Study In People With Type 2 Diabetes

To be eligible for Randomization into the trial, a subject must satisfy all of the following glycemic criteria: •HbA1c level via central laboratory at the pre-screening visit •If HbA1c ≥ 8.0% but ≤ 10.0%: subject may proceed to Randomization; •If HbA1c ≥ 7.8% but < 8.0%, subject not eligible to proceed, but may be retested once to establish eligibility (or lack thereof). If HbA1c level ≥ 8.0% upon retest, subject is eligible to proceed; otherwise they should be withdrawn. •If HbA1c < 7.8%, subject not eligible to proceed (no retest allowed). •FPG level via central laboratory at the pre-screening visit must be < 270 mg/dL (15.0 mmol/L). FPG may be retested within a week to confirm eligibility (or lack thereof).

Concurrent T2DM therapy: •Diet and/or exercise treated: Must not have taken antidiabetic medication for at least 2 months prior to the pre-screening visit, OR •Metformin monotherapy: Subjects entering the study on metformin must be on the same dose, formulation and regimen of metformin for at least 2 months prior to the pre-screening visit, AND •TZDs and insulin are excluded in the 3 months prior to the Screening visit for all subjects.

If female, eligible to enter and participate in this study: •If of non-childbearing potential (i.e., physiologically incapable of becoming pregnant (tubal ligation), including any female who is post-menopausal [>1 year without menstrual period]); or, •If of child-bearing potential, has a negative pregnancy test at Screening (serum), at Randomization (urine) and: ○ 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 ○ Uses double-barrier methods of contraception; condoms with the use of caps (with spermicide) and IUDs are acceptable, or ○ Uses hormonal contraceptives (oral, depots, patches etc) with double- barrier methods of contraception as outlined above, or ○ Abstains from sexual intercourse, or ○ Is with a same sex partner and does not participate in bisexual activities where there is any risk of pregnancy.

Metabolic Disease including: •Diagnosis of Type 1 diabetes mellitus •Uncorrected thyroid dysfunction. (NOTE: subjects with hypothyroidism on a stable dose of thyroid replacement therapy for at least 1 month prior to Screening, and who have a screening thyroid stimulating hormone (TSH) within the upper limit of normal may participate). •Significant weight gain or loss (defined as > 5% of total body weight) within the 3 months prior to Screening.

History of recent clinically significant cardiovascular disease including: •History or ECG evidence of prior myocardial infarction within 6 months prior to Screening. •Current unstable angina or history of unstable angina in past 6 months. •Coronary revascularization including percutaneous transluminal coronary angioplasty (PTCA) or coronary artery bypass graft (CABG) surgery that is either planned or occurred in the 6 months prior to Screening. •Clinically significant arrhythmia or valvular heart disease. •Congestive heart failure (CHF) with New York Heart Association (NYHA) Class II-IV symptoms (see Section 15.4, Appendix 4). •Blood pressure > 160/100 mmHg or resting heart rate > 100 bpm. Note: subjects using antihypertensives [e.g., beta blockers, angiotensin converting enzyme (ACE) inhibitors, angiotensin II antagonists, calcium channel blockers and diuretics] must be on stable doses during the 30 days prior to Screening and during the trial. •Has a QTc interval (Bazett's) > 440 msec in males and > 450 msec in females at Screening. •Clinically significant ECG abnormalities which, in the opinion of the Investigator, may affect the interpretation of safety data, or which otherwise, contraindicates participation in a clinical trial with a new chemical entity.

Documented history of hepato-biliary disease including a history of, or positive laboratory results for hepatitis (hepatitis B surface antigen and/or hepatitis C antibody) at Screening, and/or clinically significant hepatic enzyme elevation including: •Any one of the following enzymes greater than 2.5 times the upper limit of normal (ULN) value at Screening: ○ Alanine aminotransferase (ALT) ○ Aspartate aminotransferase (AST) ○ Alkaline phosphatase (ALP) ○ Total or direct bilirubin > 1.5 times the ULN at Screening, unless consistent with presumed or diagnosed Gilbert's disease.

Is currently taking or has taken any of the following medications in the 3 months prior to the pre-screening visit: •Anti-obesity agents (including fat absorption blocking agents) •St. John's Wort •Warfarin and other oral anticoagulants (excluding aspirin and non-steroidal anti-inflammatory drugs) •Digoxin •Oral or injectable corticosteroids (inhaled and intranasal steroids are acceptable) •Use of antidiabetic agents (other than metformin) in the 2 months prior to the pre-screening visit. •Use of TZDs in the 3 months prior to the pre-screening visit. •Methotrexate, cyclosporine or monoclonal antibodies (e.g., alemtuzumab, gemtuzumab ozogamicin, rituximab, trastuzumab, ibritumomab, tiuxetan) for rheumatoid arthritis or psoriasis. •Atypical antipsychotic medications [e.g., aripiprazole (Abilify), risperidone (Risperdal), clozapine (Clozaril), olanzapine (Zyprexa), quetiapine (Seroquel), and ziprasidone (Geodon)]. •Antiretroviral drugs •Use of lipid lowering agents within 3 months prior to the pre-screening visit. This includes statins, fibrates, ezetimibe (Zetia), niacin and bile acid sequestrants. •Monoamine oxidase inhibitors

History of cancer except for the following: •Basal cell carcinoma or superficial squamous cell carcinoma treated by local excision. •Cervical cancer in situ treated definitively more than 6 months prior to screening.

Has a history of substance and/or alcohol abuse within the past year as determined by the Investigator at screening or during treatment: •Unwilling to refrain from the use of illicit drugs and adhere to other protocol-stated restrictions while participating in the study. •History of alcohol abuse defined as an average weekly intake of greater than 21 units or an average daily intake of greater than 3 units (males) or defined as an average weekly intake of greater than 14 units or an average daily intake of greater than 2 units (females). One unit is equivalent to a half-pint of beer or 1 measure of spirits or 1 glass of wine.