<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/NCT02200991</url>
  </required_header>
  <id_info>
    <org_study_id>LIXISL06651</org_study_id>
    <secondary_id>U1111-1159-5323</secondary_id>
    <nct_id>NCT02200991</nct_id>
  </id_info>
  <brief_title>Effect of Lixisenatide on Postprandial Plasma Glucose Compared to Sitagliptin in Combination With Insulin Glargine</brief_title>
  <official_title>A Randomized, Multicenter, Open-Label, Parallel-Group, 28 Days Phase IV Study Comparing The Postprandial Plasma Glucose Profile of Lixisenatide With That of Sitagliptin Add-On to Insulin Glargine in Type 2 Diabetes Mellitus</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 significant reduction in postprandial plasma glucose (ΔAUC0:30-4:30h) after a&#xD;
      standardized breakfast from baseline to Day 29.&#xD;
&#xD;
      Secondary Objectives:&#xD;
&#xD;
      To demonstrate:&#xD;
&#xD;
        -  Changes from baseline to Day 29 in maximum postprandial plasma glucose excursion,&#xD;
           C-peptide and glucagon levels after a standardized breakfast&#xD;
&#xD;
        -  Delaying gastric emptying (13C-acetic acid breath test)&#xD;
&#xD;
        -  Safety and tolerability&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The duration per patient could be minimum of 38 to 47 days depending on screening visit and&#xD;
      post-treatment observation allowances.&#xD;
&#xD;
      13C-acetic acid breath test will be conducted only in investigational site which can be&#xD;
      implemented (about 40 patients).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>August 2014</start_date>
  <completion_date type="Actual">November 2015</completion_date>
  <primary_completion_date type="Actual">November 2015</primary_completion_date>
  <phase>Phase 4</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 from baseline in postprandial plasma glucose at Day 29 after a standardized breakfast</measure>
    <time_frame>Day 29 after first intake of investigational product</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in maximum postprandial plasma glucose excursion at Day 29 after a standardized breakfast</measure>
    <time_frame>Day 29 after first intake of investigational product</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in plasma C-peptide levels at Day 29 after a standardized breakfast</measure>
    <time_frame>Day 29 after first intake of investigational product</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in glucagon levels at Day 29 after a standardized breakfast</measure>
    <time_frame>Day 29 after first intake of investigational product</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in gastric emptying half life (13C-acetic acid breath test)</measure>
    <time_frame>Day 29 after first intake of investigational product</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of patients with adverse events</measure>
    <time_frame>Up to Day 33 from the first intake of investigational medicinal product</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">136</enrollment>
  <condition>Type 2 Diabetes Mellitus</condition>
  <arm_group>
    <arm_group_label>Lixisenatide</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Lyxumia solostar: Initially started with 10 μg once-daily and increased up to 20 μg once daily (dose increased by 5 μg every week), subcutaneous injection in the abdomen, administered 30 minutes before breakfast. The period of administration is 4 weeks.&#xD;
Lantus solostar as base treatment: Subcutaneous injection in the abdomen.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sitagliptin - Januvia</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>50 mg tablet, administered orally once-daily, 30 minutes before breakfast. The period of administration is 4 weeks.&#xD;
Lantus solostar as base treatment: Subcutaneous injection in the abdomen.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>LIXISENATIDE AVE0010</intervention_name>
    <description>Pharmaceutical form:solution Route of administration: subcutaneous</description>
    <arm_group_label>Lixisenatide</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Sitagliptin</intervention_name>
    <description>Pharmaceutical form:tablet Route of administration: oral</description>
    <arm_group_label>Sitagliptin - Januvia</arm_group_label>
    <other_name>Januvia</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Insulin glargine HOE901</intervention_name>
    <description>Pharmaceutical form:solution Route of administration: subcutaneous</description>
    <arm_group_label>Lixisenatide</arm_group_label>
    <arm_group_label>Sitagliptin - Januvia</arm_group_label>
    <other_name>Lantus</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion criteria:&#xD;
&#xD;
          -  Type 2 diabetes mellitus, treated with Lantus±SU; ≥5-year after diagnosis&#xD;
&#xD;
          -  Aged 20-75 years&#xD;
&#xD;
          -  Hemoglobin A1C ≥7.0%-≤10.0%&#xD;
&#xD;
          -  Fasting plasma glucose ≤180 mg/dL at screening&#xD;
&#xD;
          -  Stable treatment (±20%) with Lantus for 3 months or more prior to screening.&#xD;
&#xD;
          -  Sulfonylurea dose stable for 3 months or more prior to screening&#xD;
&#xD;
        Exclusion criteria:&#xD;
&#xD;
          -  Type 1 diabetes mellitus&#xD;
&#xD;
          -  Pregnancy or lactation&#xD;
&#xD;
          -  Hypersensitivity to Lixisenatide&#xD;
&#xD;
          -  Severely uncontrolled glycemic situation&#xD;
&#xD;
          -  History of unexplained pancreatitis, chronic pancreatitis, pancreatectomy,&#xD;
             stomach/gastric surgery or inflammatory bowel disease&#xD;
&#xD;
          -  History of metabolic acidosis, including diabetic ketoacidosis, within 1 year prior to&#xD;
             screening&#xD;
&#xD;
          -  History within the previous 6 months of myocardial infarction, stroke or heart failure&#xD;
             requiring hospitalization or drug or alcohol abuse&#xD;
&#xD;
          -  Uncontrolled/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;
          -  Amylase and/or lipase &gt;3 times or aspartate aminotransferase (AST), alanine&#xD;
             aminotransferase (ALT) or alkaline phosphatase (ALP) &gt;2 times the upper limit of the&#xD;
             normal laboratory range&#xD;
&#xD;
          -  End-stage renal disease and/or dialysis and clinically relevant history of&#xD;
             gastrointestinal disease&#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>20 Years</minimum_age>
    <maximum_age>75 Years</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 392-107</name>
      <address>
        <city>Atsugi-shi</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 392-125</name>
      <address>
        <city>Chiyoda-ku</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 392-121</name>
      <address>
        <city>Chuoh-ku</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 392-102</name>
      <address>
        <city>Ichihara-shi</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 392-103</name>
      <address>
        <city>Kawaguchi-shi</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 392-114</name>
      <address>
        <city>Kitamoto-shi</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 392-122</name>
      <address>
        <city>Kobe-shi</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 392-126</name>
      <address>
        <city>Kumamoto-shi</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 392-127</name>
      <address>
        <city>Kumamoto-shi</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 392-101</name>
      <address>
        <city>Kyoto-shi</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 392-106</name>
      <address>
        <city>Matsudo-shi</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 392-124</name>
      <address>
        <city>Mitaka-shi</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 392-108</name>
      <address>
        <city>Mito-shi</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 392-119</name>
      <address>
        <city>Nerima-ku</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 392-117</name>
      <address>
        <city>Okayama-shi</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 392-111</name>
      <address>
        <city>Sagamihara-shi</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 392-110</name>
      <address>
        <city>Sapporo-shi</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 392-116</name>
      <address>
        <city>Satsumasendai-shi</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 392-105</name>
      <address>
        <city>Shizuoka-shi</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 392-118</name>
      <address>
        <city>Suita-shi</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Japan</country>
  </location_countries>
  <verification_date>October 2016</verification_date>
  <study_first_submitted>July 23, 2014</study_first_submitted>
  <study_first_submitted_qc>July 24, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 25, 2014</study_first_posted>
  <last_update_submitted>October 4, 2016</last_update_submitted>
  <last_update_submitted_qc>October 4, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 5, 2016</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>Sitagliptin Phosphate</mesh_term>
    <mesh_term>Lixisenatide</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/NCT02200991
org study id: LIXISL06651
secondary id: U1111-1159-5323
nct id: NCT02200991
lead sponsor: 
has dmc: No
Primary Objective:

      To demonstrate significant reduction in postprandial plasma glucose (ΔAUC0:30-4:30h) after a
      standardized breakfast from baseline to Day 29.

      Secondary Objectives:

      To demonstrate:

        -  Changes from baseline to Day 29 in maximum postprandial plasma glucose excursion,
           C-peptide and glucagon levels after a standardized breakfast

        -  Delaying gastric emptying (13C-acetic acid breath test)

        -  Safety and tolerability
The duration per patient could be minimum of 38 to 47 days depending on screening visit and
      post-treatment observation allowances.

      13C-acetic acid breath test will be conducted only in investigational site which can be
      implemented (about 40 patients).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Change from baseline in postprandial plasma glucose at Day 29 after a standardized breakfast
time frame: Day 29 after first intake of investigational product
measure: Change from baseline in maximum postprandial plasma glucose excursion at Day 29 after a standardized breakfast
time frame: Day 29 after first intake of investigational product
measure: Change from baseline in plasma C-peptide levels at Day 29 after a standardized breakfast
time frame: Day 29 after first intake of investigational product
measure: Change from baseline in glucagon levels at Day 29 after a standardized breakfast
time frame: Day 29 after first intake of investigational product
measure: Change in gastric emptying half life (13C-acetic acid breath test)
time frame: Day 29 after first intake of investigational product
measure: Proportion of patients with adverse events
time frame: Up to Day 33 from the first intake of investigational medicinal product
arm group label: Lixisenatide
arm group type: Experimental
description: Lyxumia solostar: Initially started with 10 μg once-daily and increased up to 20 μg once daily (dose increased by 5 μg every week), subcutaneous injection in the abdomen, administered 30 minutes before breakfast. The period of administration is 4 weeks.
Lantus solostar as base treatment: Subcutaneous injection in the abdomen.
arm group label: Sitagliptin - Januvia
arm group type: Active Comparator
description: 50 mg tablet, administered orally once-daily, 30 minutes before breakfast. The period of administration is 4 weeks.
Lantus solostar as base treatment: Subcutaneous injection in the abdomen.
intervention type: Drug
intervention name: LIXISENATIDE AVE0010
description: Pharmaceutical form:solution Route of administration: subcutaneous
arm group label: Lixisenatide
intervention type: Drug
intervention name: Sitagliptin
description: Pharmaceutical form:tablet Route of administration: oral
arm group label: Sitagliptin - Januvia
other name: Januvia
intervention type: Drug
intervention name: Insulin glargine HOE901
description: Pharmaceutical form:solution Route of administration: subcutaneous
arm group label: Lixisenatide
arm group label: Sitagliptin - Januvia
other name: Lantus
criteria: 
gender: All
minimum age: 20 Years
maximum age: 75 Years
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: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Japan
responsible party type: Sponsor
mesh term: Diabetes Mellitus
mesh term: Diabetes Mellitus, Type 2
mesh term: Insulin Glargine
mesh term: Sitagliptin Phosphate
mesh term: Lixisenatide