- 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 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
- 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.