- Patients with type 2 diabetes mellitus who are taking either no medication for the
treatment of diabetes (diet/exercise therapy only), or who are taking only a single
oral anti-diabetic drug (OAD) that can be temporarily discontinued for approximately
8-10 weeks. For those taking a single OAD, treatment should be stable, where this is
defined as no change in the treatment, including dose, over the past 3 months prior to
Screening. OAD medications that are acceptable to be discontinued include: a
sulfonylurea (SU), a meglitinide, a biguanide (eg, metformin), a dipeptidyl peptidase
4 inhibitor (DPP-4i), or an alpha glucosidase inhibitor.
- Body Mass Index (BMI) of 18.5 to 45.0 kg/m2; and a total body weight >50 kg (110 lbs).
- HbA1c >/=7% and =10% if the patient is on diet/exercise therapy only and does not
require any OAD discontinuation. HbA1c >/=6.5% and =9% if the patient requires to be
washed off an OAD.
- Evidence or history of diabetic complications with significant end organ damage.
- History of stroke or transient ischemic attack.
- History of myocardial infarction.
- History of coronary artery bypass graft or stent implantation.
- Clinically significant peripheral vascular disease.
- Any history or clinical evidence of congestive heart failure, NYHA Classes II IV.
- Current history of angina/unstable angina.
- One or more episodes of hypoglycemia within the last 3 months, or two or more episodes
of hypoglycemia within the last 6 months.
- A positive urine drug screen.
- Use of tobacco or nicotine-containing products in excess of the equivalent of 10
cigarettes per day.
- Blood pressure >/=160 mm Hg (systolic) or >/=100 mm Hg (diastolic), following at least
5 minutes of rest.
- Pregnant or nursing females; females of childbearing potential.