NCT01276106

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
259

participants targeted

Target at P75+ for phase_2 type-2-diabetes-mellitus

Timeline
Completed

Started Jan 2011

Geographic Reach
2 countries

21 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2011

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

January 11, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 13, 2011

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2012

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2012

Completed
2.7 years until next milestone

Results Posted

Study results publicly available

November 18, 2014

Completed
Last Updated

May 22, 2018

Status Verified

April 1, 2018

Enrollment Period

1.1 years

First QC Date

January 11, 2011

Results QC Date

November 7, 2014

Last Update Submit

April 24, 2018

Conditions

Type 2 Diabetes Mellitus

Keywords

AC-201Interleukin 1 inhibitor

Outcome Measures

Primary Outcomes (1)

  • Change in HbA1c From Baseline

    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

Study Arms (4)

AC-201, 25mg

EXPERIMENTAL

25mg BID for 24 weeks

Drug: AC-201, 25mg

AC-201, 50mg

EXPERIMENTAL

50mg BID for 24 weeks

Drug: AC-201, 50mg

AC-201, 75mg

EXPERIMENTAL

75mg BID for 24 weeks

Drug: AC-201, 75mg

Placebo

PLACEBO COMPARATOR

Placebo BID for 24 weeks

Drug: Placebo

Interventions

AC-201, 25mgDRUG

Capsule, 25mg BID

AC-201, 25mg
AC-201, 50mgDRUG

Capsule, 50mg BID

AC-201, 50mg
AC-201, 75mgDRUG

Capsule, 75mg BID

AC-201, 75mg
PlaceboDRUG

Placebo BID

Placebo

Eligibility Criteria

Age20 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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
  • +18 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (21)

Catalina Research Institute, LLC

Chino, California, United States

Location

National Research Institute

Los Angeles, California, United States

Location

Clinical Research of South Florida

Coral Gables, Florida, United States

Location

Jacksonville Impotence Treatment Center

Jacksonville, Florida, United States

Location

Chicago Clinical Research Institute, Inc.

Chicago, Illinois, United States

Location

Clinical Investigation Specialists, Inc.

Gurnee, Illinois, United States

Location

Midwest Institute for Clinical Research, Inc.

Indianapolis, Indiana, United States

Location

L-MARC Research Center

Louisville, Kentucky, United States

Location

New Orleans Center for Clinical Research

New Orleans, Louisiana, United States

Location

Sterling Research Group, Ltd

Cincinnati, Ohio, United States

Location

PriMed Clinical Research

Kettering, Ohio, United States

Location

National Clinical Research-Richmond, Inc.

Richmond, Virginia, United States

Location

Rainier Clinical Research Center, Inc.

Renton, Washington, United States

Location

Changhua Christian Hospital

Changhua, Taiwan

Location

Cheng Ching General Hospital

Taichung, Taiwan

Location

Chung Shan Medical University Hospital

Taichung, Taiwan

Location

Kuang Tien General Hospital

Taichung, Taiwan

Location

Cardinal Tien Hospital

Taipei, Taiwan

Location

Taipei Medical University Hospital

Taipei, Taiwan

Location

Taipei Medical University-Shuang Ho Hospital

Taipei, Taiwan

Location

Tri-Service General Hospital

Taipei, Taiwan

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

diacerein

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Results Point of Contact

Title
Medical Director
Organization
TWi Biotechnology, Inc.
Carl.Brown@twipharma.com
+886-2-26573350

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
LTE60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 11, 2011

First Posted

January 13, 2011

Study Start

January 1, 2011

Primary Completion

February 1, 2012

Study Completion

March 1, 2012

Last Updated

May 22, 2018

Results First Posted

November 18, 2014

Record last verified: 2018-04

Locations

TW(8)US(13)