Out-Patient Study in Patients With Type 2 Diabetes Mellitus Who Are Taking no Diabetes Medication or Metformin Only

Inclusion Criteria

• Has type 2 diabetes mellitus as defined by the criteria of the American Diabetes Association and recognized by World Health Organization Expert Committee on the Diagnosis and Classification of Diabetes Mellitus [American Diabetes Association, 2004a] at least three months preceding screening
• Has concurrent type 2 diabetes mellitus therapy: Must be diet and exercise treated; must not have taken antidiabetic medication for at least three months prior to prescreening or Monotherapy with metformin, with a history of a stable dose for at least three months before prescreening (not taking more than one oral antidiabetic agent)
• Has HbA1c level at screening ≥7 and ≤10%
• Is male or female 18 to 75 years of age, inclusive, at screening
• Has body mass index ≥20 and ≤40 kg/m²
• If subject is a smoker, must be able to abstain while in clinic at each visit
• If female, is eligible to enter and participate throughout the study, including the follow-up period: 1) If of nonchildbearing potential (i.e. physiologically incapable of becoming pregnant {tubal ligation}, including any female who is postmenopausal [>1 year without menstrual period]); or, 2) If of childbearing potential, has negative pregnancy tests at screening (serum) and at baseline (urine) and: 3) Has a male partner who is sterile prior to the female subject's entry into the study and is the sole sexual partner for that female subject, or 4) Uses double-barrier methods of contraception; condoms (with spermicide) and intrauterine devices are acceptable, or 5) Uses hormonal contraceptives (oral, depots, patches, etc) with double-barrier methods of contraception as outlined above, or, 6) Abstains from sexual intercourse, or 7) Is with a same-sex partner and does not participate in bisexual activities where there is any risk of pregnancy
• Signs and dates informed consent before any study-related procedures are performed

Exclusion Criteria

• Has metabolic disease including but not limited to: 1) Diagnosis of type 1 diabetes mellitus, 2) Uncorrected thyroid dysfunction (NOTE: subjects with hypothyroidism on a stable dose of thyroid replacement therapy for at least three months prior to screening, and who have a screening thyroid-stimulating hormone within the limits of normal may participate)
• Has qualitative changes in lifestyle that, in the opinion of the investigator, would affect the subject's weight or disease status
• Had previous use of insulin within one month prior to screening, or more than seven total days of insulin treatment within three months prior to screening
• Has clinically significant cardiovascular and/or cerebrovascular disease including, but not limited to: 1) Previous history of stroke or transient ischemic attack, 2) Active, unstable coronary heart disease within the past six months, 3) Documented myocardial infarction within a year prior to screening 4) Any cardiac surgery including percutaneous transluminal coronary angioplasty or coronary artery bypass graft surgery within a year prior to screening 5) Unstable angina 6) Clinically significant arrhythmia or valvular heart disease within the past year 7) Congestive heart failure with New York Heart Association Class II to Class IV symptoms. Class I is acceptable. 8) Untreated hypertension, with systolic pressure greater than 160mm Hg and/or diastolic pressure greater than 95mm Hg. 9) ECG exclusion criteria: Heart rate is 110 beats per minute, PR Interval is 210msec, QRS duration is 120msec, QTc interval (Bazett) is >450msec or >480msec with bundle branch block
• Has fasting serum triglycerides ≥800mg/dL or 9mmol/L at screening (Visit 2). Subjects receiving lipid-lowering therapy must have been on the same dose of therapy for the past three months. Fasting is defined as no food/drink for at least eight hours prior to sampling
• If female, is currently lactating, pregnant, or actively trying to become pregnant
• Has significant renal disease as manifested by one or more of the fol