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



Status:Completed
Conditions:Diabetes, Diabetes
Therapuetic Areas:Endocrinology
Healthy:No
Age Range:18 - 70
Updated:4/13/2015
Start Date:August 2014
End Date:March 2015
Contact:Pfizer CT.gov Call Center
Phone:1-800-718-1021

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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

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.


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.
We found this trial at
19
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Renton, Washington 98057
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860 Peachwood Drive
DeLand, Florida 32720
(386) 740-0770
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4460 Red Bank Expressway
Cincinnati, Ohio 45227
513-721-3868
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825 South 8th Street
Minneapolis, Minnesota 55404
888-345-2567
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100 West Gore St # 202
Orlando, Florida 32806
(407) 426-9299
Compass Research LLC Compass Research is a clinical research company dedicated to testing new medications...
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7940 Floyd Curl Dr.
San Antonio, Texas 78229
210-949-0122
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6141 Sunset Dr # 301
South Miami, Florida 33143
(305) 598-3125
Miami Research Associates Miami Research Associates (MRA) is the largest privately-owned multi-specialty clinical research center...
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1085 N Harbor Blvd
Anaheim, California 92801
(714) 774-7777
Anaheim Clinical Trials, LLC Anaheim Clinical Trials (ACT) is a research center of excellence for...
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Buffalo, New York 14202
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Chula Vista, California 91911
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Eatontown, New Jersey 07724
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High Point, North Carolina 27265
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Marlton, New Jersey 08053
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Miami, Florida 33126
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Miami, Florida 33126
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South Miami, Florida 33143
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South Miami, Florida 33143
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Walnut creek, California 94598
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