Liraglutide impresses in Ph III trials

Danish insulin giant Novo Nordisk says that its investigational drug liraglutide, a once-daily human GLP-1 analog, improved glucose control and lowered body weight in diabetic patients during two Phase III clinical trials.

The studies, which form part of the LEAD evaluation program, ran for 26 weeks and were designed to assess the effect of liraglutide on diabetes symptoms at a range of doses. In LEAD-1, glimepride-treated patients were randomized to add either liraglutide, rosiglitazone or placebo to their therapeutic regimen, while the LEAD-2 trial assigned participants liraglutide, glimepride or placebo in addition to standard metformin therapy.

The results showed that, in both trials, liraglutide allowed around 40% of patients to achieve the less than 7% HbA1c target, from an average baseline level of 8.5%. In addition, study subjects who received liraglutide plus either metformin or glimepride saw a weight difference of between 2kg and 4kg, compared with those given glimepride and rosiglitazone, respectively. The firm added that it plans to announce the results from two further ongoing LEAD trials later in the year.