<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/NCT03813316</url>
  </required_header>
  <id_info>
    <org_study_id>58214</org_study_id>
    <nct_id>NCT03813316</nct_id>
  </id_info>
  <brief_title>Approaches To Therapy Escalation In T2D</brief_title>
  <acronym>ATTACC</acronym>
  <official_title>Approaches To Therapy Escalation In T2D: A Cluster Randomized Control Trial (ATTACC)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>LMC Diabetes &amp; Endocrinology Ltd.</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Merck Sharp &amp; Dohme LLC</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
    <collaborator>
      <agency>Syreon Corporation</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>LMC Diabetes &amp; Endocrinology Ltd.</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>
  </oversight_info>
  <brief_summary>
    <textblock>
      Type 2 diabetes mellitus (T2D) is a serious public health challenge which affects more than&#xD;
      9% of Canadians older than 20 years, an estimated prevalence that is anticipated to increase&#xD;
      by over 40% in the next decade. The microvascular and macrovascular complications of T2D&#xD;
      markedly increase the risks of hospitalization, heart disease, amputation, blindness, end&#xD;
      stage renal disease and death, with profound socio-economic consequences for patients,&#xD;
      families and society.&#xD;
&#xD;
      Optimal glycemic control is fundamental to the management of T2D, as glycated hemoglobin&#xD;
      (A1C) levels &gt; 7.0% are associated with a significantly increased risk of both microvascular&#xD;
      and cardiovascular complications. But despite detailed clinical practice guidelines for&#xD;
      management of hyperglycemia, glycemic control remains sub-optimal in a large proportion of&#xD;
      patients. For example, in over 5000 Canadian diabetic patients managed by primary care&#xD;
      physicians (PCPs), more than 50% had an A1C &gt; 7% and more than 20% an A1C &gt; 8%.&#xD;
&#xD;
      For patients not achieving glycemic target on metformin monotherapy and without clinical CVD,&#xD;
      Diabetes Canada 2018 Guidelines suggest that the preferred oral antihyperglycemic agents as&#xD;
      add-on therapy be either DPP-4 inhibitors or SGLT2 inhibitors if avoidance of hypoglycemia&#xD;
      and/or weight gain is a priority. Since most patients with type 2 diabetes would benefit from&#xD;
      avoidance of hypoglycemia and/or weight gain, there is clinical rationale for adding DPP-4&#xD;
      inhibitors or SGLT2 inhibitors as oral therapy before considering other oral agents like&#xD;
      sulfonylureas or thiazolidinediones. This study is designed to explore the possibility of&#xD;
      improving care by providing more precise management guidance to primary care physicians when&#xD;
      utilizing DPP-4 inhibitors or SGLT2 inhibitors as add-on therapy to metformin.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This cluster-based study will be conducted in a Primary Care clinical practice setting in&#xD;
      Canada. A total of approximately 60 physician practices will be stratified into single (1&#xD;
      PCP) or group (&gt;1 PCP) practices and randomized 1:1 into two arms each consisting of&#xD;
      approximately 30 Primary Care practices forming the Interventional arm and the Control arm.&#xD;
      The study population will include approximately 600 male and female adult participants living&#xD;
      in Canada; who have been diagnosed with T2D; who are being treated for this condition by&#xD;
      their PCP; who do not have clinical cardiovascular disease (CVD) and whose eGFR is ≥&#xD;
      60ml/min; who are receiving metformin at a dose of ≥1500 mg/day as monotherapy for T2D; who&#xD;
      are not at the target for glycemic control and whose most recent A1C level is between 7.1 %&#xD;
      and 9.0 %. Participant enrollment may be adjusted to ensure balanced distribution of glycemic&#xD;
      values at entry across this range between study arms.&#xD;
&#xD;
      All physicians in both arms will receive training on the most current Diabetes Canada 2018&#xD;
      Guidelines for pharmacologic management of type 2 diabetes and the role of DPP-4 inhibitors&#xD;
      or SGLT2 inhibitors as add-on therapy to metformin. Physicians in the Interventional arm will&#xD;
      receive additional training on specific individualized management for adding DPP-4 inhibitors&#xD;
      or SGLT2 inhibitors to metformin. The nature of the additional training will be described&#xD;
      separately in a physician training manual. To avoid contamination, only physicians who have&#xD;
      been randomized to the Interventional arm will be given access to the physician training&#xD;
      manual during the operation of the study, while those physicians randomized into the Control&#xD;
      arm will continue to follow their routine clinical practice for utilizing DPP-4 inhibitors or&#xD;
      SGLT2 inhibitors as add-on to metformin according to the current Diabetes Canada Practice&#xD;
      Guidelines.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    Lack of funding availability to complete project&#xD;
  </why_stopped>
  <start_date type="Actual">May 1, 2019</start_date>
  <completion_date type="Actual">September 18, 2019</completion_date>
  <primary_completion_date type="Actual">September 18, 2019</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>
    <intervention_model_description>Model Description&quot; by adding another sentence as follows: &quot;Randomization with be cluster-based by investigator to either standard care or specific individualized training for adding DPP-4 inhibitors and/or SGLT2 inhibitors to metformin</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>The percentage of participants achieving an A1C value of ≤ 7% at 24 weeks</measure>
    <time_frame>24 Weeks</time_frame>
    <description>This study is designed to test the hypothesis that the provision of physician guidance and specialized training on utilizing DPP-4 inhibitors or SGLT2 inhibitors as add-on to metformin will result in more participants achieving glycemic target at Week 24 when compared to a usual care approach.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>The percentage of participants achieving an A1C value ≤ 7% at 12 weeks</measure>
    <time_frame>12 weeks</time_frame>
    <description>This secondary endpoint will be the proportion of participants who achieve an A1C value of ≤7%</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The absolute reduction in A1C from Baseline at 24 weeks</measure>
    <time_frame>Week 12 and Week 24.</time_frame>
    <description>This secondary endpoint will be the absolute reduction in A1C values between Baseline and Week 12 / Week 24.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The percentage of participants requiring a change of therapy or rescue therapy at 12 weeks</measure>
    <time_frame>At 12 weeks</time_frame>
    <description>Change in therapy will be defined as a change from baseline in the medications or doses of these medications used for glycemic control during the 26 weeks of observation for each participant. Rescue therapy will be allowable at any time during the study for urgent clinical need, this should be delayed, if possible, for at least 12 weeks following the administration of the study drugs. At 12 weeks, if A1C is &gt; 9.0%, rescue therapy can be initiated.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Drug tolerability including percentage of participants with hypoglycemic events, and percentage with adverse events.events.</measure>
    <time_frame>24 weeks</time_frame>
    <description>Hypoglycemic events will be diagnosed based on symptoms (confirmed by self-monitored blood glucose ≤ 3.9 mmol/L where available) and will be categorized into 4 groups of: (a) severe, ie requiring the assistance of another person, (b) non-severe, ie those that could be self-managed, (c) nocturnal, (d) daytime.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The absolute reduction in FPG from Baseline at 24 weeks</measure>
    <time_frame>24 weeks</time_frame>
    <description>This secondary endpoint will be the absolute reduction in FPG values between Baseline and Week 24.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The absolute change in body weight from Baseline at 24 weeks</measure>
    <time_frame>24 weeks</time_frame>
    <description>This secondary endpoint will be the absolute change in body weight between Baseline and Week 24.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The absolute change in systolic blood pressure from Baseline at 24 weeks</measure>
    <time_frame>24 weeks</time_frame>
    <description>This secondary endpoint will be the absolute change in systolic blood pressure from Baseline to Week 24.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The percentage of participants achieving the composite outcome of A1C ≤ 7.0%, no weight gain and no hypoglycemia at Week 24.</measure>
    <time_frame>24 weeks</time_frame>
    <description>This secondary endpoint will be the percentage of participants achieving the composite outcome of A1C ≤ 7.0%, no weight gain and no hypoglycemia at Week 24.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The percentage of participants on statin therapy at 24 weeks</measure>
    <time_frame>24 weeks</time_frame>
    <description>This secondary endpoint will be the percentage of participants on statin therapy at Week 24.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The percentage of participants on antihypertensive therapy at Week 24.</measure>
    <time_frame>24 weeks</time_frame>
    <description>This secondary endpoint will be the percentage of participants on antihypertensive therapy at Week 24.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Type2 Diabetes</condition>
  <arm_group>
    <arm_group_label>Interventional Arm</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Adding a DPP-4i (sitagliptin) and/or an SGLT2i (ertugliflozin) to metformin after receiving extra training on individualized care.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control Arm</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Adding a DPP-4i (sitagliptin) and/or an SGLT2i (ertugliflozin) to metformin as per standard care/Diabetes Canada guidelines.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>DPP-4 inhibitor</intervention_name>
    <description>Adding sitagliptin (DPP-4i) add-on using a fixed-dose combination with metformin (Janumet® 50/1000 mg BID).</description>
    <arm_group_label>Control Arm</arm_group_label>
    <arm_group_label>Interventional Arm</arm_group_label>
    <other_name>Sitagliptin</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>SGLT2 inhibitor</intervention_name>
    <description>Adding ertugliflozin (SGLT2i) add-on using a fixed-dose combination with metformin(Segluromet® 2.5/1000 mg BID)</description>
    <arm_group_label>Control Arm</arm_group_label>
    <arm_group_label>Interventional Arm</arm_group_label>
    <other_name>Ertugliflozin</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>SGLT2 inhibitor and DPP-4 inhibitor</intervention_name>
    <description>Adding both a DPP-4i as Fixed dose combination (Janumet) plus SGLT2i ertugliflozin (steglatro) as add-on to metformin.</description>
    <arm_group_label>Control Arm</arm_group_label>
    <arm_group_label>Interventional Arm</arm_group_label>
    <other_name>Ertugliflozin and Sitagliptin</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        In order to be eligible to participate in this study, an individual must meet all of the&#xD;
        following criteria:&#xD;
&#xD;
          1. Provision of signed and dated informed consent form&#xD;
&#xD;
          2. Stated willingness to comply with all study procedures and availability for the&#xD;
             duration of the study&#xD;
&#xD;
          3. Male or female, aged 18 years of age or older&#xD;
&#xD;
          4. Previously diagnosed with T2D&#xD;
&#xD;
          5. Have a glycated hemoglobin (A1C) result at Baseline between 7.1% and 9%&#xD;
&#xD;
          6. Have an eGFR value at Baseline ≥60 ml/min/1.73m2&#xD;
&#xD;
          7. Receiving stable (≥ 8 weeks) metformin at a dose of ≥1500 mg/day as monotherapy for&#xD;
             T2D&#xD;
&#xD;
          8. Ability to take oral medication and be willing to adhere to the study intervention&#xD;
             regimen&#xD;
&#xD;
          9. Agreement to adhere to Lifestyle Considerations (see section 5.3) throughout study&#xD;
             duration&#xD;
&#xD;
         10. No reason for investigator to suspect they will not tolerate the study medication&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        An individual who meets any of the following criteria will be excluded from participation&#xD;
        in this study:&#xD;
&#xD;
          1. Treated with antihyperglycemic agents other than metformin monotherapy.&#xD;
&#xD;
          2. Known allergies or contraindications to the use of either DPP-4 inhibitors or SGLT2&#xD;
             inhibitors&#xD;
&#xD;
          3. Presence of clinical evidence of cardiovascular disease including a history of heart&#xD;
             failure, myocardial infarction, unstable angina, severe atherosclerotic cardiovascular&#xD;
             disease on angiography, peripheral arterial disease and/or prior low extremity&#xD;
             amputation, revascularization or stroke.&#xD;
&#xD;
          4. Known pregnancy or current lactation&#xD;
&#xD;
          5. Women of child bearing age not willing to use a method of contraception.&#xD;
&#xD;
          6. Febrile illness within 30 days of signing informed consent&#xD;
&#xD;
          7. Treatment with another investigational drug or other intervention within 90 days of&#xD;
             signing informed consent&#xD;
&#xD;
          8. Any physical or psychological condition(s) or diagnoses that in the opinion of the&#xD;
             treating physician may preclude participation&#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>Ronald M. Goldenberg, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>LMC Clinical Research Inc.</affiliation>
  </overall_official>
  <verification_date>September 2019</verification_date>
  <study_first_submitted>December 24, 2018</study_first_submitted>
  <study_first_submitted_qc>January 21, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 23, 2019</study_first_posted>
  <last_update_submitted>September 25, 2019</last_update_submitted>
  <last_update_submitted_qc>September 25, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">September 27, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Diabetes</keyword>
  <keyword>Type 2</keyword>
  <keyword>T2D</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Sitagliptin Phosphate</mesh_term>
    <mesh_term>Ertugliflozin</mesh_term>
    <mesh_term>Dipeptidyl-Peptidase IV Inhibitors</mesh_term>
    <mesh_term>Sodium-Glucose Transporter 2 Inhibitors</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/NCT03813316
org study id: 58214
nct id: NCT03813316
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Type 2 diabetes mellitus (T2D) is a serious public health challenge which affects more than
      9% of Canadians older than 20 years, an estimated prevalence that is anticipated to increase
      by over 40% in the next decade. The microvascular and macrovascular complications of T2D
      markedly increase the risks of hospitalization, heart disease, amputation, blindness, end
      stage renal disease and death, with profound socio-economic consequences for patients,
      families and society.

      Optimal glycemic control is fundamental to the management of T2D, as glycated hemoglobin
      (A1C) levels > 7.0% are associated with a significantly increased risk of both microvascular
      and cardiovascular complications. But despite detailed clinical practice guidelines for
      management of hyperglycemia, glycemic control remains sub-optimal in a large proportion of
      patients. For example, in over 5000 Canadian diabetic patients managed by primary care
      physicians (PCPs), more than 50% had an A1C > 7% and more than 20% an A1C > 8%.

      For patients not achieving glycemic target on metformin monotherapy and without clinical CVD,
      Diabetes Canada 2018 Guidelines suggest that the preferred oral antihyperglycemic agents as
      add-on therapy be either DPP-4 inhibitors or SGLT2 inhibitors if avoidance of hypoglycemia
      and/or weight gain is a priority. Since most patients with type 2 diabetes would benefit from
      avoidance of hypoglycemia and/or weight gain, there is clinical rationale for adding DPP-4
      inhibitors or SGLT2 inhibitors as oral therapy before considering other oral agents like
      sulfonylureas or thiazolidinediones. This study is designed to explore the possibility of
      improving care by providing more precise management guidance to primary care physicians when
      utilizing DPP-4 inhibitors or SGLT2 inhibitors as add-on therapy to metformin.
This cluster-based study will be conducted in a Primary Care clinical practice setting in
      Canada. A total of approximately 60 physician practices will be stratified into single (1
      PCP) or group (>1 PCP) practices and randomized 1:1 into two arms each consisting of
      approximately 30 Primary Care practices forming the Interventional arm and the Control arm.
      The study population will include approximately 600 male and female adult participants living
      in Canada; who have been diagnosed with T2D; who are being treated for this condition by
      their PCP; who do not have clinical cardiovascular disease (CVD) and whose eGFR is ≥
      60ml/min; who are receiving metformin at a dose of ≥1500 mg/day as monotherapy for T2D; who
      are not at the target for glycemic control and whose most recent A1C level is between 7.1 %
      and 9.0 %. Participant enrollment may be adjusted to ensure balanced distribution of glycemic
      values at entry across this range between study arms.

      All physicians in both arms will receive training on the most current Diabetes Canada 2018
      Guidelines for pharmacologic management of type 2 diabetes and the role of DPP-4 inhibitors
      or SGLT2 inhibitors as add-on therapy to metformin. Physicians in the Interventional arm will
      receive additional training on specific individualized management for adding DPP-4 inhibitors
      or SGLT2 inhibitors to metformin. The nature of the additional training will be described
      separately in a physician training manual. To avoid contamination, only physicians who have
      been randomized to the Interventional arm will be given access to the physician training
      manual during the operation of the study, while those physicians randomized into the Control
      arm will continue to follow their routine clinical practice for utilizing DPP-4 inhibitors or
      SGLT2 inhibitors as add-on to metformin according to the current Diabetes Canada Practice
      Guidelines.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Model Description" by adding another sentence as follows: "Randomization with be cluster-based by investigator to either standard care or specific individualized training for adding DPP-4 inhibitors and/or SGLT2 inhibitors to metformin
primary purpose: Treatment
masking: None (Open Label)
measure: The percentage of participants achieving an A1C value of ≤ 7% at 24 weeks
time frame: 24 Weeks
description: This study is designed to test the hypothesis that the provision of physician guidance and specialized training on utilizing DPP-4 inhibitors or SGLT2 inhibitors as add-on to metformin will result in more participants achieving glycemic target at Week 24 when compared to a usual care approach.
measure: The percentage of participants achieving an A1C value ≤ 7% at 12 weeks
time frame: 12 weeks
description: This secondary endpoint will be the proportion of participants who achieve an A1C value of ≤7%
measure: The absolute reduction in A1C from Baseline at 24 weeks
time frame: Week 12 and Week 24.
description: This secondary endpoint will be the absolute reduction in A1C values between Baseline and Week 12 / Week 24.
measure: The percentage of participants requiring a change of therapy or rescue therapy at 12 weeks
time frame: At 12 weeks
description: Change in therapy will be defined as a change from baseline in the medications or doses of these medications used for glycemic control during the 26 weeks of observation for each participant. Rescue therapy will be allowable at any time during the study for urgent clinical need, this should be delayed, if possible, for at least 12 weeks following the administration of the study drugs. At 12 weeks, if A1C is > 9.0%, rescue therapy can be initiated.
measure: Drug tolerability including percentage of participants with hypoglycemic events, and percentage with adverse events.events.
time frame: 24 weeks
description: Hypoglycemic events will be diagnosed based on symptoms (confirmed by self-monitored blood glucose ≤ 3.9 mmol/L where available) and will be categorized into 4 groups of: (a) severe, ie requiring the assistance of another person, (b) non-severe, ie those that could be self-managed, (c) nocturnal, (d) daytime.
measure: The absolute reduction in FPG from Baseline at 24 weeks
time frame: 24 weeks
description: This secondary endpoint will be the absolute reduction in FPG values between Baseline and Week 24.
measure: The absolute change in body weight from Baseline at 24 weeks
time frame: 24 weeks
description: This secondary endpoint will be the absolute change in body weight between Baseline and Week 24.
measure: The absolute change in systolic blood pressure from Baseline at 24 weeks
time frame: 24 weeks
description: This secondary endpoint will be the absolute change in systolic blood pressure from Baseline to Week 24.
measure: The percentage of participants achieving the composite outcome of A1C ≤ 7.0%, no weight gain and no hypoglycemia at Week 24.
time frame: 24 weeks
description: This secondary endpoint will be the percentage of participants achieving the composite outcome of A1C ≤ 7.0%, no weight gain and no hypoglycemia at Week 24.
measure: The percentage of participants on statin therapy at 24 weeks
time frame: 24 weeks
description: This secondary endpoint will be the percentage of participants on statin therapy at Week 24.
measure: The percentage of participants on antihypertensive therapy at Week 24.
time frame: 24 weeks
description: This secondary endpoint will be the percentage of participants on antihypertensive therapy at Week 24.
arm group label: Interventional Arm
arm group type: Experimental
description: Adding a DPP-4i (sitagliptin) and/or an SGLT2i (ertugliflozin) to metformin after receiving extra training on individualized care.
arm group label: Control Arm
arm group type: Experimental
description: Adding a DPP-4i (sitagliptin) and/or an SGLT2i (ertugliflozin) to metformin as per standard care/Diabetes Canada guidelines.
intervention type: Drug
intervention name: DPP-4 inhibitor
description: Adding sitagliptin (DPP-4i) add-on using a fixed-dose combination with metformin (Janumet® 50/1000 mg BID).
arm group label: Control Arm
arm group label: Interventional Arm
other name: Sitagliptin
intervention type: Drug
intervention name: SGLT2 inhibitor
description: Adding ertugliflozin (SGLT2i) add-on using a fixed-dose combination with metformin(Segluromet® 2.5/1000 mg BID)
arm group label: Control Arm
arm group label: Interventional Arm
other name: Ertugliflozin
intervention type: Drug
intervention name: SGLT2 inhibitor and DPP-4 inhibitor
description: Adding both a DPP-4i as Fixed dose combination (Janumet) plus SGLT2i ertugliflozin (steglatro) as add-on to metformin.
arm group label: Control Arm
arm group label: Interventional Arm
other name: Ertugliflozin and Sitagliptin
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Ronald M. Goldenberg, MD
role: Principal Investigator
affiliation: LMC Clinical Research Inc.
responsible party type: Sponsor
mesh term: Sitagliptin Phosphate
mesh term: Ertugliflozin
mesh term: Dipeptidyl-Peptidase IV Inhibitors
mesh term: Sodium-Glucose Transporter 2 Inhibitors