Starlix(R) Comparable to Metformin in Reducing HbA1c Levels In Type 2 Diabetes Patients Previously Managed by Diet and Exercise Alone

Basel, Switzerland (ots-PRNewswire) - Novartis (NYSE: NVS)
announced today that an analysis of data published in the November issue of Diabetes Care show that Starlix(R) (nateglinide), reduced HbA1c levels comparable to metformin in patients on no previous drug therapy regimen.

"Previous studies have demonstrated the efficacy of Starlix in reducing the acute rise in glucose levels after a meal and their contribution to overall glucose control," said Edward Horton*, MD, Vice President and Director of the Clinical Research at Joslin Diabetes Center and Professor of Medicine at the Harvard Medical School, Boston, USA. "These data are significant because they show that, in patients who previously relied only on diet and exercise to manage their diabetes, Starlix enhanced long-term glucose control, as measured by HbA1c, comparable to the commonly prescribed metformin."

The analysis of this double-blind, randomized, parallel-group study focused on patients whose diabetes was inadequately controlled by diet and exercise alone, a situation commonly seen by physicians. In the study, Starlix (120 mg) and metformin (500 mg) monotherapy groups achieved the same 0.8% adjusted mean decrease in HbA1c from baseline.

In combination, Starlix and metformin achieved even greater reductions, decreasing HbA1c levels by 2.5% relative to placebo. The combination also had a greater effect on reducing mealtime glucose spikes and fasting plasma glucose (FPG). This confirms previous data showing that the combination of Starlix plus metformin was more effective than either agent used alone. This effect was achieved with minimal weight gain and low incidence of hypoglycemia.

"Starlix reduces the post-meal glucose levels by restoring the early insulin secretion lost in people with type 2 diabetes; metformin, in comparison, primarily acts on FPG," explained Dr Horton. "By combining Starlix with metformin, which has a complementary mode of action, the entire glycaemic risk can be effectively managed, with increased reductions in HbA1c to manage the chronic glucose toxicity and sustained management of the acute toxicity caused by post-meal excursions."

About Diabetes

It is estimated that 125 million people worldwide have type 2 diabetes. This number is expected to increase to 300 million by the year 2025. The main cited reasons for the increasing prevalence are earlier detection, longer survival, and urbanization and lifestyle changes, such as reduced physical exercise, and dietary changes, leading to obesity.

Forward Looking Statement

The forgoing press release contains forward-looking statements which can be identified by terminology such as, "studies have demonstrated," "show," or similar expressions. Such forward looking statements involve known and unknown risks, uncertainties and other factors that may cause actual results to be materially different from any future results, performance or achievements expressed or implied by such statements. There are no guarantees that the aforementioned clinical trials will result in the commercialization of Starlix. Any such commercialization can be affected by, amongst other things, uncertainties relating to product development, regulatory actions or delays or government regulation generally, the ability to obtain or maintain patent or other proprietary intellectual property protection and competition in general.

About Novartis

Novartis is a world leader in healthcare with core businesses in pharmaceuticals, consumer health, generics, eye-care, and animal health. In 1999, the Group (including Agribusiness) achieved sales of CHF 32.5 billion (USD 21.6 billion) and invested more than CHF 4.2 billion (USD 2.8 billion) in R&D. Headquartered in Basel, Switzerland, Novartis employs about 82,500 people and operates in over 140 countries around the world. The Group plans to spin off its Crop Protection and Seeds sectors and to merge them with the agrochemicals business of AstraZeneca in the fourth quarter of 2000.

*On occasion Dr. Horton has served as a consultant for Novartis.

ots Original Text Service: Novartis Pharma AG

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