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Novartis Pharma AG, of Basel, Switzerland, announced the launch of a massive-scale diabetes prevention trial aimed at finding out if taking a Starlix (nateglinide) or Diovan (valsartan) over a long period of time will offset diabetes and heart disease. The trial will be conducted on individuals with impaired glucose tolerance (IGT) who are at high risk for cardiovascular disease.
Entitled NAVIGATOR (Nateglinide and Valsartan in Impaired Glucose Tolerance Outcomes Research), the four-arm study will involve 7,500 subjects from 600 to 800 research centers in 40 different countries. Participants will be 50 years of age or older with at least one type of cardiovascular disease, or at least 55 with at least one risk factor for heart disease. Subjects will be given either Starlix (60 mg before meals) or Diovan (160 mg daily), or both, or a placebo. In the first of two phases, the effect of Starlix and Diovan on the progression of diabetes will be studied for three years. In the second phase, researchers will examine the effect of the drugs on cardiovascular disease.
The protocol for the study is currently under review by the Food and Drug Administration.
"With as many as one in seven people over 40 being affected by IGT, it is essential that we evaluate strategies to improve the outlook of people with this condition," said Thomas Ebeling, CEO of Novartis Pharma AG, in the company's press release.
"The NAVIGATOR trial, which is nearly twice the size of any comparable trial, will show us whether restoration of early phase insulin secretion and improvements in insulin sensitivity can arrest decline to type 2 diabetes and prevent cardiovascular disease in this high-risk group," said Rury Holman, of University of Oxford, UK, one of the trial's lead investigators.
Starlix is an oral drug used to treat post-meal hyperglycemia. Diovan is an angiotensin II receptor blocker used to treat high blood pressure.
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