Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Pfizer
Age
18–70
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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.
You may not be if
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.
