Get Ready for NAVIGATOR

largest ever diabetes prevention trial

By Dave Joffe, Editor

 

We all know the effects of IGT, but now the world’s largest study of IGT patients is about to start.   To learn more about IGT visit http://www.diabetesincontrol.com/features/feature41.shtml 

November 14 2001, Basel -  NAVIGATOR – the largest ever diabetes prevention trial – is due to start this month.  This announcement comes on World Diabetes Day, when the International Diabetes Federation and World Health Organisation highlight the devastating impact of cardiovascular disease (CVD) on people with type 2 diabetes.  People with diabetes are two to four times more likely to suffer a heart attack than people without diabetes, and 70% of people with diabetes will die as a result of cardiovascular disease.

The NAVIGATOR (Nateglinide And Valsartan in Impaired Glucose Tolerance Outcomes Research) trial represents a significant milestone in the quest for prevention of type 2 diabetes and cardiovascular disease.  NAVIGATOR is estimated to determine whether long-term administration of Starlix® (nateglinide) or Diovan® (valsartan) reduce or delay the development of type 2 diabetes and cardiovascular disease in people who have impaired glucose tolerance (IGT) and are at high cardiovascular risk.  

The trial, expected to run until 2007, will involve 40 countries worldwide.  Rury Holman, Professor of Diabetic Medicine at the University of Oxford, UK, and one of the trial’s lead investigators, underlined the trial’s importance: “IGT is a silent condition which puts unsuspecting people at dual risk since they may well develop both diabetes and CVD.  The NAVIGATOR trial will determine whether identification of people with IGT and intervention with specific pharmacological agents can prevent progression to diabetes and/or CVD.” 

As many as one in seven people over the age of 40 has IGT and 40-50% of adults with IGT will develop type 2 diabetes within ten years.  Although people with IGT are at significantly increased risk of CVD, it is seldom diagnosed.  Many people only become aware that they have IGT or have developed type 2 diabetes after they have had a cardiovascular event.  Nearly half of those who are diagnosed with type 2 diabetes already have complications by the time they are diagnosed. 

 Professor Holman adds “As a large proportion of patients have already developed CVD by the time their type 2 diabetes is diagnosed, we need to identify people at high risk much earlier if we are to prevent CV complications.  Trials like NAVIGATOR are essential if the burden that diabetes and CVD place on health services worldwide is to be reduced.” 

Mealtime glucose spikes have been identified as an important risk factor for CV disease and mortality in people with type 2 diabetes.  In addition studies have shown that drugs that block the effects of angiotensin II reduce the incidence of cardiovascular disease in high-risk groups.  Evidence is also emerging that these drugs may improve insulin sensitivity and reduce the risk of developing type 2 diabetes.

For more information on the Navigator Study Click here for a White Paper.

IGT is an intermediate state between normal blood glucose control and type 2 diabetes.  To learn more about IGT and it’s effects go to http://www.diabetesincontrol.com/features/feature41.shtml