Study of AC-201 in Patients With Type 2 Diabetes Mellitus
Study of AC-201 in Patients With Type 2 Diabetes Mellitus
This is a 24-week randomized placebo-controlled study to investigate the effect of an oral
 IL-1beta inhibitor AC-201 in patients with type 2 diabetes mellitus already treated on
 different background diabetes therapies.
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.