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....
Download a slide deck showing the primary NAVIGATOR results of the effects of nateglinide and valsartan on the incidence of diabetes and cardiovascular events by clicking on the link below.
Baseline Characteristics of the Nateglinide and Valsartan Impaired Glucose Tolerance Outcomes Research (NAVIGATOR) Trial Population: Comparison with Other Diabetes Prevention Trials
Henry Krum, John J.V....
Prevention of diabetes and cardiovascular disease in patients with impaired glucose tolerance: Rationale and design of the Nateglinide And Valsartan in Impaired Glucose Tolerance Outcomes Research (NAVIGATOR) Trial Rationale and design of the Nateglinide And Valsartan in Impaired Glucose Tolerance Outcomes Research (NAVIGATOR) Trial
Robert M. Califf, Mitradev Boolell, Steven M....