CTRI/2009/091/000636未知2/3 期
Dose Finding, Safety and Efficacy of Monthly Subcutaneous Canakinumab Administration for the Treatment of Hyperglycemia in Metformin Monotherapy Treated Type 2 Diabetic Patients: a Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study
适应症
试验速览
- 阶段
- 2/3 期
- 入组人数
- 555
- 试验地点
- 12
- 主要终点
- To assess safety and tolerability of four doses of ACZ885 vs. placebo over 4 months in patients with T2DM To assess the effect on HbA1c of four doses of ACZ885 vs. placebo as an add-on regimen over 4 months in patients with T2DM
研究概览
简要总结
Target number of patients from India is 80.The expected recruitment from India is on 5th Nov 2009.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant, Investigator and Outcome Assessor Blinded
入排标准
入选标准
- •1.Patients must have a documented diagnosis of Type 2 diabetes confirmed by WHO criteria either a FPG greater than or equal to 7.0 mmol/l (126 mg/dl) or an OGTT test 2-hour PG greater than or equal to 11.1 mmol/l (200 mg/dl).
- •2.Patients must:* be naïve to anti-diabetes drug therapy (except for short term treatment courses with insulin in connection with hospitalization, etc.) * meet protocol specified HBA1C criteria * be eligible for metformin monotherapy OR * be on stable metformin monotherapy treatment for at least three months at Screening * meet protocol specified HBA1C criteria * take metformin as their first and only treatment with anti-diabetes drug therapy
- •Patients must have a morning fasting plasma glucose result < 180 mg/dl at Visit 3 (Month -1) analyzed by the Central Laboratory.
排除标准
- •Any of the following significant laboratory abnormalities:* Serum GAD-antibody positivity * Clinically significant TSH outside of normal range at Screening * Renal function indicating high risk metformin use, including serum creatinine concentrations (>=1.5 mg/dL for males,>=1.4 mg/dL for females) or other evidence of abnormal creatinine clearance.
- •* Alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) > 2 x upper limit of normal (ULN) at Screening, confirmed with repeat measure within one week.
- •2.History or current findings of active pulmonary disease 3.Risk factors for TB as defined in protocol 4.Known presence or suspicion of active or recurrent bacterial, fungal or viral infection at the time of enrollment.
- •Stroke, myocardial infarction, acute coronary syndrome, revascularization procedure or recurrent TIA within the last 6 months.
- •Unwillingness to use insulin glargine as the additional medication should glycemic control deteriorate.
- •Other protocol-defined inclusion/exclusion criteria may apply.
结局指标
主要结局
To assess safety and tolerability of four doses of ACZ885 vs. placebo over 4 months in patients with T2DM To assess the effect on HbA1c of four doses of ACZ885 vs. placebo as an add-on regimen over 4 months in patients with T2DM
时间窗: Time Frame: 4 months
次要结局
- To evaluate the effect of 4-month treatment of ACZ885 at 4 doses vs. placebo on the following variables: ? Glucose, C-peptide and insulin following meal test ? 7-point glucose meter data ? hsCRP(Time Frame: 4 months)
- To evaluate the effect of 4-month treatment of ACZ885 vs. placebo on cardiovascular events and infections.(Time Frame: 4 months)
研究者
研究点 (12)
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