NCT01302028已完成1 期
An Open-label, Parallel Group Study to Assess the Effect of Different Grades of Renal Impairment in Patients With Type 2 Diabetes Mellitus on the Pharmacokinetics, Pharmacodynamics and Safety & Tolerability of ASP1941 Relative to Type 2 Diabetes Mellitus With Normal Renal Function and Healthy Volunteers
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 40
- 主要终点
- Effect of grade of renal impairment on the pharmacokinetics of ASP1941
研究概览
简要总结
A study to investigate if the pharmacokinetics of ASP1941 is different in Type 2 Diabetes Mellitus (T2DM) patients with different grades of renal failure compared with T2DM patients with normal renal function and healthy volunteers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 45 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patient with stable type 2 diabetes mellitus or healthy subject
- •Subject must have pre-dose estimated Glomerular filtration rate (GFR) values (Modification of diet in renal disease (MDRD) method) at screening of:
- •>90 (normal renal function)
- •60-90 (mild renal impairment)
- •30-60 (moderate renal impairment)
- •15-30 (severe renal impairment)
- •BMI between 25.0-40.0 kg/m2, inclusive
- •Fasted plasma glucose (FPG) <11.5 mmol/l (type 2 DM patients) or >5.6 mmol/l (Healthy volunteers)
排除标准
- •Patients with Type 1 diabetes
- •Pulse <40 or >90; SBP >160 mmHg; DBP > 100 mmHg
- •T2DM patients who are not on a stable regimen for their current medication (1 month or 5 half lives, whichever is longer) to control their disease
- •Healthy Volunteers: Any of the liver function tests above the upper limit of normal
- •T2DM: The liver function tests should be within the following ranges:
- •AST/ALT: <2 x ULN
- •Bilirubin: <1.5 x ULN
- •Alk Phos: < 1.5 x ULN
- •Patients with renal impairment who have a history of a clinically significant illness (other than renal diseases and T2DM and associated clinical symptoms), medical condition, or laboratory abnormality within 3 months prior to screening
- •Patients with renal impairment who have not been on a stable dose of concomitant medications for at least 2 weeks for at least 2 weeks (or 5 halflives, whichever is longer) and/or for whom dose changes are likely to occur during the study
- •Patients with T2DM treated with a diet only
- •T2DM patients with recent evidence (e.g within the last 6 months) of severe hypoglycemia, for example plasma glucose < 3mmol/l (<55 mg/dl), help from others to resolve the hypo or requiring hospitalization
- •T2DM patients with a Hemoglobin value < 9 g/dl (5.6 mmol/l)
研究组 & 干预措施
Healthy volunteers with normal renal function
Active Comparator
Oral
干预措施: ASP1941 (Drug)
T2DM patient with normal renal function
Experimental
Oral
干预措施: ASP1941 (Drug)
T2DM patient with mild renal impairment
Experimental
Oral
干预措施: ASP1941 (Drug)
T2DM patient with moderate renal impairment
Experimental
Oral
干预措施: ASP1941 (Drug)
T2DM patient with severe renal impairment
Experimental
Oral
干预措施: ASP1941 (Drug)
结局指标
主要结局
Effect of grade of renal impairment on the pharmacokinetics of ASP1941
时间窗: 5 days
次要结局
- Effect of grade of renal impairment on the pharmacodynamics of ASP1941(5 days)
- Assessment of safety through evaluation of adverse events, physical examination, vital sins, lab-tests and 12-lead ECG(5 days)
研究者
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