A Drug-Drug Interaction Study of GK Activator (2) and Simvastatin in Patients With Type 2 Diabetes.
Status:
Completed
Trial end date:
2007-04-01
Target enrollment:
Participant gender:
Summary
This study will assess the potential pharmacokinetic interaction between GK Activator (2) and
simvastatin, and the potential effect of simvastatin on the glucose-lowering effect of GK
Activator (2) in patients with type 2 diabetes. Patients will be randomized to one of 6
treatment sequences to receive single doses of a)GK Activator (2) 100mg po, b)simvastatin
80mg po and c)GK Activator (2) 100mg + simvastatin 80mg po. Dosing will take place on study
days 1, 8 and 15, and there will be a 7-14 day follow-up period after the last dose. The
anticipated time on study treatment is <3 months, and the target sample size is <100
individuals.