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Study: Starlix enhances glucose control in people with impaired tolerance

New research presented at the World Congress of Cardiology describes results from the first study to show that Starlix (nateglinide) enhances early insulin secretion and controls post-prandial blood glucose in people with impaired glucose tolerance (IGT). This suggests that Starlix may be a useful agent for controlling post-prandial hyperglycaemia in this pre-diabetic patient group.

It is estimated that as many as 150 million people may have IGT. People with IGT show abnormalities in both insulin secretion and response to insulin (insulin sensitivity), and are at high risk of progressing to type 2 diabetes, with a 40-50% chance of developing the disease within ten years. IGT is an intermediate state between normal blood glucose control and type 2 diabetes and is characterised by an excessive rise in blood glucose following an oral glucose tolerance test. IGT is also a major risk factor for cardiovascular disease.

Dr Leif Groop of the University of Lund in Sweden, one of the study's lead investigators, commented: "Loss of early insulin secretion is one of the first pathophysiological signs of progression to type 2 diabetes. By restoring the normal, physiological pattern of insulin secretion, nateglinide essentially normalised glucose tolerance in these patients".

The study, which took place at centers in six European countries, involved 288 people with IGT. Results showed that Starlix enhanced early insulin secretion and reduced both the size of the blood glucose peak and the total increase in blood glucose over the three hours following the meal. Fasting glucose levels were not affected.

People with IGT are the ideal population to be involved in diabetes prevention trials. The mode of action of nateglinide and its excellent safety profile have led to its inclusion in the NAVIGATOR trial launched in November 2001. NAVIGATOR will be the largest diabetes prevention trial to date, involving 7,500 subjects in 40 countries, and will determine whether long-term administration of Starlix (60 mg before main meals) or the angiotensin II receptor blocker Diovan (valsartan) (160 mg a day) prevents or delays type 2 diabetes and cardiovascular disease in people who have IGT and are at high cardiovascular risk.

Dr Richard Pratley, Medical Director for the NAVIGATOR trial at Novartis Pharma Corp explained: "With type 2 diabetes increasing rapidly all over the world, it is now vital that we explore prevention strategies. This study demonstrates the clear rationale for including Starlix in the NAVIGATOR trial. NAVIGATOR will show us whether restoring early insulin secretion with Starlix can slow decline to type 2 diabetes and prevent cardiovascular disease in this high-risk group."

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Posted: May 2002