Galvus showed a 1.8% reduction in blood sugar levels, comparable to Avandia, but without weight gain overall and with a lower incidence of edema (fluid retention) – both of which are side effects commonly associated with the drug.
Professor Emanuele Bosi, director of the diabetes & endocrinology unit at San Raffaele University Hospital in Milan, Italy, said: “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. These results are very reassuring for patients who have to take medications to treat their diabetes for a long time.”
Type 2 diabetes currently affects about 230 million people worldwide and is expected to grow to more than 350 million by 2025, according to the International Diabetes Federation. Galvus, a member of the DPP-4 inhibitor class, works through a novel mechanism of action targeting the pancreatic islet dysfunction that causes high blood sugar levels in people with type 2 diabetes.
The European marketing application for Galvus was filed in August 2006, while the US submission was completed in March 2006. The submissions included data from clinical trials involving more than 5,400 patients worldwide.