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Nateglinide And Valsartan in Impaired Glucose Tolerance Outcomes Research



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.