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

NCT ID: NCT01276106

Last Updated: 2018-05-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 259 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-01-31
• Study Completion Date: 2012-03-31

Brief 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.

Conditions

Type 2 Diabetes Mellitus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

AC-201, 25mg

25mg BID for 24 weeks

Group Type: EXPERIMENTAL

AC-201, 25mg

Intervention Type: DRUG

Capsule, 25mg BID

AC-201, 50mg

50mg BID for 24 weeks

Group Type: EXPERIMENTAL

AC-201, 50mg

Intervention Type: DRUG

Capsule, 50mg BID

AC-201, 75mg

75mg BID for 24 weeks

Group Type: EXPERIMENTAL

AC-201, 75mg

Intervention Type: DRUG

Capsule, 75mg BID

Placebo

Placebo BID for 24 weeks

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo BID

Interventions

AC-201, 25mg

Capsule, 25mg BID

Intervention Type: DRUG

AC-201, 50mg

Capsule, 50mg BID

Intervention Type: DRUG

AC-201, 75mg

Capsule, 75mg BID

Intervention Type: DRUG

Placebo

Placebo BID

Intervention Type: DRUG

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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

TWi Biotechnology, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

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

Countries

United States; Taiwan

Other Identifiers

AC-201-DM-001

Identifier Type: -

Identifier Source: org_study_id