Novartis Announces Largest Diabetes and Cardiovascular Disease Prevention Trial With Starlix(R) And Diovan(R).

EAST HANOVER, N.J., June 22 /PRNewswire/ --

Novartis Pharmaceuticals Corporation today announced plans to conduct the largest clinical trial to date on the prevention of type 2 diabetes and cardiovascular disease. The NAVIGATOR (Nateglinide And Valsartan in Impaired Glucose Tolerance Outcomes Research) trial will investigate whether the oral antidiabetic agent Starlix(R) (nateglinide) or the high blood pressure medication Diovan(R) (valsartan) can prevent diabetes and/or cardiovascular events in individuals with impaired glucose tolerance (IGT) who are at high risk for cardiovascular events.

NAVIGATOR is a multinational study that will involve about 7,500 individuals in over 30 countries. Nateglinide is licensed to Novartis Pharma AG from Ajinomoto Company, Inc., which is cosponsoring the NAVIGATOR trial with Novartis. The NAVIGATOR protocol is under review with the U.S. Food and Drug Administration and European health authorities.

"People with IGT are at high risk for developing diabetes and cardiovascular disease. NAVIGATOR will evaluate the effects of earlier and more aggressive treatment of IGT with nateglinide or valsartan," said Steven M. Haffner, MD, MPH, professor of medicine at the University of Texas Health Sciences Center at San Antonio and member of the NAVIGATOR executive committee. "When you…