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

• Status: Completed
• Trial end date: 2012-03-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: TWi Biotechnology, Inc.

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.