The new diabetes drug from Novartis, Galvus cuts blood sugar levels as much as GlaxoSmithKlines established medicine Avandia and without the side effects. Galvus, which is awaiting regulatory approval in the United States and Europe, reduced levels of hemoglobin A1C — a common measure of blood sugar — by an average 1.8 percent, comparable with Avandia, in a head-to-head monotherapy clinical study.
The reduction was achieved without overall weight gain and with a lower incidence of fluid retention. Both are common side effects associated with insulin sensitizers such as Avandia.
"Many patients and physicians have come to unfortunately regard the side effects of current therapies as normal and accept them as part of their treatment," Professor Emanuele Bosi of Milan’s San Raffaele University Hospital told the European Association for the Study of Diabetes.
"These results are very reassuring for patients who have to take medications to treat their diabetes for a long time."
The six-month study, involving 697 patients, tested 100 milligrams daily of Novartis’s Galvus, or vildagliptin, against 8 mg of Avandia, or rosiglitazone.
The Phase III trial is one of several on Galvus being presented at the medical meeting in Copenhagen. Novartis hopes the data will underline the potential of its new product for Type 2 diabetes.
Another 279-patient study showed Galvus was just as effective given once-daily as when taken twice a day.
Galvus is tipped by analysts to become a $1 billion-a-year plus seller, but it faces fierce competition from Merck & Co Inc.’s new drug, Januvia.
Galvus and Januvia represent the first of a class of drugs called DPP-IV inhibitors, which work by enhancing the body’s own ability to lower blood sugar levels. Analysts believe DPP-IV drugs could become a popular treatment in the oral anti-diabetes market, since they are not associated with weight gain.
Both drugs have already been filed for approval with the U.S. Food and Drug Administration and, if given a green light, could be launched next year in a neck-and-neck race.
EASD: Sept. 2006 European Association for the Study of Diabetes.