Positive Phase III Data for Novartis' Diabetes Drug
Posted on: Friday, 16 June 2006, 06:00 CDT
Novartis' investigational drug candidate Galvus, 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 at 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). 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 Dr James Shannon, head of development at Novartis Pharma AG.
Source: Datamonitor
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