A Study of the Effect of Renal Impairment on the Activity of GK Activator (2) in Patients With Type 2 Diabetes.
Status:
Completed
Trial end date:
2007-08-01
Target enrollment:
Participant gender:
Summary
This study will investigate the effect of renal impairment on the
pharmacokinetics/pharmacodynamics of GK Activator (2) in patients with type 2 diabetes, and
will evaluate the effect of renal function on the safety of the drug. Patients will be
assigned to treatment groups according to their renal function (normal, moderate renal
impairment, or severe renal impairment). After a 1 week washout period from current oral
anti-diabetic treatment, all patients will receive a single oral dose of 100mg GK Activator
(2), and blood and urine samples will be taken up to 96h post-dose. The anticipated time on
study treatment is <3 months, and the target sample size is <100 individuals.