study of ac-201 in patients with type 2 diabetes mellitus

Conditions: Type 2 Diabetes Mellitus

Summary: 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.


Eligibility 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.

Keywords: ac-201 interleukin 1 inhibitor