Safety, Tolerability, Pharmacokinetics And Pharmacodynamics Study Of PF-06291874 As Oral Monotherapy To Treat Adults With Type 2 Diabetes Mellitus
NCT02175121
ABOUT THIS STUDY
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- 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.
- 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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Descriptive Information | ||||
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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 |
| |||
Study Arms ICMJE |
| |||
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 | 172 | |||
Original Estimated Enrollment ICMJE | 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:
Exclusion Criteria:
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Sex/Gender ICMJE |
| |||
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 |
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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 |