Chair:Robert Califf
Co-chair:Rury Holman
Funder:Novartis
Reference number:NCT00097786
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.
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.
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.
[Link]
Effect of Valsartan on the Incidence of Diabetes and Cardiovascular Events
The NAVIGATOR Study Group
N Engl J Med 2010 on-line (10.1056/NEJMoa1001121)
Background
It is not known whether drugs that block the renin-angiotensin system reduce the risk of diabetes and cardiovascular events in patients with impaired glucose tolerance.
Methods
In this double-blind, randomized clinical trial with a 2-by-2 factorial design, we assigned 9306 patients with impaired glucose tolerance and established cardiovascular disease or cardiovascular risk factors to receive valsartan (up to 160 mg daily) or placebo (and nateglinide or placebo) in addition to lifestyle modification....
Effect of Nateglinide on the Incidence of Diabetes and Cardiovascular Events
The NAVIGATOR Study Group
N Engl J Med 2010 on-line (10.1056/NEJMoa1001122)
Background
The ability of short-acting insulin secretagogues to reduce the risk of diabetes or cardiovascular events in people with impaired glucose tolerance is unknown.
Methods
In a double-blind, randomized clinical trial, we assigned 9306 participants with impaired glucose tolerance and either cardiovascular disease or cardiovascular risk factors to receive nateglinide (up to 60 mg three times daily) or placebo, in a 2-by-2 factorial design with valsartan or placebo, in addition to participation in a lifestyle modification program....