<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/NCT01663220</url>
  </required_header>
  <id_info>
    <org_study_id>Beta Cell - Protocol 1d</org_study_id>
    <nct_id>NCT01663220</nct_id>
  </id_info>
  <brief_title>Characterization of the Variability of Insulin Secretory Parameters in the Meal Tolerance and the Maximal Stimulation Tests of Subjects With Type 2 Diabetes Mellitus</brief_title>
  <official_title>Characterization of the Variability of Insulin Secretory Parameters in the Meal Tolerance and the Maximal Stimulation Tests of Subjects With Type 2 Diabetes Mellitus</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Foundation for the National Institutes of Health</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
    <collaborator>
      <agency>Juvenile Diabetes Research Foundation</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Amylin Pharmaceuticals, LLC.</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
    <collaborator>
      <agency>Merck Sharp &amp; Dohme LLC</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
    <collaborator>
      <agency>Pfizer</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
    <collaborator>
      <agency>Eli Lilly and Company</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
    <collaborator>
      <agency>Takeda</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
    <collaborator>
      <agency>Johnson &amp; Johnson Pharmaceutical Research &amp; Development, L.L.C.</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
    <collaborator>
      <agency>Novartis</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Foundation for the National Institutes of Health</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      A multi-year clinical study to improve tools for measuring the function of insulin-producing&#xD;
      beta cells in people with type 2 diabetes mellitus.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A three-year observational study to standardize the meal tolerance and maximum stimulational&#xD;
      tests for measuring beta cell function in the clinical setting. It also aims to improve&#xD;
      methods for the early prediction of the long-term response to an intervention and for&#xD;
      identification of patients at risk for rapid beta cell function deterioration, thereby&#xD;
      enabling future clinical studies that examine diabetes progression.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>May 2012</start_date>
  <completion_date type="Actual">February 2013</completion_date>
  <primary_completion_date type="Actual">February 2013</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Crossover</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">20</enrollment>
  <condition>Type 2 Diabetes</condition>
  <arm_group>
    <arm_group_label>obese individuals with type 2 diabetes mellitus</arm_group_label>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        obese individuals with type 2 diabetes mellitus&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Ability to give informed consent and comply with all study requirements&#xD;
&#xD;
          2. Overweight and obese men and women. Healthy is defined as no clinically relevant&#xD;
             abnormalities identified by a detailed medical history (with the exception of glucose,&#xD;
             see below), full physical examination, including blood pressure and pulse rate&#xD;
             measurement, 12 lead ECG and clinical laboratory tests.&#xD;
&#xD;
          3. T2D diagnosis by ADA criteria 2011&#xD;
&#xD;
          4. Glucose Parameters:&#xD;
&#xD;
               1. Fasting glucose 126-270 mg/dL&#xD;
&#xD;
               2. HbA1c 7.0%--10.0%&#xD;
&#xD;
          5. Diabetes medications allowed: metformin only: stable dose (8 weeks or longer) and&#xD;
             500-2000 mg/day ;&#xD;
&#xD;
          6. Estimated creatinine clearance, by Cockcroft-Gault, &gt;60 cc/min&#xD;
&#xD;
          7. No washout of medications allowed&#xD;
&#xD;
          8. Women of child-bearing potential are allowed (but must agree to use non-hormonal&#xD;
             contraception and not plan to become pregnant for the duration of the study). Must&#xD;
             agree to maintain the same contraceptive measures throughout the study. Acceptable&#xD;
             contraceptive methods for female subjects of childbearing potential include one of the&#xD;
             following:&#xD;
&#xD;
               -  Abstinence.&#xD;
&#xD;
               -  One (1) of the following methods:&#xD;
&#xD;
                    -  Tubal ligation&#xD;
&#xD;
                    -  Copper-containing intrauterine device (IUD)&#xD;
&#xD;
                    -  Condom AND spermicidal foam/gel/film/cream/suppository&#xD;
&#xD;
                    -  Male partner who has had a vasectomy for at least 6 months.&#xD;
&#xD;
          9. It is required that all male subjects use an acceptable method of contraception (as&#xD;
             outlined below), starting from the first dose of study medication and continuing for&#xD;
             at least 28 days after the last dose of study drug:&#xD;
&#xD;
               1. Abstinence&#xD;
&#xD;
               2. A condom AND one of the following:&#xD;
&#xD;
                    -  Vasectomy for more than 6 months.&#xD;
&#xD;
                    -  Female partner who meets one of the following conditions:&#xD;
&#xD;
                         -  Has had a tubal ligation, hysterectomy, or bilateral oophorectomy; or&#xD;
&#xD;
                         -  Is post menopausal (menopause is defined as over the age of 60 years,&#xD;
                            or between 45 and 60 years being amenorrheic for at least 2 years with&#xD;
                            plasma (FSH) level &gt; 30 UI/L) or&#xD;
&#xD;
                         -  Or for female partners of the male participants, in addition to&#xD;
                            hysterectomy, oophorectorectomy, or post-menopausal status, that the&#xD;
                            use of a spermicidal gel or foam will constitute adequate protection in&#xD;
                            conjunction with use of a condom by the male.&#xD;
&#xD;
         10. BMI 27-40; stable weight (less than 3% change in past 3 months)&#xD;
&#xD;
         11. Age Range: 30-65&#xD;
&#xD;
         12. Other conditions may be allowed, if medically stable and controlled for at least four&#xD;
             weeks within clinically acceptable limits, including: hypertension, dyslipidemia,&#xD;
             osteoarthritis, osteoporosis&#xD;
&#xD;
         13. Smokers allowed, but must be able to participate on inpatient stay and not smoke&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Subjects presenting with any of the following will not be included in the study:&#xD;
&#xD;
          1. Evidence or history of clinically significant hematological, renal, endocrine,&#xD;
             pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic,&#xD;
             neoplastic, or allergic or clinical findings at Screening (seasonal allergies&#xD;
             allowed).&#xD;
&#xD;
          2. Any condition possibly affecting absorption (eg, gastrectomy, malabsorption syndromes,&#xD;
             abdominal surgery other than appendectomy, cholecystectomy or hysterectomy).&#xD;
&#xD;
          3. Use of unacceptable medications (see Appendix A)&#xD;
&#xD;
          4. A positive urine drug screen.&#xD;
&#xD;
          5. History of regular alcohol consumption exceeding 7 drinks/week for females or 14&#xD;
             drinks/week for men (1 drink = 5 ounces (150 mL) of wine or 12 ounces (360 mL) of beer&#xD;
             or 1.5 ounces (45 mL) of hard liquor) within 6 months of Screening.&#xD;
&#xD;
          6. Treatment with an investigational drug within 30 days or 5 half-lives preceding the&#xD;
             first dose of study medication.&#xD;
&#xD;
          7. 12 lead ECG demonstrating QTc &gt;450 msec at Screening for males, 470 msec for females.&#xD;
             If QTc exceeds 450/470 msec, the ECG should be repeated two more times and the average&#xD;
             of the three QTc values should be used to determine the subject's eligibility. An ECG&#xD;
             with evidence for possible old myocardial infarction will need to have prior ECGs to&#xD;
             document stability of finding.&#xD;
&#xD;
          8. Supine blood pressure &gt;=140 mm Hg (systolic) or 90 mm Hg (diastolic), on a single&#xD;
             measurement. If elevated, confirm by a single repeat, following at least 10 minutes of&#xD;
             rest.&#xD;
&#xD;
          9. Screening serum alanine transaminase (ALT) or serum aspartate transaminase (AST)&#xD;
             greater than 2X the upper limit of the laboratory reference range.&#xD;
&#xD;
         10. Elevated fasting triglycerides at screening (&gt;500 mg/dL), confirmed by a single repeat&#xD;
             if deemed necessary.&#xD;
&#xD;
         11. Pregnant or nursing females; inability to use effective contraception.&#xD;
&#xD;
         12. Blood donation of approximately 1 pint (500 mL) within 56 days prior to dosing.&#xD;
&#xD;
         13. Participation in a clinical biomedical research study within prior two months may be&#xD;
             excluded, depending on study type and details.&#xD;
&#xD;
         14. History of sensitivity to heparin or heparin-induced thrombocytopenia, if utilized by&#xD;
             the site for blood draws.&#xD;
&#xD;
         15. Unwilling or unable to comply with directions and procedures described in this&#xD;
             protocol.&#xD;
&#xD;
         16. Subject is the Investigator or a sub-Investigator, research assistant, pharmacist,&#xD;
             study coordinator, other staff, or a relative of study personnel directly involved&#xD;
             with the conduct of the study.&#xD;
&#xD;
         17. Other severe acute or chronic medical or psychiatric condition or laboratory&#xD;
             abnormality that may increase the risk associated with study participation or&#xD;
             investigational product administration or may interfere with the interpretation of&#xD;
             study results and, in the judgment of the investigator, would make the subject&#xD;
             inappropriate for entry into this study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>30 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>George Atiee, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>ICON Development Solutions</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>ICON Development Solutions, Gault Lane</name>
      <address>
        <city>San Antonio</city>
        <state>Texas</state>
        <zip>78209</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2013</verification_date>
  <study_first_submitted>August 9, 2012</study_first_submitted>
  <study_first_submitted_qc>August 9, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 13, 2012</study_first_posted>
  <last_update_submitted>August 13, 2013</last_update_submitted>
  <last_update_submitted_qc>August 13, 2013</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 14, 2013</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>type 2 diabetes</keyword>
  <keyword>beta cell function</keyword>
  <keyword>meal tolerance test</keyword>
  <keyword>maximum stimulation test</keyword>
  <keyword>method standardization</keyword>
  <keyword>insulin secretion</keyword>
  <keyword>prediabetes</keyword>
  <keyword>insulin sensitivity</keyword>
  <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>
  <!-- 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/NCT01663220
org study id: Beta Cell - Protocol 1d
nct id: NCT01663220
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
A multi-year clinical study to improve tools for measuring the function of insulin-producing
      beta cells in people with type 2 diabetes mellitus.
A three-year observational study to standardize the meal tolerance and maximum stimulational
      tests for measuring beta cell function in the clinical setting. It also aims to improve
      methods for the early prediction of the long-term response to an intervention and for
      identification of patients at risk for rapid beta cell function deterioration, thereby
      enabling future clinical studies that examine diabetes progression.
observational model: Case-Crossover
time perspective: Prospective
arm group label: obese individuals with type 2 diabetes mellitus
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 30 Years
maximum age: 65 Years
healthy volunteers: No
last name: George Atiee, MD
role: Principal Investigator
affiliation: ICON Development Solutions
facility: 
country: United States
responsible party type: Sponsor
mesh term: Diabetes Mellitus
mesh term: Diabetes Mellitus, Type 2