Novo Nordisk has been boosted by the publication of positive data from a late-stage trial comparing the Danish firm’s investigational diabetes drug liraglutide with Sanofi-Aventis’ Amaryl.
Data from a 52-week, 746-patient Phase III study called LEAD 3, have been published in The Lancet which show that a once-daily injection of liraglutide, a glucagon-like peptide-1 analogue, produces “statistically significant and sustained improvements” in blood sugar control in patients with early type 2 diabetes, whencompared with oral Amaryl (glimepiride).
After 52 weeks, 62% of treatment-naive patients treated with liraglutide 1.8mg achieved an average reduction in blood sugar below the American Diabetes Association target for HbA1c of less than 7%. In addition, patients lost an average of 5lbs, compared with an average weight gain of 2lbs for those on Amaryl, while the rate of minor hypoglycaemia was statistically significantly lower in both liraglutide dose groups (1.2mg and 1.8mg) compared with the glimepiride-treated arm.
Principal study investigator Alan Garber, of the Baylor College of Medicine, Texas, said that the publication of this data in The Lancet “means that more physicians will have access to these key results on liraglutide’s efficacy as monotherapy”.
Novo has high hopes for liraglitude which was submitted to regulators on both sides of the Atlantic in May. Other data has shown that it provides statistically significantly better blood glucose control than Eli Lilly/Amylin’s GLP-1 blockbuster Byetta (exenatide).
However advisors to the US Food and Drug Administration recently recommended that the agency require drugmakers to conduct long-term trials of new diabetes treatments to evaluate cardiovascular risks. This could delay the launch of any new products by up to three years. Furthermore the recent announcement of deaths of patients on Byetta from pancreatitis has cast something of a cloud over GLP-1 analogues as a class.
