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

April 24, 2018 updated by: TWi Biotechnology, Inc.

A Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Phase II Study of AC-201 in Patients With Type 2 Diabetes Mellitus

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

259

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

TWi Biotechnology, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2011

Primary Completion (Actual)

February 1, 2012

Study Completion (Actual)

March 1, 2012

Study Registration Dates

First Submitted

January 11, 2011

First Submitted That Met QC Criteria

January 12, 2011

First Posted (Estimate)

January 13, 2011

Study Record Updates

Last Update Posted (Actual)

May 22, 2018

Last Update Submitted That Met QC Criteria

April 24, 2018

Last Verified

April 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AC-201-DM-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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