<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/NCT02967224</url>
  </required_header>
  <id_info>
    <org_study_id>LPS13931</org_study_id>
    <secondary_id>2015-001831-18</secondary_id>
    <secondary_id>U1111-1170-8104</secondary_id>
    <nct_id>NCT02967224</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 Insulins in Insulin Naïve Patients Initiating Insulin</brief_title>
  <acronym>Reach-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 Toujeo® Compared to &quot;Standard of Care&quot; Insulin for Initiating Basal Insulin in Insulin Naïve Patients With Uncontrolled Type 2 Diabetes Mellitus, With 6-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&#xD;
      measured as glycosylated hemoglobin (HbA1c) change&#xD;
&#xD;
      Secondary Objectives:&#xD;
&#xD;
        -  To demonstrate superiority of Toujeo versus &quot;standard of care&quot; basal insulin if&#xD;
           noninferiority is met, measured as 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 the incidence of documented symptomatic or severe&#xD;
           hypoglycemic events [as defined by the American Diabetes Association (ADA] Workgroup on&#xD;
           Hypoglycemia).&#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>November 5, 2015</start_date>
  <completion_date type="Actual">October 16, 2017</completion_date>
  <primary_completion_date type="Actual">October 16, 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 hypoglycemia</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 to Month 12</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of patients whose HbA1c decreased at least 1%</measure>
    <time_frame>At Month 6 and Month 12</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of patients whose HbA1c decreased at least 1%</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>Baseline to Month 6 and Month 12</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">705</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 noninsulin 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 or Tresiba or other basal insulin, including biosimilar insulin will be administered once or twice daily according to label in addition to noninsulin 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) standard of care with oral agents (metformin, sulfonylurea, thiazolidinediones,&#xD;
        DPP-4 inhibitor, SGLT-2 inhibitor, glinides, α glucosidase inhibitors) and with or without&#xD;
        GLP-1 receptor agonist, and eligible to basal insulin treatment, per investigator's&#xD;
        judgment.&#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 insulin since the time of diagnosis with T2DM other than&#xD;
             temporary use during a pregnancy or hospitalization.&#xD;
&#xD;
          -  Use of any product containing insulin occurring within 3 months prior to the time of&#xD;
             screening.&#xD;
&#xD;
          -  Use of oral hypoglycemic agents other than those noted in the inclusion criteria, GLP&#xD;
             1 receptor agonists not approved for use with insulin, or any investigational agent&#xD;
             (drug, biologic, device) within 3 months prior to the time of screening.&#xD;
&#xD;
          -  All contraindications to commercially available insulin therapy or&#xD;
             warnings/precautions of use as displayed in the respective National Product labeling&#xD;
             for these products.&#xD;
&#xD;
          -  Hypersensitivity to insulin glargine or Toujeo excipients.&#xD;
&#xD;
          -  Patient is the Investigator or any Sub-investigator, research assistant, pharmacist,&#xD;
             study coordinator, other staff or relative thereof directly involved in the conduct of&#xD;
             the protocol.&#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 076005</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 076008</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 076007</name>
      <address>
        <city>São paulo</city>
        <zip>01223-001</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 076003</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 250060</name>
      <address>
        <city>Alencon Cedex</city>
        <zip>61014</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 250023</name>
      <address>
        <city>Amiens Cedex 1</city>
        <zip>80054</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 250057</name>
      <address>
        <city>Bar le Duc</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 250050</name>
      <address>
        <city>BETHUNE Cedex</city>
        <zip>62408</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 250008</name>
      <address>
        <city>BOIS GUILLAUME Cedex</city>
        <zip>76233</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 250024</name>
      <address>
        <city>Bordeaux</city>
        <zip>33000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 250028</name>
      <address>
        <city>Brest</city>
        <zip>29000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 250014</name>
      <address>
        <city>Caen</city>
        <zip>14000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 250003</name>
      <address>
        <city>CAHORS Cedex 9</city>
        <zip>46005</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 250064</name>
      <address>
        <city>CHALONS EN CHAMPAGNE Cedex</city>
        <zip>51005</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 250026</name>
      <address>
        <city>Cholet</city>
        <zip>49300</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 250025</name>
      <address>
        <city>Corbeil Essonnes</city>
        <zip>91100</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 250011</name>
      <address>
        <city>Eaubonne</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 250013</name>
      <address>
        <city>La Roche Sur Yon</city>
        <zip>85025</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 250058</name>
      <address>
        <city>La Rochelle Cedex 1</city>
        <zip>17019</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 250027</name>
      <address>
        <city>La Seyne sur Mer</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 250034</name>
      <address>
        <city>Lamagistere</city>
        <zip>82360</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 250017</name>
      <address>
        <city>Le Puy En Velay Cedex</city>
        <zip>43012</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 250012</name>
      <address>
        <city>Marseille</city>
        <zip>13008</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 250054</name>
      <address>
        <city>Maubeuge</city>
        <zip>59600</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 250045</name>
      <address>
        <city>Montpellier</city>
        <zip>34059</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 250020</name>
      <address>
        <city>Montpellier</city>
        <zip>34295</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 250016</name>
      <address>
        <city>Montpellier</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 250035</name>
      <address>
        <city>Mulhouse</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 250004</name>
      <address>
        <city>NARBONNE Cedex</city>
        <zip>11018</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 250046</name>
      <address>
        <city>Nevers</city>
        <zip>58000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 250041</name>
      <address>
        <city>Nimes</city>
        <zip>30029</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 250044</name>
      <address>
        <city>Orleans</city>
        <zip>45100</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 250063</name>
      <address>
        <city>Paris</city>
        <zip>75012</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 250053</name>
      <address>
        <city>Paris</city>
        <zip>75014</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 250005</name>
      <address>
        <city>Paris</city>
        <zip>75018</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 250032</name>
      <address>
        <city>Paris</city>
        <zip>75020</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 250021</name>
      <address>
        <city>Pierre-Bénite</city>
        <zip>69310</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 250030</name>
      <address>
        <city>Pierre-Bénite</city>
        <zip>69310</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 250052</name>
      <address>
        <city>POITIERS Cedex</city>
        <zip>86021</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 250051</name>
      <address>
        <city>PRINGY Cedex</city>
        <zip>74374</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 250039</name>
      <address>
        <city>Reims Cedex</city>
        <zip>51092</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 250022</name>
      <address>
        <city>Roubaix</city>
        <zip>59100</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 250033</name>
      <address>
        <city>Saint-Mandé</city>
        <zip>94160</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 250055</name>
      <address>
        <city>Sete</city>
        <zip>34200</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 250031</name>
      <address>
        <city>Strasbourg Cedex 2</city>
        <zip>67098</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 250056</name>
      <address>
        <city>Strasbourg</city>
        <zip>67000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 250001</name>
      <address>
        <city>Strasbourg</city>
        <zip>67091</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 250043</name>
      <address>
        <city>Tarbes</city>
        <zip>65013</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 250002</name>
      <address>
        <city>Toulouse Cedex 3</city>
        <zip>31076</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 250029</name>
      <address>
        <city>Vandoeuvre Les Nancy Cedex</city>
        <zip>54511</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 250009</name>
      <address>
        <city>Venissieux</city>
        <zip>69200</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 250007</name>
      <address>
        <city>VICHY Cedex</city>
        <zip>03201</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 250006</name>
      <address>
        <city>Vichy</city>
        <zip>03200</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 250059</name>
      <address>
        <city>Villeneuve sur Lot</city>
        <zip>47300</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 276013</name>
      <address>
        <city>Bornheim</city>
        <zip>53332</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 276002</name>
      <address>
        <city>Dresden</city>
        <zip>01279</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 276001</name>
      <address>
        <city>Dresden</city>
        <zip>01307</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 276016</name>
      <address>
        <city>Hamburg</city>
        <zip>22607</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 276014</name>
      <address>
        <city>Hohenmölsen</city>
        <zip>06679</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 276017</name>
      <address>
        <city>Münster</city>
        <zip>48153</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 276012</name>
      <address>
        <city>Neumünster</city>
        <zip>24534</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 276009</name>
      <address>
        <city>Neuwied</city>
        <zip>56564</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 276008</name>
      <address>
        <city>Oldenburg</city>
        <zip>26133</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 276006</name>
      <address>
        <city>Pirna</city>
        <zip>01796</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 276010</name>
      <address>
        <city>Rehlingen-Siersburg</city>
        <zip>66780</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 276005</name>
      <address>
        <city>Riesa</city>
        <zip>01587</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 276011</name>
      <address>
        <city>Schweinfurt</city>
        <zip>97421</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 276007</name>
      <address>
        <city>Sulzbach-Rosenberg</city>
        <zip>92237</zip>
        <country>Germany</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 327002</name>
      <address>
        <city>Dublin 7</city>
        <country>Ireland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 642001</name>
      <address>
        <city>Bucuresti</city>
        <zip>010825</zip>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 642002</name>
      <address>
        <city>Bucuresti</city>
        <zip>022441</zip>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 642007</name>
      <address>
        <city>Bucuresti</city>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 642004</name>
      <address>
        <city>Cluj-Napoca</city>
        <zip>400006</zip>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 642005</name>
      <address>
        <city>Galati</city>
        <zip>800291</zip>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 642009</name>
      <address>
        <city>Iasi</city>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 642006</name>
      <address>
        <city>Oradea</city>
        <zip>410169</zip>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 642008</name>
      <address>
        <city>Targoviste</city>
        <zip>130083</zip>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 724013</name>
      <address>
        <city>Almansa</city>
        <zip>02640</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 724024</name>
      <address>
        <city>Badalona</city>
        <zip>08915</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 724016</name>
      <address>
        <city>Barakaldo</city>
        <zip>48903</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 724005</name>
      <address>
        <city>Barcelona</city>
        <zip>08025</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 724017</name>
      <address>
        <city>Barcelona</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 724008</name>
      <address>
        <city>Burgos</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 724018</name>
      <address>
        <city>Donostia</city>
        <zip>20014</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 724026</name>
      <address>
        <city>Ferrol</city>
        <zip>15405</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 724021</name>
      <address>
        <city>Gerona</city>
        <zip>17007</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 724027</name>
      <address>
        <city>Huelva</city>
        <zip>21005</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 724014</name>
      <address>
        <city>La Coruña</city>
        <zip>15006</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 724025</name>
      <address>
        <city>Madrid</city>
        <zip>28040</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 724028</name>
      <address>
        <city>Madrid</city>
        <zip>28041</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 724006</name>
      <address>
        <city>Majadahonda</city>
        <zip>28222</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 724030</name>
      <address>
        <city>Málaga</city>
        <zip>29004</zip>
        <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 724012</name>
      <address>
        <city>Sabadell</city>
        <zip>08208</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 724009</name>
      <address>
        <city>Santiago de Compostela</city>
        <zip>15706</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 724010</name>
      <address>
        <city>Sevilla</city>
        <zip>41010</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 724011</name>
      <address>
        <city>Sevilla</city>
        <zip>41013</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 724002</name>
      <address>
        <city>Valencia</city>
        <zip>46009</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 724022</name>
      <address>
        <city>Valencia</city>
        <zip>46014</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 724007</name>
      <address>
        <city>Vitoria</city>
        <zip>1009</zip>
        <country>Spain</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 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 826011</name>
      <address>
        <city>Chesterfield</city>
        <zip>S404TF</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 826028</name>
      <address>
        <city>Chippenham</city>
        <zip>SN152SB</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 826027</name>
      <address>
        <city>Cornwall</city>
        <zip>PL231DT</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 826003</name>
      <address>
        <city>Craigavon</city>
        <zip>BT635QQ</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 826015</name>
      <address>
        <city>Larbert</city>
        <zip>FK54WR</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 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_countries>
    <country>Brazil</country>
    <country>France</country>
    <country>Germany</country>
    <country>Ireland</country>
    <country>Romania</country>
    <country>Spain</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/NCT02967224
org study id: LPS13931
secondary id: 2015-001831-18
secondary id: U1111-1170-8104
nct id: NCT02967224
lead sponsor: 
has dmc: No
Primary Objective:

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

      Secondary Objectives:

        -  To demonstrate superiority of Toujeo versus "standard of care" basal insulin if
           noninferiority is met, measured as 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 the incidence of documented symptomatic or severe
           hypoglycemic events [as defined by the American Diabetes Association (ADA] Workgroup on
           Hypoglycemia).

        -  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 hypoglycemia
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 to Month 12
measure: Percentage of patients whose HbA1c decreased at least 1%
time frame: At Month 6 and Month 12
measure: Percentage of patients whose HbA1c decreased at least 1%
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: 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 noninsulin 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 or Tresiba or other basal insulin, including biosimilar insulin will be administered once or twice daily according to label in addition to noninsulin 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: France
country: Germany
country: Ireland
country: Romania
country: Spain
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