An Adaptive Design Study for the Assessment of the Pharmacokinetics of Albiglutide in Subjects With Normal Renal Function and Subjects With Moderate-to-severe Renal Impairment and Hemodialysis.
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 75
- 试验地点
- 7
- 主要终点
- The primary objective is to characterize the PK of albiglutide in subjects with type 2 diabetes and varying degrees of renal impairment, including subjects requiring hemodialysis, and in age, gender and BMI-matched subjects.
研究概览
简要总结
The purpose of this study is to assess the pharmacokinetics and safety of a single subcutaneously injected dose of albiglutide in subjects with type 2 diabetes mellitus with varying degrees of renal function, including subjects requiring hemodialysis.
详细描述
This adaptive design, non-randomized, open-label, staggered parallel group study evaluates the pharmacokinetics and safety of a single subcutaneously injected dose of albiglutide in subjects with type 2 diabetes mellitus with varying degrees of renal function. During Stage 1, a single dose of albiglutide will be administered to subjects with normal renal function and subjects with moderate-to-severe renal impairment not requiring hemodialysis. In addition to subjects with normal renal function and moderate renal impairment, Stage 2 of the study will also include cohorts of subjects requiring hemodialysis, subjects with severe renal impairment not requiring hemodialysis, and potentially subjects with mild renal impairment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 30 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •normal renal function or renal impairment
- •stable hemodialysis treatment for at least 3 months before screening and able to tolerate a hemodialysis treatment lasting 3-4 hours with blood flow rates of >200mL/min (cohort 3 only)
- •neither pregnant nor lactating
- •HbA1c 6-10.5% inclusive
- •females of childbearing potential must be practicing adequate contraception.
排除标准
- •inability to meet the PK objectives of the study
- •history of hypoglycemia unawareness or severe hypoglycemia
- •liver function tests greater than or equal to 2 times the ULN
- •clinically significant cardiovascular and/or cerebrovascular disease
- •positive test results for hepatitis B, hepatitis C, or HIV
- •documented hypertension or hypotension at screening
- •known hepatic or biliary abnormalities
- •current use of sulfonylureas
- •active history of tobacco use within 6 months before screening
- •donation of blood in excess of 500mL within 56 days before albiglutide dosing
- •receipt of any investigational drug within the 30days or 5 half lives, whichever is longer, before dosing
- •previous or current receipt of exenatide or any other GLP-1 agonist
研究组 & 干预措施
Stage 2 mild renal impairment
Subjects with GFR >= 50 mL/min and <= 80 mL/min
干预措施: albiglutide (Biological)
Stage 2 severe renal impairment not requiring hemodialysis
Subjects with GFR less than 30 mL/min
干预措施: albiglutide (Biological)
Stage 2 subjects requiring hemodialysis
Subjects who require hemodialysis
干预措施: albiglutide (Biological)
Stage 2 moderate renal impairment
Subject with estimated GFR >= 30 mL/min and less than 50 mL/min
干预措施: albiglutide (Biological)
Stage 2 normal renal function
Subject with GFR greater than 80 mL/min
干预措施: albiglutide (Biological)
Stage 1 moderate/severe renal function
Subject with estimated GFR >= 20 mL/min and less than 50 mL/min
干预措施: albiglutide (Biological)
Stage 1 normal renal function
Subject with estimated glomerular filtration rate (GFR) greater than 80 milliliter per minute (mL/min)
干预措施: albiglutide (Biological)
结局指标
主要结局
The primary objective is to characterize the PK of albiglutide in subjects with type 2 diabetes and varying degrees of renal impairment, including subjects requiring hemodialysis, and in age, gender and BMI-matched subjects.
时间窗: 42 days
次要结局
- To assess the safety and tolerability of a single dose of albiglutide in subjects with varying degrees of renal impairment and in age, gender and BMI-matched subjects with normal renal function(42 days)
- To assess the effects of hemodialysis on the overall PK profile of albiglutide(42 days)
- To assess the PK of albiglutide in subjects with varying degrees of proteinuria(42 days)