Novartis say Galvus reduces blood sugar by 2.8% in patients with poor glycemic control

By Elaine Rigoli

Tampa, Fla., June 13 - Novartis Pharmaceuticals said Tuesday that Galvus (vildagliptin), its once-daily oral treatment for type 2 diabetes, has demonstrated impressive efficacy, especially in patients with poor glycemic control, as well as weight loss benefits in obese patients.

A reduction of up to 2.8% in HbA1C (a measure of blood-sugar control also known as A1C) was seen among patients with poor glycemic control who had the highest mean baseline blood-sugar levels (about 10%) as measured by A1C, according to a news release.

The company said that the combination of Galvus, a member of the DPP-4 inhibitor class, and pioglitazone led to an overall 1.9% reduction in A1C. Pioglitazone is an insulin sensitizer known as a thiazolidinedione, or TZD.

Two-thirds of people (65%) on Galvus and pioglitazone achieved the American Diabetes Association-defined A1C goal of less than or equal to 7% versus 42% of those who achieved this goal on monotherapy (Galvus 42.5%, pioglitazone 42.9%).

Also in this study, patients over age 65 who were given Galvus and pioglitazone showed an A1C drop of 2.3% from a mean A1C baseline of 8.4%.

In obese patients, patients given Galvus and pioglitazone showed a decline of 2.2% from a mean A1C baseline of 8.6%.

In a separate head-to-head comparison with rosiglitazone, another insulin sensitizer, Galvus demonstrated comparable efficacy, the release said.

Among severely obese Galvus-treated patients, there was a mean reduction of body weight greater than 1 kg, with an overall mean difference of 2.8 kg between the Galvus and rosiglitazone treatment groups.

"The magnitude of A1C reductions seen with the combination of Galvus and a TZD is encouraging for patients struggling to reach and maintain their blood-sugar levels. The trial results for Galvus continue to reinforce the benefits of treating both islet dysfunction and insulin resistance in type 2 diabetes," said James Shannon, head of development, in a statement.

Located in East Hanover, N.J., Novartis Pharmaceuticals is an affiliate of Novartis AG.

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