Diabetes :: Galvus controls blood sugar in type 2 diabetes patients

Galvus (vildagliptin) by Novartis AG (NYSE: NVS), a new once-daily oral treatment for type 2 diabetes submitted for approval in the US and Europe, has been shown in new clinical data to deliver consistent and robust blood sugar reductions in patients with this progressive disease estimated to affect about 246 million people worldwide.

The findings, presented at the 67th Annual Scientific Sessions of the American Diabetes Association (ADA), are consistent with earlier results demonstrating the efficacy and tolerability of Galvus both as a monotherapy and when added to many commonly used diabetes medicines in a range of patients across the type 2 diabetes disease spectrum.

These include varied ethnic groups and the elderly as well as patients with impaired glucose tolerance at high risk of developing diabetes and those with uncontrolled blood sugar levels.

“These results further reinforce the clinical benefits of Galvus as an important new treatment option for patients with type 2 diabetes,” said James Shannon, MD, Global Head of Development at Novartis Pharma AG. “We remain convinced that Galvus is safe and effective and will continue to work with health authorities to ensure this medicine can be made available to patients worldwide as soon as possible.”

A member of a new class of diabetes medicines called DPP-4 inhibitors, Galvus is currently approved in Brazil and Mexico. A European regulatory decision is anticipated by the end of 2007. In the US, Novartis received an approvable letter in February 2007, and discussions are ongoing with the US Food and Drug Administration on steps needed to move forward to approval.

New data presented at the ADA showed that Galvus, when added to the sulfonylurea glimepiride, produced an additional significant blood sugar reduction of 0.6% in HbA1c compared to glimepiride alone[2]. HbA1c is a measure of plasma glucose levels over the preceding three months, and indicates how well diabetes is being controlled over time.

These data supplement existing findings with Galvus when used in combination with widely prescribed diabetes medicines such as metformin, an oral thiazolidinedione (TZD) and insulin.

Galvus works through a novel mechanism of action, targeting a dysfunction in the pancreatic islets that causes high blood sugar levels in people with type 2 diabetes. In clinical studies, Galvus has demonstrated significant reductions in blood sugar sustained at two years.

Leave a Comment