A Study of the Effect of Renal Impairment on the Activity of GK Activator (2) in Patients With Type 2 Diabetes.
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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.
An Open-label Study to Investigate the Effect of Renal Impairment on the Pharmacokinetics/Pharmacodynamics and Safety of GK Activator (2) Following a Single Oral Dose Administration in Patients With Type 2 Diabetes.
Study Start Date
Actual Primary Completion Date
Actual Study Completion Date
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Ages Eligible for Study:
18 Years to 75 Years (Adult, Senior)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
adult patients, 18-75 years of age;
type 2 diabetes, taken off current sulfonylureas and/or metformin therapy for >=1 week prior to dosing with GK Activator (2);
normal renal function, or moderate or severe impairment.
type 1 diabetes;
treatment with insulin or PPAR gamma agonist within 6 months of screening.