Safety, Tolerability, Pharmacokinetics And Pharmacodynamics Study Of PF-06291874 As Oral Monotherapy To Treat Adults With Type 2 Diabetes Mellitus
NCT ID: NCT02175121
Last Updated: 2016-06-15
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
172 participants
INTERVENTIONAL
2014-08-31
2015-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Treatment A- Placebo
Placebo
Tablet, once daily for 28 days
Treatment B- PF-06291874
PF-06291874
Tablet, 15 mg, once daily for 28 days
Treatment C- PF-06291874
PF-06291874
Tablet, 35 mg, once daily for 28 days
Treatment D- PF-06291874
PF-06291874
Tablet, 75 mg, once daily for 28 days
Treatment E- PF-06291874
PF-06291874
Tablet, 150 mg, once daily for 28 days
Interventions
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Placebo
Tablet, once daily for 28 days
PF-06291874
Tablet, 15 mg, once daily for 28 days
PF-06291874
Tablet, 35 mg, once daily for 28 days
PF-06291874
Tablet, 75 mg, once daily for 28 days
PF-06291874
Tablet, 150 mg, once daily for 28 days
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
70 Years
ALL
No
Sponsors
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Pfizer
INDUSTRY
Responsible Party
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Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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Anaheim Clinical Trials, LLC
Anaheim, California, United States
Profil Institute for Clinical Research, Inc.
Chula Vista, California, United States
Diablo Clinical Research, Inc.
Walnut Creek, California, United States
Avail Clinical Research, LLC
DeLand, Florida, United States
SeaView Research, Inc.
Miami, Florida, United States
SeaView Research, Inc.
Miami, Florida, United States
Compass Research, LLC
Orlando, Florida, United States
Miami Research Associates, Inc.
South Miami, Florida, United States
MRA Clinical Research, LLC
South Miami, Florida, United States
MRA Clinical Research
South Miami, Florida, United States
Louisville Metabolic and Atherosclerosis Research Center
Louisville, Kentucky, United States
DaVita Clinical Research
Minneapolis, Minnesota, United States
Clinilabs, Inc.
Eatontown, New Jersey, United States
PRA International
Marlton, New Jersey, United States
Buffalo Clinical Research Center, LLC
Buffalo, New York, United States
High Point Clinical Trials Center, LLC
High Point, North Carolina, United States
Community Research
Cincinnati, Ohio, United States
Clinical Trials of Texas, Inc.
San Antonio, Texas, United States
Rainier Clinical Research Center, Inc.
Renton, Washington, United States
Countries
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Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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B4801011
Identifier Type: -
Identifier Source: org_study_id
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