NCT00388518已完成2 期
A Randomized, Double-blind Study to Investigate the Effect of Aleglitazar on Glycemic Control 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
- 332
- 主要终点
- Absolute change from baseline in Hemoglobin A1c (HbA1c)
研究概览
简要总结
This 6 arm study will assess the efficacy, safety, tolerability and pharmacokinetics of aleglitazar therapy in patients with Type 2 diabetes. Patients will be randomised to one of 6 treatment arms, to receive one of 4 doses of aleglitazar, Actos as an open-label active comparator, or placebo. Aleglitazar will be administered starting from a dose of 0.05mg po daily, and Actos will be administered at a dose of 45mg once daily. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •adult patients, 18-75 years of age;
- •type 2 diabetes, diagnosed >=1 month of screening;
- •either drug-naive, or pretreated with a maximum of 2 oral antihyperglycemic agents at submaximal doses;
- •HbA1c <=10.0% at screening, and 7.0-10.0% at pre-randomisation visit.
排除标准
- •type 1 diabetes;
- •currently or previously treated with insulin, a thiazolidinedione, or a dual Peroxisome Proliferator Activated Receptor (PPAR) agonist;
- •clinically significant cardiovascular disease;
- •Congestive Heart Failure (CHF) New York Heart Association (NYHA) 3-4.
研究组 & 干预措施
Actos
Active Comparator
干预措施: Actos (Drug)
Aleglitazar 1
Experimental
干预措施: aleglitazar (Drug)
Aleglitazar 2
Experimental
干预措施: aleglitazar (Drug)
Aleglitazar 3
Experimental
干预措施: aleglitazar (Drug)
Aleglitazar 4
Experimental
干预措施: aleglitazar (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Absolute change from baseline in Hemoglobin A1c (HbA1c)
时间窗: 16 weeks
次要结局
- Adverse Events (AEs), laboratory parameters.(Throughout study)
- Absolute change from baseline in Fasting Plasma Glucose (FPG), HbA1c response rate, insulin sensitivity, beta cell function and cardiovascular markers.(16 weeks)
研究者
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