Long-term Study of ASP1941 - Long-term Study in Patients With Type 2 Diabetes Mellitus With Decreased Renal Function (Japanese)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 165
- 主要终点
- changes in Hemoglobin A1c (HbA1c)
研究概览
简要总结
This study is to assess the effect of renal function on the efficacy and safety of ASP1941 in type 2 diabetic patients with mild to moderate renal impairment.
详细描述
This study will be conducted in patients with type 2 diabetes mellitus and mild to moderate renal impairment who have inadequate glycemic control on an exercise program and stable diet, or one oral hypoglycemic agent.
The severity of the reduction in renal function in each subject will be classified according to the glomerular filtration rate (GFR) estimated using the Japanese GFR estimation equation. Subjects will start with a screening period, followed by a single-blind placebo run-in period, and will be randomized to the ASP1941 groups or the placebo group at a ratio of 2:1. For randomization, subjects will be stratified according to the severity of the reduction in renal function. In a treatment period, subject will receive study drug or placebo for 24 weeks under double-blind conditions.
At 24 week, subjects who are willing to continue participation in the study will receive study drug for another 28 weeks in an open label condition. ASP1941 can be increased. After completion of the study drug administration, a follow-up period will be provided.
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 74 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •type 2 diabetes mellitus patient
- •subject has been on an exercise program and stable diet, or one oral hypoglycemic agent (alpha-glucosidase inhibitor, sulfonylurea agent and pioglitazone)
- •estimated GFR value based on the Japanese GFR estimation equation of ≥ 30 mL/min/1.73 m2 and < 90 mL/min/1.73 m2
- •HbA1C value between 6.5 and 8.5%
- •body mass index (BMI) 29.0 - 45.0 kg/m2
排除标准
- •type 1 diabetes mellitus patients
- •proliferative diabetic retinopathy
- •subject has received insulin within 12 weeks before the study
- •subject has a chronic disease which requires the continuous use of adrenocortical steroids, immunosuppressant, and loop diuretic
- •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
研究组 & 干预措施
placebo group
oral
干预措施: placebo (Drug)
ASP group
oral
干预措施: ASP1941 (Drug)
结局指标
主要结局
changes in Hemoglobin A1c (HbA1c)
时间窗: baseline and 24 weeks
次要结局
- changes in fasting serum insulin level(baseline and 24 weeks)
- changes in fasting plasma glucose(baseline and 24 weeks)
- changes in eGFR (estimated glomerular filtration rate)(baseline and 52 weeks)
- safety assessed by the incidence of adverse events, vital signs, laboratory tests and 12-lead ECGs(for 52 weeks)