Clinical Drug Experience Knowledgebase

Criteria

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.