A Drug-Drug Interaction Study of GK Activator (2) and Simvastatin in Patients With Type 2 Diabetes.

Condition(s) targeted: Diabetes Mellitus, Type 2

Intervention: GK Activator (2) (Drug); Simvastatin (Drug)

Phase: Phase 1

Status: Completed

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 individuals.

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

Primary outcome:

AUC0-inf of GK Activator (2) and simvastatin acid.

AUC0-6h of plasma glucose from pre-dose to 6h post-dose.

Secondary outcome:

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. Gender(s): Both.

Criteria:

Inclusion Criteria:

- adult patients aged 18-75 years;

- type 2 diabetes mellitus;

- untreated, or taken off anti-diabetic or statin therapy >=2 weeks before study start.

Exclusion Criteria:

- 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.

SAN ANTONIO, Texas 78229, United States

TACOMA, Washington 98418, United States

Ending date: April 2007
Last updated: June 17, 2008