NCT01691755已完成3 期
A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase III Study to Assess the Efficacy, Safety and Tolerability of Aleglitazar Monotherapy Compared With Placebo in Patients With Type 2 Diabetes Mellitus (T2D) Who Are Drug-Naïve to Anti-Hyperglycemic Therapy
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
- 196
- 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 monotherapy compared with placebo in patients with type 2 diabetes mellitus who have not previously received anti-hyperglycemic therapy. 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 within 12 months prior to screening
- •Patients who have not received a anti-hyperglycemic medication for at least 12 weeks prior to screening and for not longer than 3 consecutive months in the past
- •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 peroxisome proliferator activated receptor (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
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
aleglitazar
Experimental
干预措施: aleglitazar (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
- Safety: incidence of adverse events(30 weeks (26 weeks treatment and 4 weeks follow-up))
- 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 A1c (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)
研究者
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