Safety, Tolerability, Pharmacokinetics And Pharmacodynamics Study Of PF-06291874 As Oral Monotherapy To Treat Adults With Type 2 Diabetes Mellitus

NCT02175121

Last updated date
Study Location
Anaheim Clinical Trials, LLC
Anaheim, California, 92801, United States
Contact
1-800-718-1021

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Pfizer Clinical Trials Contact Center

1-800-718-1021

By email

Contact

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Type II Diabetes Mellitus
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-70 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Male subjects and non-childbearing potential female subjects between the ages of 18 and 70 years old.

- Body Mass Index of 18.0 to 45.4 kg/m2; and a total body weight of >50 kg

- HbA1c value at the screening visit meeting once of the following criteria:

- Currently taking acceptable oral antiglycemic drug therapy within 6.5 to 9.5%

- Not currently taking any oral antiglycemic drug therapy within 7 to 10.5%

- Fasting plasma glucose concentrations<270mg/dL at the screening and run-in visit, confirmed by a single repeat, if deemed necessary.

- Subjects must be willing and able to perform self-tests of blood glucose at least 4 times per day, and maintain a diary for the duration of participation in the study; and therefore, subjects must be literate.

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


- History of Type 1 diabetes mellitus or secondary forms of diabetes


- One or more self-reported hypoglycemic episodes of sever intensity within 3 months of
screening; or 2 or more self-reported hypoglycemic episodes of severe intensity within
the previous 6 months.


- History of myocardial infarction, unstable angina, arterial revascularization, stroke,
New York Heart Association Functional Class II-IV heart failure, or transient ischemic
attach within 6 months of screening.


- History or evidence of diabetic complications with significant end organ damage, such
as


- Proliferative retinopathy and/or macular edema;


- Diabetic neuropathy complicated by neuropathic ulcers;


- Screening seated systolic blood pressure >160 mm Hg and/or diastolic blood pressure
>100 mm Hg after at least a 5 minute seated rest. If the blood pressure exceeds this
limit, the blood pressure may be repeated 2 more times following approximately 2
minutes of rest between measurements and the median of the 3 values should be used to
determine subject eligibility;


- Male subjects with partners currently pregnant; or male subjects capable of conceiving
children who are unwilling or unable to use a highly effective method of contraception
as outlined in this protocol for the duration of the study and for at least 28 days
after the last dose of investigational product.

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Type II Diabetes MellitusSafety, Tolerability, Pharmacokinetics And Pharmacodynamics Study Of PF-06291874 As Oral Monotherapy To Treat Adults With Type 2 Diabetes Mellitus
NCT02175121
  1. Anaheim, California
  2. Chula Vista, California
  3. Walnut Creek, California
  4. DeLand, Florida
  5. Miami, Florida
  6. Miami, Florida
  7. Orlando, Florida
  8. South Miami, Florida
  9. South Miami, Florida
  10. South Miami, Florida
  11. Louisville, Kentucky
  12. Minneapolis, Minnesota
  13. Eatontown, New Jersey
  14. Marlton, New Jersey
  15. Buffalo, New York
  16. High Point, North Carolina
  17. Cincinnati, Ohio
  18. San Antonio, Texas
  19. Renton, Washington
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE Safety, Tolerability, Pharmacokinetics And Pharmacodynamics Study Of PF-06291874 As Oral Monotherapy To Treat Adults With Type 2 Diabetes Mellitus
Official Title  ICMJE A Phase 2, Randomized, Double-blind, Placebo-controlled, Parallel Group Trial To Assess The Safety, Tolerability, Pharmacokinetics And Pharmacodynamics Of Multiple Oral Doses Of Pf-06291874 Given As Monotherapy To Adults With Type 2 Diabetes Mellitus
Brief Summary This study is going to assess the safety and tolerability of PF-06291874 in adults with Type 2 Diabetes Mellitus as monotherapy, to evaluate the significance of overall glycemic control in these subjects.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Diabetes Mellitus, Type II
Intervention  ICMJE
  • Drug: Placebo
    Tablet, once daily for 28 days
  • Drug: PF-06291874
    Tablet, 15 mg, once daily for 28 days
  • Drug: PF-06291874
    Tablet, 35 mg, once daily for 28 days
  • Drug: PF-06291874
    Tablet, 75 mg, once daily for 28 days
  • Drug: PF-06291874
    Tablet, 150 mg, once daily for 28 days
Study Arms  ICMJE
  • Placebo Comparator: Treatment A- Placebo
    Intervention: Drug: Placebo
  • Experimental: Treatment B- PF-06291874
    Intervention: Drug: PF-06291874
  • Experimental: Treatment C- PF-06291874
    Intervention: Drug: PF-06291874
  • Experimental: Treatment D- PF-06291874
    Intervention: Drug: PF-06291874
  • Experimental: Treatment E- PF-06291874
    Intervention: Drug: PF-06291874
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 20, 2015)
172
Original Estimated Enrollment  ICMJE
 (submitted: June 24, 2014)
160
Actual Study Completion Date  ICMJE March 2015
Actual Primary Completion Date March 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Male subjects and non-childbearing potential female subjects between the ages of 18 and 70 years old.
  • Body Mass Index of 18.0 to 45.4 kg/m2; and a total body weight of >50 kg
  • HbA1c value at the screening visit meeting once of the following criteria:

    • Currently taking acceptable oral antiglycemic drug therapy within 6.5 to 9.5%
    • Not currently taking any oral antiglycemic drug therapy within 7 to 10.5%
  • Fasting plasma glucose concentrations<270mg/dL at the screening and run-in visit, confirmed by a single repeat, if deemed necessary.
  • Subjects must be willing and able to perform self-tests of blood glucose at least 4 times per day, and maintain a diary for the duration of participation in the study; and therefore, subjects must be literate.

Exclusion Criteria:

  • History of Type 1 diabetes mellitus or secondary forms of diabetes
  • One or more self-reported hypoglycemic episodes of sever intensity within 3 months of screening; or 2 or more self-reported hypoglycemic episodes of severe intensity within the previous 6 months.
  • History of myocardial infarction, unstable angina, arterial revascularization, stroke, New York Heart Association Functional Class II-IV heart failure, or transient ischemic attach within 6 months of screening.
  • History or evidence of diabetic complications with significant end organ damage, such as

    • Proliferative retinopathy and/or macular edema;
    • Diabetic neuropathy complicated by neuropathic ulcers;
  • Screening seated systolic blood pressure >160 mm Hg and/or diastolic blood pressure >100 mm Hg after at least a 5 minute seated rest. If the blood pressure exceeds this limit, the blood pressure may be repeated 2 more times following approximately 2 minutes of rest between measurements and the median of the 3 values should be used to determine subject eligibility;
  • Male subjects with partners currently pregnant; or male subjects capable of conceiving children who are unwilling or unable to use a highly effective method of contraception as outlined in this protocol for the duration of the study and for at least 28 days after the last dose of investigational product.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02175121
Other Study ID Numbers  ICMJE B4801011
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date May 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP