drugset / Trial / NCT00368368

A Study of the Effect of Renal Impairment on the Activity of GK Activator (2) in Patients With Type 2 Diabetes.

NCT00368368

Phase 1 Completed 5 enrolled Hoffmann-La Roche
Non-randomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2006-01
Primary completion
2007-08
Completion
2007-08

Drugs

EvaluationDrugModalityDoseRoute
Subject GK Activator (2) Unknown 100 mg Oral