Characterization of the Variability of Insulin Secretory Parameters in the Meal Tolerance and the Maximal Stimulation Tests of Subjects With Type 2 Diabetes Mellitus

NCT01663220

Last updated date
Study Location
ICON Development Solutions, Gault Lane
San Antonio, Texas, 78209, United States
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Type 2 Diabetes
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
30-65 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

1. Ability to give informed consent and comply with all study requirements

2. Overweight and obese men and women. Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history (with the exception of glucose, see below), full physical examination, including blood pressure and pulse rate measurement, 12 lead ECG and clinical laboratory tests.

3. T2D diagnosis by ADA criteria 2011

4. Glucose Parameters:

1. Fasting glucose 126-270 mg/dL

2. HbA1c 7.0%--10.0%

5. Diabetes medications allowed: metformin only: stable dose (8 weeks or longer) and 500-2000 mg/day ;

6. Estimated creatinine clearance, by Cockcroft-Gault, >60 cc/min

7. No washout of medications allowed

8. Women of child-bearing potential are allowed (but must agree to use non-hormonal contraception and not plan to become pregnant for the duration of the study). Must agree to maintain the same contraceptive measures throughout the study. Acceptable contraceptive methods for female subjects of childbearing potential include one of the following:

- Abstinence.

- One (1) of the following methods:

- Tubal ligation

- Copper-containing intrauterine device (IUD)

- Condom AND spermicidal foam/gel/film/cream/suppository

- Male partner who has had a vasectomy for at least 6 months.

9. It is required that all male subjects use an acceptable method of contraception (as outlined below), starting from the first dose of study medication and continuing for at least 28 days after the last dose of study drug:

1. Abstinence

2. A condom AND one of the following:

- Vasectomy for more than 6 months.

- Female partner who meets one of the following conditions:

- Has had a tubal ligation, hysterectomy, or bilateral oophorectomy; or

- Is post menopausal (menopause is defined as over the age of 60 years, or between 45 and 60 years being amenorrheic for at least 2 years with plasma (FSH) level > 30 UI/L) or

- Or for female partners of the male participants, in addition to hysterectomy, oophorectorectomy, or post-menopausal status, that the use of a spermicidal gel or foam will constitute adequate protection in conjunction with use of a condom by the male.

10. BMI 27-40; stable weight (less than 3% change in past 3 months)

11. Age Range: 30-65

12. Other conditions may be allowed, if medically stable and controlled for at least four weeks within clinically acceptable limits, including: hypertension, dyslipidemia, osteoarthritis, osteoporosis

13. Smokers allowed, but must be able to participate on inpatient stay and not smoke

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


Subjects presenting with any of the following will not be included in the study:


1. Evidence or history of clinically significant hematological, renal, endocrine,
pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic,
neoplastic, or allergic or clinical findings at Screening (seasonal allergies
allowed).


2. Any condition possibly affecting absorption (eg, gastrectomy, malabsorption syndromes,
abdominal surgery other than appendectomy, cholecystectomy or hysterectomy).


3. Use of unacceptable medications (see Appendix A)


4. A positive urine drug screen.


5. History of regular alcohol consumption exceeding 7 drinks/week for females or 14
drinks/week for men (1 drink = 5 ounces (150 mL) of wine or 12 ounces (360 mL) of beer
or 1.5 ounces (45 mL) of hard liquor) within 6 months of Screening.


6. Treatment with an investigational drug within 30 days or 5 half-lives preceding the
first dose of study medication.


7. 12 lead ECG demonstrating QTc >450 msec at Screening for males, 470 msec for females.
If QTc exceeds 450/470 msec, the ECG should be repeated two more times and the average
of the three QTc values should be used to determine the subject's eligibility. An ECG
with evidence for possible old myocardial infarction will need to have prior ECGs to
document stability of finding.


8. Supine blood pressure >=140 mm Hg (systolic) or 90 mm Hg (diastolic), on a single
measurement. If elevated, confirm by a single repeat, following at least 10 minutes of
rest.


9. Screening serum alanine transaminase (ALT) or serum aspartate transaminase (AST)
greater than 2X the upper limit of the laboratory reference range.


10. Elevated fasting triglycerides at screening (>500 mg/dL), confirmed by a single repeat
if deemed necessary.


11. Pregnant or nursing females; inability to use effective contraception.


12. Blood donation of approximately 1 pint (500 mL) within 56 days prior to dosing.


13. Participation in a clinical biomedical research study within prior two months may be
excluded, depending on study type and details.


14. History of sensitivity to heparin or heparin-induced thrombocytopenia, if utilized by
the site for blood draws.


15. Unwilling or unable to comply with directions and procedures described in this
protocol.


16. Subject is the Investigator or a sub-Investigator, research assistant, pharmacist,
study coordinator, other staff, or a relative of study personnel directly involved
with the conduct of the study.


17. Other severe acute or chronic medical or psychiatric condition or laboratory
abnormality that may increase the risk associated with study participation or
investigational product administration or may interfere with the interpretation of
study results and, in the judgment of the investigator, would make the subject
inappropriate for entry into this study.

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Advanced Information
Descriptive Information
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
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
Brief Summary A multi-year clinical study to improve tools for measuring the function of insulin-producing beta cells in people with type 2 diabetes mellitus.
Detailed Description 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.
Study Type Observational
Study Design Observational Model: Case-Crossover
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population obese individuals with type 2 diabetes mellitus
Condition Type 2 Diabetes
Intervention Not Provided
Study Groups/Cohorts obese individuals with type 2 diabetes mellitus
Publications * Ruetten H, Gebauer M, Raymond RH, Calle RA, Cobelli C, Ghosh A, Robertson RP, Shankar SS, Staten MA, Stefanovski D, Vella A, Wright K, Fryburg DA; Foundation for the NIH Biomarkers Consortium Beta Cell Project Team. Mixed Meal and Intravenous L-Arginine Tests Both Stimulate Incretin Release Across Glucose Tolerance in Man: Lack of Correlation with ? Cell Function. Metab Syndr Relat Disord. 2018 Oct;16(8):406-415. doi: 10.1089/met.2018.0022. Epub 2018 Aug 17. Erratum in: Metab Syndr Relat Disord. 2019 Mar;17(2):128.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Estimated Enrollment
 (submitted: August 9, 2012)
20
Original Estimated Enrollment Same as current
Actual Study Completion Date February 2013
Actual Primary Completion Date February 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  1. Ability to give informed consent and comply with all study requirements
  2. Overweight and obese men and women. Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history (with the exception of glucose, see below), full physical examination, including blood pressure and pulse rate measurement, 12 lead ECG and clinical laboratory tests.
  3. T2D diagnosis by ADA criteria 2011
  4. Glucose Parameters:

    1. Fasting glucose 126-270 mg/dL
    2. HbA1c 7.0%--10.0%
  5. Diabetes medications allowed: metformin only: stable dose (8 weeks or longer) and 500-2000 mg/day ;
  6. Estimated creatinine clearance, by Cockcroft-Gault, >60 cc/min
  7. No washout of medications allowed
  8. Women of child-bearing potential are allowed (but must agree to use non-hormonal contraception and not plan to become pregnant for the duration of the study). Must agree to maintain the same contraceptive measures throughout the study. Acceptable contraceptive methods for female subjects of childbearing potential include one of the following:

    • Abstinence.
    • One (1) of the following methods:

      • Tubal ligation
      • Copper-containing intrauterine device (IUD)
      • Condom AND spermicidal foam/gel/film/cream/suppository
      • Male partner who has had a vasectomy for at least 6 months.
  9. It is required that all male subjects use an acceptable method of contraception (as outlined below), starting from the first dose of study medication and continuing for at least 28 days after the last dose of study drug:

    1. Abstinence
    2. A condom AND one of the following:

      • Vasectomy for more than 6 months.
      • Female partner who meets one of the following conditions:

        • Has had a tubal ligation, hysterectomy, or bilateral oophorectomy; or
        • Is post menopausal (menopause is defined as over the age of 60 years, or between 45 and 60 years being amenorrheic for at least 2 years with plasma (FSH) level > 30 UI/L) or
        • Or for female partners of the male participants, in addition to hysterectomy, oophorectorectomy, or post-menopausal status, that the use of a spermicidal gel or foam will constitute adequate protection in conjunction with use of a condom by the male.
  10. BMI 27-40; stable weight (less than 3% change in past 3 months)
  11. Age Range: 30-65
  12. Other conditions may be allowed, if medically stable and controlled for at least four weeks within clinically acceptable limits, including: hypertension, dyslipidemia, osteoarthritis, osteoporosis
  13. Smokers allowed, but must be able to participate on inpatient stay and not smoke

Exclusion Criteria:

Subjects presenting with any of the following will not be included in the study:

  1. Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, neoplastic, or allergic or clinical findings at Screening (seasonal allergies allowed).
  2. Any condition possibly affecting absorption (eg, gastrectomy, malabsorption syndromes, abdominal surgery other than appendectomy, cholecystectomy or hysterectomy).
  3. Use of unacceptable medications (see Appendix A)
  4. A positive urine drug screen.
  5. History of regular alcohol consumption exceeding 7 drinks/week for females or 14 drinks/week for men (1 drink = 5 ounces (150 mL) of wine or 12 ounces (360 mL) of beer or 1.5 ounces (45 mL) of hard liquor) within 6 months of Screening.
  6. Treatment with an investigational drug within 30 days or 5 half-lives preceding the first dose of study medication.
  7. 12 lead ECG demonstrating QTc >450 msec at Screening for males, 470 msec for females. If QTc exceeds 450/470 msec, the ECG should be repeated two more times and the average of the three QTc values should be used to determine the subject's eligibility. An ECG with evidence for possible old myocardial infarction will need to have prior ECGs to document stability of finding.
  8. Supine blood pressure >=140 mm Hg (systolic) or 90 mm Hg (diastolic), on a single measurement. If elevated, confirm by a single repeat, following at least 10 minutes of rest.
  9. Screening serum alanine transaminase (ALT) or serum aspartate transaminase (AST) greater than 2X the upper limit of the laboratory reference range.
  10. Elevated fasting triglycerides at screening (>500 mg/dL), confirmed by a single repeat if deemed necessary.
  11. Pregnant or nursing females; inability to use effective contraception.
  12. Blood donation of approximately 1 pint (500 mL) within 56 days prior to dosing.
  13. Participation in a clinical biomedical research study within prior two months may be excluded, depending on study type and details.
  14. History of sensitivity to heparin or heparin-induced thrombocytopenia, if utilized by the site for blood draws.
  15. Unwilling or unable to comply with directions and procedures described in this protocol.
  16. Subject is the Investigator or a sub-Investigator, research assistant, pharmacist, study coordinator, other staff, or a relative of study personnel directly involved with the conduct of the study.
  17. Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study.
Sex/Gender
Sexes Eligible for Study:All
Ages 30 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT01663220
Other Study ID Numbers Beta Cell - Protocol 1d
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Foundation for the National Institutes of Health
Study Sponsor Foundation for the National Institutes of Health
Collaborators
  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
  • Juvenile Diabetes Research Foundation
  • Amylin Pharmaceuticals, LLC.
  • Merck Sharp & Dohme Corp.
  • Pfizer
  • Eli Lilly and Company
  • Takeda
  • Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
  • Novartis
Investigators
Principal Investigator:George Atiee, MDICON Development Solutions
PRS Account Foundation for the National Institutes of Health
Verification Date August 2013