<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/NCT02227212</url>
  </required_header>
  <id_info>
    <org_study_id>PDY14065</org_study_id>
    <secondary_id>2014-001253-16</secondary_id>
    <secondary_id>U1111-1155-7309</secondary_id>
    <nct_id>NCT02227212</nct_id>
  </id_info>
  <brief_title>Ease of Use and Safety of the New U300 Pen Injector in Insulin-Naïve Patients With T2DM</brief_title>
  <official_title>A Multi-Center,Open-Label, Single-Arm, Multiple Dose Study With HOE901-U300 to Assess The Ease of Use And Safety of a New U300 Pen Injector in Insulin-Naïve Patients With T2DM</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 the ease of use of the U300 pen injector in pen-naïve and insulin-naïve type 2&#xD;
      diabetes mellitus (T2DM) patients in a 4-week once-daily dosing regimen with HOE901-U300.&#xD;
&#xD;
      Secondary Objectives:&#xD;
&#xD;
      To assess in a 4-week once-daily dosing regimen with HOE901-U300 in pen-naïve and&#xD;
      insulin-naïve T2DM patients.&#xD;
&#xD;
      The safety and usability of the U300 pen injector. The glycemic control with the U300 pen&#xD;
      injector. The safety of HOE901-U300.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The total study duration for a participants can be approximately up to 10 weeks.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>August 2014</start_date>
  <completion_date type="Actual">November 2014</completion_date>
  <primary_completion_date type="Actual">November 2014</primary_completion_date>
  <phase>Phase 3</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>Ease-of-use / ease of learning questionnaire</measure>
    <time_frame>Day 1, Day 7 , 4-weeks</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in treatment satisfaction score (sum of items 1, 4, 5, 6, 7, and 8 from Diabetes Treatment Satisfaction Questionnaire [status]) from baseline to Week 4</measure>
    <time_frame>Baseline, week 4</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in perception of hyper- and hypoglycemia score (items 2 and 3 from Diabetes Treatment Satisfaction Questionnaire [status]) from baseline to Week 4</measure>
    <time_frame>Baseline, week 4</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in fasting plasma glucose (FPG) (mmol/L) from baseline to Week 4</measure>
    <time_frame>Baseline, week 4</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of participants with Product Technical Complaints (PTC)</measure>
    <time_frame>Baseline to week 4</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of participants with adverse events and hypoglycemic events related to PTC</measure>
    <time_frame>Baseline to week 4</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in daily insulin dose (U and U/kg) from Day 1 to Week 4 (patient diary)</measure>
    <time_frame>Baseline, week 4</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of participants with adverse events</measure>
    <time_frame>screening to week 6</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence and frequency of hypoglycemia episodes. Hypoglycemia will be analyzed by hypoglycemia categories as defined by American Diabetes Association</measure>
    <time_frame>screening to week 6</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Potentially clinically significant changes in laboratory evaluations, vital signs, electrocardiogram (ECG)</measure>
    <time_frame>screening, baseline, week 4</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of participants with site injection site reactions / hypersensitivity reactions</measure>
    <time_frame>baseline to week 6</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">40</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>Once daily subcutaneous injection for 4 weeks</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Insulin glargine U300 (new formulation of insulin glargine) HOE901</intervention_name>
    <description>Pharmaceutical form:solution for injection Route of administration: subcutaneous</description>
    <arm_group_label>Insulin glargine U300</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion criteria:&#xD;
&#xD;
          -  Patients with T2DM inadequately controlled with non-insulin, non-injectable&#xD;
             anti-hyperglycemic drug(s) and for whom the Investigator/treating physicians has&#xD;
             decided that basal insulin is appropriate.&#xD;
&#xD;
          -  Signed written informed consent.&#xD;
&#xD;
        Exclusion criteria:&#xD;
&#xD;
          -  Glycated hemoglobin A1c (HbA1c) &lt;7.0% (&lt;53 mmol/mol) or &gt;11% (97 mmol/mol) at&#xD;
             screening.&#xD;
&#xD;
          -  Age &lt;18 years at the time of screening.&#xD;
&#xD;
          -  Body Mass Index (BMI) &gt;40 kg/m2.&#xD;
&#xD;
          -  Diabetes other than T2DM.&#xD;
&#xD;
          -  History of T2DM for less than 1 year before screening.&#xD;
&#xD;
          -  Less than 6 months anti-hyperglycemic treatment before screening.&#xD;
&#xD;
          -  Initiation of new glucose-lowering medications and/or weight loss drug in the last 3&#xD;
             months before screening visit.&#xD;
&#xD;
          -  Previous treatment with Glucagon Like Peptide-1 (GLP-1) agonist.&#xD;
&#xD;
          -  Patients receiving only non-insulin anti-hyperglycemic drugs not approved for&#xD;
             combination with insulin according to local labeling/local treatment guidelines and/or&#xD;
             sulfonylurea or glinides.&#xD;
&#xD;
          -  Current or previous insulin use except for a maximum of 8 consecutive days and a total&#xD;
             of 14 days (eg, acute illness, surgery) during the last year prior to screening.&#xD;
&#xD;
          -  Any contraindication to insulin glargine (Lantus) according to the National Product&#xD;
             labeling or any excipients.&#xD;
&#xD;
          -  Any contraindication to the mandatory background non-insulin anti-hyperglycemic&#xD;
             medication according to the respective National Product labeling.&#xD;
&#xD;
          -  Latest eye examination by an ophthalmologist &gt;12 months prior to inclusion.&#xD;
&#xD;
          -  More than one episode of severe hypoglycemia with seizure, coma or requiring&#xD;
             assistance of another person during the past 6 months.&#xD;
&#xD;
          -  Unstable proliferative diabetic retinopathy or any other rapidly progressive diabetic&#xD;
             retinopathy or macular edema likely to require treatment (eg, laser, surgical&#xD;
             treatment or injectable drugs) during the study period.&#xD;
&#xD;
        The above information is not intended to contain all considerations relevant to a 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 276011</name>
      <address>
        <city>Augsburg</city>
        <zip>86150</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 276008</name>
      <address>
        <city>Berlin</city>
        <zip>10115</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 276009</name>
      <address>
        <city>Essen</city>
        <zip>45355</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 276002</name>
      <address>
        <city>Hamburg</city>
        <zip>22607</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 276001</name>
      <address>
        <city>Münster</city>
        <zip>48145</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 276007</name>
      <address>
        <city>Potsdam</city>
        <zip>14469</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 276004</name>
      <address>
        <city>Wangen</city>
        <zip>88239</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>December 2014</verification_date>
  <study_first_submitted>August 26, 2014</study_first_submitted>
  <study_first_submitted_qc>August 26, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 28, 2014</study_first_posted>
  <last_update_submitted>December 2, 2014</last_update_submitted>
  <last_update_submitted_qc>December 2, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 3, 2014</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, 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 Glargine</mesh_term>
  </intervention_browse>
  <!-- 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/NCT02227212
org study id: PDY14065
secondary id: 2014-001253-16
secondary id: U1111-1155-7309
nct id: NCT02227212
lead sponsor: 
has dmc: No
Primary Objective:

      To demonstrate the ease of use of the U300 pen injector in pen-naïve and insulin-naïve type 2
      diabetes mellitus (T2DM) patients in a 4-week once-daily dosing regimen with HOE901-U300.

      Secondary Objectives:

      To assess in a 4-week once-daily dosing regimen with HOE901-U300 in pen-naïve and
      insulin-naïve T2DM patients.

      The safety and usability of the U300 pen injector. The glycemic control with the U300 pen
      injector. The safety of HOE901-U300.
The total study duration for a participants can be approximately up to 10 weeks.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Ease-of-use / ease of learning questionnaire
time frame: Day 1, Day 7 , 4-weeks
measure: Change in treatment satisfaction score (sum of items 1, 4, 5, 6, 7, and 8 from Diabetes Treatment Satisfaction Questionnaire [status]) from baseline to Week 4
time frame: Baseline, week 4
measure: Change in perception of hyper- and hypoglycemia score (items 2 and 3 from Diabetes Treatment Satisfaction Questionnaire [status]) from baseline to Week 4
time frame: Baseline, week 4
measure: Change in fasting plasma glucose (FPG) (mmol/L) from baseline to Week 4
time frame: Baseline, week 4
measure: Number of participants with Product Technical Complaints (PTC)
time frame: Baseline to week 4
measure: Number of participants with adverse events and hypoglycemic events related to PTC
time frame: Baseline to week 4
measure: Change in daily insulin dose (U and U/kg) from Day 1 to Week 4 (patient diary)
time frame: Baseline, week 4
measure: Number of participants with adverse events
time frame: screening to week 6
measure: Incidence and frequency of hypoglycemia episodes. Hypoglycemia will be analyzed by hypoglycemia categories as defined by American Diabetes Association
time frame: screening to week 6
measure: Potentially clinically significant changes in laboratory evaluations, vital signs, electrocardiogram (ECG)
time frame: screening, baseline, week 4
measure: Number of participants with site injection site reactions / hypersensitivity reactions
time frame: baseline to week 6
arm group label: Insulin glargine U300
arm group type: Experimental
description: Once daily subcutaneous injection for 4 weeks
intervention type: Drug
intervention name: Insulin glargine U300 (new formulation of insulin glargine) HOE901
description: Pharmaceutical form:solution for injection Route of administration: subcutaneous
arm group label: Insulin glargine U300
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Clinical Sciences & Operations
role: Study Director
affiliation: Sanofi
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Germany
responsible party type: Sponsor
mesh term: Diabetes Mellitus, Type 2
mesh term: Insulin
mesh term: Insulin Glargine