You are here

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

Last updated on February 17, 2019

FOR MORE INFORMATION
Study Location
Anaheim Clinical Trials, LLC
Anaheim, California, 92801 United States
Contact
1-800-718-1021
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 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.

NCT02175121
Pfizer
Completed
Safety, Tolerability, Pharmacokinetics And Pharmacodynamics Study Of PF-06291874 As Oral Monotherapy To Treat Adults With Type 2 Diabetes Mellitus

NEED INFO?

Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center

Pfizer Clinical Trials Contact Center

1-800-718-1021

[email protected]

call now

Try a new search

Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your city or zip code to find studies near you.

Based on your search, you may also be interested in

Type II Diabetes Mellitus
NCT01247896
All Genders
18+
Years
Bruxelles,

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]

Call Now