NCT01276106已完成2 期
A Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Phase II Study of AC-201 in Patients With Type 2 Diabetes Mellitus
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 259
- 试验地点
- 21
- 主要终点
- Change in HbA1c From Baseline
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 20 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Placebo
Placebo Comparator
Placebo BID for 24 weeks
干预措施: Placebo (Drug)
AC-201, 25mg
Experimental
25mg BID for 24 weeks
干预措施: AC-201, 25mg (Drug)
AC-201, 50mg
Experimental
50mg BID for 24 weeks
干预措施: AC-201, 50mg (Drug)
AC-201, 75mg
Experimental
75mg BID for 24 weeks
干预措施: AC-201, 75mg (Drug)
结局指标
主要结局
Change in HbA1c From Baseline
时间窗: 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.
次要结局
未报告次要终点
研究者
研究点 (21)
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