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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01276106
Recruitment Status : Completed
First Posted : January 13, 2011
Results First Posted : November 18, 2014
Last Update Posted : November 18, 2014
Information provided by (Responsible Party):
TWi Biotechnology, Inc.

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.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Mellitus Drug: AC-201, 25mg Drug: AC-201, 50mg Drug: AC-201, 75mg Drug: Placebo Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 259 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Phase II Study of AC-201 in Patients With Type 2 Diabetes Mellitus
Study Start Date : January 2011
Actual Primary Completion Date : February 2012
Actual Study Completion Date : March 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: AC-201, 25mg
25mg BID for 24 weeks
Drug: AC-201, 25mg
Capsule, 25mg BID
Experimental: AC-201, 50mg
50mg BID for 24 weeks
Drug: AC-201, 50mg
Capsule, 50mg BID
Experimental: AC-201, 75mg
75mg BID for 24 weeks
Drug: AC-201, 75mg
Capsule, 75mg BID
Placebo Comparator: Placebo
Placebo BID for 24 weeks
Drug: Placebo
Placebo BID

Primary Outcome Measures :
  1. Change in HbA1c From Baseline [ Time Frame: 24 weeks ]
    For efficacy analyses, the primary analysis was at Week 24 Endpoint, defined as the last valid post-baseline measurement taken at or before Week 24. Efficacy results for treatment groups were considered statistically significant if change from baseline relative to placebo had p<0.05.

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01276106

United States, California
Catalina Research Institute, LLC
Chino, California, United States
National Research Institute
Los Angeles, California, United States
United States, Florida
Clinical Research of South Florida
Coral Gables, Florida, United States
Jacksonville Impotence Treatment Center
Jacksonville, Florida, United States
United States, Illinois
Chicago Clinical Research Institute, Inc.
Chicago, Illinois, United States
Clinical Investigation Specialists, Inc.
Gurnee, Illinois, United States
United States, Indiana
Midwest Institute for Clinical Research, Inc.
Indianapolis, Indiana, United States
United States, Kentucky
L-MARC Research Center
Louisville, Kentucky, United States
United States, Louisiana
New Orleans Center for Clinical Research
New Orleans, Louisiana, United States
United States, Ohio
Sterling Research Group, Ltd
Cincinnati, Ohio, United States
PriMed Clinical Research
Kettering, Ohio, United States
United States, Virginia
National Clinical Research-Richmond, Inc.
Richmond, Virginia, United States
United States, Washington
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
Sponsors and Collaborators
TWi Biotechnology, Inc.

Responsible Party: TWi Biotechnology, Inc. Identifier: NCT01276106     History of Changes
Other Study ID Numbers: AC-201-DM-001
First Posted: January 13, 2011    Key Record Dates
Results First Posted: November 18, 2014
Last Update Posted: November 18, 2014
Last Verified: November 2014

Keywords provided by TWi Biotechnology, Inc.:
Interleukin 1 inhibitor

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases