Safety, Tolerability, Pharmacokinetics And Pharmacodynamics Study Of PF-06291874 As Oral Monotherapy To Treat Adults With Type 2 Diabetes Mellitus
Condition: Diabetes Mellitus, Type II
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: Placebo; PF-06291874; PF-06291874; PF-06291874; PF-06291874
Intervention description: Tablet, once daily for 28 days; Tablet, 15 mg, once daily for 28 days; Tablet, 35 mg, once daily for 28 days; Tablet, 75 mg, once daily for 28 days; Tablet, 150 mg, once daily for 28 days
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 172.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No

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.
    

Eligibility criteria:

        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.