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New Data from Multiple Studies Show Galvus Delivers Consistent and,Robust Blood Sugar Control in Patients with Type 2 Diabetes

nes 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.

In the Galvus clinical program no evidence has been seen of overall weight gain[7] or hypoglycemia (dangerously low blood sugar levels)[8], side effects commonly associated with some type 2 diabetes medications. The overall incidence of side effects, including edema (fluid retention), was similar to placebo in monotherapy trials[8].

"Taken together, these data provide evidence that vildagliptin could provide a safe, effective and well-tolerated therapy when used alone or in combination with other anti-diabetic therapies," said Alan J. Garber, MD, Ph.D, Professor of Medicine, Biochemistry and Molecular Biology, and Molecular and Cellular Biology at the Baylor College of Medicine in Houston, Texas. "The majority of patients with type 2 diabetes have not achieved their A1c goals and it may therefore be helpful to have additional therapeutic options such as vildagliptin."

In most developed nations, diabetes is the fourth leading cause of death[9]. Controlling blood sugar levels is difficult even among patients receiving treatment, and more than half of patients with type 2 diabetes currently taking
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