A Drug-Drug Interaction Study of GK Activator (2) and Simvastatin in Patients With Type 2 Diabetes.
Information source: Hoffmann-La Roche
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Diabetes Mellitus, Type 2
Intervention: GK Activator (2) (Drug); Simvastatin (Drug)
Phase: Phase 1
Sponsored by: Hoffmann-La Roche
Official(s) and/or principal investigator(s):
Clinical Trials, Study Director, Affiliation: Hoffmann-La Roche, +1 973 235 5000
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
Official title: A Randomized, Open-Label Crossover Study to Investigate the Potential Interaction Between GK Activator (2) and Simvastatin in Patients With Type 2 Diabetes
Study design: Treatment, Randomized, Open Label, Active Control, Crossover Assignment, Pharmacokinetics/Dynamics Study
AUC0-inf of GK Activator (2) and simvastatin acid.
AUC0-6h of plasma glucose from pre-dose to 6h post-dose.
AUC0-6h of GK Activator (2) and simvastatin acid
AUC0-inf of M4 and simvastatin; CL/F, Cmax, tmax, t1/2.
Cmin, tmin, Cmax, tmax, plasma glucose.
AEs, laboratory parameters.
Minimum age: 18 Years.
Maximum age: 75 Years.
- adult patients aged 18-75 years;
- type 2 diabetes mellitus;
- untreated, or taken off anti-diabetic or statin therapy >=2 weeks before study start.
- type 1 diabetes mellitus, or latent autoimmune diabetes in adults;
- diabetic neuropathy, retinopathy or nephropathy;
- patients treated with insulin or PPAR gamma agonist within 6 weeks of screening.
Locations and Contacts
SAN ANTONIO, Texas 78229, United States
TACOMA, Washington 98418, United States
Ending date: April 2007
Last updated: June 17, 2008