<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/NCT03766750</url>
  </required_header>
  <id_info>
    <org_study_id>EMS0318-LIMA</org_study_id>
    <nct_id>NCT03766750</nct_id>
  </id_info>
  <brief_title>Efficacy and Safety of Lima Association in the Control of Type II Diabetes Mellitus.</brief_title>
  <official_title>Randomized, Double-blind, Multicenter, National, Phase III Clinical Trial to Evaluate the Efficacy and Safety of Lima Association in the Control of Type II Diabetes Mellitus</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>EMS</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>EMS</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to evaluate the efficacy and safety of Lima association in the&#xD;
      control of type 2 diabetes mellitus&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    Sponsor decision&#xD;
  </why_stopped>
  <start_date type="Anticipated">December 2021</start_date>
  <completion_date type="Anticipated">November 2023</completion_date>
  <primary_completion_date type="Anticipated">October 2023</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>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Reduction of glycated hemoglobin levels measured between the first visit and the last visit.</measure>
    <time_frame>120 days</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Incidence and severity of adverse events recorded during the study.</measure>
    <time_frame>210 days</time_frame>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Type2 Diabetes Mellitus</condition>
  <arm_group>
    <arm_group_label>LIMA</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Tradjenta®</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Forxiga®</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>LIMA association</intervention_name>
    <description>1 coated tablet, oral, once a day.</description>
    <arm_group_label>LIMA</arm_group_label>
    <other_name>EMS association</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Tradjenta</intervention_name>
    <description>1 coated tablet, oral, once a day.</description>
    <arm_group_label>Tradjenta®</arm_group_label>
    <other_name>Linagliptin 5 mg</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Forxiga</intervention_name>
    <description>1 coated tablet, oral, once a day.</description>
    <arm_group_label>Forxiga®</arm_group_label>
    <other_name>Dapagliflozin 10 mg</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Participants of both sexes, aged 18 years or more;&#xD;
&#xD;
          -  Participants presenting the diagnosis of type II diabetes mellitus, which have already&#xD;
             received previous dietary and physical exercise guidance, who are not receiving any&#xD;
             antidiabetic treatment, defined as never taking any antidiabetic medication, or in&#xD;
             antidiabetic therapy after being subjected to a washout period;&#xD;
&#xD;
          -  Treatment-naive participants with HbA1c between 7.5% and 10.5% and pretreated patients&#xD;
             with HbA1c between 7,5% and 9,5% at the screening visit;&#xD;
&#xD;
          -  Patients with HbA1c between 7.5% and 10.5% at the randomization visit;&#xD;
&#xD;
          -  Participants with BMI (body mass index) &gt; 19 Kg/m2 and ≤ 45 Kg/m2.&#xD;
&#xD;
          -  Signed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Any clinical and laboratory findings that, in the judgment of the investigator, may&#xD;
             interfere with the safety of research participants;&#xD;
&#xD;
          -  History of alcohol abuse or illicit drug use;&#xD;
&#xD;
          -  Participation in clinical trial in the year prior to this study.&#xD;
&#xD;
          -  Fasting glycemia above 300 mg/dL;&#xD;
&#xD;
          -  Risk factors for severe volume depletion;&#xD;
&#xD;
          -  Diuretic use less than 60 days, except for spironolactone;&#xD;
&#xD;
          -  History of diabetic ketoacidosis;&#xD;
&#xD;
          -  Medical history of acute coronary syndrome, stroke or transient ischemic attack within&#xD;
             3 months prior to informed consent;&#xD;
&#xD;
          -  Impaired hepatic function;&#xD;
&#xD;
          -  Impaired renal function and end stage renal disease;&#xD;
&#xD;
          -  Bariatric surgery in the last two years and/ or other gastrointestinal surgeries;&#xD;
&#xD;
          -  Current medical history of cancer and/ or cancer treatment in the last 5 years;&#xD;
&#xD;
          -  Medical history of blood dyscrasia or any other hemolytic disorders;&#xD;
&#xD;
          -  Medical history of pancreatitis and chronic pancreatitis;&#xD;
&#xD;
          -  Treatment with anti-obesity drugs for less than 2 months or with dose change in the&#xD;
             last 2 months;&#xD;
&#xD;
          -  Current and prolonged treatment for more than 15 days with systemic steroids at the&#xD;
             moment of informed consent;&#xD;
&#xD;
          -  Any other uncontrolled endocrine disorder, except type 2 diabetes mellitus;&#xD;
&#xD;
          -  History hypersensitivity to the active ingredients used in the study;&#xD;
&#xD;
          -  Pregnancy or risk of pregnancy and lactating patients;&#xD;
&#xD;
          -  Systemic disease that is not controlled and can put the participant at risk;&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>July 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>July 25, 2022</last_update_submitted>
  <last_update_submitted_qc>July 25, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">July 27, 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>Dapagliflozin</mesh_term>
    <mesh_term>Linagliptin</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/NCT03766750
org study id: EMS0318-LIMA
nct id: NCT03766750
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to evaluate the efficacy and safety of Lima association in the
      control of type 2 diabetes mellitus
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Reduction of glycated hemoglobin levels measured between the first visit and the last visit.
time frame: 120 days
measure: Incidence and severity of adverse events recorded during the study.
time frame: 210 days
arm group label: LIMA
arm group type: Experimental
arm group label: Tradjenta®
arm group type: Active Comparator
arm group label: Forxiga®
arm group type: Active Comparator
intervention type: Drug
intervention name: LIMA association
description: 1 coated tablet, oral, once a day.
arm group label: LIMA
other name: EMS association
intervention type: Drug
intervention name: Tradjenta
description: 1 coated tablet, oral, once a day.
arm group label: Tradjenta®
other name: Linagliptin 5 mg
intervention type: Drug
intervention name: Forxiga
description: 1 coated tablet, oral, once a day.
arm group label: Forxiga®
other name: Dapagliflozin 10 mg
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
responsible party type: Sponsor
mesh term: Diabetes Mellitus
mesh term: Diabetes Mellitus, Type 2
mesh term: Dapagliflozin
mesh term: Linagliptin