<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/NCT02967237</url>
  </required_header>
  <id_info>
    <org_study_id>GLARGL07667</org_study_id>
    <secondary_id>2015-002416-33</secondary_id>
    <secondary_id>U1111-1176-6203</secondary_id>
    <nct_id>NCT02967237</nct_id>
  </id_info>
  <brief_title>Evaluation of Toujeo Insulin in Type 2 Diabetes Patients Inadequately Control With Their Basal Insulin Treatment</brief_title>
  <acronym>Transition II</acronym>
  <official_title>An Interventional, Open-label, Single-arm, Multicenter, 24 Weeks Phase 4 Study Assessing the Efficacy and Safety of Toujeo in Patients With Type 2 Diabetes Inadequately Controlled With Basal Insulin</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;
      The primary objective is to describe the effect of insulin glargine (U300) in type 2 diabetes&#xD;
      mellitus (T2DM) patients uncontrolled with their current basal insulin therapy and eligible&#xD;
      for basal switching, according to the Physician decision, on glycated hemoglobin (HbA1c)&#xD;
      improvement.&#xD;
&#xD;
      Secondary Objectives:&#xD;
&#xD;
        -  Evolution of fasting plasma glucose&#xD;
&#xD;
        -  Evolution of insulin dose and body weight&#xD;
&#xD;
        -  Hypoglycemia incidence&#xD;
&#xD;
        -  Safety&#xD;
&#xD;
        -  Patients satisfaction when they change their insulin for HOE901-U300&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The total study duration per patient is approximately 28 weeks.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>January 4, 2016</start_date>
  <completion_date type="Actual">July 24, 2017</completion_date>
  <primary_completion_date type="Actual">July 24, 2017</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Mean change from baseline in HbA1c</measure>
    <time_frame>Baseline, Week 24</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Percentage of patients who reach target fasting plasma glucose (90-130 mg/dL)</measure>
    <time_frame>At Weeks 12 and 24</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of patients with HbA1c &lt;7%, &lt;7.5%, and &lt;8%</measure>
    <time_frame>At Week 24</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean change from baseline in HbA1c across HbA1c subgroups category (≤8%, &gt;8 to 9%, and &gt;9%)</measure>
    <time_frame>Baseline to Week 12 and Week 24</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean change from baseline in fasting plasma glucose</measure>
    <time_frame>Baseline to Week 12 and Week 24</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assessment of patient reported outcomes (satisfaction on treatment and perception of hypoglycemia/hyperglycemia) based on the Diabetes Treatment Satisfaction Questionnaire (DTSQ)</measure>
    <time_frame>Baseline to Week 24</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Diabetes Treatment Satisfaction Questionnaire score</measure>
    <time_frame>Week 24</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of hypoglycemic events</measure>
    <time_frame>From inclusion up to Week 24</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of adverse events</measure>
    <time_frame>From inclusion up to Week 24</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">136</enrollment>
  <condition>Diabetes Mellitus, Type 2</condition>
  <arm_group>
    <arm_group_label>Insulin glargine (U300)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Type 2 diabetes mellitus patients uncontrolled with their current basal insulin therapy switched according to the physician decision, to insulin glargine (U300) administered subcutaneously and once daily using a pre-filled pen</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>insulin glargine (U300)</intervention_name>
    <description>Pharmaceutical form: solution Route of administration: subcutaneous</description>
    <arm_group_label>Insulin glargine (U300)</arm_group_label>
    <other_name>HOE901; Toujeo</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion criteria :&#xD;
&#xD;
          -  Type 2 diabetic adult patients treated with basal insulin, with or without oral&#xD;
             anti-diabetic agents, with or without glucagon-like peptide-1 (GLP-1) receptor agonist&#xD;
&#xD;
          -  HbA1c &gt; 7.5%&#xD;
&#xD;
        Exclusion criteria:&#xD;
&#xD;
          -  Patients with high dose of insulin (&gt;1.2 U/kg)&#xD;
&#xD;
          -  Use of prandial insulin&#xD;
&#xD;
          -  Change of dose of antidiabetic drugs within the last 8 weeks&#xD;
&#xD;
          -  Use of systemic glucocorticoids during at least 2 weeks in the last 12 weeks&#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 250017</name>
      <address>
        <city>Alencon Cedex</city>
        <zip>61014</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 250073</name>
      <address>
        <city>Ales</city>
        <zip>30100</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 250047</name>
      <address>
        <city>Amiens Cedex 1</city>
        <zip>80054</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 250028</name>
      <address>
        <city>Amilly</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 250062</name>
      <address>
        <city>Bagnols-sur-Cèze</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 250093</name>
      <address>
        <city>Bar le Duc</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 250020</name>
      <address>
        <city>Besancon</city>
        <zip>25030</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 250081</name>
      <address>
        <city>BETHUNE Cedex</city>
        <zip>62408</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 250034</name>
      <address>
        <city>Bondy</city>
        <zip>93143</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 250070</name>
      <address>
        <city>Brest Cedex</city>
        <zip>29610</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 250022</name>
      <address>
        <city>Brest</city>
        <zip>29000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 250060</name>
      <address>
        <city>CAHORS Cedex 9</city>
        <zip>46005</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 250096</name>
      <address>
        <city>Cannes</city>
        <zip>06401</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 250037</name>
      <address>
        <city>CHALONS EN CHAMPAGNE Cedex</city>
        <zip>51005</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 250072</name>
      <address>
        <city>Chambery</city>
        <zip>73000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 250018</name>
      <address>
        <city>Cholet</city>
        <zip>49300</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 250068</name>
      <address>
        <city>Clermont Ferrand</city>
        <zip>63000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 250098</name>
      <address>
        <city>Cognac</city>
        <zip>16112</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 250048</name>
      <address>
        <city>Colmar</city>
        <zip>68024</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 250088</name>
      <address>
        <city>Contamines Sur Arve</city>
        <zip>74130</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 250054</name>
      <address>
        <city>Coudray</city>
        <zip>28630</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 250063</name>
      <address>
        <city>Dijon</city>
        <zip>21000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 250013</name>
      <address>
        <city>Eaubonne</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 250095</name>
      <address>
        <city>Etampes</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 250104</name>
      <address>
        <city>Grenoble</city>
        <zip>38043</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 250004</name>
      <address>
        <city>La Roche Sur Yon</city>
        <zip>85025</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 250002</name>
      <address>
        <city>La Rochelle Cedex 1</city>
        <zip>17019</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 250019</name>
      <address>
        <city>La Seyne sur Mer</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 250030</name>
      <address>
        <city>Lamagistere</city>
        <zip>82360</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 250103</name>
      <address>
        <city>LE CHESNAY Cedex</city>
        <zip>78157</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 250053</name>
      <address>
        <city>Le Creusot</city>
        <zip>71200</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 250044</name>
      <address>
        <city>Le Mans Cedex 9</city>
        <zip>72037</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 250056</name>
      <address>
        <city>Lens</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 250051</name>
      <address>
        <city>Lourdes</city>
        <zip>65000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 250071</name>
      <address>
        <city>Mantes La Jolie</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 250092</name>
      <address>
        <city>Marseille</city>
        <zip>13006</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 250064</name>
      <address>
        <city>Marseille</city>
        <zip>13008</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 250089</name>
      <address>
        <city>Maubeuge</city>
        <zip>59600</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 250083</name>
      <address>
        <city>Merignac</city>
        <zip>33700</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 250035</name>
      <address>
        <city>Montpellier</city>
        <zip>34000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 250061</name>
      <address>
        <city>Montpellier</city>
        <zip>34059</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 250010</name>
      <address>
        <city>Montpellier</city>
        <zip>34295</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 250008</name>
      <address>
        <city>Montpellier</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 250032</name>
      <address>
        <city>Mulhouse</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 250043</name>
      <address>
        <city>Nancy</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 250005</name>
      <address>
        <city>NARBONNE Cedex</city>
        <zip>11018</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 250069</name>
      <address>
        <city>Nevers</city>
        <zip>58000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 250052</name>
      <address>
        <city>Nimes</city>
        <zip>30029</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 250059</name>
      <address>
        <city>Noisy Le Grand</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 250058</name>
      <address>
        <city>Orleans</city>
        <zip>45100</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 250031</name>
      <address>
        <city>Paris</city>
        <zip>75008</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 250105</name>
      <address>
        <city>Paris</city>
        <zip>75012</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 250086</name>
      <address>
        <city>Paris</city>
        <zip>75014</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 250026</name>
      <address>
        <city>Paris</city>
        <zip>75020</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 250084</name>
      <address>
        <city>PERIGUEUX Cedex</city>
        <zip>24019</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 250101</name>
      <address>
        <city>Pessac Cedex</city>
        <zip>33604</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 250107</name>
      <address>
        <city>Pointe À Pitre</city>
        <zip>97159</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 250067</name>
      <address>
        <city>Pontoise</city>
        <zip>95300</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 250078</name>
      <address>
        <city>PRINGY Cedex</city>
        <zip>74374</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 250042</name>
      <address>
        <city>Reims Cedex</city>
        <zip>51092</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 250012</name>
      <address>
        <city>Roubaix</city>
        <zip>59100</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 250055</name>
      <address>
        <city>Roubaix</city>
        <zip>59100</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 250102</name>
      <address>
        <city>Saint Brieuc</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 250108</name>
      <address>
        <city>Saint Pierre</city>
        <zip>97448</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 250065</name>
      <address>
        <city>Saint-Denis</city>
        <zip>93200</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 250029</name>
      <address>
        <city>Saint-Mandé</city>
        <zip>94160</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 250087</name>
      <address>
        <city>Seclin</city>
        <zip>59113</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 250090</name>
      <address>
        <city>Sete</city>
        <zip>34200</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 250024</name>
      <address>
        <city>Strasbourg Cedex 2</city>
        <zip>67098</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 250006</name>
      <address>
        <city>Strasbourg</city>
        <zip>67000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 250033</name>
      <address>
        <city>Suresnes</city>
        <zip>92150</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 250057</name>
      <address>
        <city>Tarbes</city>
        <zip>65013</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 250082</name>
      <address>
        <city>Toulouse Cedex 3</city>
        <zip>31076</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 250001</name>
      <address>
        <city>Toulouse</city>
        <zip>31000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 250076</name>
      <address>
        <city>Toulouse</city>
        <zip>31027</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 250050</name>
      <address>
        <city>Toulouse</city>
        <zip>31100</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 250027</name>
      <address>
        <city>Tours</city>
        <zip>37000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 250075</name>
      <address>
        <city>Tours</city>
        <zip>37000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 250041</name>
      <address>
        <city>Valenciennes</city>
        <zip>59322</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 250021</name>
      <address>
        <city>Vandoeuvre Les Nancy Cedex</city>
        <zip>54511</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 250023</name>
      <address>
        <city>Venissieux</city>
        <zip>69200</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 250046</name>
      <address>
        <city>VICHY Cedex</city>
        <zip>03201</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 250039</name>
      <address>
        <city>Vichy</city>
        <zip>03200</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 250100</name>
      <address>
        <city>Villeneuve sur Lot</city>
        <zip>47300</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 250007</name>
      <address>
        <city>Warloy Baillon</city>
        <zip>80300</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</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 Glargine</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/NCT02967237
org study id: GLARGL07667
secondary id: 2015-002416-33
secondary id: U1111-1176-6203
nct id: NCT02967237
lead sponsor: 
has dmc: No
Primary Objective:

      The primary objective is to describe the effect of insulin glargine (U300) in type 2 diabetes
      mellitus (T2DM) patients uncontrolled with their current basal insulin therapy and eligible
      for basal switching, according to the Physician decision, on glycated hemoglobin (HbA1c)
      improvement.

      Secondary Objectives:

        -  Evolution of fasting plasma glucose

        -  Evolution of insulin dose and body weight

        -  Hypoglycemia incidence

        -  Safety

        -  Patients satisfaction when they change their insulin for HOE901-U300
The total study duration per patient is approximately 28 weeks.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Mean change from baseline in HbA1c
time frame: Baseline, Week 24
measure: Percentage of patients who reach target fasting plasma glucose (90-130 mg/dL)
time frame: At Weeks 12 and 24
measure: Percentage of patients with HbA1c <7%, <7.5%, and <8%
time frame: At Week 24
measure: Mean change from baseline in HbA1c across HbA1c subgroups category (≤8%, >8 to 9%, and >9%)
time frame: Baseline to Week 12 and Week 24
measure: Mean change from baseline in fasting plasma glucose
time frame: Baseline to Week 12 and Week 24
measure: Assessment of patient reported outcomes (satisfaction on treatment and perception of hypoglycemia/hyperglycemia) based on the Diabetes Treatment Satisfaction Questionnaire (DTSQ)
time frame: Baseline to Week 24
measure: Change in Diabetes Treatment Satisfaction Questionnaire score
time frame: Week 24
measure: Number of hypoglycemic events
time frame: From inclusion up to Week 24
measure: Number of adverse events
time frame: From inclusion up to Week 24
arm group label: Insulin glargine (U300)
arm group type: Experimental
description: Type 2 diabetes mellitus patients uncontrolled with their current basal insulin therapy switched according to the physician decision, to insulin glargine (U300) administered subcutaneously and once daily using a pre-filled pen
intervention type: Drug
intervention name: insulin glargine (U300)
description: Pharmaceutical form: solution Route of administration: subcutaneous
arm group label: Insulin glargine (U300)
other name: HOE901; Toujeo
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: France
responsible party type: Sponsor
mesh term: Diabetes Mellitus
mesh term: Diabetes Mellitus, Type 2
mesh term: Insulin Glargine
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