Time Point From Baseline to Month 6
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. Only 8-point SMPG profiles measurements performed before initiation of rescue therapy were considered in the analysis. Month 6 value corresponds to the observed value at Month 6 visit.
measure: Change in 24-hour Average 8-point SMPG Profile From Baseline to Month 6 Endpoint
time frame: Baseline, Month 6
description: Change in 24-hour average of 8-point SMPG profile. 8-point SMPG was assessed at: 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. Only 24-hour average 8-point SMPG measurements performed before initiation of rescue therapy were considered in the analysis. Month 6 Endpoint is either the observed value at Month 6 visit or value retrieved according to time windows.
measure: Change in Variability of 24 Hour Average 8-point SMPG Profiles From Baseline to Month 6 Endpoint
time frame: Baseline, Month 6
description: Variability is assessed by the mean of coefficient of variation calculated as 100 multiplied by (standard deviation/mean) over at least 5 measurements of the 8-point profiles. Only variability of 24-hour 8-point SMPG measurements performed before initiation of rescue therapy were considered in the analysis. Month 6 Endpoint is either the observed value at Month 6 visit or value retrieved according to time windows.
measure: Change in Daily Basal Insulin Dose From Baseline to Month 6
time frame: Baseline, Month 6
description: Only insulin dose measurements performed before initiation of rescue therapy were considered in the analysis. Month 6 value corresponds to the observed value at Month 6 visit.
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. Only DTSQ total score measurements performed before initiation of rescue therapy were considered in the analysis. Month 6 Endpoint is either the observed value at Month 6 visit or value retrieved according to time windows.
measure: Percentage of Participants With Hypoglycemia (All and Nocturnal) Events From Baseline up to Month 12
time frame: Up to 12 months
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
arm group label: Lantus
arm group type: Active Comparator
intervention type: Drug
intervention name: HOE901-U300 (new formulation of insulin glargine)
description: HOE901-U300 (new insulin glargine 300 units per milliliter [U/mL]) subcutaneous (SC) injection once daily (evening) for 12 months on top of non-insulin antihyperglycemic drug(s). 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: HOE901-U300
intervention type: Drug
intervention name: Lantus (insulin glargine)
description: Lantus (HOE901-U100, insulin glargine 100 U/mL) SC injection once daily (evening) for 12 months on top of non-insulin antihyperglycemic drug(s). Dose titration seeking fasting plasma glucose 4.4-5.6 mmol/L (80 - 100 mg/dL).
arm group label: Lantus
other name: 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: Bulgaria
country: Canada
country: Czech Republic
country: Denmark
country: Estonia
country: Finland
country: Hungary
country: Japan
country: Latvia
country: Lithuania
country: Netherlands
country: Puerto Rico
country: Romania
country: Slovakia
country: Sweden
country: United States
citation: Bolli GB, Riddle MC, Bergenstal RM, Ziemen M, Sestakauskas K, Goyeau H, Home PD; on behalf of the EDITION 3 study investigators. New insulin glargine 300 U/ml compared with glargine 100 U/ml in insulin-naive people with type 2 diabetes on oral glucose-lowering drugs: a randomized controlled trial (EDITION 3). Diabetes Obes Metab. 2015 Apr;17(4):386-94. doi: 10.1111/dom.12438. Epub 2015 Feb 12.
PMID: 25641260
responsible party type: Sponsor
mesh term: Diabetes Mellitus
mesh term: Diabetes Mellitus, Type 2
mesh term: Insulin
mesh term: Insulin, Globin Zinc
mesh term: Insulin Glargine
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 