A Study of the Pharmacokinetics of Albiglutide in Normal and Renally Impaired Subjects.

GlaxoSmithKline (GSK)

Status and phase: Completed; Phase 1

Conditions: Diabetes Mellitus, Type 2

Treatments: Biological: albiglutide

Study type: Interventional

Funder types: Industry

Identifiers

NCT00938158

108370

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 75 patients

Sex: All

Ages: 30 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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.

Exclusion criteria

• 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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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75 participants in 7 patient groups

Stage 1 normal renal function

Experimental group

Description:

Subject with estimated glomerular filtration rate (GFR) greater than 80 milliliter per minute (mL/min)

Treatment:

Biological: albiglutide

Stage 1 moderate/severe renal function

Experimental group

Description:

Subject with estimated GFR \>= 20 mL/min and less than 50 mL/min

Treatment:

Biological: albiglutide

Stage 2 normal renal function

Experimental group

Description:

Subject with GFR greater than 80 mL/min

Treatment:

Biological: albiglutide

Stage 2 moderate renal impairment

Experimental group

Description:

Subject with estimated GFR \>= 30 mL/min and less than 50 mL/min

Treatment:

Biological: albiglutide

Stage 2 subjects requiring hemodialysis

Experimental group

Description:

Subjects who require hemodialysis

Treatment:

Biological: albiglutide

Stage 2 severe renal impairment not requiring hemodialysis

Experimental group

Description:

Subjects with GFR less than 30 mL/min

Treatment:

Biological: albiglutide

Stage 2 mild renal impairment

Experimental group

Description:

Subjects with GFR \>= 50 mL/min and \<= 80 mL/min

Treatment:

Biological: albiglutide