Novartis Unveils Further Impressive Efficacy Data For Galvus
Basel - BasGalvus®* (vildagliptin), seeking to become a new once-daily oral treatment option for type 2 diabetes, has demonstrated impressive efficacy, especially in patients with poor glycemic control, as well as weight loss benefits in obese patients.
These new findings from Phase III studies were presented recently at a late-breaker session at the 66th Scientific Sessions of the American Diabetes Association (ADA) meeting in Washington, DC.
The combination of Galvus, a member of the DPP-4 inhibitor class, and pioglitazone led to an overall 1.9% reduction in HbA1c (a measure of blood sugar control also known as A1c). Pioglitazone is an insulin sensitizer known as a thiazolidinedione, or TZD. Two-thirds of people (65%) on Galvus and pioglitazone achieved the ADA-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%).
More importantly, a reduction of up to 2.8% in A1c was seen among patients with poor glycemic control who had the highest mean baseline blood sugar levels (about 10%) as measured by A1c.
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, with a Body Mass Index (BMI) equal to or over 35, 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. 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.
"These new data underscore the significant efficacy and good tolerability that have been consistently observed in the robust Galvus clinical development program," said James Shannon, MD, Head of Development at Novartis Pharma AG.
"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," Shannon said.
Throughout the Phase III program, Galvus has shown clinically significant and consistent A1c reductions both as monotherapy and in combination with other oral and injectable anti-diabetic agents. Galvus has demonstrated a good tolerability profile in these studies, with no weight gain overall and an incidence of hypoglycemia (excessively low blood sugar) and edema (fluid retention) similar to placebo in monotherapy trials.
"As the diabetes epidemic continues to grow worldwide, there is a very real and urgent need for new ways to help control blood sugar levels in people with type 2 diabetes," said Julio Rosenstock, MD, Director of Dallas Diabetes and Endocrine Center at Medical City, Clinical Professor of Medicine, University of Texas, Southwestern Medical School Dallas, Texas and a lead investigator in the Galvus/pioglitazone trial. "We were pleased to see the especially steep reductions of glucose in the subanalysis of patients with the highest blood sugar levels. However, this high baseline population represents a difficult to treat group and these patients usually require a multi-drug strategy to reach glycemic goal."
Galvus was accepted for US regulatory review earlier in 2006. The submission includes data from clinical trials involving more than 4,300 patients worldwide. Regulatory filings in the EU are planned to be completed later in 2006.
SOURCE: Novartis