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www.fdanews.com/articles/81178-vildagliptin-shows-advantages-over-existing-diabetes-therapies

VILDAGLIPTIN SHOWS ADVANTAGES OVER EXISTING DIABETES THERAPIES

September 26, 2005

Newly-released Phase III data for vildagliptin, the first of a new class of oral antidiabetic drugs known as dipeptidyl peptidase-IV (DPP-IV) inhibitors, show the drug improves on currently available therapeutic options in several respects. Its developer, Novartis, claims it also has the potential to prevent prediabetic patients developing Type 2 diabetes along with cardiovascular and metabolic complications of the disease. Available data show vildagliptin avoids the GI side effects of metformin, it avoids the weight-gain seen with thiazolidinediones, and it cuts insulin requirements by approximately half.

Data presented at a recent Novartis research and development meeting for analysts showed how vildagliptin is performing clinically in large studies. Previously-reported smaller Phase II studies have shown vildagliptin reduces HbA1c, improves insulin sensitivity and sustains insulin levels suggesting improvement in beta-cell function. Preclinical studies have shown the drug increases beta-cell mass.

In a 780-patient Phase III trial comparing it against the European gold standard treatment for Type 2 diabetes, metformin, vildapgliptin was better tolerated than metformin while achieving similar sustained reductions in HbA1c over one year.