<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/NCT02967211</url>
  </required_header>
  <id_info>
    <org_study_id>LPS14060</org_study_id>
    <secondary_id>2015-001832-39</secondary_id>
    <secondary_id>U1111-1170-8132</secondary_id>
    <nct_id>NCT02967211</nct_id>
  </id_info>
  <brief_title>A &quot;Real World&quot; Trial to Determine Efficacy and Health Outcomes of Toujeo Compared to &quot;Standard of Care&quot; Basal Insulin in Patients Already Using Basal Insulin</brief_title>
  <acronym>REGAIN CONTROL</acronym>
  <official_title>A Twenty-six Week, Randomized, Open-label, 2-arm Parallel Group Real World Pragmatic Trial to Assess the Clinical and Health Outcomes Benefit of Transition to Toujeo Compared to &quot;Standard of Care&quot; Insulin in Basal Insulin Treated Patients With Uncontrolled Type 2 Diabetes Mellitus, With Six-Month Extension</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 demonstrate noninferiority of Toujeo versus &quot;standard of care&quot; basal insulin therapy as&#xD;
      measured by glycated hemoglobin (HbA1c) change&#xD;
&#xD;
      Secondary Objectives:&#xD;
&#xD;
        -  To demonstrate superiority of Toujeo versus &quot;standard of care&quot; basal insulin if&#xD;
           non-inferiority criterion is met, measured by HbA1c change.&#xD;
&#xD;
        -  To compare Toujeo to other &quot;standard of care&quot; basal insulin in terms of patient&#xD;
           persistence with assigned basal insulin therapy with or without intensification.&#xD;
&#xD;
        -  Risk of hypoglycemia including documented, symptomatic hypoglycemia (≤70 mg/dL) or&#xD;
           severe (according to ADA Working Group).&#xD;
&#xD;
        -  Change in fasting plasma glucose (FPG).&#xD;
&#xD;
        -  Change in body weight.&#xD;
&#xD;
        -  Differences in patient reported outcomes measured by Diabetes Treatment Satisfaction&#xD;
           Questionnaire Status and Change versions (DTSQs and DTSQc).&#xD;
&#xD;
        -  Change in hypoglycemic control subscale (HCS).&#xD;
&#xD;
        -  Healthcare resource utilization including hospitalizations and emergency department or&#xD;
           other health care provider visits and healthcare costs.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The total study duration will be up to 55 weeks, consisting of a 1 week screening period at&#xD;
      the site, a 26 week treatment period, and a 26 week extension period.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>December 21, 2015</start_date>
  <completion_date type="Actual">October 20, 2017</completion_date>
  <primary_completion_date type="Actual">October 20, 2017</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in HbA1c (percentage %)</measure>
    <time_frame>Baseline to 6 months</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Proportion of patients who remain on assigned basal insulin therapy before intensification (persistent with assigned therapy)</measure>
    <time_frame>At Month 6 and Month 12</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of patients who remain on assigned basal insulin therapy whether intensification occurred or not</measure>
    <time_frame>At Month 6 and Month 12</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of patients who achieve target HbA1c (&lt;6.5%, &lt;7%, &lt;7.5%, &lt;8.0%)</measure>
    <time_frame>At Month 6 and Month 12</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of patients with HbA1c target (thresholds listed above) (attainment of metabolic benefit) without documented (blood glucose (BG) ≤70 mg/dl [3.9 mmol/L]) symptomatic or severe</measure>
    <time_frame>At Month 6 and Month 12</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of patients with HbA1c target (thresholds listed above) (attainment of metabolic benefit) without documented (BG &lt;54 mg/dL, [3.0 mmol/L]) symptomatic or severe hypoglycemia</measure>
    <time_frame>At Month 6 and Month 12</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in HbA1c (percentage %)</measure>
    <time_frame>Baseline, Month 12</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of patients whose HbA1c decreased at least 0.5%</measure>
    <time_frame>At Month 6 and Month 12</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of patients whose HbA1c decreased at least 0.5%</measure>
    <time_frame>At Month 6 and maintained at Month 12</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of patients requiring intensification</measure>
    <time_frame>At Month 6 and Month 12</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to intensification</measure>
    <time_frame>At Month 6 and Month 12</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in fasting plasma glucose</measure>
    <time_frame>From baseline to Month 6 and Month 12</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">609</enrollment>
  <condition>Diabetes Mellitus, Type 2</condition>
  <arm_group>
    <arm_group_label>Toujeo</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Toujeo will be administered once daily in addition to non-insulin antidiabetic agents</description>
  </arm_group>
  <arm_group>
    <arm_group_label>&quot;Standard of care&quot; commercially available basal insulin</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Lantus, Humulin Neutral Protamine Hagedorn (NPH), Levemir, and Tresiba or other basal insulin, including biosimilar insulin will be administered once or twice daily according to label in addition to non-insulin antidiabetic agents</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>insulin glargine (U300)</intervention_name>
    <description>Pharmaceutical form: solution&#xD;
Route of administration: subcutaneous</description>
    <arm_group_label>Toujeo</arm_group_label>
    <other_name>HOE901; Toujeo</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>insulin glargine (U100)</intervention_name>
    <description>Pharmaceutical form: solution&#xD;
Route of administration: subcutaneous</description>
    <arm_group_label>&quot;Standard of care&quot; commercially available basal insulin</arm_group_label>
    <other_name>HOE901; Lantus</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>NPH insulin</intervention_name>
    <description>Pharmaceutical form: solution&#xD;
Route of administration: subcutaneous</description>
    <arm_group_label>&quot;Standard of care&quot; commercially available basal insulin</arm_group_label>
    <other_name>Humulin NPH</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>insulin detemir</intervention_name>
    <description>Pharmaceutical form: solution&#xD;
Route of administration: subcutaneous</description>
    <arm_group_label>&quot;Standard of care&quot; commercially available basal insulin</arm_group_label>
    <other_name>Levemir</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>insulin degludec</intervention_name>
    <description>Pharmaceutical form: solution&#xD;
Route of administration: subcutaneous</description>
    <arm_group_label>&quot;Standard of care&quot; commercially available basal insulin</arm_group_label>
    <other_name>Tresiba</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion criteria :&#xD;
&#xD;
          -  Patients with type 2 diabetes insufficiently controlled (HbA1c &gt;7%) with current (≥6&#xD;
             months) &quot;standard of care&quot; basal insulin therapy (including insulin glargine U100,&#xD;
             Levemir, NPH, or Tresiba) with or without oral agents (metformin, sulfonylurea,&#xD;
             thiazolidinedione, DPP-4 inhibitor, SGLT-2 inhibitor, glinides, α glucosidase&#xD;
             inhibitors) and with or without use of a GLP-1 receptor agonist.&#xD;
&#xD;
          -  Fasting plasma glucose (FPG) &gt;130 mg/dL (7.2 mmol/L).&#xD;
&#xD;
          -  Adult patients who have signed Informed Consent Form (ICF) and privacy form(s).&#xD;
&#xD;
        Exclusion criteria:&#xD;
&#xD;
          -  HbA1c ≤7%, no upper bound.&#xD;
&#xD;
          -  Age &lt;18 years.&#xD;
&#xD;
          -  Type 1 diabetes mellitus.&#xD;
&#xD;
          -  Any clinically significant abnormality identified on physical examination, laboratory&#xD;
             tests, or vital signs at the time of screening, or any major systemic disease&#xD;
             resulting in short life expectancy that in the opinion of the Investigator would&#xD;
             restrict or limit the patient's successful participation for the duration of the&#xD;
             study.&#xD;
&#xD;
          -  Use of any product containing short or rapid acting insulin since the time of&#xD;
             diagnosis with type 2 diabetes mellitus other than temporary use during a pregnancy or&#xD;
             hospitalization.&#xD;
&#xD;
          -  Use of any product containing short or rapid acting insulin occurring within 3 months&#xD;
             prior to the time of screening.&#xD;
&#xD;
          -  Use of oral hypoglycemic agents other than those noted in the inclusion criteria,&#xD;
             GLP-1 receptor agonists not approved for use with insulin, or any investigational&#xD;
             agent (drug, biologic, device) within 3 months prior to the time of screening.&#xD;
&#xD;
          -  All contraindications to &quot;standard of care&quot; insulin therapy or warnings/precautions of&#xD;
             use as displayed in the respective National Product labeling for these products.&#xD;
&#xD;
          -  Hypersensitivity to insulin glargine or Toujeo excipients.&#xD;
&#xD;
          -  Pregnancy or lactation.&#xD;
&#xD;
          -  Women of childbearing potential with no effective contraceptive method.&#xD;
&#xD;
        The above information is not intended to contain all considerations relevant to a patient's&#xD;
        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 076-001</name>
      <address>
        <city>Curitiba</city>
        <zip>80810-140</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 076008</name>
      <address>
        <city>Fortaleza</city>
        <zip>60115-282</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 076004</name>
      <address>
        <city>Fortaleza</city>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 076009</name>
      <address>
        <city>Rio de Janeiro</city>
        <zip>202110340</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 076-003</name>
      <address>
        <city>Sao Paulo</city>
        <zip>01244-030</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 076011</name>
      <address>
        <city>São José dos Campos</city>
        <zip>12243-280</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 076006</name>
      <address>
        <city>São paulo</city>
        <zip>01223-001</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 076005</name>
      <address>
        <city>São Paulo</city>
        <zip>04024-002</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 076010</name>
      <address>
        <city>Taguatinga</city>
        <zip>72155000</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 246008</name>
      <address>
        <city>Helsinki</city>
        <zip>00100</zip>
        <country>Finland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 246007</name>
      <address>
        <city>Muurame</city>
        <zip>40930</zip>
        <country>Finland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 246002</name>
      <address>
        <city>Oulu</city>
        <zip>90100</zip>
        <country>Finland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 246001</name>
      <address>
        <city>Oulu</city>
        <zip>90220</zip>
        <country>Finland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 246009</name>
      <address>
        <city>Pori</city>
        <zip>28100</zip>
        <country>Finland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 246004</name>
      <address>
        <city>Rauma</city>
        <zip>26100</zip>
        <country>Finland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 250008</name>
      <address>
        <city>Amiens Cedex 1</city>
        <zip>80054</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 250011</name>
      <address>
        <city>Bordeaux</city>
        <zip>33000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 250009</name>
      <address>
        <city>Caen</city>
        <zip>14000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 250001</name>
      <address>
        <city>Corbeil Essonnes</city>
        <zip>91100</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 250005</name>
      <address>
        <city>Eaubonne</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 250026</name>
      <address>
        <city>La Rochelle Cedex 1</city>
        <zip>17019</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 250020</name>
      <address>
        <city>Montpellier</city>
        <zip>34059</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 250015</name>
      <address>
        <city>Mulhouse</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 250003</name>
      <address>
        <city>Paris</city>
        <zip>75018</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 250010</name>
      <address>
        <city>Pierre-Bénite</city>
        <zip>69310</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 250014</name>
      <address>
        <city>Pierre-Bénite</city>
        <zip>69310</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 250025</name>
      <address>
        <city>POITIERS Cedex</city>
        <zip>86021</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 250002</name>
      <address>
        <city>Valenciennes</city>
        <zip>59322</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 250013</name>
      <address>
        <city>Vandoeuvre Les Nancy Cedex</city>
        <zip>54511</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 300002</name>
      <address>
        <city>Athens</city>
        <zip>18454</zip>
        <country>Greece</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 300003</name>
      <address>
        <city>Kalamata</city>
        <country>Greece</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 300001</name>
      <address>
        <city>Lamia</city>
        <zip>35100</zip>
        <country>Greece</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 300004</name>
      <address>
        <city>Thessaloniki</city>
        <zip>56429</zip>
        <country>Greece</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 372003</name>
      <address>
        <city>Dublin 4</city>
        <country>Ireland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 372002</name>
      <address>
        <city>Dublin 7</city>
        <country>Ireland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 380033</name>
      <address>
        <city>Arzignano (VI)</city>
        <zip>36071</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 380016</name>
      <address>
        <city>Catania</city>
        <zip>95122</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 380004</name>
      <address>
        <city>Catania</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 380006</name>
      <address>
        <city>Catanzaro</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 380031</name>
      <address>
        <city>Eboli</city>
        <zip>84025</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 380007</name>
      <address>
        <city>Forlì</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 380018</name>
      <address>
        <city>Genova</city>
        <zip>16132</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 380020</name>
      <address>
        <city>Iglesias (CI)</city>
        <zip>09016</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 380015</name>
      <address>
        <city>Milano</city>
        <zip>20132</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 380001</name>
      <address>
        <city>Milano</city>
        <zip>20162</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 380012</name>
      <address>
        <city>Milano</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 380011</name>
      <address>
        <city>Orbassano (TO)</city>
        <zip>10043</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 380026</name>
      <address>
        <city>Padova</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 380021</name>
      <address>
        <city>Palermo</city>
        <zip>90127</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 380014</name>
      <address>
        <city>Partinico</city>
        <zip>90047</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 380032</name>
      <address>
        <city>Roma</city>
        <zip>00133</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 380002</name>
      <address>
        <city>Roma</city>
        <zip>00161</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 380023</name>
      <address>
        <city>Roma</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 380036</name>
      <address>
        <city>San Benedetto del Tronto</city>
        <zip>63074</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 380024</name>
      <address>
        <city>Sarzana</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 380013</name>
      <address>
        <city>Savigliano (CN)</city>
        <zip>12038</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 380017</name>
      <address>
        <city>Sesto S. Giovanni</city>
        <zip>20099</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 380025</name>
      <address>
        <city>Torino</city>
        <zip>10128</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 642008</name>
      <address>
        <city>Arad</city>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 642005</name>
      <address>
        <city>Baia MAre</city>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 642002</name>
      <address>
        <city>Brasov</city>
        <zip>500326</zip>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 642006</name>
      <address>
        <city>Brasov</city>
        <zip>500326</zip>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 642003</name>
      <address>
        <city>Cluj-Napoca</city>
        <zip>400006</zip>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 642007</name>
      <address>
        <city>Cluj-Napoca</city>
        <zip>400006</zip>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 642004</name>
      <address>
        <city>Targu-Mures</city>
        <zip>540015</zip>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 642001</name>
      <address>
        <city>Timisoara</city>
        <zip>300125</zip>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 724002</name>
      <address>
        <city>Barcelona</city>
        <zip>08003</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 724019</name>
      <address>
        <city>Barcelona</city>
        <zip>08035</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 724012</name>
      <address>
        <city>Barcelona</city>
        <zip>08036</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 724011</name>
      <address>
        <city>Barcelona</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 724027</name>
      <address>
        <city>Castellón</city>
        <zip>12004</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 724028</name>
      <address>
        <city>Córdoba</city>
        <zip>14004</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 724008</name>
      <address>
        <city>Galdakao (Bilbao)</city>
        <zip>48960</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 724010</name>
      <address>
        <city>León</city>
        <zip>24071</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 724001</name>
      <address>
        <city>LLeida</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 724013</name>
      <address>
        <city>Madrid</city>
        <zip>28007</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 724018</name>
      <address>
        <city>Madrid</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 724020</name>
      <address>
        <city>Málaga</city>
        <zip>29010</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 724025</name>
      <address>
        <city>Móstoles</city>
        <zip>28933</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 724006</name>
      <address>
        <city>Palma de Mallorca</city>
        <zip>07010</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 724007</name>
      <address>
        <city>Palma de Mallorca</city>
        <zip>07010</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 724024</name>
      <address>
        <city>Pontevedra</city>
        <zip>36071</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 724017</name>
      <address>
        <city>Sabadell</city>
        <zip>08208</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 724022</name>
      <address>
        <city>San Cristóbal De La Laguna - Santa Cruz De Tenerife</city>
        <zip>38320</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 724003</name>
      <address>
        <city>San Juan de Alicante</city>
        <zip>3550</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 724030</name>
      <address>
        <city>Sant Joan Despí</city>
        <zip>08970</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 724023</name>
      <address>
        <city>Santa Cruz de Tenerife</city>
        <zip>38010</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 724014</name>
      <address>
        <city>Santiago de Compostela</city>
        <zip>15706</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 724005</name>
      <address>
        <city>Sevilla</city>
        <zip>41003</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 724016</name>
      <address>
        <city>Sevilla</city>
        <zip>41010</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 724004</name>
      <address>
        <city>Sevilla</city>
        <zip>41071</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 724021</name>
      <address>
        <city>Valencia</city>
        <zip>46010</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 724009</name>
      <address>
        <city>Valladolid</city>
        <zip>47011</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 724029</name>
      <address>
        <city>Vigo</city>
        <zip>36200</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 756003</name>
      <address>
        <city>Bern</city>
        <zip>3010</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 756002</name>
      <address>
        <city>St. Gallen</city>
        <zip>9007</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 826033</name>
      <address>
        <city>Atherstone</city>
        <zip>CV91EU</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 826016</name>
      <address>
        <city>Ayr</city>
        <zip>KA66DX</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 826039</name>
      <address>
        <city>Blackburn</city>
        <zip>BB21AX</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 826008</name>
      <address>
        <city>Bradford on Avon</city>
        <zip>BA151DQ</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 826004</name>
      <address>
        <city>Chertsey</city>
        <zip>KT160PZ</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 826038</name>
      <address>
        <city>Cornwall</city>
        <zip>PL143XA</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 826031</name>
      <address>
        <city>Coventry</city>
        <zip>CV22DX</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 826024</name>
      <address>
        <city>Darlington</city>
        <zip>DL36HX</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 826035</name>
      <address>
        <city>Dudley</city>
        <zip>DY1 2HQ</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 826017</name>
      <address>
        <city>Glasgow</city>
        <zip>G213UW</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 826025</name>
      <address>
        <city>Huntingdon</city>
        <zip>PE296JN</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 826002</name>
      <address>
        <city>Liverpool</city>
        <zip>L97AL</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 826018</name>
      <address>
        <city>Manchester</city>
        <zip>M239LT</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 826019</name>
      <address>
        <city>Manchester</city>
        <zip>M85RB</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 826037</name>
      <address>
        <city>Manchester</city>
        <zip>M86RB</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 826023</name>
      <address>
        <city>Norwich</city>
        <zip>nr34dg</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 826009</name>
      <address>
        <city>Nuneaton</city>
        <zip>CV107DJ</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 826021</name>
      <address>
        <city>Plymouth</city>
        <zip>PL53JB</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 826006</name>
      <address>
        <city>Portsmouth</city>
        <zip>PO63LY</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 826020</name>
      <address>
        <city>Southampton</city>
        <zip>SO303JB</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 826013</name>
      <address>
        <city>Taunton</city>
        <zip>TA15DA</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 826007</name>
      <address>
        <city>Welwyn Garden City</city>
        <zip>AL74HQ</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Brazil</country>
    <country>Finland</country>
    <country>France</country>
    <country>Greece</country>
    <country>Ireland</country>
    <country>Italy</country>
    <country>Romania</country>
    <country>Spain</country>
    <country>Switzerland</country>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>April 2022</verification_date>
  <study_first_submitted>November 16, 2016</study_first_submitted>
  <study_first_submitted_qc>November 16, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 18, 2016</study_first_posted>
  <last_update_submitted>April 21, 2022</last_update_submitted>
  <last_update_submitted_qc>April 21, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">April 25, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Diabetes Mellitus</mesh_term>
    <mesh_term>Diabetes Mellitus, Type 2</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Insulin</mesh_term>
    <mesh_term>Insulin, Globin Zinc</mesh_term>
    <mesh_term>Insulin Glargine</mesh_term>
    <mesh_term>Insulin Detemir</mesh_term>
    <mesh_term>Insulin, Isophane</mesh_term>
    <mesh_term>Isophane Insulin, Human</mesh_term>
    <mesh_term>Isophane insulin, beef</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org</ipd_description>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</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/NCT02967211
org study id: LPS14060
secondary id: 2015-001832-39
secondary id: U1111-1170-8132
nct id: NCT02967211
lead sponsor: 
has dmc: No
Primary Objective:

      To demonstrate noninferiority of Toujeo versus "standard of care" basal insulin therapy as
      measured by glycated hemoglobin (HbA1c) change

      Secondary Objectives:

        -  To demonstrate superiority of Toujeo versus "standard of care" basal insulin if
           non-inferiority criterion is met, measured by HbA1c change.

        -  To compare Toujeo to other "standard of care" basal insulin in terms of patient
           persistence with assigned basal insulin therapy with or without intensification.

        -  Risk of hypoglycemia including documented, symptomatic hypoglycemia (≤70 mg/dL) or
           severe (according to ADA Working Group).

        -  Change in fasting plasma glucose (FPG).

        -  Change in body weight.

        -  Differences in patient reported outcomes measured by Diabetes Treatment Satisfaction
           Questionnaire Status and Change versions (DTSQs and DTSQc).

        -  Change in hypoglycemic control subscale (HCS).

        -  Healthcare resource utilization including hospitalizations and emergency department or
           other health care provider visits and healthcare costs.
The total study duration will be up to 55 weeks, consisting of a 1 week screening period at
      the site, a 26 week treatment period, and a 26 week extension period.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Change in HbA1c (percentage %)
time frame: Baseline to 6 months
measure: Proportion of patients who remain on assigned basal insulin therapy before intensification (persistent with assigned therapy)
time frame: At Month 6 and Month 12
measure: Proportion of patients who remain on assigned basal insulin therapy whether intensification occurred or not
time frame: At Month 6 and Month 12
measure: Proportion of patients who achieve target HbA1c (<6.5%, <7%, <7.5%, <8.0%)
time frame: At Month 6 and Month 12
measure: Proportion of patients with HbA1c target (thresholds listed above) (attainment of metabolic benefit) without documented (blood glucose (BG) ≤70 mg/dl [3.9 mmol/L]) symptomatic or severe
time frame: At Month 6 and Month 12
measure: Proportion of patients with HbA1c target (thresholds listed above) (attainment of metabolic benefit) without documented (BG <54 mg/dL, [3.0 mmol/L]) symptomatic or severe hypoglycemia
time frame: At Month 6 and Month 12
measure: Change in HbA1c (percentage %)
time frame: Baseline, Month 12
measure: Percentage of patients whose HbA1c decreased at least 0.5%
time frame: At Month 6 and Month 12
measure: Percentage of patients whose HbA1c decreased at least 0.5%
time frame: At Month 6 and maintained at Month 12
measure: Percentage of patients requiring intensification
time frame: At Month 6 and Month 12
measure: Time to intensification
time frame: At Month 6 and Month 12
measure: Change in fasting plasma glucose
time frame: From baseline to Month 6 and Month 12
arm group label: Toujeo
arm group type: Experimental
description: Toujeo will be administered once daily in addition to non-insulin antidiabetic agents
arm group label: "Standard of care" commercially available basal insulin
arm group type: Active Comparator
description: Lantus, Humulin Neutral Protamine Hagedorn (NPH), Levemir, and Tresiba or other basal insulin, including biosimilar insulin will be administered once or twice daily according to label in addition to non-insulin antidiabetic agents
intervention type: Drug
intervention name: insulin glargine (U300)
description: Pharmaceutical form: solution
Route of administration: subcutaneous
arm group label: Toujeo
other name: HOE901; Toujeo
intervention type: Drug
intervention name: insulin glargine (U100)
description: Pharmaceutical form: solution
Route of administration: subcutaneous
arm group label: "Standard of care" commercially available basal insulin
other name: HOE901; Lantus
intervention type: Drug
intervention name: NPH insulin
description: Pharmaceutical form: solution
Route of administration: subcutaneous
arm group label: "Standard of care" commercially available basal insulin
other name: Humulin NPH
intervention type: Drug
intervention name: insulin detemir
description: Pharmaceutical form: solution
Route of administration: subcutaneous
arm group label: "Standard of care" commercially available basal insulin
other name: Levemir
intervention type: Drug
intervention name: insulin degludec
description: Pharmaceutical form: solution
Route of administration: subcutaneous
arm group label: "Standard of care" commercially available basal insulin
other name: Tresiba
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: Brazil
country: Finland
country: France
country: Greece
country: Ireland
country: Italy
country: Romania
country: Spain
country: Switzerland
country: United Kingdom
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
mesh term: Insulin Detemir
mesh term: Insulin, Isophane
mesh term: Isophane Insulin, Human
mesh term: Isophane insulin, beef
sharing ipd: Yes
ipd description: Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org