<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/NCT03798080</url>
  </required_header>
  <id_info>
    <org_study_id>EFC14944</org_study_id>
    <secondary_id>U1111-1190-7781</secondary_id>
    <nct_id>NCT03798080</nct_id>
  </id_info>
  <brief_title>Comparison of the Efficacy and Safety of Insulin Glargine/Lixisenatide Fixed Ratio Combination to Insulin Glargine in Patients With Type 2 Diabetes Insufficiently Controlled on Basal Insulin</brief_title>
  <acronym>Lixilan-L-CN</acronym>
  <official_title>A Randomized, 30-week, Active-controlled, Open-label, 2 Treatment-arm, Parallel Group, Multicenter Study Comparing Efficacy and Safety of iGlarLixi to Insulin Glargine With or Without Metformin in Patients With Type 2 Diabetes Mellitus Insufficiently Controlled on Basal Insulin With or Without Oral Antidiabetic Drug(s)</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 the superiority of iGlarLixi (fixed ratio combination of insulin glargine and&#xD;
      lixisenatide) to insulin glargine on glycemic control as assessed by glycated hemoglobin A1c&#xD;
      (HbA1c) change in patients with type 2 diabetes mellitus (T2DM) who are not sufficiently&#xD;
      controlled with basal insulin.&#xD;
&#xD;
      Secondary Objectives:&#xD;
&#xD;
        -  To assess the effects of iGlarLixi in comparison with insulin glargine&#xD;
&#xD;
        -  To assess the safety in each treatment group&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The maximum study duration per patient will be approximately 33 weeks: an up to 2-week&#xD;
      screening period (it can be exceptionally extended up to one additional week), a 30-week,&#xD;
      open label randomized treatment period comparing iGlarLixi to insulin glargine (± metformin&#xD;
      for both treatments), and a 3-day post-treatment safety follow-up period.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 19, 2019</start_date>
  <completion_date type="Actual">December 1, 2020</completion_date>
  <primary_completion_date type="Actual">December 1, 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 HbA1c</measure>
    <time_frame>From Baseline to Week 30</time_frame>
    <description>Change in glycated hemoglobin (HbA1c) from baseline to Week 30</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Patients with HbA1c &lt;7.0%</measure>
    <time_frame>At Week 30</time_frame>
    <description>Percentage of patients reaching HbA1c &lt;7% at Week 30</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patients with HbA1c ≤ 6.5%</measure>
    <time_frame>At Week 30</time_frame>
    <description>Percentage of patients reaching HbA1c ≤ 6.5% at Week 30</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in postprandial plasma glucose (PPG)</measure>
    <time_frame>From Baseline to Week 30</time_frame>
    <description>Absolute change in 2-hour blood glucose excursion and PPG during meal test from baseline to Week 30</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in self-monitored plasma glucose (SMPG) profile</measure>
    <time_frame>From Baseline to Week 30</time_frame>
    <description>Absolute change in 7-point SMPG profiles from baseline to Week 30 (each time point and average daily value)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patients with HbA1c &lt;7.0% with no body weight gain</measure>
    <time_frame>At Week 30</time_frame>
    <description>Percentage of patients reaching HbA1c &lt;7% with no body weight gain at Week 30</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in body weight</measure>
    <time_frame>From Baseline to Week 30</time_frame>
    <description>Absolute change in body weight from baseline to Week 30</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patients with HbA1c &lt;7.0% with no body weight gain and no documented symptomatic hypoglycemia</measure>
    <time_frame>At Week 30</time_frame>
    <description>Percentage of patients reaching HbA1c &lt;7% with no body weight gain at Week 30 and no documented (plasma glucose [PG] ≤70 mg/dL [3.9mmol/L]) symptomatic hypoglycemia during the 30-week randomized treatment period</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patients requiring rescue therapy</measure>
    <time_frame>From Baseline to Week 30</time_frame>
    <description>Percentage of patients requiring rescue therapy during the 30-week randomized treatment period</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in fasting plasma glucose (FPG)</measure>
    <time_frame>From Baseline to Week 30</time_frame>
    <description>Absolute change in FPG from baseline to Week 30</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Confirmed hypoglycemia</measure>
    <time_frame>From Baseline to Week 30</time_frame>
    <description>Severe hypoglycemia and episodes of hypoglycemia documented with PG ≤ 70 mg/dL (3.9mmol/L) regardless of symptoms</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adverse events (AEs)</measure>
    <time_frame>From Baseline to Week 30</time_frame>
    <description>Number of AEs, Serious AEs, AEs of Special Interest, and AEs requiring specific monitoring from baseline to Week 30</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Immunogenicity (antibody variables)</measure>
    <time_frame>From Baseline to Week 30</time_frame>
    <description>Anti-lixisenatide antibodies (in iGlarLixi group) and anti-insulin antibodies from baseline to Week 30</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">426</enrollment>
  <condition>Type 2 Diabetes Mellitus</condition>
  <arm_group>
    <arm_group_label>Soliqua (insulin glargine/lixisenatide)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>iGlarLixi (insulin glargine/lixisenatide) will be self-administered subcutaneously once daily in the morning with or without metformin for 30 weeks</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Lantus (insulin glargine)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Insulin glargine will be self-administered subcutaneously once daily at any time of the day with or without metformin for 30 weeks</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Insulin glargine/Lixisenatide (HOE901/AVE0010)</intervention_name>
    <description>Pharmaceutical form: solution&#xD;
Route of administration: subcutaneous</description>
    <arm_group_label>Soliqua (insulin glargine/lixisenatide)</arm_group_label>
    <other_name>Soliqua</other_name>
    <other_name>iGlarLixi</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Insulin glargine (HOE901)</intervention_name>
    <description>Pharmaceutical form: solution&#xD;
Route of administration: subcutaneous</description>
    <arm_group_label>Lantus (insulin glargine)</arm_group_label>
    <other_name>Lantus</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Metformin</intervention_name>
    <description>Pharmaceutical form: tablet&#xD;
Route of administration: oral</description>
    <arm_group_label>Lantus (insulin glargine)</arm_group_label>
    <arm_group_label>Soliqua (insulin glargine/lixisenatide)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion criteria :&#xD;
&#xD;
          -  Patients with type 2 diabetes mellitus (T2DM) diagnosed for at least 1 year and&#xD;
             treated with basal insulin for at least 6 months before screening visit (V1).&#xD;
&#xD;
          -  Patients who have been treated with a stable basal insulin regimen (ie, type of&#xD;
             insulin and time/frequency of the injection), for at least 3 months before screening&#xD;
             visit (V1).&#xD;
&#xD;
          -  Stable total daily basal insulin dose (±20 %) in the range of 10 and 25 U/day for at&#xD;
             least 2 months before screening visit (V1). Total daily dose should be within the&#xD;
             range of 10-25 U, both inclusive, on the day of screening, but individual fluctuations&#xD;
             of ±20% within 2 months prior to screening are acceptable.&#xD;
&#xD;
          -  For patients receiving basal insulin AND 1 or 2 oral anti-diabetic drugs (OADs): the&#xD;
             OAD dose(s) must be stable during the 3 months prior to screening. The OAD(s) can be 1&#xD;
             to 2 out of:&#xD;
&#xD;
          -  Metformin (≥1500 mg/day or maximal tolerated dose).&#xD;
&#xD;
          -  Sulfonylurea (SU)/glinide.&#xD;
&#xD;
          -  Alpha-glucosidase inhibitor (alpha-GI).&#xD;
&#xD;
          -  Sodium-glucose co-transporter 2 (SGLT2) inhibitor.&#xD;
&#xD;
          -  Dipeptidyl-peptidase-4 (DPP-4) inhibitor.&#xD;
&#xD;
          -  Fasting plasma glucose (FPG) ≤160 mg/dL (8.9 mmol/L) at screening visit (V1) (can be&#xD;
             repeated once to confirm).&#xD;
&#xD;
          -  Signed written informed consent.&#xD;
&#xD;
        Exclusion criteria:&#xD;
&#xD;
          -  Age &lt;18 years at screening visit (V1).&#xD;
&#xD;
          -  Screening glycated hemoglobin A1c(HbA1c) &lt;7.0% or &gt;10.5%.&#xD;
&#xD;
          -  History of hypoglycemia unawareness.&#xD;
&#xD;
          -  History of metabolic acidosis, including diabetic ketoacidosis within one year prior&#xD;
             to screening.&#xD;
&#xD;
          -  Use of oral or injectable glucose-lowering agents other than those stated in the&#xD;
             inclusion criteria within 3 months prior to screening.&#xD;
&#xD;
          -  Previous use of insulin regimen other than basal insulin, eg, prandial or pre-mixed&#xD;
             insulin, within one year prior to screening (Note: Short term treatment [≤10 days] due&#xD;
             to intercurrent illness is allowed).&#xD;
&#xD;
          -  History of discontinuation of a previous treatment with glucagon-like-peptide-1&#xD;
             receptor agonists (GLP-1 RAs) due to safety/tolerability reason or lack of efficacy.&#xD;
&#xD;
          -  Use of systemic glucocorticoids (excluding topical application or inhaled forms) for 1&#xD;
             week or more within 3 months prior to screening.&#xD;
&#xD;
          -  Use of weight loss drugs within 3 months prior to screening.&#xD;
&#xD;
          -  Use of any investigational drug within 1 month or 5 half-lives, whichever is longer,&#xD;
             prior to screening.&#xD;
&#xD;
          -  Within 6 months prior to screening: history of myocardial infarction, stroke, or heart&#xD;
             failure requiring hospitalization.&#xD;
&#xD;
          -  Planned coronary, carotid, or peripheral revascularization procedures to be performed&#xD;
             during the study period.&#xD;
&#xD;
          -  Known history of drug or alcohol abuse within 6 months prior to screening.&#xD;
&#xD;
          -  Uncontrolled or inadequately controlled hypertension at the time of screening with a&#xD;
             resting systolic blood pressure &gt;180 mmHg or diastolic blood pressure &gt;95 mmHg.&#xD;
&#xD;
          -  Laboratory findings at screening visit:&#xD;
&#xD;
          -  Amylase and/or lipase &gt;3 times the upper limit of normal (ULN) laboratory range.&#xD;
&#xD;
          -  Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) &gt;3 ULN.&#xD;
&#xD;
          -  Total bilirubin &gt;1.5 ULN (except in case of Gilbert's syndrome).&#xD;
&#xD;
          -  Calcitonin ≥20 pg/mL (5.9 pmol/L).&#xD;
&#xD;
          -  Hemoglobin &lt;10.5 g/dL and/or neutrophils &lt;1500/mm3 and/or platelets &lt;100 000/mm3.&#xD;
&#xD;
          -  Positive test for hepatitis B surface antigen (HBsAg) and/or hepatitis C antibody&#xD;
             (HCAb).&#xD;
&#xD;
          -  Positive urine pregnancy test in female of childbearing potential.&#xD;
&#xD;
          -  For patient not treated with metformin at screening: severe renal function impairment&#xD;
             with an estimated glomerular filtration rate (eGFR) &lt;30 mL/min/1.73m2 or end-stage&#xD;
             renal disease.&#xD;
&#xD;
          -  Clinically relevant history of gastrointestinal disease associated with prolonged&#xD;
             nausea and vomiting, including (but not limited to): gastroparesis, unstable (ie,&#xD;
             worsening) or not controlled (ie, prolonged nausea and vomiting) gastroesophageal&#xD;
             reflux disease requiring medical treatment, within 6 months prior to the time of&#xD;
             screening visit; or history of surgery affecting gastric emptying.&#xD;
&#xD;
          -  History of pancreatitis (unless pancreatitis was related to gallstones and&#xD;
             cholecystectomy has been performed), pancreatitis during previous treatment with&#xD;
             incretin therapies, chronic pancreatitis, pancreatectomy.&#xD;
&#xD;
          -  Personal or immediate family history of medullary thyroid cancer (MTC) or genetic&#xD;
             conditions that predispose to MTC (eg, multiple endocrine neoplasia syndromes).&#xD;
&#xD;
          -  Mean fasting self-monitored plasma glucose (SMPG) is &gt;160 mg/dL (8.9 mmol/L),&#xD;
             calculated from all available (minimum of 4 self-measurements) values during the 7&#xD;
             days prior to randomization.&#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 1560044</name>
      <address>
        <city>Baotou</city>
        <zip>014010</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 1560001</name>
      <address>
        <city>Beijing</city>
        <zip>100034</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 1560039</name>
      <address>
        <city>Beijing</city>
        <zip>102218</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 1560005</name>
      <address>
        <city>Changchun</city>
        <zip>130033</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 1560054</name>
      <address>
        <city>Changchun</city>
        <zip>130041</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 1560015</name>
      <address>
        <city>Changsha</city>
        <zip>410013</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 1560010</name>
      <address>
        <city>Chenzhou</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 1560030</name>
      <address>
        <city>Chongqing</city>
        <zip>400010</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 1560025</name>
      <address>
        <city>Fuzhou</city>
        <zip>354200</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 1560016</name>
      <address>
        <city>Guangzhou</city>
        <zip>510080</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 1560053</name>
      <address>
        <city>Guangzhou</city>
        <zip>510080</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 1560045</name>
      <address>
        <city>Guangzhou</city>
        <zip>510515</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 1560021</name>
      <address>
        <city>Hefei</city>
        <zip>230022</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 1560018</name>
      <address>
        <city>Hohhot</city>
        <zip>010017</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 1560019</name>
      <address>
        <city>Huanggang</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 1560041</name>
      <address>
        <city>Jiaxing</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 1560040</name>
      <address>
        <city>Jinan</city>
        <zip>250000</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 1560007</name>
      <address>
        <city>Jinan</city>
        <zip>250013</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 1560026</name>
      <address>
        <city>Jinzhou</city>
        <zip>121000</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 1560042</name>
      <address>
        <city>Kaifeng</city>
        <zip>475000</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 1560003</name>
      <address>
        <city>Kunming</city>
        <zip>650032</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 1560032</name>
      <address>
        <city>Lanzhou</city>
        <zip>730000</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 1560033</name>
      <address>
        <city>Luoyang</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 1560028</name>
      <address>
        <city>Nanjing</city>
        <zip>210008</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 1560013</name>
      <address>
        <city>Nanjing</city>
        <zip>210011</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 1560017</name>
      <address>
        <city>Nanjing</city>
        <zip>210029</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 1560035</name>
      <address>
        <city>Nanjing</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 1560038</name>
      <address>
        <city>Nanjing</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 1560046</name>
      <address>
        <city>Nantong</city>
        <zip>226001</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 1560008</name>
      <address>
        <city>Pingxiang</city>
        <zip>337055</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 1560037</name>
      <address>
        <city>Qingdao</city>
        <zip>266003</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 1560031</name>
      <address>
        <city>Qinhuangdao</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 1560011</name>
      <address>
        <city>Shanghai</city>
        <zip>200240</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 1560002</name>
      <address>
        <city>Shanghai</city>
        <zip>201700</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 1560027</name>
      <address>
        <city>Shanghai</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 1560047</name>
      <address>
        <city>Shanghai</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 1560012</name>
      <address>
        <city>Shenyang</city>
        <zip>110004</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 1560006</name>
      <address>
        <city>Tianjin</city>
        <zip>300121</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 1560049</name>
      <address>
        <city>Urumqi</city>
        <zip>830000</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 1560020</name>
      <address>
        <city>Xining</city>
        <zip>810007</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 1560050</name>
      <address>
        <city>Xining</city>
        <zip>810016</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 1560036</name>
      <address>
        <city>Xuzhou</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 1560023</name>
      <address>
        <city>Yangzhou</city>
        <zip>225001</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 1560022</name>
      <address>
        <city>Zhuzhou</city>
        <zip>412007</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 1560052</name>
      <address>
        <city>Zigong</city>
        <zip>643002</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <reference>
    <citation>Yuan X, Guo X, Zhang J, Dong X, Lu Y, Pang W, Gu S, Niemoeller E, Ping L, Nian G, Souhami E; LixiLan-L-CN investigators. Improved glycaemic control and weight benefit with iGlarLixi versus insulin glargine 100 U/mL in Chinese people with type 2 diabetes advancing their therapy from basal insulin plus oral antihyperglycaemic drugs: Results from the LixiLan-L-CN randomized controlled trial. Diabetes Obes Metab. 2022 Nov;24(11):2182-2191. doi: 10.1111/dom.14803. Epub 2022 Jul 25.</citation>
    <PMID>35762489</PMID>
  </reference>
  <verification_date>April 2022</verification_date>
  <study_first_submitted>January 7, 2019</study_first_submitted>
  <study_first_submitted_qc>January 7, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 9, 2019</study_first_posted>
  <last_update_submitted>July 14, 2022</last_update_submitted>
  <last_update_submitted_qc>July 14, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">July 19, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Diabetes Mellitus</mesh_term>
    <mesh_term>Diabetes Mellitus, Type 2</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Insulin</mesh_term>
    <mesh_term>Insulin, Globin Zinc</mesh_term>
    <mesh_term>Metformin</mesh_term>
    <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/NCT03798080
org study id: EFC14944
secondary id: U1111-1190-7781
nct id: NCT03798080
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
is us export: No
Primary Objective:

      To demonstrate the superiority of iGlarLixi (fixed ratio combination of insulin glargine and
      lixisenatide) to insulin glargine on glycemic control as assessed by glycated hemoglobin A1c
      (HbA1c) change in patients with type 2 diabetes mellitus (T2DM) who are not sufficiently
      controlled with basal insulin.

      Secondary Objectives:

        -  To assess the effects of iGlarLixi in comparison with insulin glargine

        -  To assess the safety in each treatment group
The maximum study duration per patient will be approximately 33 weeks: an up to 2-week
      screening period (it can be exceptionally extended up to one additional week), a 30-week,
      open label randomized treatment period comparing iGlarLixi to insulin glargine (± metformin
      for both treatments), and a 3-day post-treatment safety follow-up period.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Change in HbA1c
time frame: From Baseline to Week 30
description: Change in glycated hemoglobin (HbA1c) from baseline to Week 30
measure: Patients with HbA1c <7.0%
time frame: At Week 30
description: Percentage of patients reaching HbA1c <7% at Week 30
measure: Patients with HbA1c ≤ 6.5%
time frame: At Week 30
description: Percentage of patients reaching HbA1c ≤ 6.5% at Week 30
measure: Change in postprandial plasma glucose (PPG)
time frame: From Baseline to Week 30
description: Absolute change in 2-hour blood glucose excursion and PPG during meal test from baseline to Week 30
measure: Change in self-monitored plasma glucose (SMPG) profile
time frame: From Baseline to Week 30
description: Absolute change in 7-point SMPG profiles from baseline to Week 30 (each time point and average daily value)
measure: Patients with HbA1c <7.0% with no body weight gain
time frame: At Week 30
description: Percentage of patients reaching HbA1c <7% with no body weight gain at Week 30
measure: Change in body weight
time frame: From Baseline to Week 30
description: Absolute change in body weight from baseline to Week 30
measure: Patients with HbA1c <7.0% with no body weight gain and no documented symptomatic hypoglycemia
time frame: At Week 30
description: Percentage of patients reaching HbA1c <7% with no body weight gain at Week 30 and no documented (plasma glucose [PG] ≤70 mg/dL [3.9mmol/L]) symptomatic hypoglycemia during the 30-week randomized treatment period
measure: Patients requiring rescue therapy
time frame: From Baseline to Week 30
description: Percentage of patients requiring rescue therapy during the 30-week randomized treatment period
measure: Change in fasting plasma glucose (FPG)
time frame: From Baseline to Week 30
description: Absolute change in FPG from baseline to Week 30
measure: Confirmed hypoglycemia
time frame: From Baseline to Week 30
description: Severe hypoglycemia and episodes of hypoglycemia documented with PG ≤ 70 mg/dL (3.9mmol/L) regardless of symptoms
measure: Adverse events (AEs)
time frame: From Baseline to Week 30
description: Number of AEs, Serious AEs, AEs of Special Interest, and AEs requiring specific monitoring from baseline to Week 30
measure: Immunogenicity (antibody variables)
time frame: From Baseline to Week 30
description: Anti-lixisenatide antibodies (in iGlarLixi group) and anti-insulin antibodies from baseline to Week 30
arm group label: Soliqua (insulin glargine/lixisenatide)
arm group type: Experimental
description: iGlarLixi (insulin glargine/lixisenatide) will be self-administered subcutaneously once daily in the morning with or without metformin for 30 weeks
arm group label: Lantus (insulin glargine)
arm group type: Active Comparator
description: Insulin glargine will be self-administered subcutaneously once daily at any time of the day with or without metformin for 30 weeks
intervention type: Drug
intervention name: Insulin glargine/Lixisenatide (HOE901/AVE0010)
description: Pharmaceutical form: solution
Route of administration: subcutaneous
arm group label: Soliqua (insulin glargine/lixisenatide)
other name: Soliqua
other name: iGlarLixi
intervention type: Drug
intervention name: Insulin glargine (HOE901)
description: Pharmaceutical form: solution
Route of administration: subcutaneous
arm group label: Lantus (insulin glargine)
other name: Lantus
intervention type: Drug
intervention name: Metformin
description: Pharmaceutical form: tablet
Route of administration: oral
arm group label: Lantus (insulin glargine)
arm group label: Soliqua (insulin glargine/lixisenatide)
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: China
citation: Yuan X, Guo X, Zhang J, Dong X, Lu Y, Pang W, Gu S, Niemoeller E, Ping L, Nian G, Souhami E; LixiLan-L-CN investigators. Improved glycaemic control and weight benefit with iGlarLixi versus insulin glargine 100 U/mL in Chinese people with type 2 diabetes advancing their therapy from basal insulin plus oral antihyperglycaemic drugs: Results from the LixiLan-L-CN randomized controlled trial. Diabetes Obes Metab. 2022 Nov;24(11):2182-2191. doi: 10.1111/dom.14803. Epub 2022 Jul 25.
PMID: 35762489
responsible party type: Sponsor
mesh term: Diabetes Mellitus
mesh term: Diabetes Mellitus, Type 2
mesh term: Insulin
mesh term: Insulin, Globin Zinc
mesh term: Metformin
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