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Title: Starlix (Nateglinide) Significantly Improves Glycemic Control In Rosiglitazone Patients With Type 2 Diabetes

"Starlix (Nateglinide) Significantly Improves Glycemic Control In Rosiglitazone Patients With Type 2 Diabetes"

Combination therapy with a Thiazolidinedione significantly and safely reduces HbA1c BASEL, SWITZERLAND -- May 30, 2003 -- "Results of a new study to be published in the June edition of Diabetes Care find that the addition of Starlix® (nateglinide) improves glycemic control and is well-tolerated in patients whose type 2 diabetes is inadequately controlled by taking rosiglitazone alone. The double-blind study demonstrated that the addition of nateglinide to rosiglitazone (Avandia* Avandia is a trademark of GlaxoSmithKline ) monotherapy significantly reduced both HbA1c and post-prandial glucose levels and also restored insulin levels, with a favorable safety and tolerability profile. "The study showed that nateglinide produced a meaningful improvement in overall glycemic exposure in patients inadequately controlled with rosiglitazone alone, without exacerbating known side-effects of this class of medication, the thiazolidinediones," said Vivian Fonseca, M.D., Medical Director from Tulane University Medical Center New Orleans, Louisiana and the lead investigator of the study. Previous research has shown that over time there is a progressive need for multiple therapies in order to treat type 2 diabetes and maintain a target HbA1c of less than 7.0%.1 The team of researchers from 30 centers in North America carried out the 24-week double blind randomized study to compare the efficacy of nateglinide (120mg) and placebo added to ongoing open-label rosiglitazone (8mg) in patients with type 2 diabetes, who had an HbA1c level between 7% and 11%. The 402 patients taking part in the trial had been diagnosed with type 2 diabetes at least six months previously and treated with rosiglitazone monotherapy (8 mg), diet and exercise for at least three months prior to the trial. In patients randomized to nateglinide there was a clinically and statistically significant decrease in HbA1c from the baseline of 8.3% to 7.5% (p<0.0001). Target HbA1c (<7.0%) was achieved by 38% of patients treated with nateglinide/rosiglitazone combination therapy and by 9% of patients remaining on rosiglitazone monotherapy (p<0.001). "The two agents work in a complementary way to address the dual defect in type 2 diabetes," explained Dr. Fonseca. "While rosiglitazone reduces insulin resistance, nateglinide stimulates insulin secretion at mealtime and targets post-prandial blood glucose." In nateglinide-treated patients, there were clinically and statistically significant reductions in fasting plasma glucose (FPG) and 2- hour post-prandial glucose (PPG) levels. In contrast, in patients maintaining rosiglitazone monotherapy, there were no changes in either FPG or PPG. Previous studies have shown the effects of nateglinide on meal-stimulated insulin levels are clearly apparent within 15 minutes of food consumption and such effects decrease in a glucose dependent manner as the plasma glucose level drops.2 Through this selective stimulation of early insulin release, nateglinide greatly reduces post-prandial glucose levels while minimizing the overall insulin exposure. Research has shown that improved glycemic control, as measured by a reduction of HbA1c levels, may lead to a dramatic lowering of deaths and complications from diabetes. Even a 1% reduction in HbA1c can correlate to a 21% decrease in deaths from diabetes and a 14% decrease in heart attacks.3 About Starlix Starlix was approved in the United States in 2001 both as a monotherapy for drug-naïve patients with type 2 diabetes and also in combination with metformin, a leading oral antidiabetic agent. In December 2002, Novartis filed a supplemental new drug application (sNDA) for Starlix for use in combination with a thiazolidinedione (TZD). Starlix has an excellent safety and tolerability profile across all clinical trials. Starlix is also approved in many countries around the world for the treatment of type 2 diabetes. Nateglinide is licensed to Novartis Pharma AG from Ajinomoto Co., Inc. SOURCE: Novartis International AG

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