Novo Nordisk has presented interesting data from a late-stage trial at the American Diabetes Association meeting in San Francisco which demonstrates that the firm’s recently-filed liraglutide provides statistically significantly better blood glucose control than Eli Lilly/Amylin’s Byetta.

In the 26-week LEAD 6 study, the first to compare the two glucagon-like peptide-1 (GLP-1) analogues, 464 patients with type 2 diabetes were randomised to receive either once-daily liraglutide or twice-daily Byetta (exenatide) in combination with existing treatments consisting of metformin, sulfonylurea or a combination of both. Novo said that patients who received liraglutide achieved a more than 1.1% reduction in HbA1c, compared with a 0.8% decrease in those on Byetta.

Mads Krogsgaard Thomsen, Novo’s chief science officer, said the results were encouraging, noting that treatment with the drug leads to weight loss and is associated with a very low risk of hypoglycaemia. The Danish firm submitted liraglutide to regulators on both sides of the Atlantic in May and analysts believe that if approved in 2009, the treatment will have about a year to build up market share before a once-daily version of Byetta is launched.

Novo’s data did enough to cause alarm for Amylin investors and the latter’s shares declined 8.7% to $29.93.

Levemir as effective as Sanofi’s Lantus
The Copenhagen-headquartered firm also presented data from a head-to-head study which demonstrated that Levemir (insulin detemir) can be used once-daily and had a comparable blood glucose response to Sanofi-Aventis’ Lantus (insulin glargine), over a 24-hour period in patients with type 2 diabetes.

The firm added that a retrospective study using recent data from “a large US health plan database” showed that in addition to providing similar blood glucose response as glargine, Levemir had no significant difference against Sanofi in daily average consumption and diabetes-related pharmacy costs.

Novo also announced the first and only full scale study of once-daily Levemir versus a single daily dose of glargine to generate the first robust comparative data set of the two treatments. Mr Thomsen said that by “establishing the efficacy profiles of these drugs in a direct comparison, we will help physicians choose the best possible treatment for their patients”.

He added once-daily Levemir has shown 24-hour glycaemic and improved HbA1c control and a low incidence of of hypoglycaemic events, without the weight gain observed for other insulins. It may therefore offer “a favourable balance between effect and side effects”.