A Phase III Study to Assess the Efficacy, Safety and Tolerability of ASP1941 in Combination With Pioglitazone in Patients With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Pioglitazone Alone
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 152
- 主要终点
- Change from baseline in HbA1c
研究概览
简要总结
This study is to evaluate the efficacy and safety after concomitant administration of ASP1941 and pioglitazone in patients with diabetes mellitus.
详细描述
This study is to evaluate the efficacy (HbA1c change from baseline) and safety of ASP1941 in combination with pioglitazone in subjects with type 2 diabetes mellitus (T2DM) who have inadequate glycemic control with pioglitazone alone. The effects of ASP1941 are compared with those of placebo. Double blind period continues for 24 weeks followed by open period in each patient.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Type 2 diabetic patients receiving pioglitazone mono-therapy for at least 4 weeks
- •HbA1c value between 7.0 and 9.5%
- •Body Mass Index (BMI) 20.0 - 45.0 kg/m2
排除标准
- •Type 1 diabetes mellitus patients
- •Serum creatinine > upper limit of normal
- •Proteinuria (albumin/creatinine ratio > 300mg/g)
- •Dysuria and/or urinary tract infection, genital infection
- •Significant renal, hepatic or cardiovascular diseases
- •Severe gastrointestinal diseases
- •Heart failure patients
研究组 & 干预措施
ASP group
ASP1941 and pioglitazone
干预措施: ipragliflozin (Drug)
ASP group
ASP1941 and pioglitazone
干预措施: Pioglitazone (Drug)
Placebo group
placebo and pioglitazone
干预措施: Placebo (Drug)
Placebo group
placebo and pioglitazone
干预措施: Pioglitazone (Drug)
结局指标
主要结局
Change from baseline in HbA1c
时间窗: Baseline and for 24 weeks
次要结局
- Safety as reflected by adverse events, routine safety laboratories, vital signs, physical examinations and 12-lead electrocardiograms (ECGs)(For 52 weeks)
- Change from baseline in fasting serum insulin(Baseline and for 24 weeks)
- Change from baseline in fasting plasma glucose(Baseline and for 24 weeks)