<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/NCT03767543</url>
  </required_header>
  <id_info>
    <org_study_id>LPS15544</org_study_id>
    <secondary_id>U1111-1215-0238</secondary_id>
    <nct_id>NCT03767543</nct_id>
  </id_info>
  <brief_title>Study Comparing the Efficacy and Safety of Insulin Glargine (Basal Insulin)/Lixisenatide (GLP-1 Receptor Agonist) Combination (Soliqua™) in Patients With Type 2 Diabetes Mellitus (T2DM)</brief_title>
  <acronym>LixilanOne CAN</acronym>
  <official_title>A Randomized, 26-week, Open-label, 2-treatment Arm, Parallel Group Multicenter Study Comparing the Efficacy and Safety of Insulin Glargine/Lixisenatide Fixed-ratio Combination (Soliqua™) Titrated Using a Simple Titration Algorithm (One Unit Daily Adjustment) Compared With Insulin Glargine/Lixisenatide Fixed-ratio Combination (Soliqua™) Titrated by Weekly Adjustment in Patients With Type 2 Diabetes Mellitus (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>
    <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 demonstrate that the simple daily titration algorithm is non-inferior to the weekly&#xD;
      titration algorithm according to Canadian labeling.&#xD;
&#xD;
      Secondary Objective:&#xD;
&#xD;
      To gain additional information on the efficacy and safety of using a simple patient-titration&#xD;
      protocol for administration of insulin glargine/lixisenatide fixed-ratio combination&#xD;
      (iGlarLixi).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The maximum duration of study per patient is approximately 29 weeks including a 2-week&#xD;
      screening, a 26-week randomized active-controlled treatment period, and 3-day post-treatment&#xD;
      safety follow-up period.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 11, 2019</start_date>
  <completion_date type="Actual">October 23, 2020</completion_date>
  <primary_completion_date type="Actual">October 23, 2020</primary_completion_date>
  <phase>Phase 3</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 glycated hemoglobin (HbA1c)%</measure>
    <time_frame>Baseline to Week 26</time_frame>
    <description>Absolute mean change in HbA1c from baseline to Week 26; HbA1c is expressed in % (unit)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Percentage of patients achieving HbA1c ≤7% at Week 26</measure>
    <time_frame>At Week 26</time_frame>
    <description>Percentage of patients achieving A1c ≤7%</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in fasting plasma glucose (FPG) from baseline to Week 12</measure>
    <time_frame>Baseline to Week 12</time_frame>
    <description>Change in FPG from baseline to Week 12</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in FPG from baseline to Week 26</measure>
    <time_frame>Baseline to Week 26</time_frame>
    <description>Change in FPG from baseline to Week 26</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in fasting self-monitoring plasma glucose (SMPG) from baseline to Week 12</measure>
    <time_frame>Baseline to Week 12</time_frame>
    <description>Change in fasting SMPG from baseline to Week 12</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in fasting SMPG from baseline to Week 26</measure>
    <time_frame>Baseline to Week 26</time_frame>
    <description>Change in fasting SMPG from baseline to Week 26</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in 7-point SMPG profile from baseline to Week 12</measure>
    <time_frame>Baseline to Week 12</time_frame>
    <description>Change in 7-point SMPG profile from baseline to Week 12</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in 7-point SMPG profile from baseline to Week 26</measure>
    <time_frame>Baseline to Week 26</time_frame>
    <description>Change in 7-point SMPG profile from baseline to Week 26</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in body weight from baseline to Week 26</measure>
    <time_frame>Baseline to Week 26</time_frame>
    <description>Change in body weight (kg)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of patients achieving A1c ≤7% with no body weight gain and/or hypoglycemia (severe or documented symptomatic (≤3.9 mmol/L) at Week 26</measure>
    <time_frame>Baseline to Week 26</time_frame>
    <description>Composite endpoint expressed as percentage of patients A1c ≤7% with no body weight gain and/or hypoglycemia (severe or documented symptomatic (≤3.9 mmol/L)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Insulin glargine dose</measure>
    <time_frame>At Week 26</time_frame>
    <description>Insulin glargine dose (expressed in units)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of patients requiring rescue therapy</measure>
    <time_frame>Baseline to Week 26</time_frame>
    <description>Percentage of patients requiring rescue therapy during the 26-week open-label treatment period</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of patients experiencing at least 1 hypoglycemia episode (≤3.9 mmol/L) over 26 weeks</measure>
    <time_frame>Baseline to Week 26</time_frame>
    <description>Percentage of patients experiencing at least 1 hypoglycemia episode defined as ≤3.9 mmol/L</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of patients experiencing at least 1 hypoglycemia episode (&lt;3.0 mmol/L) over 26 weeks</measure>
    <time_frame>Baseline to Week 26</time_frame>
    <description>Percentage of patients experiencing at least 1 hypoglycemia episode defined as &lt;3.0 mmol/L</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Annualized rate of hypoglycemia (≤3.9 mmol/L) over 26 weeks</measure>
    <time_frame>Baseline to Week 26</time_frame>
    <description>Mean number of hypoglycemia episodes (≤3.9 mmol/L) per patient year of exposure over 1 year</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Annualized rate of hypoglycemia (&lt;3.0 mmol/L) over 26 weeks</measure>
    <time_frame>Baseline to Week 26</time_frame>
    <description>Mean number of hypoglycemia episodes (&lt;3.0 mmol/L) per patient year of exposure over 1 year</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">265</enrollment>
  <condition>Type 2 Diabetes Mellitus</condition>
  <arm_group>
    <arm_group_label>iGlarlixi DAILY</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Titration Group 1: Addition of 1 unit per day until pre-stated fasting self-monitoring plasma glucose (SMBG) level is reached</description>
  </arm_group>
  <arm_group>
    <arm_group_label>iGlarlixi WEEKLY</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Titration Group 2: Algorithm of weekly adjustment until pre-stated fasting self-monitoring plasma glucose (SMBG) level is reached</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>INSULIN GLARGINE/LIXISENATIDE HOE901/AVE0010</intervention_name>
    <description>Pharmaceutical form: Solution for injection Route of administration: Subcutaneous</description>
    <arm_group_label>iGlarlixi DAILY</arm_group_label>
    <arm_group_label>iGlarlixi WEEKLY</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion criteria:&#xD;
&#xD;
          -  Adult subject ≥ 18 years&#xD;
&#xD;
          -  Patients with type 2 diabetes mellitus (T2DM) based on Diabetes Canada 2018 Clinical&#xD;
             Practice Guidelines criteria and diagnosed at least 6 months prior to the screening&#xD;
             visit&#xD;
&#xD;
          -  Uncontrolled glycemia with an A1c ≥7.5% and ≤10.5%&#xD;
&#xD;
          -  Patients treated for at least 6 months on any basal insulin (including but not limited&#xD;
             to insulin glargine, Toujeo®, Degludec®, etc.) ± oral anti-diabetic drug (OADs)&#xD;
&#xD;
          -  The total basal insulin dose must be ≤ 40 units/day&#xD;
&#xD;
          -  The OADs allowed at inclusion are metformin, insulin secretagogues,&#xD;
             dipeptidyl-peptidase-4 inhibitors (DPP4) inhibitors and SGLT2 inhibitors; with no&#xD;
             change in OAD dose for at least 2 months prior to randomization&#xD;
&#xD;
          -  Body mass index (BMI) between 20 kg/m2 and 40 kg/m2 inclusively&#xD;
&#xD;
        Exclusion criteria:&#xD;
&#xD;
          -  History of severe hypoglycemia or hypoglycemia unawareness&#xD;
&#xD;
          -  History of metabolic acidosis, including diabetic ketoacidosis within 1 year prior to&#xD;
             screening visit&#xD;
&#xD;
          -  Current or previous (known intolerance to GLP-1s) treatment with glucagon like&#xD;
             peptide-1 (GLP-1) receptor agonist&#xD;
&#xD;
          -  Current use of rapid-acting insulin or premix insulins or use of these insulins within&#xD;
             3 months prior to the screening visit&#xD;
&#xD;
          -  Use of systemic glucocorticoids (excluding topical and inhaled forms) for a total&#xD;
             duration of 1 week or more within 3 months prior to the screening visit&#xD;
&#xD;
          -  Use of weight loss drugs within 3 months prior to the screening visit&#xD;
&#xD;
          -  Patients with conditions/concomitant diseases that will affect safe participation in&#xD;
             this study (e.g. active malignant tumor, major systemic diseases, presence of&#xD;
             clinically significant diabetic retinopathy or presence of macular edema likely to&#xD;
             require treatment within the study period, etc.)&#xD;
&#xD;
          -  Women of childbearing potential (WOCBP) not protected by an effective contraceptive&#xD;
             method of birth control and/or who are unwilling or unable to be tested for pregnancy&#xD;
&#xD;
          -  Positive serum pregnancy test in WOCBP, pregnancy or lactation&#xD;
&#xD;
          -  Clinically relevant history of gastrointestinal disease associated with prolonged&#xD;
             nausea and vomiting, including (but not limited to): gastroparesis, unstable (i.e.&#xD;
             worsening) or uncontrolled (i.e. prolonged nausea and vomiting) gastroesophageal&#xD;
             reflux disease requiring medical treatment within 6 months prior to the time of&#xD;
             screening visit&#xD;
&#xD;
          -  History of pancreatitis (unless pancreatitis was related to gallstones and treated&#xD;
             with cholecystectomy), pancreatitis during previous treatment with incretin therapies,&#xD;
             chronic pancreatitis, pancreatectomy, or stomach/gastric surgery&#xD;
&#xD;
          -  Personal or immediate family history of medullary thyroid cancer or genetic conditions&#xD;
             that predispose the patient to medullary thyroid cancer (e.g. multiple endocrine&#xD;
             neoplasia syndromes)&#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 1240004</name>
      <address>
        <city>Barrie</city>
        <zip>L4N4L3</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 1240006</name>
      <address>
        <city>Brampton</city>
        <zip>L6S0C9</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 1240002</name>
      <address>
        <city>Brampton</city>
        <zip>L6T4V3</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 1240005</name>
      <address>
        <city>Burlington</city>
        <zip>L7R1A4</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 1240003</name>
      <address>
        <city>Calgary</city>
        <zip>T2H2G4</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 1240024</name>
      <address>
        <city>Chicoutimi</city>
        <zip>G7H7K9</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 1240014</name>
      <address>
        <city>Concord</city>
        <zip>L4K4M2</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 1240017</name>
      <address>
        <city>Etobicoke</city>
        <zip>M9R4E1</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 1240030</name>
      <address>
        <city>Greenfield Park</city>
        <zip>J4V2G8</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 1240031</name>
      <address>
        <city>Halifax</city>
        <zip>B3H1V7</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 1240026</name>
      <address>
        <city>Hamilton</city>
        <zip>L8S4K1</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 1240011</name>
      <address>
        <city>Laval</city>
        <zip>H7T 2P5</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 1240016</name>
      <address>
        <city>London</city>
        <zip>N6A 4V2</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 1240015</name>
      <address>
        <city>London</city>
        <zip>N6G 4X8</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 1240019</name>
      <address>
        <city>Mirabel</city>
        <zip>J7J2K8</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 1240018</name>
      <address>
        <city>Montreal</city>
        <zip>H1M1B1</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 1240023</name>
      <address>
        <city>Montreal</city>
        <zip>H4A2C6</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 1240020</name>
      <address>
        <city>Montreal</city>
        <zip>H4A3T2</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 1240029</name>
      <address>
        <city>Montreal</city>
        <zip>H4T1Z9</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 1240027</name>
      <address>
        <city>Nepan</city>
        <zip>K2J0V2</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 1240025</name>
      <address>
        <city>Newmarket</city>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 1240021</name>
      <address>
        <city>Oakville</city>
        <zip>L6M1M1</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 1240009</name>
      <address>
        <city>Oshawa</city>
        <zip>L1H7K4</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 1240008</name>
      <address>
        <city>Quebec</city>
        <zip>G1G3Y8</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 1240022</name>
      <address>
        <city>Quebec</city>
        <zip>G1V4W2</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 1240028</name>
      <address>
        <city>Saint-Lambert</city>
        <zip>J4P2H4</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 1240013</name>
      <address>
        <city>St-Marc-des-Carrieres</city>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 1240033</name>
      <address>
        <city>Toronto</city>
        <zip>M3J0K2</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 1240001</name>
      <address>
        <city>Toronto</city>
        <zip>M4G3E8</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 1240012</name>
      <address>
        <city>Vancouver</city>
        <zip>V5Y3W2</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 1240007</name>
      <address>
        <city>Victoriaville</city>
        <zip>G6P6P6</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 1240032</name>
      <address>
        <city>Winnipeg</city>
        <zip>R2V4W3</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>April 2022</verification_date>
  <study_first_submitted>December 5, 2018</study_first_submitted>
  <study_first_submitted_qc>December 5, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 6, 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>
    <mesh_term>Lixisenatide</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/NCT03767543
org study id: LPS15544
secondary id: U1111-1215-0238
nct id: NCT03767543
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
is us export: No
Primary Objective:

      To demonstrate that the simple daily titration algorithm is non-inferior to the weekly
      titration algorithm according to Canadian labeling.

      Secondary Objective:

      To gain additional information on the efficacy and safety of using a simple patient-titration
      protocol for administration of insulin glargine/lixisenatide fixed-ratio combination
      (iGlarLixi).
The maximum duration of study per patient is approximately 29 weeks including a 2-week
      screening, a 26-week randomized active-controlled treatment period, and 3-day post-treatment
      safety follow-up period.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Change in glycated hemoglobin (HbA1c)%
time frame: Baseline to Week 26
description: Absolute mean change in HbA1c from baseline to Week 26; HbA1c is expressed in % (unit)
measure: Percentage of patients achieving HbA1c ≤7% at Week 26
time frame: At Week 26
description: Percentage of patients achieving A1c ≤7%
measure: Change in fasting plasma glucose (FPG) from baseline to Week 12
time frame: Baseline to Week 12
description: Change in FPG from baseline to Week 12
measure: Change in FPG from baseline to Week 26
time frame: Baseline to Week 26
description: Change in FPG from baseline to Week 26
measure: Change in fasting self-monitoring plasma glucose (SMPG) from baseline to Week 12
time frame: Baseline to Week 12
description: Change in fasting SMPG from baseline to Week 12
measure: Change in fasting SMPG from baseline to Week 26
time frame: Baseline to Week 26
description: Change in fasting SMPG from baseline to Week 26
measure: Change in 7-point SMPG profile from baseline to Week 12
time frame: Baseline to Week 12
description: Change in 7-point SMPG profile from baseline to Week 12
measure: Change in 7-point SMPG profile from baseline to Week 26
time frame: Baseline to Week 26
description: Change in 7-point SMPG profile from baseline to Week 26
measure: Change in body weight from baseline to Week 26
time frame: Baseline to Week 26
description: Change in body weight (kg)
measure: Percentage of patients achieving A1c ≤7% with no body weight gain and/or hypoglycemia (severe or documented symptomatic (≤3.9 mmol/L) at Week 26
time frame: Baseline to Week 26
description: Composite endpoint expressed as percentage of patients A1c ≤7% with no body weight gain and/or hypoglycemia (severe or documented symptomatic (≤3.9 mmol/L)
measure: Insulin glargine dose
time frame: At Week 26
description: Insulin glargine dose (expressed in units)
measure: Percentage of patients requiring rescue therapy
time frame: Baseline to Week 26
description: Percentage of patients requiring rescue therapy during the 26-week open-label treatment period
measure: Percentage of patients experiencing at least 1 hypoglycemia episode (≤3.9 mmol/L) over 26 weeks
time frame: Baseline to Week 26
description: Percentage of patients experiencing at least 1 hypoglycemia episode defined as ≤3.9 mmol/L
measure: Percentage of patients experiencing at least 1 hypoglycemia episode (<3.0 mmol/L) over 26 weeks
time frame: Baseline to Week 26
description: Percentage of patients experiencing at least 1 hypoglycemia episode defined as <3.0 mmol/L
measure: Annualized rate of hypoglycemia (≤3.9 mmol/L) over 26 weeks
time frame: Baseline to Week 26
description: Mean number of hypoglycemia episodes (≤3.9 mmol/L) per patient year of exposure over 1 year
measure: Annualized rate of hypoglycemia (<3.0 mmol/L) over 26 weeks
time frame: Baseline to Week 26
description: Mean number of hypoglycemia episodes (<3.0 mmol/L) per patient year of exposure over 1 year
arm group label: iGlarlixi DAILY
arm group type: Experimental
description: Titration Group 1: Addition of 1 unit per day until pre-stated fasting self-monitoring plasma glucose (SMBG) level is reached
arm group label: iGlarlixi WEEKLY
arm group type: Active Comparator
description: Titration Group 2: Algorithm of weekly adjustment until pre-stated fasting self-monitoring plasma glucose (SMBG) level is reached
intervention type: Drug
intervention name: INSULIN GLARGINE/LIXISENATIDE HOE901/AVE0010
description: Pharmaceutical form: Solution for injection Route of administration: Subcutaneous
arm group label: iGlarlixi DAILY
arm group label: iGlarlixi WEEKLY
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: Canada
responsible party type: Sponsor
mesh term: Diabetes Mellitus
mesh term: Diabetes Mellitus, Type 2
mesh term: Insulin Glargine
mesh term: Lixisenatide
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