New metabolic focus could alter diabetes treatment

Drug Store News,  June 26, 2006  by Amanda Chater

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WASHINGTON -- A new diabetes therapy was unveiled this month at the 66th annual meeting of the American Diabetes Association that some believe could change the way diabetes is treated by focusing on pancreatic function.

DPP-4 inhibitors are a new class of oral anti-diabetes drugs that increase the level of the body's own supply of GLP-1, a hormone produced by the intestines after eating that has a positive effect on blood glucose levels by blocking the enzyme DPP-4, which breaks down GLP-1. Research has demonstrated GLP's positive effect on blood glucose control, and researchers have examined ways to incorporate it with the treatment of type 2 diabetes.

At the ADA meeting, Novartis unveiled the DPP-4 inhibitor Galvus (vildagliptin), a once-daily oral treatment option for type 2 diabetes, which has just completed phase III trials. According to Novartis, Galvus has proved efficacious, particularly in patients with poor glycemic control, and has demonstrated weight-loss benefits for obese patients.

A combination of Galvus and pioglitazone led to an overall 1.9 percent reduction in A1c. Pioglitazone is an insulin sensitizer also known as thiazolidinedione, or TZD.

In the trials, a reduction of up to 2.8 percent in A1c was seen among patients with the highest mean baseline blood sugar levels (close to 10 percent). Patients in the study over 65 showed an HbA1c drop of 2.3 percent from a mean A1c baseline of 8.4 percent. And obese patients, who had a body mass index of 35 or more, showed a decline of 2.2 percent from a mean A1c baseline of 8.6 percent.

"The magnitude of A1c reductions seen with the combination of Galvus and TZD is encouraging for patients struggling to maintain their blood sugar levels," said James Shannon, M.D., head of development for Novartis. "The trial results for Galvus continue to reinforce the benefits of treating both islet dysfunction and insulin resistance in type 2 diabetes."

Throughout the trial, Galvus showed significant and consistent A1c reductions as both a monotherapy and in combination with other anti-diabetic agents. It also showed no significant additional weight gain inpatients and less edema, or fluid retention, compared with pioglitazone alone.

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