<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/NCT03760991</url>
  </required_header>
  <id_info>
    <org_study_id>LPS15396</org_study_id>
    <secondary_id>U1111-1203-8663</secondary_id>
    <nct_id>NCT03760991</nct_id>
  </id_info>
  <brief_title>Evaluation of the Efficacy and Safety of Insulin Glargine 300 U/mL in Patients With Type 2 Diabetes Mellitus Uncontrolled on Other Kinds of Insulin</brief_title>
  <acronym>ARTEMIS-DM</acronym>
  <official_title>A Multicenter, Multinational, Prospective, Interventional, Single-arm, Phase IV Study Evaluating the Clinical Efficacy and Safety of 26 Weeks of Treatment With Insulin Glargine 300 U/mL (Gla-300) in Patients With Type 2 Diabetes Mellitus Uncontrolled on 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>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Primary Objective:&#xD;
&#xD;
      To assess the efficacy of Gla-300 on glycemic control measured by hemoglobin A1c (HbA1c)&#xD;
      change in patients with type 2 diabetes mellitus (T2DM) uncontrolled with their current basal&#xD;
      insulin following the switch to Gla-300.&#xD;
&#xD;
      Secondary Objectives:&#xD;
&#xD;
      To evaluate the effects of Gla-300 on glycemic control, treatment satisfaction, and health&#xD;
      care resource utilization (HCRU) outcomes.&#xD;
&#xD;
      To evaluate the safety of Gla-300.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Study duration per participant is approximately 29 weeks including a screening period of up&#xD;
      to 2 weeks, a 26-week treatment period, and a post treatment follow-up phone call visit at&#xD;
      Week 27.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 18, 2018</start_date>
  <completion_date type="Actual">September 23, 2020</completion_date>
  <primary_completion_date type="Actual">September 23, 2020</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>Change in glycated hemoglobin (HbA1c)</measure>
    <time_frame>Baseline to Week 26</time_frame>
    <description>Absolute change in HbA1c</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in glycated hemoglobin (HbA1c)</measure>
    <time_frame>Baseline to Week 12</time_frame>
    <description>Absolute change in HbA1c</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Participants with HbA1c below 7%</measure>
    <time_frame>Week 12 and 26</time_frame>
    <description>Percentage of participants with HbA1c below 7%</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Participants with fasting self-monitored plasma glucose (SMPG) of 80 to 110 mg/dL (4.4 to 7.2 mmol/L)</measure>
    <time_frame>Week 12 and 26</time_frame>
    <description>Percentage of participants reaching targeted fasting SMPG of 80 to 110 mg/dL (4.4 to 7.2 mmol/L)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in fasting SMPG</measure>
    <time_frame>Baseline to Week 26</time_frame>
    <description>Absolute change in fasting SMPG</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in SMPG profile</measure>
    <time_frame>Baseline to Week 26</time_frame>
    <description>Absolute change in SMPG profile</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in fasting plasma glucose (FPG)</measure>
    <time_frame>Baseline to Week 26</time_frame>
    <description>Absolute change in FPG</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of participants requiring rescue therapy</measure>
    <time_frame>Baseline to Week 12 and 26</time_frame>
    <description>Percentage of participants requiring rescue therapy by additional antidiabetic medication</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of participants with hypoglycemia events</measure>
    <time_frame>Baseline to Week 26</time_frame>
    <description>Number of participants with at least 1 hypoglycemia event</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of participants with adverse events (AEs)</measure>
    <time_frame>Baseline to Week 27</time_frame>
    <description>Number of participants with AEs, serious adverse events (SAEs) (including hypoglycemic episodes associated with seizures, coma, or unconsciousness).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Treatment satisfaction</measure>
    <time_frame>Baseline to Week 26</time_frame>
    <description>Change in treatment satisfaction as measured by insulin treatment satisfaction questionnaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of participants with health care utilization</measure>
    <time_frame>Baseline to Week 26</time_frame>
    <description>Number of participants with health care utilization, including hospitalization, emergency room visits, and office [or specialty] visits</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">372</enrollment>
  <condition>Type 2 Diabetes Mellitus</condition>
  <arm_group>
    <arm_group_label>Insulin glargine (U300)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Insulin glargine (U300) (Gla-300) once daily for 26 weeks on top of any other antidiabetic treatment except other basal insulin</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>INSULIN GLARGINE (U300)</intervention_name>
    <description>Pharmaceutical form: Solution for injection in a prefilled pen&#xD;
Route of administration: Subcutaneous</description>
    <arm_group_label>Insulin glargine (U300)</arm_group_label>
    <other_name>HOE901, Toujeo, Gla-300</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion criteria :&#xD;
&#xD;
          -  Participants with type 2 diabetes mellitus.&#xD;
&#xD;
          -  Participants on &quot;standard of care&quot; basal insulin therapy administered once or twice&#xD;
             daily, as per labeling for at least 6 months prior to screening visit, with or without&#xD;
             other antidiabetics approved for using with insulin.&#xD;
&#xD;
          -  Glycated hemoglobin (HbA1c) between 7.5% (58 mmol/mol) and 10% (86 mmol/mol)&#xD;
             inclusive, during screening.&#xD;
&#xD;
          -  Fasting plasma glucose values above 130 mg/dL.&#xD;
&#xD;
        Exclusion criteria:&#xD;
&#xD;
          -  Unstable basal insulin regimen in the last 8 weeks prior to screening visit (ie, type&#xD;
             of insulin and time/frequency of the injection, insulin doses [variation more than&#xD;
             ±20%]).&#xD;
&#xD;
          -  Treatment with insulin other than basal insulin: mixed insulin (premixes), rapid&#xD;
             insulin, fast acting insulin analogues in the last 6 months before screening visit&#xD;
             (use ≤10 days in relation to hospitalization or an acute illness is accepted).&#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 Argentina</name>
      <address>
        <city>Buenos Aires</city>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>investigational site COLOMBIA</name>
      <address>
        <city>Colombia</city>
        <country>Colombia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>investigational site Egypt</name>
      <address>
        <city>Egypt</city>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>investigational site HONG KONG</name>
      <address>
        <city>Hong Kong</city>
        <country>Hong Kong</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>investigational site INDIA</name>
      <address>
        <city>India</city>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational site Indonesia</name>
      <address>
        <city>Indonesia</city>
        <country>Indonesia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>investigational site LEBANON</name>
      <address>
        <city>Lebanon</city>
        <country>Lebanon</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational site Malaysia</name>
      <address>
        <city>Putrajaya</city>
        <country>Malaysia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational site PERU</name>
      <address>
        <city>Peru</city>
        <country>Peru</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>investigational site PHILIPPINES</name>
      <address>
        <city>Philippines</city>
        <country>Philippines</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational site Saudi Arabia</name>
      <address>
        <city>Saudi Arabia</city>
        <country>Saudi Arabia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational site South Africa</name>
      <address>
        <city>South Africa</city>
        <country>South Africa</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational site Thailand</name>
      <address>
        <city>Thailand</city>
        <country>Thailand</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>investigational site TURKEY</name>
      <address>
        <city>Turkey</city>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Argentina</country>
    <country>Colombia</country>
    <country>Egypt</country>
    <country>Hong Kong</country>
    <country>India</country>
    <country>Indonesia</country>
    <country>Lebanon</country>
    <country>Malaysia</country>
    <country>Peru</country>
    <country>Philippines</country>
    <country>Saudi Arabia</country>
    <country>South Africa</country>
    <country>Thailand</country>
    <country>Turkey</country>
  </location_countries>
  <verification_date>April 2022</verification_date>
  <study_first_submitted>November 29, 2018</study_first_submitted>
  <study_first_submitted_qc>November 29, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 3, 2018</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/NCT03760991
org study id: LPS15396
secondary id: U1111-1203-8663
nct id: NCT03760991
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
is us export: No
Primary Objective:

      To assess the efficacy of Gla-300 on glycemic control measured by hemoglobin A1c (HbA1c)
      change in patients with type 2 diabetes mellitus (T2DM) uncontrolled with their current basal
      insulin following the switch to Gla-300.

      Secondary Objectives:

      To evaluate the effects of Gla-300 on glycemic control, treatment satisfaction, and health
      care resource utilization (HCRU) outcomes.

      To evaluate the safety of Gla-300.
Study duration per participant is approximately 29 weeks including a screening period of up
      to 2 weeks, a 26-week treatment period, and a post treatment follow-up phone call visit at
      Week 27.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Change in glycated hemoglobin (HbA1c)
time frame: Baseline to Week 26
description: Absolute change in HbA1c
measure: Change in glycated hemoglobin (HbA1c)
time frame: Baseline to Week 12
description: Absolute change in HbA1c
measure: Participants with HbA1c below 7%
time frame: Week 12 and 26
description: Percentage of participants with HbA1c below 7%
measure: Participants with fasting self-monitored plasma glucose (SMPG) of 80 to 110 mg/dL (4.4 to 7.2 mmol/L)
time frame: Week 12 and 26
description: Percentage of participants reaching targeted fasting SMPG of 80 to 110 mg/dL (4.4 to 7.2 mmol/L)
measure: Change in fasting SMPG
time frame: Baseline to Week 26
description: Absolute change in fasting SMPG
measure: Change in SMPG profile
time frame: Baseline to Week 26
description: Absolute change in SMPG profile
measure: Change in fasting plasma glucose (FPG)
time frame: Baseline to Week 26
description: Absolute change in FPG
measure: Percentage of participants requiring rescue therapy
time frame: Baseline to Week 12 and 26
description: Percentage of participants requiring rescue therapy by additional antidiabetic medication
measure: Number of participants with hypoglycemia events
time frame: Baseline to Week 26
description: Number of participants with at least 1 hypoglycemia event
measure: Number of participants with adverse events (AEs)
time frame: Baseline to Week 27
description: Number of participants with AEs, serious adverse events (SAEs) (including hypoglycemic episodes associated with seizures, coma, or unconsciousness).
measure: Change in Treatment satisfaction
time frame: Baseline to Week 26
description: Change in treatment satisfaction as measured by insulin treatment satisfaction questionnaire
measure: Number of participants with health care utilization
time frame: Baseline to Week 26
description: Number of participants with health care utilization, including hospitalization, emergency room visits, and office [or specialty] visits
arm group label: Insulin glargine (U300)
arm group type: Experimental
description: Insulin glargine (U300) (Gla-300) once daily for 26 weeks on top of any other antidiabetic treatment except other basal insulin
intervention type: Drug
intervention name: INSULIN GLARGINE (U300)
description: Pharmaceutical form: Solution for injection in a prefilled pen
Route of administration: Subcutaneous
arm group label: Insulin glargine (U300)
other name: HOE901, Toujeo, Gla-300
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: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Argentina
country: Colombia
country: Egypt
country: Hong Kong
country: India
country: Indonesia
country: Lebanon
country: Malaysia
country: Peru
country: Philippines
country: Saudi Arabia
country: South Africa
country: Thailand
country: Turkey
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