Glycemic Control, Safety and Tolerability of TC-6987 Monotherapy in Type 2 Diabetes Mellitus

Inclusion Criteria: * Males or postmenopausal/surgically sterile females * Being treated for T2DM with oral antidiabetic agents (excluding glitazones) * BMI limit ≤ 38 * Subjects at least 80% compliant on reporting daily SMBG values during washout * At the end of washout the subject's fasting SMBG is higher than it was at the start of washout and the fasting SMBG ≤ 280.g treated for T2DM with oral antidiabetic agents (excluding glitazones) Exclusion Criteria: * Type 1 diabetes mellitus * Severe complications of T2DM (especially diabetic retinopathy imminently requiring treatment for preserving or restoring vision, diabetic neuropathy with symptomatic orthostatic hypotension, urinary retention, gastric stasis, or pedal ulcers) * Current treatment with insulin or a glitazone * Use of moderate to strong cytochrome P450 3A4 (CYP3A4) inhibitors * FSH level of \< 35 IU/L and a LH level \< 25 IU/L except for confirmed surgically sterile women with functioning ovaries * Significant cardiovascular diseases (including arrhythmia) or congestive heart failure, or severe ischemic disease within the last 3 months prior to Screening, or evidence of stroke, myocardial infarction, unstable angina, coronary bypass and/or percutaneous transluminal coronary angioplasty * History of significant other major or unstable neurological, metabolic, hepatic, renal, hematological, pulmonary, CV, GI, or urological disorder; or diagnosis of major depressive disorder; if stable medical disorder, any medical treatment must be stable for last 2 months prior to Screening * History of diabetic ketoacidosis * Patients who have an increased red blood cell (RBC) turn-over or thalassemia or anemia * Known HIV or history of viral hepatitis type B or C * Systemic infection with TB * Current or previous use of oral or injectable corticosteroids 3 months prior to screening. * Subject has persistent, uncontrolled severe hypertension as indicated by a systolic blood pressure \> 180 mmHg or a diastolic blood pressure of \> 110 mmHg, with or without treatment * Subject has had a malignancy in the last 5 years, except for successfully treated basal or squamous cell carcinoma of the skin or of the cervix * Subject is receiving chemotherapy * Tobacco user within 4 months prior to Screening * Smoking cessation therapy within 4 months prior to Screening and/or planned during the study * Use of prohibited concomitant medications including psychoactive agents * History within 6 months prior to Screening of alcohol abuse or illicit drug abuse * Was administered study medication in another clinical trial in the past 3 months prior to Screening