East Hanover, June 13, 2005 Researchers reported yesterday that in a two-year, controlled study people with type 2 diabetes receiving Starlix (nateglinide) in combination with metformin experienced equivalent levels of overall blood glucose control and a lower incidence and severity of hypoglycemia compared to the those taking the commonly used sulfonylurea agent, glyburide, in combination with metformin. This trial is the first to prospectively evaluate the long-term safety and efficacy of the Starlix/metformin combination for two years. Researchers also observed that treatment with Starlix plus metformin was weight neutral, while participants in the glyburide/metformin arm of the trial gained about 1 kg over the two-year study period. These data were presented yesterday at the Annual Scientific Sessions of the American Diabetes Association.

"Physicians and patients are always looking for improved treatment strategies and combinations to help them achieve their target blood glucose goals," said John Gerich, M.D., University of Rochester. "Results from this trial have important clinical implications: In the past, the risk of hypoglycemia, or very low blood sugar, has been a limiting factor for early and aggressive therapy. Hypoglycemia can be life threatening for people with diabetes. There were 50 percent fewer cases of hypoglycemia with the Starlix/metformin combination."

Consistent with the mechanism of action of Starlix, which mimics the body's natural response to meals, the Starlix plus metformin group had greater reductions in post-meal glucose levels (post prandial glucose or PPG) than the glyburide and metformin group.

"Starlix's ability to lower overall blood glucose (or HbA1c) by controlling PPG is complementary to metformin's action, which lowers fasting plasma glucose levels (FPG)," continued Dr. Gerich. "A drug combination that reduces HbA1c by lowering both PPG and FPG offers doctors and patients an effective way to re
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Contact: Alison Poole
poolea@fleishman.com
Novartis Pharmaceuticals
28-Sep-2005

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