Novo Nordisk has announced clinical results from the fourth of five phase III studies with liraglutide - the once-daily human GLP-1 analogue. The 26-week Lead 4 study is part of the Lead (Liraglutide Effect and Action in Diabetes) programme. The study investigated the effect of different doses of liraglutide in combination with metformin and rosiglitazone, and included 533 patients with type 2 diabetes.
After a run-in period of metformin and rosiglitazone, patients in the study were randomised to add-on treatment with either liraglutide or placebo. The average HbA1c level at the beginning of the study was around 8.5 per cent and the average body weight was just above 95 kg.
At the end of the study, more than 50 per cent of the patients in the liraglutide-treated group had reached the American Diabetes Association goal of HbA1c < 7 per cent. Furthermore, more than 35 per cent achieved the American Association of Clinical Endocrinologists HbA1c target of <= 6.5 per cent. The HbA1c reduction achieved in the liraglutide-treated group was close to 1.5 percentage points compared to baseline. In addition, a weight difference of around 2.5 kg compared to placebo in favour of liraglutide was observed.
Liraglutide in combination with metformin and rosiglitazone was well tolerated. The most frequently reported adverse event during liraglutide treatment was nausea, reported by around 30-40 per cent of the subjects with a frequency decreasing over time. As expected, a low rate of hypoglycaemic events was reported, and these were related to the degree of blood glucose control.
Mads Krogsgaard Thomsen, executive vice president and chief science officer of Novo Nordisk, said, "The new clinical results confirm the strong efficacy data in terms of glucose control with a low risk of hypoglycaemia together with weight loss that we have seen in the previously announced phase III trials. With data from now approximately 85 per cent of all patients in the phase III programme, we are confident that liraglutide will become a valuable new treatment option for people with type 2 diabetes."
Novo Nordisk expects to announce headline results from the last outstanding study (LEAD 3) before the end of the first quarter of 2008. Detailed results from the full LEAD programme are expected to be published in peer-reviewed journals and communicated at future scientific meetings.
The results of the phase III trial do not change Novo Nordisk's expectations for the company's financial results for 2007, which were provided on 3 August in connection with the release of the financial results for the first six months of 2007.