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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT01276106
• Date of registration: 11/01/2011
• Prospective Registration: No
• Primary sponsor: TWi Biotechnology, Inc.
• Public title: Study of AC-201 in Patients With Type 2 Diabetes Mellitus
• Scientific title: A Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Phase II Study of AC-201 in Patients With Type 2 Diabetes Mellitus
• Date of first enrolment: January 2011
• Target sample size: 259
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01276106
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Triple (Participant, Care Provider, Investigator).
• Phase: Phase 2

Countries of recruitment

Taiwan, United States

Key inclusion & exclusion 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.



Age minimum: 20 Years
Age maximum: 75 Years
Gender: All

Health Condition(s) or Problem(s) studied

Type 2 Diabetes Mellitus

Intervention(s)

Drug: Placebo

Drug: AC-201, 50mg

Drug: AC-201, 25mg

Drug: AC-201, 75mg

Primary Outcome(s)

Change in HbA1c From Baseline [Time Frame: 24 weeks]

Secondary ID(s)

AC-201-DM-001

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 18/11/2014
• URL: https://clinicaltrials.gov/ct2/show/results/NCT01276106