Endocrinologist Dr. Philip A. Levin, Director of The Diabetes
Center at Mercy, is seeking participants in a medical research trial for the prevention of diabetes in patients with "Impaired Glucose Tolerance" or IGT. Eligible participants should be over the age of 50, have a family history of diabetes, possible cardiac factors and/or had gestational diabetes.

The trial is part of a national clinical investigation known as
the Navigator study (Nateglinide And Valsartan in Impaired Glucose Tolerance Outcomes Research), the largest-ever diabetes prevention clinical trial to date. The study will seek to determine whether long-term administration of Starlix® (nateglinide) or Diovan® (valsartan) reduce or delay the development of type 2 diabetes and cardiovascular (CV) disease in people who have impaired glucose tolerance (IGT) and are at high cardiovascular risk.

Recent studies suggest that people with IGT are 34% more likely to die from CV disease than people with normal blood glucose control.

IGT is an intermediate state between normal blood glucose control and type 2 diabetes. IGT is characterized by an excessive rise in blood glucose following consumption of 75g glucose. 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 also a major risk factor for CV disease.

According to Dr. Levin, while there is significant evidence that controlling weight and increasing exercise can greatly reduce people's risk of developing diabetes and cardiovascular illness, "it's unfortunate that many do not respond to education about improving their lifestyle choices.
Therefore, in addition to redoubling our efforts to reach people with this message, we must seek new modalities and treatments to stem the tide of this disease that now impacts more than 300,000 Marylanders. This study is indicative of this effort," Dr. Levin said.

The Navigator study will be the largest diabetes prevention trial to date, involving 7500 subjects recruited from 600-800 centers worldwide, including Mercy Medical Center. Participants must be at least 50 years of age, with at
least one cardiovascular disease, or 55 years and older with at least one CV risk factor.

In the four arm study, subjects will be randomized to receive Starlix (60mg before main meals), Diovan (160mg daily), both, or placebo. The effects of the two drugs will be assessed independently. The Navigator protocol is
approved by the U.S. Food and Drug Administration and European health authorities.

The study will be carried out in two phases. In the first phase, designed to run for three years after the last subject is enrolled, the effect of Starlix and Diovan on progression to diabetes will be evaluated. In the second, or 'extension' phase, the drugs' effects on CV disease will be evaluated. This phase will last until 1,000 subjects have had a cardiovascular event. The total duration of Navigator follow-up is estimated at nearly six years.

Mealtime glucose spikes have been identified as an important risk factor for CV disease and mortality in people with type 2 diabetes. Starlix is an oral anti-diabetic drug which, when taken before main meals, rapidly stimulates a short-acting burst of insulin secretion, thereby reducing post-meal
hyperglycemia with minimal risk of subsequent hypoglycemia. The pattern of insulin secretion produced by Starlix is similar to the physiological pattern of insulin secretion that is progressively lost in people with IGT and type 2 diabetes.

"Therefore, in theory, Starlix would appear to be an ideal drug to use in the treatment of IGT. That's what we hope to learn through this trial," Dr. Levin said.

Diovan is an angiotensin II receptor blocker (ARB) indicated for treatment of high blood pressure. 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.

"It is hoped that the Navigator trial will show us whether restoring insulin secretion and improving insulin sensitivity will stop people from developing type 2 diabetes and prevent heart disease in this high-risk group," Dr. Levin said. "Approximately half of all those who develop type 2 diabetes
already have further medical complications by the time they are diagnosed. Diabetes is the fastest growing medical problem in this country. One strategy to arrest this growth is to help people from getting diabetes in the first place," he added.

The Navigator trial has been organized by Novartis, a world leader in healthcare with core businesses in pharmaceuticals, consumer health, generics, eye-care, and animal health. Headquartered in Basel, Switzerland, Novartis employs about 67 600 people and operates in over 140 countries around the world. For further information please consult http://www.novartis.com