NCT01691846已完成3 期
A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase III Study to Assess the Efficacy, Safety and Tolerability of Aleglitazar Plus Metformin Combination Therapy Compared With Placebo Plus Metformin in Patients With T2D Inadequately Controlled With Metformin Monotherapy
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 200
- 主要终点
- Change from baseline in hemoglobin HbA1c
研究概览
简要总结
This multicenter, randomized, double-blind, placebo-controlled study will assess the efficacy, safety and tolerability of aleglitazar plus metformin combination therapy compared with placebo plus metformin in patients with type 2 diabetes mellitus who are inadequately controlled with metformin monotherapy. Patients will be randomized to receive oral doses of 150 mcg aleglitazar once daily or placebo. The anticipated time on study treatment is 26 weeks.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients, >/=18 years of age
- •Diagnosis of diabetes mellitus type 2
- •Patients treated with stable metformin monotherapy for at least 12 weeks prior to screening
- •HbA1c >/=7% and </=9.5% at screening or within 4 weeks prior to screening and at pre-randomization visit
- •Fasting plasma glucose </=240 mg/dL at pre-randomization visit
- •Agreement to maintain diet and exercise habits during the study
排除标准
- •Patients with Type 1 diabetes mellitus, secondary diabetes, diabetes resulting from pancreatic injury, or acute metabolic diabetic complications within the past 6 months
- •Any previous treatment with thiazolidinedione or a dual PPAR agonist
- •Any body weight lowering or lipoprotein-modifying therapy within 12 weeks prior to screening (except stable dose of statin)
- •Symptomatic congestive heart failure classified as New York Heart Association class II-IV at screening
研究组 & 干预措施
aleglitazar
Experimental
干预措施: aleglitazar+metformin (Drug)
placebo
Placebo Comparator
干预措施: placebo+metformin (Drug)
结局指标
主要结局
Change from baseline in hemoglobin HbA1c
时间窗: From baseline to week 26
次要结局
- Change in lipid profile(From baseline to week 26)
- Change from baseline in fasting plasma glucose(From baseline to week 26)
- Responder rate as defined of hemoglobin HbAc1 <7.0% (<6.5%)(From baseline to week 26)
- Change from baseline in homeostatic index of insulin sensitivity (HOMA-IS)(From baseline to week 26)
- Change from baseline in homeostatic index of beta cell function (HOMA-BCF)(From baseline to week 26)
- Safety: incidence of adverse events(30 weeks (26 weeks treatment and 4 weeks follow-up))
研究者
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