xml: <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/NCT06017544</url>
    </required_header>
    <id_info>
      <org_study_id>0124.082023</org_study_id>
      <nct_id>NCT06017544</nct_id>
    </id_info>
    <brief_title>GLP-1RAs) and SGLT2is Combination Therapy and MACEs in Patients With Type 2 Diabetes.</brief_title>
    <official_title>Glucagon-Like Peptide-1 Receptor Agonists (GLP-1RAs) and Sodium-Glucose Cotransporter-2 Inhibitors (SGLT2is) Combination Therapy and Major Adverse Cardiovascular Events After Acute Myocardial Infarction: an Observational Study in Patients With Type 2 Diabetes.</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University of Campania &quot;Luigi Vanvitelli&quot;</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>University of Campania &quot;Luigi Vanvitelli&quot;</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        Management of type 2 diabetes mellitus (T2DM) has evolved from a glucocentric to a&#xD;
        cardiometabolic approach. Both glucagon-like peptide-1 receptor agonists (GLP-1RAs) and&#xD;
        sodium-glucose cotransporter-2 inhibitors (SGLT2is) reduce cardiovascular and kidney outcomes&#xD;
        in T2DM patients with a low hypoglycemia risk. The T2DM di per se still carries a higher risk&#xD;
        of mortality and major cardiovascular complications, doubling the case fatality rate. Tacking&#xD;
        that GLP-1RAs and SGLT2is have different mechanisms of action, resulting in complementary&#xD;
        pharmacokinetics and pharmacodynamics, the combination use may present clinical efficacy and&#xD;
        safety in T2DM patients with AMI. However, there is limited clinical evidence that supports&#xD;
        the combined use of these drugs, and there are currently no studies investigating the effects&#xD;
        of combination treatment in T2DM patients with acute cardiovascular events, on MACE as well&#xD;
        as on myocardial post-infarction rescue. Therefore, authors will conduct an observational&#xD;
        prospective study to evaluate the effects GLP-1RAs and SGLT2is combination therapy on MACE&#xD;
        such as mortality, acute coronary syndrome and heart failure, and myocardial salvage index&#xD;
        (MSI) after acute myocardial infarction (AMI) in T2DM patients.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Management of type 2 diabetes mellitus (T2DM) has evolved from a glucocentric to a&#xD;
        cardiometabolic approach. Consequently, choosing anti-hyperglycemic therapies with proven&#xD;
        cardiovascular and renal benefits is now a cornerstone of T2DM management. Both glucagon-like&#xD;
        peptide-1 receptor agonists (GLP-1RAs) and sodium-glucose cotransporter-2 inhibitors&#xD;
        (SGLT2is) individually been shown to reduce cardiovascular and kidney outcomes in T2DM&#xD;
        patients with a low hypoglycemia risk. Thus, the American Diabetes Association (ADA) and the&#xD;
        European Association for the Study of Diabetes (EASD) indifferently recommended both classes&#xD;
        as first-line therapy in patients with T2DM and established atherosclerotic cardiovascular&#xD;
        disease (ASCVD) or multiple ASCVD risk factors to reduce the risk of major adverse&#xD;
        cardiovascular events (MACE). However, although these drugs have singularly improved survival&#xD;
        in both T2DM and non-T2DM patients with acute myocardial infarction (AMI), the presence of&#xD;
        T2DM still carries a higher risk of mortality and major cardiovascular complications,&#xD;
        doubling the case fatality rate. Tacking that GLP-1RAs and SGLT2is have different mechanisms&#xD;
        of action, resulting in complementary pharmacokinetics and pharmacodynamics, the combination&#xD;
        use may present clinical efficacy and safety in T2DM patients with AMI. In such patients, the&#xD;
        ADA-EASD 2022 consensus report also recommends the combination of GLP-1RAs and SGLT2is when&#xD;
        the haemoglobin A1c (HbA1c) target is not reached with a drug from one of the two classes&#xD;
        [6]. However, there is limited clinical evidence that supports the combined use of these&#xD;
        drugs, and there are currently no studies investigating the effects of combination treatment&#xD;
        in T2DM patients with acute cardiovascular events, on MACE as well as on myocardial&#xD;
        post-infarction rescue. Therefore, authors will conduct an observational prospective study to&#xD;
        evaluate the effects GLP-1RAs and SGLT2is combination therapy on MACE such as mortality,&#xD;
        acute coronary syndrome and heart failure, and myocardial salvage index (MSI) after acute&#xD;
        myocardial infarction (AMI) in T2DM patients.&#xD;
  &#xD;
        Methods Study design Authors will perform a three-centres, prospective observational study&#xD;
        with post-enrollment allocation of groups. Consecutive T2DM patients, treated with GLP-1 RA&#xD;
        or SGLT-2i, with acute myocardial infarction will be enlisted for this study. All T2DM&#xD;
        patients hospitalized due to AMI as a primary diagnosis, both ST-elevation myocardial&#xD;
        infarction (STEMI) and non-ST-elevation myocardial infarction (NSTEMI), referred for&#xD;
        percutaneous coronary intervention (PCI), will be initially screened from January 1, 2018,&#xD;
        through December 31, 2022. Patients will be stratified according to their glycemic control at&#xD;
        the time of hospitalization. As suggested by the ADA Standard of Care in diabetes, T2DM&#xD;
        patients with HbA1c &lt;7% wil be considered in good glycemic control. T2DM patients in good&#xD;
        glycemic control will be further stratified according to GLP-1 RA or SGLT-2i treatment for at&#xD;
        least 3 months before index hospitalization. According to the ADA and the EASD&#xD;
        recommendations, the combination of GLP-1RA and SGLT2i will be adopted in T2DM in poor&#xD;
        glycemic control (HbA1c &gt;7%). Exclusion criteria will include evidence of heart failure,&#xD;
        valvular defects, malignant neoplasms, or secondary causes of hypertension. After discharge&#xD;
        from the hospital, all T2DM patients will be managed and followed quarterly for two years&#xD;
        after PCI as outpatients to maintain HbA1c level at &lt;7%, blood glucose level of 80-130 mg/dl,&#xD;
        and post-prandial blood glucose level of &lt;180 mg/dl. A multifactorial person-centered&#xD;
        approach will be adopted during the follow-up to maintain the glycemic, weight, and&#xD;
        cardiorenal goals. According to the ADA and EASD recommendations, patients initially treated&#xD;
        with GLP-1 RA or SGLT-2i will be switched to combination therapy when HbA1c was &gt;7% during&#xD;
        follow-up. The myocardial rescue will be evaluated by MSI (SPECT) before the hospital&#xD;
        discharge and at the end of follow-up, as previously described. Briefly, authors will use the&#xD;
        total perfusion deficit (TPD) to calculate the area at risk (AAR) and infarct size. Regarding&#xD;
        quantitative gated SPECT (QGS) data, QGS software (Cedars-Sinai Medical Center, Los Angeles,&#xD;
        CA, USA) will be used to calculate LV function and volume. The SPECT data will be collected&#xD;
        and calculated as follows: AAR (%) as TPD on 123I-BMIPP polar-map; infarct size (%) as TPD on&#xD;
        99mTc-tetrofosmin polar-map; MSI = (AAR - infarct size)/AAR; LV volume and function (LV&#xD;
        end-systolic volume [LVESV], LV end-diastolic volume [LVEDV], and LV ejection fraction&#xD;
        [LVEF]) based on 99mTc-tetrofosmin QGS data. All SPECT analyses will be performed by&#xD;
        experienced radiology technologists who will be unaware of patients' and angiographic&#xD;
        characteristics With regard to full medical therapy, the protocol stated that the use of&#xD;
        concomitant treatment should be as uniform as possible and according to evidence-based&#xD;
        international guidelines for AMI. Patients with incomplete data or lost during follow-up will&#xD;
        be excluded from the analysis.&#xD;
  &#xD;
        Study endpoints The study's primary endpoint will be the composite of mortality, acute heart&#xD;
        failure, and acute coronary syndrome (SCA) requiring hospitalization. To avoid interference,&#xD;
        each patient could only account for one event classification. The secondary endpoint will be&#xD;
        the MSI.&#xD;
  &#xD;
        Statistical analysis Data will be presented as numbers and frequencies for categorical&#xD;
        variables and as means and standard deviations for continuous variables. The distribution of&#xD;
        variables will be assessed with the Shapiro-Wilk test. The differences between the three&#xD;
        study groups will be assessed using ANOVA and Mann-Whitney tests, as appropriate. Categorical&#xD;
        variables will be described using frequencies and percentages and compared using χ2 -test.&#xD;
        Differences among the three groups for continuous and categorical variables will be assessed&#xD;
        by ANOVA and χ2-test, respectively. Cox regression analysis will be used to examine the&#xD;
        association between the combination of GLP-1RAs and SGLT2is and the incidence of the&#xD;
        composite outcome and will be adjusted for age, sex, BMI, diabetes duration, 24-months HbA1c&#xD;
        mean levels, admission HbA1c mean levels 3-months HbA1c mean levels, LDL-cholesterol,&#xD;
        troponin, creatinine, the prevalence of hypertension, dyslipidemia and smoking. P values &lt;&#xD;
        0.05 will be considered statistically significant. All calculations will be performed using&#xD;
        SPSS 29.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">January 1, 2021</start_date>
    <completion_date type="Anticipated">June 1, 2024</completion_date>
    <primary_completion_date type="Actual">August 1, 2023</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Case-Control</observational_model>
      <time_perspective>Prospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>MACE</measure>
      <time_frame>12 months</time_frame>
      <description>The study's primary endpoint was the composite of mortality, acute heart failure, and acute coronary syndrome (SCA) requiring hospitalization.</description>
    </primary_outcome>
    <number_of_groups>3</number_of_groups>
    <enrollment type="Anticipated">257</enrollment>
    <condition>Diabetes Mellitus, Type 2</condition>
    <condition>Myocardial Infarction</condition>
    <arm_group>
      <arm_group_label>T2DM patients with GLP-1 RA</arm_group_label>
      <description>T2DM patients hospitalized due to AMI as a primary diagnosis, both STEMI and NSTEMI, referred for PCI, and under GLP-1 RA.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>T2DM patients with SGLT2-is</arm_group_label>
      <description>T2DM patients hospitalized due to AMI as a primary diagnosis, both STEMI and NSTEMI, referred for PCI, and under SGLT2-is.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>T2DM patients with GLP-1 RA plus SGLT2-is</arm_group_label>
      <description>T2DM patients hospitalized due to AMI as a primary diagnosis, both STEMI and NSTEMI, referred for PCI, and under GLP-1 RA plus SGLT2-is.</description>
    </arm_group>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>PCI</intervention_name>
      <description>The T2DM affected by AMI will be referred for receiving PCI.</description>
      <arm_group_label>T2DM patients with GLP-1 RA</arm_group_label>
      <arm_group_label>T2DM patients with GLP-1 RA plus SGLT2-is</arm_group_label>
      <arm_group_label>T2DM patients with SGLT2-is</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          T2DM patients, treated with GLP-1 RA or SGLT-2i, hospitalized due to AMI (STEMI and&#xD;
          NSTEMI), and referred for PCI. The patients will be stratified according to their glycemic&#xD;
          control at the time of hospitalization: T2DM patients with HbA1c &lt;7% will be considered in&#xD;
          good glycemic control.&#xD;
  &#xD;
          T2DM patients in good glycemic control will be further stratified according to GLP-1 RA or&#xD;
          SGLT-2i treatment for at least 3 months before index hospitalization. The combination of&#xD;
          GLP-1RA and SGLT2i will be adopted in T2DM in poor glycemic control (HbA1c &gt;7%). After&#xD;
          discharge from the hospital, all T2DM patients will be managed and followed quarterly for&#xD;
          two years after PCI as outpatients to maintain HbA1c level at &lt;7%, blood glucose level of&#xD;
          80-130 mg/dl, and post-prandial blood glucose level of &lt;180 mg/dl.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Consecutive T2DM patients, treated with GLP-1 RA or SGLT-2i, with AMI;&#xD;
  &#xD;
            -  both STEMI and NSTEMI patients referred for PCI;&#xD;
  &#xD;
          Exclusion criteria:&#xD;
  &#xD;
            -  heart failure and valvular defects;&#xD;
  &#xD;
            -  inflammatory chronic diseases;&#xD;
  &#xD;
            -  neoplastic diseases.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>75 Years</maximum_age>
    </eligibility>
    <overall_contact>
      <last_name>Celestino Sardu</last_name>
      <phone>3336664543</phone>
      <email>drsarducele@gmail.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>Celestino Sardu</name>
        <address>
          <city>Naples</city>
          <zip>80138</zip>
          <country>Italy</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Raffaele Marfella, MD, PhD</last_name>
        <phone>+39 0810815665110</phone>
        <email>raffaele.marfella@unicampania.it</email>
      </contact>
      <contact_backup>
        <last_name>Celestino Sardu, MD, MSc, PhD</last_name>
        <phone>+393336664543</phone>
        <email>drsarducele@gmail.com</email>
      </contact_backup>
    </location>
    <location_countries>
      <country>Italy</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 24, 2023</study_first_submitted>
    <study_first_submitted_qc>August 24, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 30, 2023</study_first_posted>
    <last_update_submitted>August 31, 2023</last_update_submitted>
    <last_update_submitted_qc>August 31, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 5, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>University of Campania &quot;Luigi Vanvitelli&quot;</investigator_affiliation>
      <investigator_full_name>Celestino Sardu</investigator_full_name>
      <investigator_title>Professor of Medicine</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Myocardial Infarction</mesh_term>
      <mesh_term>Diabetes Mellitus</mesh_term>
      <mesh_term>Diabetes Mellitus, Type 2</mesh_term>
      <mesh_term>Infarction</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Undecided</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06017544
  org study id: 0124.082023
  nct id: NCT06017544
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  Management of type 2 diabetes mellitus (T2DM) has evolved from a glucocentric to a
        cardiometabolic approach. Both glucagon-like peptide-1 receptor agonists (GLP-1RAs) and
        sodium-glucose cotransporter-2 inhibitors (SGLT2is) reduce cardiovascular and kidney outcomes
        in T2DM patients with a low hypoglycemia risk. The T2DM di per se still carries a higher risk
        of mortality and major cardiovascular complications, doubling the case fatality rate. Tacking
        that GLP-1RAs and SGLT2is have different mechanisms of action, resulting in complementary
        pharmacokinetics and pharmacodynamics, the combination use may present clinical efficacy and
        safety in T2DM patients with AMI. However, there is limited clinical evidence that supports
        the combined use of these drugs, and there are currently no studies investigating the effects
        of combination treatment in T2DM patients with acute cardiovascular events, on MACE as well
        as on myocardial post-infarction rescue. Therefore, authors will conduct an observational
        prospective study to evaluate the effects GLP-1RAs and SGLT2is combination therapy on MACE
        such as mortality, acute coronary syndrome and heart failure, and myocardial salvage index
        (MSI) after acute myocardial infarction (AMI) in T2DM patients.
  Management of type 2 diabetes mellitus (T2DM) has evolved from a glucocentric to a
        cardiometabolic approach. Consequently, choosing anti-hyperglycemic therapies with proven
        cardiovascular and renal benefits is now a cornerstone of T2DM management. Both glucagon-like
        peptide-1 receptor agonists (GLP-1RAs) and sodium-glucose cotransporter-2 inhibitors
        (SGLT2is) individually been shown to reduce cardiovascular and kidney outcomes in T2DM
        patients with a low hypoglycemia risk. Thus, the American Diabetes Association (ADA) and the
        European Association for the Study of Diabetes (EASD) indifferently recommended both classes
        as first-line therapy in patients with T2DM and established atherosclerotic cardiovascular
        disease (ASCVD) or multiple ASCVD risk factors to reduce the risk of major adverse
        cardiovascular events (MACE). However, although these drugs have singularly improved survival
        in both T2DM and non-T2DM patients with acute myocardial infarction (AMI), the presence of
        T2DM still carries a higher risk of mortality and major cardiovascular complications,
        doubling the case fatality rate. Tacking that GLP-1RAs and SGLT2is have different mechanisms
        of action, resulting in complementary pharmacokinetics and pharmacodynamics, the combination
        use may present clinical efficacy and safety in T2DM patients with AMI. In such patients, the
        ADA-EASD 2022 consensus report also recommends the combination of GLP-1RAs and SGLT2is when
        the haemoglobin A1c (HbA1c) target is not reached with a drug from one of the two classes
        [6]. However, there is limited clinical evidence that supports the combined use of these
        drugs, and there are currently no studies investigating the effects of combination treatment
        in T2DM patients with acute cardiovascular events, on MACE as well as on myocardial
        post-infarction rescue. Therefore, authors will conduct an observational prospective study to
        evaluate the effects GLP-1RAs and SGLT2is combination therapy on MACE such as mortality,
        acute coronary syndrome and heart failure, and myocardial salvage index (MSI) after acute
        myocardial infarction (AMI) in T2DM patients.
  
        Methods Study design Authors will perform a three-centres, prospective observational study
        with post-enrollment allocation of groups. Consecutive T2DM patients, treated with GLP-1 RA
        or SGLT-2i, with acute myocardial infarction will be enlisted for this study. All T2DM
        patients hospitalized due to AMI as a primary diagnosis, both ST-elevation myocardial
        infarction (STEMI) and non-ST-elevation myocardial infarction (NSTEMI), referred for
        percutaneous coronary intervention (PCI), will be initially screened from January 1, 2018,
        through December 31, 2022. Patients will be stratified according to their glycemic control at
        the time of hospitalization. As suggested by the ADA Standard of Care in diabetes, T2DM
        patients with HbA1c <7% wil be considered in good glycemic control. T2DM patients in good
        glycemic control will be further stratified according to GLP-1 RA or SGLT-2i treatment for at
        least 3 months before index hospitalization. According to the ADA and the EASD
        recommendations, the combination of GLP-1RA and SGLT2i will be adopted in T2DM in poor
        glycemic control (HbA1c >7%). Exclusion criteria will include evidence of heart failure,
        valvular defects, malignant neoplasms, or secondary causes of hypertension. After discharge
        from the hospital, all T2DM patients will be managed and followed quarterly for two years
        after PCI as outpatients to maintain HbA1c level at <7%, blood glucose level of 80-130 mg/dl,
        and post-prandial blood glucose level of <180 mg/dl. A multifactorial person-centered
        approach will be adopted during the follow-up to maintain the glycemic, weight, and
        cardiorenal goals. According to the ADA and EASD recommendations, patients initially treated
        with GLP-1 RA or SGLT-2i will be switched to combination therapy when HbA1c was >7% during
        follow-up. The myocardial rescue will be evaluated by MSI (SPECT) before the hospital
        discharge and at the end of follow-up, as previously described. Briefly, authors will use the
        total perfusion deficit (TPD) to calculate the area at risk (AAR) and infarct size. Regarding
        quantitative gated SPECT (QGS) data, QGS software (Cedars-Sinai Medical Center, Los Angeles,
        CA, USA) will be used to calculate LV function and volume. The SPECT data will be collected
        and calculated as follows: AAR (%) as TPD on 123I-BMIPP polar-map; infarct size (%) as TPD on
        99mTc-tetrofosmin polar-map; MSI = (AAR - infarct size)/AAR; LV volume and function (LV
        end-systolic volume [LVESV], LV end-diastolic volume [LVEDV], and LV ejection fraction
        [LVEF]) based on 99mTc-tetrofosmin QGS data. All SPECT analyses will be performed by
        experienced radiology technologists who will be unaware of patients' and angiographic
        characteristics With regard to full medical therapy, the protocol stated that the use of
        concomitant treatment should be as uniform as possible and according to evidence-based
        international guidelines for AMI. Patients with incomplete data or lost during follow-up will
        be excluded from the analysis.
  
        Study endpoints The study's primary endpoint will be the composite of mortality, acute heart
        failure, and acute coronary syndrome (SCA) requiring hospitalization. To avoid interference,
        each patient could only account for one event classification. The secondary endpoint will be
        the MSI.
  
        Statistical analysis Data will be presented as numbers and frequencies for categorical
        variables and as means and standard deviations for continuous variables. The distribution of
        variables will be assessed with the Shapiro-Wilk test. The differences between the three
        study groups will be assessed using ANOVA and Mann-Whitney tests, as appropriate. Categorical
        variables will be described using frequencies and percentages and compared using χ2 -test.
        Differences among the three groups for continuous and categorical variables will be assessed
        by ANOVA and χ2-test, respectively. Cox regression analysis will be used to examine the
        association between the combination of GLP-1RAs and SGLT2is and the incidence of the
        composite outcome and will be adjusted for age, sex, BMI, diabetes duration, 24-months HbA1c
        mean levels, admission HbA1c mean levels 3-months HbA1c mean levels, LDL-cholesterol,
        troponin, creatinine, the prevalence of hypertension, dyslipidemia and smoking. P values <
        0.05 will be considered statistically significant. All calculations will be performed using
        SPSS 29.
  observational model: Case-Control
  time perspective: Prospective
  measure: MACE
  time frame: 12 months
  description: The study's primary endpoint was the composite of mortality, acute heart failure, and acute coronary syndrome (SCA) requiring hospitalization.
  arm group label: T2DM patients with GLP-1 RA
  description: T2DM patients hospitalized due to AMI as a primary diagnosis, both STEMI and NSTEMI, referred for PCI, and under GLP-1 RA.
  arm group label: T2DM patients with SGLT2-is
  description: T2DM patients hospitalized due to AMI as a primary diagnosis, both STEMI and NSTEMI, referred for PCI, and under SGLT2-is.
  arm group label: T2DM patients with GLP-1 RA plus SGLT2-is
  description: T2DM patients hospitalized due to AMI as a primary diagnosis, both STEMI and NSTEMI, referred for PCI, and under GLP-1 RA plus SGLT2-is.
  intervention type: Procedure
  intervention name: PCI
  description: The T2DM affected by AMI will be referred for receiving PCI.
  arm group label: T2DM patients with GLP-1 RA
  arm group label: T2DM patients with GLP-1 RA plus SGLT2-is
  arm group label: T2DM patients with SGLT2-is
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 75 Years
  last name: Celestino Sardu
  phone: 3336664543
  email: drsarducele@gmail.com
  facility: 
  status: Recruiting
  contact: 
  contact backup: 
  country: Italy
  responsible party type: Principal Investigator
  investigator affiliation: University of Campania "Luigi Vanvitelli"
  investigator full name: Celestino Sardu
  investigator title: Professor of Medicine
  mesh term: Myocardial Infarction
  mesh term: Diabetes Mellitus
  mesh term: Diabetes Mellitus, Type 2
  mesh term: Infarction
  sharing ipd: Undecided