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NOVARTIS TO COMPARE GALVUS WITH OTHER DIABETES DRUGS

October 12, 2006

Swiss drugmaker Novartis has announced the start of the GALIANT trial, which will involve more than 7,500 people, to compare the company's investigational oral Type 2 diabetes medication Galvus (vildagliptin) with commonly prescribed antidiabetic oral medicines called thiazolidinediones (TZDs).

Clinical trials have demonstrated that treatment with Galvus results in consistent, significant and sustained reductions in blood sugar levels, leading to improved glucose control. Diabetes currently affects about 230 million people worldwide and is estimated to grow to 350 million by 2025, Novartis said, citing the International Diabetes Federation.

GALIANT will be a three-month trial that plans to enroll more than 7,500 patients at 800 research centers. The study is expected to build on results presented earlier this year, which concluded that patients receiving Galvus as monotherapy saw similar and significant reductions in blood sugar levels to those treated with the GlaxoSmithKline's TZD Avandia (rosiglitazone).

"There is a great need to get people to their target blood sugar. To do this, we need effective treatments that don't increase the risk for hypoglycaemia or low blood sugar," said Richard Pratley, a principal investigator of the trial. "The GALIANT trial, with its focus on the primary care setting, will provide us with a full range of results that can be applied to many different types of people with diabetes and help determine the potential role the DPP-4 inhibitor, Galvus, may play in the treatment of Type 2 diabetes."