<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/NCT03805191</url>
  </required_header>
  <id_info>
    <org_study_id>RD-OI-1257</org_study_id>
    <nct_id>NCT03805191</nct_id>
  </id_info>
  <brief_title>A Study for Sufficient Acarbose Decreased Glucose Excursion in Type 2 Diabetic Patients</brief_title>
  <acronym>FLAT</acronym>
  <official_title>A Multicentre Observational Study to Investigate the Improvement in Glucose FLuctuation of Sufficient Acarbose Therapy on Type 2 Diabetes Patient With High Blood Glucose Fluctuation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Qilu Hospital of Shandong University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Bayer</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Qilu Hospital of Shandong University</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>
      This is a multicentre observational study to investigate the improvement in glucose&#xD;
      fluctuation of sufficient acarbose therapy on type 2 diabetes patient with high blood glucose&#xD;
      fluctuation&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Acarbose competitively inhibits the a-glycosidase on the surface of epithelial cells from the&#xD;
      duodenum and small intestine, delays the metabolism and assimilation of carbohydrates, and&#xD;
      thus effectively decreases postprandial blood glucose(PBG) as well as the risk of&#xD;
      hypoglycemia before the next meal.Acarbose is now used as the preferred drug for some&#xD;
      patients with prediabetes and newly diagnosed type 2 diabetes millitus(T2DM).This study aims&#xD;
      to investigate the glycemic excursions with different courses and glycated hemoglobin&#xD;
      A1c(HbA1c) levels after treated three months with acarbose.To minimize gastrointestinal side&#xD;
      effects，starting dosage of acarbose of 50 mg is given orally three times daily for 10&#xD;
      days(with the first bite) of each main meal. Glycemic excursions are evaluated using the mean&#xD;
      amplitude of glycemic excursions (MAGE), the postprandial glycemic excursions (PPGE) and the&#xD;
      largest amplitude of glycemic excursions (LAGE).Freestyle Libre flash glucose monitoring&#xD;
      system (FGMS，Abbott Laboratories,USA) was administered in this study. According to the&#xD;
      standard Freestyle Libre Pro operating guidelines, the FGMS is installed in all participants&#xD;
      to monitor glucose levels of interstitial fluid for 14 consecutive days. The glucose sensor&#xD;
      is inserted into the subcutaneous tissue of upper arm at 8:00-9:00 in the morning.Glucose&#xD;
      concentrations at 7 preset times per day (before meals, 2-h after meals and at bedtime) were&#xD;
      determined with VivaChek Ino Smart（VivaChek Laboratories, Inc., USA) every two weeks.Four&#xD;
      days before using acarbose and five weeks after using acarbose, FGMS was using to monitor the&#xD;
      continuous glucose.MAGE was calculated for each subject by taking the arithmetic mean of FGM&#xD;
      values increased or decreased (from nadirs to peaks or vice versa) when both ascending and&#xD;
      descending segments exceeded the value of one standard deviation (SD) of the FGM values for&#xD;
      24-h period.The primary endpoint of the study is the extent of change in MAGE.Secondary&#xD;
      endpoints are changes in PPGE,LAGE and HbA1c. Gene polymorphism is detected for enrolled&#xD;
      patient with poor acarbose effect.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">January 1, 2019</start_date>
  <completion_date type="Anticipated">December 30, 2022</completion_date>
  <primary_completion_date type="Anticipated">November 30, 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>The extent of change in MAGE</measure>
    <time_frame>8 weeks</time_frame>
    <description>Mean absolute glucose excursions (MAGE) was calculated to assess intraday glucose variability. The difference between the consecutive peaks and nadirs exceeding one standard deviation (SD) of the daily mean blood glucose (MBG) level was expressed as absolute glucose excursion (AGE). MAGE was an arithmetic mean of all absolute AGEs.The average MAGE of the last three days of the eighth week are compared with the baseline（The average MAGE of the three days before using acarbose).The extent of change in MAGE is numerical value to to assess glucose variability.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>The extent of change in PPGE,LAGE</measure>
    <time_frame>8 weeks</time_frame>
    <description>Postprandial glucose excursion (PPGE) is calculated as the peak value of glucose after meals minus the glucose level at the beginning of each meal to evaluate the influence of meals on glucose fluctuation.Largest amplitude of glycemic excursions (LAGE) is calculated as the maximum minus the minimum blood glucose levels measured in one day.The average PPGE、LAGE of the last three days of the eighth week compared with the baseline（The average PPGE、LAGE of the three days before using acarbose）.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The control rate of HbA1c</measure>
    <time_frame>12 weeks</time_frame>
    <description>When HbA1c&lt;7% was considered as the criteria, the control rate of HbA1c after 12 weeks.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Gene polymorphism</measure>
    <time_frame>12 weeks</time_frame>
    <description>Gene polymorphism is detected for enrolled patient with poor acarbose effect.</description>
  </other_outcome>
  <enrollment type="Anticipated">900</enrollment>
  <condition>Type 2 Diabetes Mellitus</condition>
  <condition>Poor Glycemic Control</condition>
  <eligibility>
    <study_pop>
      <textblock>
        According to the course of diabetes, enrolled patients are divided into three groups: A (&lt;&#xD;
        5Y), B (5-10y), C (&gt; 10Y). According to the level of HbA1c,enrolled patients are divided&#xD;
        into three groups:I (7%-8%), II (8%-9%), and III (9%-10%). Then there are nine groups,&#xD;
        namely AI, AII, AIII, BI, BII, BIII, CI, CII, and CIII.100 patients are enrolled in each&#xD;
        group.All enrolled patiens are 900.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. All enrolled patients sign the informed consent. sign the informed consent form.&#xD;
&#xD;
          2. Clinical diagnosis of T2DM(1999 WHO).&#xD;
&#xD;
          3. No acarbose in nearly 3 months.&#xD;
&#xD;
          4. 7% &lt; HbA1c ≤10% .&#xD;
&#xD;
          5. PPGE &gt;2.2mmol/L and LAGE &gt;4.4mmol/L.&#xD;
&#xD;
          6. MAGE &gt; 3.9 mmol/L.&#xD;
&#xD;
          7. The previous therapy remain the same.&#xD;
&#xD;
          8. Contraception is needed for women of child-bearing age until 28 days after the end.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Women of childbearing potential unable or unwilling to use acceptable birth control,&#xD;
             or women who are pregnant or breastfeeding.&#xD;
&#xD;
          2. Replacement or chronic systemic corticosteroid therapy. Cytochrome P450 3A4 enzyme&#xD;
             inducer or inhibitor therapy.Antiviral therapy for immunodeficiency disease.&#xD;
&#xD;
          3. History of gastrointestinal disease or surgery including Roemheld Syndrome, severe&#xD;
             hernia, intestinal obstruction, intestinal ulcer, gastroenterostomy, enterectomy,&#xD;
             bariatric surgery or lap-band procedure.&#xD;
&#xD;
          4. Known immunocompromised status, including but not limited to, individuals who had&#xD;
             undergone organ transplantation or acquired immunodeficiency syndrome (AIDS).&#xD;
&#xD;
          5. History of hemoglobinopathy .&#xD;
&#xD;
          6. Any subject who was currently abusing alcohol or other drugs or had done so within the&#xD;
             last 12 months.&#xD;
&#xD;
          7. There are contraindications listed in the acarbose instructions.&#xD;
&#xD;
          8. History of acute or chronic pancreatitis, or current acute or chronic pancreatitis.&#xD;
&#xD;
          9. Type 1 diabetees mellitus.&#xD;
&#xD;
         10. History of diabetic ketoacidosis or hyperosmolar nonketosis coma in recent 1 month.&#xD;
&#xD;
         11. Patients with clinically apparent hepatobiliary disease, including but not limited to&#xD;
             chronic active hepatitis and/or severe hepatic insufficiency. Alanine&#xD;
             Aminotransferase(ALT) or Aspartate Aminotransferase(AST) &gt; 3x upper limit of normal&#xD;
             (ULN), or serum total bilirubin (TB) &gt;34.2 μmol/L (&gt;2 mg/dL).&#xD;
&#xD;
         12. Patients with following renal disease history or renal disease related features:&#xD;
&#xD;
               1. History of unstable or rapidly progressing renal disease;&#xD;
&#xD;
               2. Patients with moderate /severe renal impairment or end-stage renal disease (eGFR&lt;&#xD;
                  60 mL/min/1.73 m2);&#xD;
&#xD;
               3. Urinary albumin: creatinine ratio &gt;1800 mg/g;&#xD;
&#xD;
               4. Serum creatinine (Cr) ≥133 μmol/L (≥1.50 mg/dL) for male subjects; Serum Cr≥124&#xD;
                  μmol/L (≥1.40 mg/dL) for female subjects;&#xD;
&#xD;
               5. Conditions of congenital renal glycosuria.&#xD;
&#xD;
         13. Any of the following cardiovascular diseases within 6 months of the enrollment visit:&#xD;
&#xD;
               1. Myocardial infarction;&#xD;
&#xD;
               2. Cardiac surgery or revascularization (coronary artery bypass graft/percutaneous&#xD;
                  transluminal coronary angioplasty);&#xD;
&#xD;
               3. Unstable angina;&#xD;
&#xD;
               4. Congestive heart failure New York Heart Association Class III or IV;&#xD;
&#xD;
               5. Transient ischemic attack or significant cerebrovascular disease.&#xD;
&#xD;
         14. Any subject , in the judgment of the investigator, was at risk that might affect the&#xD;
             interpretation of efficacy or safety data or the conduct ion of the study，including&#xD;
             laboratory and physical examination or ECG.&#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>Lin Liao, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Qianfoshan Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Yuping Zhou, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Weihai Municipal Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Shuguang Pang, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Jinan Central Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Fei Wang, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Huangdao Branch of Affiliated Hospital of Medical College,Qingdao University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Yongjun Jin, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Yantai Branch of Affiliated Binzhou Medical College</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Tianying Xu, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>People's hospital of Qihe county</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Guangzhen Zhang, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Liaocheng People's Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Yunfeng Zhang, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Linyi lanshan district diabetes hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Lin Sun, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Affiliated hospital of jining medical college</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Dadong Fei, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Zaozhuang Municipal Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Guangling Xu, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Guanxian people's hospital of liaocheng city</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Jianjun Dong, PhD.MD</last_name>
    <phone>86-18560083978</phone>
    <email>dongjianjun@sdu.edu.cn</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Piyun Gong, MM</last_name>
    <phone>86-18560087970</phone>
    <email>gongpeiyunshanda@163.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Qilu Hospital of Shandong University</name>
      <address>
        <city>Jinan</city>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jianjun Dong, PhD. MD.</last_name>
      <phone>86-18560083978</phone>
      <email>dongjianjun@sdu.edu.cn</email>
    </contact>
    <contact_backup>
      <last_name>Piyun Gong, MM.</last_name>
      <phone>86-18560087970</phone>
      <email>gongpeiyunshanda@163.com</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
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  <verification_date>April 2019</verification_date>
  <study_first_submitted>January 10, 2019</study_first_submitted>
  <study_first_submitted_qc>January 13, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 15, 2019</study_first_posted>
  <last_update_submitted>April 11, 2019</last_update_submitted>
  <last_update_submitted_qc>April 11, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">April 12, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Glycemic excursions</keyword>
  <keyword>Acarbose</keyword>
  <keyword>Continuous glucose monitoring</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Diabetes Mellitus, Type 2</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </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/NCT03805191
org study id: RD-OI-1257
nct id: NCT03805191
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This is a multicentre observational study to investigate the improvement in glucose
      fluctuation of sufficient acarbose therapy on type 2 diabetes patient with high blood glucose
      fluctuation
Acarbose competitively inhibits the a-glycosidase on the surface of epithelial cells from the
      duodenum and small intestine, delays the metabolism and assimilation of carbohydrates, and
      thus effectively decreases postprandial blood glucose(PBG) as well as the risk of
      hypoglycemia before the next meal.Acarbose is now used as the preferred drug for some
      patients with prediabetes and newly diagnosed type 2 diabetes millitus(T2DM).This study aims
      to investigate the glycemic excursions with different courses and glycated hemoglobin
      A1c(HbA1c) levels after treated three months with acarbose.To minimize gastrointestinal side
      effects，starting dosage of acarbose of 50 mg is given orally three times daily for 10
      days(with the first bite) of each main meal. Glycemic excursions are evaluated using the mean
      amplitude of glycemic excursions (MAGE), the postprandial glycemic excursions (PPGE) and the
      largest amplitude of glycemic excursions (LAGE).Freestyle Libre flash glucose monitoring
      system (FGMS，Abbott Laboratories,USA) was administered in this study. According to the
      standard Freestyle Libre Pro operating guidelines, the FGMS is installed in all participants
      to monitor glucose levels of interstitial fluid for 14 consecutive days. The glucose sensor
      is inserted into the subcutaneous tissue of upper arm at 8:00-9:00 in the morning.Glucose
      concentrations at 7 preset times per day (before meals, 2-h after meals and at bedtime) were
      determined with VivaChek Ino Smart（VivaChek Laboratories, Inc., USA) every two weeks.Four
      days before using acarbose and five weeks after using acarbose, FGMS was using to monitor the
      continuous glucose.MAGE was calculated for each subject by taking the arithmetic mean of FGM
      values increased or decreased (from nadirs to peaks or vice versa) when both ascending and
      descending segments exceeded the value of one standard deviation (SD) of the FGM values for
      24-h period.The primary endpoint of the study is the extent of change in MAGE.Secondary
      endpoints are changes in PPGE,LAGE and HbA1c. Gene polymorphism is detected for enrolled
      patient with poor acarbose effect.
observational model: Other
time perspective: Prospective
measure: The extent of change in MAGE
time frame: 8 weeks
description: Mean absolute glucose excursions (MAGE) was calculated to assess intraday glucose variability. The difference between the consecutive peaks and nadirs exceeding one standard deviation (SD) of the daily mean blood glucose (MBG) level was expressed as absolute glucose excursion (AGE). MAGE was an arithmetic mean of all absolute AGEs.The average MAGE of the last three days of the eighth week are compared with the baseline（The average MAGE of the three days before using acarbose).The extent of change in MAGE is numerical value to to assess glucose variability.
measure: The extent of change in PPGE,LAGE
time frame: 8 weeks
description: Postprandial glucose excursion (PPGE) is calculated as the peak value of glucose after meals minus the glucose level at the beginning of each meal to evaluate the influence of meals on glucose fluctuation.Largest amplitude of glycemic excursions (LAGE) is calculated as the maximum minus the minimum blood glucose levels measured in one day.The average PPGE、LAGE of the last three days of the eighth week compared with the baseline（The average PPGE、LAGE of the three days before using acarbose）.
measure: The control rate of HbA1c
time frame: 12 weeks
description: When HbA1c<7% was considered as the criteria, the control rate of HbA1c after 12 weeks.
measure: Gene polymorphism
time frame: 12 weeks
description: Gene polymorphism is detected for enrolled patient with poor acarbose effect.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Lin Liao, MD
role: Principal Investigator
affiliation: Qianfoshan Hospital
last name: Yuping Zhou, MD
role: Principal Investigator
affiliation: Weihai Municipal Hospital
last name: Shuguang Pang, MD
role: Principal Investigator
affiliation: Jinan Central Hospital
last name: Fei Wang, MD
role: Principal Investigator
affiliation: Huangdao Branch of Affiliated Hospital of Medical College,Qingdao University
last name: Yongjun Jin, MD
role: Principal Investigator
affiliation: Yantai Branch of Affiliated Binzhou Medical College
last name: Tianying Xu, MD
role: Principal Investigator
affiliation: People's hospital of Qihe county
last name: Guangzhen Zhang, MD
role: Principal Investigator
affiliation: Liaocheng People's Hospital
last name: Yunfeng Zhang, MD
role: Principal Investigator
affiliation: Linyi lanshan district diabetes hospital
last name: Lin Sun, MD
role: Principal Investigator
affiliation: Affiliated hospital of jining medical college
last name: Dadong Fei, MD
role: Principal Investigator
affiliation: Zaozhuang Municipal Hospital
last name: Guangling Xu, MD
role: Principal Investigator
affiliation: Guanxian people's hospital of liaocheng city
last name: Jianjun Dong, PhD.MD
phone: 86-18560083978
email: dongjianjun@sdu.edu.cn
last name: Piyun Gong, MM
phone: 86-18560087970
email: gongpeiyunshanda@163.com
facility: 
status: Recruiting
contact: 
contact backup: 
country: China
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responsible party type: Sponsor
mesh term: Diabetes Mellitus, Type 2
sharing ipd: Undecided