<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/NCT01699932</url>
  </required_header>
  <id_info>
    <org_study_id>GLMET_R_05823</org_study_id>
    <secondary_id>U1111-1120-0058</secondary_id>
    <nct_id>NCT01699932</nct_id>
  </id_info>
  <brief_title>Efficacy and Safety of the Fixed Dose Combination of Glimepiride+Metformin in Type 2 Diabetic Patients Inadequately Controlled</brief_title>
  <acronym>LEGEND</acronym>
  <official_title>A Multinational, Open Label, Non Comparative, 24-week Study to Evaluate the Blood Glucose Lowering Efficacy and Safety of a Fixed Dose Combination of Glimepiride and Metformin in Patients With Inadequately Controlled Type 2 Diabetes</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Sanofi</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Sanofi</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Primary Objective:&#xD;
&#xD;
      -To demonstrate the efficacy of a fixed combination of glimepiride + metformin in terms of&#xD;
      HbA1c reduction, during 24-week treatment period in patients with inadequately controlled&#xD;
      type 2 diabetes mellitus.&#xD;
&#xD;
      Secondary Objective:&#xD;
&#xD;
      To assess the effects of the fixed combination of glimepiride and metformin at week 24 on:&#xD;
&#xD;
        -  Percentage of patients reaching HbA1c &lt;7%&#xD;
&#xD;
        -  Percentage of patients reaching HbA1c &lt;6.5%.&#xD;
&#xD;
        -  Fasting Plasma Glucose (FPG)&#xD;
&#xD;
        -  Safety and tolerability&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study duration for each patient is approximately 27 weeks with 3 periods: 2-week&#xD;
      screening period followed by 24-week treatment period and 3 days follow-up period with a last&#xD;
      call phone visit.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>September 2012</start_date>
  <completion_date type="Actual">April 2014</completion_date>
  <primary_completion_date type="Actual">April 2014</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</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 HbA1c</measure>
    <time_frame>from baseline to week 24</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Percentage of patients with HbA1c &lt; 7%</measure>
    <time_frame>at week 24</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of patients with HbA1c &lt; 6.5%</measure>
    <time_frame>at week 24</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Fasting Plasma Glucose (FPG)</measure>
    <time_frame>from baseline to week 24</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of patients with adverse events</measure>
    <time_frame>over the 24-week treatment period</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hypoglycemia</measure>
    <time_frame>over the 24-week treatment period</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">167</enrollment>
  <condition>Type 2 Diabetes Mellitus</condition>
  <arm_group>
    <arm_group_label>Arm 1</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>24-week treatment period: starting dose will be of 2/1000 mg or 4/2000 mg of glimepiride/metformin fixed combination (Amaryl M® ) depending on the previous treatment and dose. The Interventional medicinal product's dose will be increased every 2 weeks up to the maximum tolerated dose of 8/2000 mg of Amaryl M® , and adjusted throughout the 24-week treatment period according to fasting Self Monitored Plasma Glucose (SMPG) values in the objective to obtain fasting SMPG values ≤ 130mg/dL (7.2mmol/L) and &gt; 70 mg/dL (3.9mmol/L) without symptomatic hypoglycemia.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Glimepiride+metformin (Amaryl M®) - HOE4900</intervention_name>
    <description>Pharmaceutical form:tablet&#xD;
Route of administration: oral</description>
    <arm_group_label>Arm 1</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion criteria:&#xD;
&#xD;
          -  Patients with type 2 diabetes mellitus inadequately controlled despite a treatment&#xD;
             with sulfonylurea (SU) alone or metformin alone or a free combination of SU and&#xD;
             metformin prior to the study entry.&#xD;
&#xD;
          -  Signed informed consent, obtained prior any study procedure&#xD;
&#xD;
        Exclusion criteria:&#xD;
&#xD;
          -  Age &lt; legal age of adulthood&#xD;
&#xD;
          -  HbA1c &lt; 7% or ≥ 11%&#xD;
&#xD;
          -  BMI &gt; 35 kg/m2&#xD;
&#xD;
          -  Treatment with a stable dose of maximally tolerated SU alone or metformin alone or the&#xD;
             free combination of SU and metformin for less than 12 weeks prior to the screening&#xD;
             visit.&#xD;
&#xD;
          -  Patients who received any anti-diabetic drug other than SU or metformin within 12&#xD;
             weeks prior to the screening visit.&#xD;
&#xD;
          -  Diabetes other than type 2 diabetes (e.g. type 1 diabetes, diabetes secondary to&#xD;
             pancreatic disorders, drug or chemical agent intake…)&#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 422-002</name>
      <address>
        <city>Beirut</city>
        <country>Lebanon</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 422-001</name>
      <address>
        <city>Hazmieh</city>
        <country>Lebanon</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 643001</name>
      <address>
        <city>Samara</city>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 643002</name>
      <address>
        <city>St-Petersburg</city>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 643-03</name>
      <address>
        <city>St.-Petersburg</city>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 804003</name>
      <address>
        <city>Chernivtsi</city>
        <zip>58022</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 804008</name>
      <address>
        <city>Donetsk</city>
        <zip>83003</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 804004</name>
      <address>
        <city>Donetsk</city>
        <zip>83059</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 804001</name>
      <address>
        <city>Donetsk</city>
        <zip>83099</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 804010</name>
      <address>
        <city>Odessa</city>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 804006</name>
      <address>
        <city>Poltava</city>
        <zip>36011</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 804007</name>
      <address>
        <city>Vinnytsya</city>
        <zip>21010</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 804002</name>
      <address>
        <city>Vinnytsya</city>
        <zip>21029</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Lebanon</country>
    <country>Russian Federation</country>
    <country>Ukraine</country>
  </location_countries>
  <verification_date>May 2014</verification_date>
  <study_first_submitted>September 26, 2012</study_first_submitted>
  <study_first_submitted_qc>October 1, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 4, 2012</study_first_posted>
  <last_update_submitted>May 7, 2014</last_update_submitted>
  <last_update_submitted_qc>May 7, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">May 8, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Diabetes Mellitus, Type 2</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Metformin</mesh_term>
    <mesh_term>Glimepiride</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/NCT01699932
org study id: GLMET_R_05823
secondary id: U1111-1120-0058
nct id: NCT01699932
lead sponsor: 
has dmc: No
Primary Objective:

      -To demonstrate the efficacy of a fixed combination of glimepiride + metformin in terms of
      HbA1c reduction, during 24-week treatment period in patients with inadequately controlled
      type 2 diabetes mellitus.

      Secondary Objective:

      To assess the effects of the fixed combination of glimepiride and metformin at week 24 on:

        -  Percentage of patients reaching HbA1c <7%

        -  Percentage of patients reaching HbA1c <6.5%.

        -  Fasting Plasma Glucose (FPG)

        -  Safety and tolerability
The study duration for each patient is approximately 27 weeks with 3 periods: 2-week
      screening period followed by 24-week treatment period and 3 days follow-up period with a last
      call phone visit.
allocation: Non-Randomized
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Change in HbA1c
time frame: from baseline to week 24
measure: Percentage of patients with HbA1c < 7%
time frame: at week 24
measure: Percentage of patients with HbA1c < 6.5%
time frame: at week 24
measure: Change in Fasting Plasma Glucose (FPG)
time frame: from baseline to week 24
measure: Number of patients with adverse events
time frame: over the 24-week treatment period
measure: Hypoglycemia
time frame: over the 24-week treatment period
arm group label: Arm 1
arm group type: Experimental
description: 24-week treatment period: starting dose will be of 2/1000 mg or 4/2000 mg of glimepiride/metformin fixed combination (Amaryl M® ) depending on the previous treatment and dose. The Interventional medicinal product's dose will be increased every 2 weeks up to the maximum tolerated dose of 8/2000 mg of Amaryl M® , and adjusted throughout the 24-week treatment period according to fasting Self Monitored Plasma Glucose (SMPG) values in the objective to obtain fasting SMPG values ≤ 130mg/dL (7.2mmol/L) and > 70 mg/dL (3.9mmol/L) without symptomatic hypoglycemia.
intervention type: Drug
intervention name: Glimepiride+metformin (Amaryl M®) - HOE4900
description: Pharmaceutical form:tablet
Route of administration: oral
arm group label: Arm 1
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: 
country: Lebanon
country: Russian Federation
country: Ukraine
responsible party type: Sponsor
mesh term: Diabetes Mellitus, Type 2
mesh term: Metformin
mesh term: Glimepiride