<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/NCT03794336</url>
  </required_header>
  <id_info>
    <org_study_id>ALOGLC08867</org_study_id>
    <secondary_id>U1111-1210-0679</secondary_id>
    <nct_id>NCT03794336</nct_id>
  </id_info>
  <brief_title>Efficacy and Safety of Alogliptin vs. Acarbose in Chinese Type 2 Diabetes Mellitus (T2DM) Patients With High CV Risk or CHD Treated With Aspirin and Inadequately Controlled With Metformin Monotherapy or Drug Naive</brief_title>
  <acronym>ACADEMIC</acronym>
  <official_title>Efficacy and Safety of Alogliptin vs. Acarbose in Chinese T2DM Patients With High CV Risk or CHD Treated With Aspirin and Inadequately Controlled With Metformin Monotherapy or Drug Naive: A Multicenter, Randomized, Open Label, Prospective Study</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>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Primary Objectives:&#xD;
&#xD;
        -  To assess efficacy in terms of change from baseline in Hemoglobin A1c (HbA1c) at the end&#xD;
           of study between the two drugs.&#xD;
&#xD;
        -  To assess tolerability in terms of overall Gastrointestinal (GI) tolerability for&#xD;
           Alogliptin compared with acarbose during the whole treatment period.&#xD;
&#xD;
      Secondary Objectives:&#xD;
&#xD;
        -  To assess efficacy in terms of the percentage of patients achieving HbA1c&lt;7%.&#xD;
&#xD;
        -  To assess efficacy in terms of percentage of patients achieving HbA1c&lt;7% without GI&#xD;
           effects.&#xD;
&#xD;
        -  To assess change from baseline in Fasting plasma glucose (FPG), 2-h Post plasma glucose&#xD;
           (2-h PPG), β-cell function (HOMA-β), lipids and body weight.&#xD;
&#xD;
        -  To assess safety in terms of occurrence of hypoglycemia events.&#xD;
&#xD;
        -  To assess safety in terms of other adverse events.&#xD;
&#xD;
        -  To assess patient adherence and tolerability.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The duration of the study for each patient will be approximately 17 weeks consisting of about&#xD;
      1 week screening period and 16-week treatment period.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 29, 2019</start_date>
  <completion_date type="Actual">December 14, 2020</completion_date>
  <primary_completion_date type="Actual">December 14, 2020</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 in Hemoglobin A1c</measure>
    <time_frame>Baseline to week 16</time_frame>
    <description>Change from baseline in Hemoglobin A1c at the end of study (week 16) between the two drugs</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Overall Gastrointestinal tolerability</measure>
    <time_frame>Baseline to week 16</time_frame>
    <description>Incidence of any gastrointestinal adverse events during the whole treatment period.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Percentage of patients achieving HbA1c &lt;7%</measure>
    <time_frame>Baseline to Week 16</time_frame>
    <description>Percentage of patients achieving HbA1c &lt;7% at the end of study</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of patients achieving HbA1c &lt;7% without gastrointestinal effects</measure>
    <time_frame>Baseline to Week 16</time_frame>
    <description>Percentage of patients achieving HbA1c &lt;7% without gastrointestinal effects at the end of study</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Fasting Plasma Glucose (FPG)</measure>
    <time_frame>Baseline to Week 16</time_frame>
    <description>Change in FPG from baseline to week 16 between the two groups of drugs</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Occurrence of hypoglycemia events</measure>
    <time_frame>Baseline to Week 16</time_frame>
    <description>Number of patients reporting hypoglycemia events</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Other Adverse Events (AEs)</measure>
    <time_frame>Baseline to Week 16</time_frame>
    <description>Number of patients reporting other Adverse Events</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall tolerability</measure>
    <time_frame>Baseline to Week 16</time_frame>
    <description>Percentage of patients who discontinued study treatment as a result of adverse drug reaction</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Postprandial Plasma Glucose 2-h (PPG)</measure>
    <time_frame>Baseline to Week 16</time_frame>
    <description>Change in PPG from baseline to week 16 between two groups of drug</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Homeostasis model assessment-β (HOMA- β)</measure>
    <time_frame>Baseline to Week 16</time_frame>
    <description>Change in HOMA- β from baseline to week 16 between two groups of drug</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Total Cholesterol (TC)</measure>
    <time_frame>Baseline to Week 16</time_frame>
    <description>Changes from baseline in TC to week 16 between the two groups</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Tri Glycerides (TG)</measure>
    <time_frame>Baseline to Week 16</time_frame>
    <description>Changes from baseline in TG to week 16 between the two groups</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in High Density Lipoprotein-Cholesterol (HDL-C)</measure>
    <time_frame>Baseline to Week 16</time_frame>
    <description>Changes from baseline in HDL-C to week 16 between the two groups</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Low Density Lipoprotein-Cholesterol (LDL-C)</measure>
    <time_frame>Baseline to Week 16</time_frame>
    <description>Changes from baseline in LDL-C to week 16 between the two groups.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in body weight</measure>
    <time_frame>Baseline to Week 16</time_frame>
    <description>Changes from baseline in body weight to week 16 between the two groups</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall adherence to Investigational Medicinal Product (IMP)</measure>
    <time_frame>Baseline to Week 16</time_frame>
    <description>Calculated as overall dosing actually taken IMPs divided by the expected overall dosing as per protocol</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Medication possession ratio (MPR)</measure>
    <time_frame>Baseline to Week 16</time_frame>
    <description>Calculated as number of days actually taken IMPs divided by the expected number of days as per protocol</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">1293</enrollment>
  <condition>Type 2 Diabetes Mellitus</condition>
  <arm_group>
    <arm_group_label>Alogliptin</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Single dose of alogliptin once daily for 16 weeks</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Acarbose</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Thrice daily dose of acarbose Dose 1 for 7 days then titrate to thrice daily dose of of acarbose Dose 2</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Alogliptin</intervention_name>
    <description>Pharmaceutical form: tablet&#xD;
Route of administration: oral administration</description>
    <arm_group_label>Alogliptin</arm_group_label>
    <other_name>Nesina</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Acarbose</intervention_name>
    <description>Pharmaceutical form: tablet&#xD;
Route of administration: oral administration</description>
    <arm_group_label>Acarbose</arm_group_label>
    <other_name>Glucobay</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Metformin</intervention_name>
    <description>Pharmaceutical form: tablet&#xD;
Route of administration: oral administration</description>
    <arm_group_label>Acarbose</arm_group_label>
    <arm_group_label>Alogliptin</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Aspirin</intervention_name>
    <description>Pharmaceutical form: tablet&#xD;
Route of administration: oral administration</description>
    <arm_group_label>Acarbose</arm_group_label>
    <arm_group_label>Alogliptin</arm_group_label>
    <other_name>Bayaspirin</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion criteria :&#xD;
&#xD;
          -  Type 2 Diabetes Mellitus patients (age ≥18yr) drug naive or treated with metformin&#xD;
             monotherapy (≥1500 mg/day or individually maximally tolerated dose) for at least 12&#xD;
             weeks with a Hemoglobin A1c between ≥ 7.5% and ≤ 11.0% at screening.&#xD;
&#xD;
          -  Fasting plasma glucose ≤13.3mmol/L(≤240mg/dL) at screening.&#xD;
&#xD;
          -  Patients with documented history of Coronary Heart Disease (CHD) or High&#xD;
             cardiovascular(CV) risk.&#xD;
&#xD;
          -  History of CHD, defined as previous myocardial infarction or unstable/stable angina.&#xD;
&#xD;
          -  High CV risk, defined as male or female (age&gt; 50 yr), combined with at least one of&#xD;
             these risk factors as below: family history of cardiovascular disease, history of&#xD;
             hypertension, smoking, dyslipidemia, or protein urine.&#xD;
&#xD;
          -  Already treated with Aspirin or should start Aspirin treatment at physician's&#xD;
             discretion.&#xD;
&#xD;
        Exclusion criteria:&#xD;
&#xD;
          -  Diagnosis of type 1 diabetes, diabetes resulting from pancreatic injury or secondary&#xD;
             forms of diabetes.&#xD;
&#xD;
          -  Previous treatment with any Dipeptidyl Peptidase -4 inhibitor or glucagon-like&#xD;
             peptide-1 (GLP-1) receptor agonists within 1 year of screening;&#xD;
&#xD;
          -  Any contraindication of Aspirin, Dipeptidyl Peptidase- 4 inhibitor and&#xD;
             Alpha-glucosidase inhibitor.&#xD;
&#xD;
          -  Clinically apparent liver disease or moderate /severe renal impairment or end-stage&#xD;
             renal disease&#xD;
&#xD;
          -  Unstable CV disorder including heart failure (New York Heart Association class III or&#xD;
             IV), refractory angina, uncontrolled arrhythmias, and severe uncontrolled hypertension&#xD;
             (systolic blood pressure ≥180 mmHg, or diastolic blood pressure ≥105 mmHg).&#xD;
&#xD;
          -  Acute coronary syndrome event within 6 month before randomization&#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>CHINA</name>
      <address>
        <city>China</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <reference>
    <citation>Gao B, Gao W, Wan H, Xu F, Zhou R, Zhang X, Ji Q. Efficacy and safety of alogliptin versus acarbose in Chinese type 2 diabetes patients with high cardiovascular risk or coronary heart disease treated with aspirin and inadequately controlled with metformin monotherapy or drug-naive: A multicentre, randomized, open-label, prospective study (ACADEMIC). Diabetes Obes Metab. 2022 Jun;24(6):991-999. doi: 10.1111/dom.14661. Epub 2022 Mar 22.</citation>
    <PMID>35112779</PMID>
  </reference>
  <verification_date>April 2022</verification_date>
  <study_first_submitted>January 3, 2019</study_first_submitted>
  <study_first_submitted_qc>January 3, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 7, 2019</study_first_posted>
  <last_update_submitted>April 18, 2022</last_update_submitted>
  <last_update_submitted_qc>April 18, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">April 25, 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>Aspirin</mesh_term>
    <mesh_term>Metformin</mesh_term>
    <mesh_term>Alogliptin</mesh_term>
    <mesh_term>Acarbose</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org</ipd_description>
  </patient_data>
  <!-- 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/NCT03794336
org study id: ALOGLC08867
secondary id: U1111-1210-0679
nct id: NCT03794336
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
is us export: No
Primary Objectives:

        -  To assess efficacy in terms of change from baseline in Hemoglobin A1c (HbA1c) at the end
           of study between the two drugs.

        -  To assess tolerability in terms of overall Gastrointestinal (GI) tolerability for
           Alogliptin compared with acarbose during the whole treatment period.

      Secondary Objectives:

        -  To assess efficacy in terms of the percentage of patients achieving HbA1c<7%.

        -  To assess efficacy in terms of percentage of patients achieving HbA1c<7% without GI
           effects.

        -  To assess change from baseline in Fasting plasma glucose (FPG), 2-h Post plasma glucose
           (2-h PPG), β-cell function (HOMA-β), lipids and body weight.

        -  To assess safety in terms of occurrence of hypoglycemia events.

        -  To assess safety in terms of other adverse events.

        -  To assess patient adherence and tolerability.
The duration of the study for each patient will be approximately 17 weeks consisting of about
      1 week screening period and 16-week treatment period.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Change in Hemoglobin A1c
time frame: Baseline to week 16
description: Change from baseline in Hemoglobin A1c at the end of study (week 16) between the two drugs
measure: Overall Gastrointestinal tolerability
time frame: Baseline to week 16
description: Incidence of any gastrointestinal adverse events during the whole treatment period.
measure: Percentage of patients achieving HbA1c <7%
time frame: Baseline to Week 16
description: Percentage of patients achieving HbA1c <7% at the end of study
measure: Percentage of patients achieving HbA1c <7% without gastrointestinal effects
time frame: Baseline to Week 16
description: Percentage of patients achieving HbA1c <7% without gastrointestinal effects at the end of study
measure: Change in Fasting Plasma Glucose (FPG)
time frame: Baseline to Week 16
description: Change in FPG from baseline to week 16 between the two groups of drugs
measure: Occurrence of hypoglycemia events
time frame: Baseline to Week 16
description: Number of patients reporting hypoglycemia events
measure: Other Adverse Events (AEs)
time frame: Baseline to Week 16
description: Number of patients reporting other Adverse Events
measure: Overall tolerability
time frame: Baseline to Week 16
description: Percentage of patients who discontinued study treatment as a result of adverse drug reaction
measure: Change in Postprandial Plasma Glucose 2-h (PPG)
time frame: Baseline to Week 16
description: Change in PPG from baseline to week 16 between two groups of drug
measure: Change in Homeostasis model assessment-β (HOMA- β)
time frame: Baseline to Week 16
description: Change in HOMA- β from baseline to week 16 between two groups of drug
measure: Change in Total Cholesterol (TC)
time frame: Baseline to Week 16
description: Changes from baseline in TC to week 16 between the two groups
measure: Change in Tri Glycerides (TG)
time frame: Baseline to Week 16
description: Changes from baseline in TG to week 16 between the two groups
measure: Change in High Density Lipoprotein-Cholesterol (HDL-C)
time frame: Baseline to Week 16
description: Changes from baseline in HDL-C to week 16 between the two groups
measure: Change in Low Density Lipoprotein-Cholesterol (LDL-C)
time frame: Baseline to Week 16
description: Changes from baseline in LDL-C to week 16 between the two groups.
measure: Change in body weight
time frame: Baseline to Week 16
description: Changes from baseline in body weight to week 16 between the two groups
measure: Overall adherence to Investigational Medicinal Product (IMP)
time frame: Baseline to Week 16
description: Calculated as overall dosing actually taken IMPs divided by the expected overall dosing as per protocol
measure: Medication possession ratio (MPR)
time frame: Baseline to Week 16
description: Calculated as number of days actually taken IMPs divided by the expected number of days as per protocol
arm group label: Alogliptin
arm group type: Experimental
description: Single dose of alogliptin once daily for 16 weeks
arm group label: Acarbose
arm group type: Active Comparator
description: Thrice daily dose of acarbose Dose 1 for 7 days then titrate to thrice daily dose of of acarbose Dose 2
intervention type: Drug
intervention name: Alogliptin
description: Pharmaceutical form: tablet
Route of administration: oral administration
arm group label: Alogliptin
other name: Nesina
intervention type: Drug
intervention name: Acarbose
description: Pharmaceutical form: tablet
Route of administration: oral administration
arm group label: Acarbose
other name: Glucobay
intervention type: Drug
intervention name: Metformin
description: Pharmaceutical form: tablet
Route of administration: oral administration
arm group label: Acarbose
arm group label: Alogliptin
intervention type: Drug
intervention name: Aspirin
description: Pharmaceutical form: tablet
Route of administration: oral administration
arm group label: Acarbose
arm group label: Alogliptin
other name: Bayaspirin
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: 
country: China
citation: Gao B, Gao W, Wan H, Xu F, Zhou R, Zhang X, Ji Q. Efficacy and safety of alogliptin versus acarbose in Chinese type 2 diabetes patients with high cardiovascular risk or coronary heart disease treated with aspirin and inadequately controlled with metformin monotherapy or drug-naive: A multicentre, randomized, open-label, prospective study (ACADEMIC). Diabetes Obes Metab. 2022 Jun;24(6):991-999. doi: 10.1111/dom.14661. Epub 2022 Mar 22.
PMID: 35112779
responsible party type: Sponsor
mesh term: Diabetes Mellitus
mesh term: Diabetes Mellitus, Type 2
mesh term: Aspirin
mesh term: Metformin
mesh term: Alogliptin
mesh term: Acarbose
sharing ipd: Yes
ipd description: Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org