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

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