Study of AC-201 in Patients With Type 2 Diabetes Mellitus

Inclusion Criteria: * Understanding of the study procedures and agreement to participate in the study by giving written informed consent * Males and females age 20 to 75 years, inclusive * HbA1c ≥7.5% and ≤10% * BMI ≤45 kg/m2 * FPG ≤270 mg/dL * Diagnosis of type 2 diabetes mellitus for ≥6 months * On a stable regimen of oral anti-diabetic medications for ≥3 months * Willingness to maintain stable diet and exercise throughout the study * Willingness to maintain current doses/regimens of vitamins and dietary supplements throughout the study * Female patients of childbearing potential and female partners of male patients must be willing to use adequate contraception during the study. All females of childbearing potential must have a negative urine pregnancy test at screening. Exclusion Criteria: * History of type 1 diabetes and/or history of ketoacidosis * History of diabetic neuropathy resulting in significant functional impairment and/or requiring active medical or surgical management, including chronic pain syndromes, gastroparesis, skin ulceration, or amputation * History of long-term therapy with insulin (\>30 days) within 1 year of screening; * Pregnancy or lactation * Current treatment with any of the following medications within 2 months of screening * Anti inflammatory drugs, including chronic daily use of systemic corticosteroids (aspirin ≤325 mg per day is allowed) * IL-1 modulators: anakinra and rilonacept * Immunosuppressive drugs: TNF inhibitors and IL-6 monoclonal antibody * History of severe hypoglycemic episodes within 6 months of screening * Hypersensitivity to AC-201 or anthraquinone derivatives * Surgery within 30 days prior to screening * Serum creatinine \>1.5 mg/dL for males or \>1.4 mg/dL for females * Presence of cancer or history of cancer within the past 5 years other than basal or squamous cell carcinoma of the skin and carcinoma in situ of the cervix * Advanced stage heart failure: New York Heart Association Class III or IV cardiac status or hospitalization for congestive heart failure * History of unstable angina, myocardial infarction, uncontrolled arrhythmias, cerebrovascular accident, transient ischemic attack, or any revascularization, including percutaneous transluminal coronary angioplasty, within 6 months of screening * Uncontrolled hypertension (defined as systolic blood pressure \>160 mmHg or diastolic blood pressure \>100 mmHg on ≥3 assessments at screening) * Known to be infected with human immunodeficiency virus (HIV) * History of acquired immune deficiency syndrome * History of TB, active TB (pulmonary, extra-pulmonary, or military), or a positive test for TB confirmed by a PA chest x-ray within 6 months prior to screening * History of acute infection with Epstein-Barr Virus (EBV), cytomegalovirus (CMV), or hepatitis C virus (HCV) within 4 weeks prior to screening * History of chronic active (not latent) hepatitis B virus, HCV, or CMV infection; * History of drug or alcohol abuse * Aspartate aminotransferase \>3 × the upper limit of normal (ULN) or alanine aminotransferase \>3 × ULN at screening * Total bilirubin \>1.5 × ULN at screening * Triglycerides \>500 mg/dL at screening * Poor mental function or any other reason to expect patient difficulty in complying with the study requirements * Acute infections that may affect blood glucose control within 4 weeks prior to screening * Known bilateral renal artery stenosis, patient with a solitary kidney, or a post renal transplant * History of autoimmune disease or collagen vascular disease * History of hyperthyroidism or hypocorticism * Participation in any AC-201 studies within 1 year prior to screening * Participation in an investigational drug study within 30 days prior to screening * Any other serious diseases which, in the opinion of the investigator, might pose a risk to the patient or make participation not in the patient's best interest.