Nateglinide And Valsartan in Impaired Glucose Tolerance Outcomes Research
NAVIGATOR is a double-blind, randomized, placebo controlled, 2x2 factorial design, multi-national clinical outcome trial in patients with documented cardiovascular disease or at high cardiovascular risk who have impaired glucose tolerance.
The trial evaluating separately the impact of nateglinide and valsartan on progression to diabetes and on a core and extended composite cardiovascular outcome. 9518 patients were randomised between 2002 and 2003 with results expected in 2010.
NAVIGATOR study raises questions on prevention of diabetes, heart disease 15 Mar 2010
In this double-blind, randomized clinical trial with a 2-by-2 factorial design, the international group of investigators and coordinators enrolled patients with impaired glucose tolerance and either established cardiovascular disease or cardiovascular risk factors. Patients were randomly assigned to receive either valsartan plus placebo, nateglinide plus placebo, nateglinide plus valsartan, or placebo plus placebo. In addition, all patients participated in a lifestyle modification program. Patients were followed for a median of 5.0 years for the development of diabetes and for 6.5 years for vital status. The effects of the drugs were evaluated on three co-primary endpoints: incidence of diabetes; an "extended" composite outcome of death from cardiovascular causes, nonfatal myocardial infarction, nonfatal stroke, or hospitalization for heart failure, arterial revascularization, or unstable angina; and a "core" composite endpoint comprising cardiovascular death, nonfatal myocardial infarction, nonfatal stroke, and hospitalization for heart failure. This program summarizes the results of the study.
NAVIGATOR was presented as a Late Breaking Clinical Trial on March 14, 2010, at the American College of Cardiology's Scientific Sessions in Atlanta, Georgia. The trial was concurrently published as two publications in the New England Journal of Medicine.