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The Novartis diabetes drug Galvus (vildagliptin) can significantly reduce blood sugar levels in seniors with type 2 diabetes without the increased risk of side effects that can accompany more aggressive treatments, researchers reported on Dec. 7.
Pooled analyses of a number of Phase III studies showed significant improvements in blood sugar control among diabetics aged 65 and older, a growing group of patients who can be difficult to treat with existing oral diabetes drugs.
The overall efficacy of once-daily dosing for Galvus, which belongs to a new class of diabetes drugs known as DPP-4 inhibitors, was also highlighted at the World Diabetes Congress in Cape Town.
The first of these new drugs, Merck's Januvia, was approved by the FDA in October and is already on the market. But Galvus was delayed by three months following evidence of skin problems in animal tests, which were not seen in human studies. Novartis now hopes for FDA approval in early 2007.
Data from studies lasting between 12 and 52 weeks showed patients taking 100 mg of Galvus daily had overall reductions of 1 percent in their HbA1c levels -- a measure of glucose control -- with reductions of up to 1.8 percent in patients with the highest blood sugar levels.
"Clinical trials show that vildagliptin may help a broad range of patients reach treatment goals, even older patients who are often difficult to treat," said Dr. Vivian Fonseca, chief of endocrinology and metabolism at Tulane University Health Sciences Centre in New Orleans. "The data also show the potential of vildagliptin to modify the natural course of type 2 diabetes."
Source: Medical Week staff, week of Dec. 3, 2006
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