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

Type 2 Diabetes Mellitus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01276106
• Other study ID #: AC-201-DM-001
• Status: Completed
• Phase: Phase 2
• Start date: January 2011
• Est. completion date: March 2012

Study information

• Verified date: April 2018
• Source: TWi Biotechnology, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 259
• Est. completion date: March 2012
• Est. primary completion date: February 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

Drug:
• AC-201, 25mg
Capsule, 25mg BID
• AC-201, 50mg
Capsule, 50mg BID
• AC-201, 75mg
Capsule, 75mg BID
• Placebo
Placebo BID

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
TWi Biotechnology, Inc.

Countries where clinical trial is conducted

United States,  Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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