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Starlix (Nateglinide) Improves Glucose In People With Pre-Diabetes, New Data Shows; Insulin Levels Increase By Up To 60 Percent Following A Meal

EAST HANOVER, NJ -- May 8, 2002 -- Starlix® (nateglinide) enhances early insulin secretion and controls mealtime glucose spikes in people with impaired glucose tolerance (IGT), a condition also known as "pre-diabetes." These data were presented today at the World Congress of Cardiology in Sydney, Australia.

"Starlix essentially restored the normal pattern of insulin secretion in this pre-diabetic population to help control mealtime glucose levels," said Leif Groop, MD, PhD, department of endocrinology, University of Lund, Sweden, one of the study's lead investigators. "Since loss of early insulin secretion is one of the first signs of progression to type 2 diabetes, these results are very encouraging."

IGT is called pre-diabetes because those with the condition have blood glucose levels higher than normal but not high enough for a diagnosis of diabetes. People with IGT show abnormalities in both insulin secretion and response to insulin (insulin sensitivity), and are at high risk of developing type 2 diabetes, with a 40-50 percent chance of developing the disease within ten years. IGT is also a major risk factor for cardiovascular disease.

The placebo-controlled, multi-center European study involved 288 people with IGT. Patients were randomized into one of four treatment groups and received varying doses of Starlix or a placebo before meals for eight weeks.

The results showed that Starlix increased early insulin secretion with rapid onset and short duration of action. The average insulin levels increased by 33 to 60 percent compared to baseline in the three Starlix-treated groups. By two hours after the meal, there was no effect of Starlix on insulin levels. Starlix was well tolerated and side effects were mild and quickly resolved. Only three patients (2.3 percent) on Starlix discontinued due to hypoglycemia.

Larger Trial Will Also Focus on Pre-Diabetes
"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 evaluating Starlix in a larger trial called NAVIGATOR," said Richard Pratley, MD, Director, Clinical Research and Development, Novartis Pharmaceuticals Corporation. "NAVIGATOR will show us whether restoring early insulin secretion with Starlix can slow progression to type 2 diabetes and prevent cardiovascular disease in those with impaired glucose tolerance."

NAVIGATOR, which is currently enrolling patients, is the largest diabetes prevention trial to date. NAVIGATOR will determine whether long-term administration of Starlix or the angiotensin II receptor blocker Diovan® (valsartan) prevents or delays type 2 diabetes and cardiovascular disease in people who have IGT.

About Starlix
Starlix works by stimulating rapid, short-acting insulin secretion that reduces the mealtime increase in blood glucose levels and effectively lowers overall blood sugar levels as measured by HbA1c (average level of glucose in the blood). Starlix is indicated as an add-on therapy for people with type 2 diabetes who are being treated with metformin (a leading oral antidiabetic). Starlix is also indicated as monotherapy for newly diagnosed or drug-naïve patients with type 2 diabetes.

The most common adverse events associated with Starlix vs. placebo in clinical trials in patients with type 2 diabetes were upper respiratory infection (10.5% vs. 8.1%), back pain (4% vs. 3.7%), flu symptoms (3.6% vs. 2.6%), dizziness (3.6% vs. 2.2%), arthropathy (3.3% vs. 2.2%) and hypoglycemia (2.4% vs. 0.4%).

The foregoing press statement contains forward-looking statements that can be identified by terminology such as "improves," "enhances," "restored," "very encouraging," "showed," "demonstrates," "will show," "will determine" or similar expressions. Such forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause the actual results to be materially different from any future results, performance, or achievements expressed or implied by such statements. In particular, management's expectation with respect to Starlix and Diovan could be affected by, among other things, uncertainties relating to clinical trials, product development, unexpected regulatory delays, adverse regulatory action or competition in general.

Located in East Hanover, New Jersey, Novartis Pharmaceuticals Corporation is an affiliate of Novartis AG, a world leader in healthcare with core businesses in pharmaceuticals, consumer health, generics, eye-care, and animal health. In 2001, the Group's businesses achieved sales of CHF 32.0 billion (USD 19.1 billion) and a net income of CHF 7.0 billion (USD 4.2 billion). The Group invested approximately CHF 4.2 billion (USD 2.5 billion) in R&D. Headquartered in Basel, Switzerland, Novartis Group companies employ about 71,000 people and operate in over 140 countries around the world. For further information please consult <http://www.novartis.com>

For a copy of the full prescribing information, additional information about Starlix or the NAVIGATOR trial, please contact:

Marian Cutler
973/781-5970
Chris Gordon
212/537-8266
Novartis Pharmaceuticals Corporation GCI Healthcare


SOURCE: Novartis Pharmaceuticals Corporation

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