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

Completed · Phase 2 · Has a placebo group

Conditions studied: Type 2 Diabetes Mellitus

In brief

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.

Key facts

Study ID

NCT01276106

Run by

TWi Biotechnology, Inc.

People needed

259

Starts

2011-01-01

Expected to finish

2012-03-01

Last updated by the study team

2018-05-22

Who can join

Age: 20 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Catalina Research Institute, LLC — Chino, California, United States
• National Research Institute — Los Angeles, California, United States
• Clinical Research of South Florida — Coral Gables, Florida, United States
• Jacksonville Impotence Treatment Center — Jacksonville, Florida, United States
• Chicago Clinical Research Institute, Inc. — Chicago, Illinois, United States
• Clinical Investigation Specialists, Inc. — Gurnee, Illinois, United States
• Midwest Institute for Clinical Research, Inc. — Indianapolis, Indiana, United States
• L-MARC Research Center — Louisville, Kentucky, United States
• New Orleans Center for Clinical Research — New Orleans, Louisiana, United States
• Sterling Research Group, Ltd — Cincinnati, Ohio, United States
• PriMed Clinical Research — Kettering, Ohio, United States
• National Clinical Research-Richmond, Inc. — Richmond, Virginia, United States
• Rainier Clinical Research Center, Inc. — Renton, Washington, United States
• Changhua Christian Hospital — Changhua, Taiwan
• Cheng Ching General Hospital — Taichung, Taiwan
• Chung Shan Medical University Hospital — Taichung, Taiwan
• Kuang Tien General Hospital — Taichung, Taiwan
• Cardinal Tien Hospital — Taipei, Taiwan
• Taipei Medical University Hospital — Taipei, Taiwan
• Taipei Medical University-Shuang Ho Hospital — Taipei, Taiwan
• Tri-Service General Hospital — Taipei, Taiwan

Full record on ClinicalTrials.gov

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