Novo Nordisk A/S of Denmark, the world's biggest maker of insulin, has filed for regulatory approval of its experimental Type 2 diabetes drug `liraglutide' in the United States and Europe.

Novo Nordisk has submitted a new drug application (NDA) to the Food and Drug Administration (FDA) in the US as well as a marketing authorisation application to the European Medicines Agency (EMEA) in Europe, for liraglutide.

Liraglutide, a once-daily dosage, is an engineered version of the human GLP-1 hormone that stimulates release of insulin when glucose levels become too high and is meant for the treatment of people with Type 2 diabetes, the company said in a release.

Liraglutide works by stimulating the release of insulin only when glucose levels become too high and by inhibiting appetite. In contrast to most other antidiabetic treatments, liraglutide also leads to weight loss instead of weight increase.

''Both the US and the European applications contain documentation from an extensive clinical development programme that included around 6,500 people of which approximately 4,200 received liraglutide,'' the company said, adding ''The majority of people were included in the Phase 3 trials constituting the `Liraglutide Effect and Action in Diabetes' programme.

"We are enthusiastic about the prospect of bringing liraglutide to market after completion of the regulatory process," said chief science officer Mads Thomsen.

Novo Nordisk expects to start marketing the drug by the middle of 2009, expecting an average approval time of 12 months.
Liraglutide works in a similar way as Eli Lilly and Amylin Pharmaceuticals' Byetta. However, analysts expects the Danish drug to have a clear edge over the version of Byetta already on the market.

Diabetics who took insulin soon after diagnosis had better control of their blood sugar levels, according to a study sponsored by Novo Nordisk.

''Blood sugar levels in at least 95 per cent of insulin users dropped to normal in fewer than six days,'' according to the study funded by Novo Nordisk, Roche Holding AG and the Chinese government

Eighty-four per cent of patients on metformin, the generic of Bristol-Myers Squibb Co's Glucophage pill, reached normal after 9.3 days. A year later, almost twice as many insulin users had normal levels.

These data suggest that use of intensive insulin therapy early in the course of Type 2 diabetes warrants further clinical investigation.

The International Diabetes Federation estimates the number of diabetics will rise by more than 50 per cent by 2025, to 380 million worldwide.

While both insulin shots and pills such as metformin and gliclazide lowered blood sugar levels, the shots may allow the pancreas' beta cells, which make insulin, to recuperate and reverse damage, the study found. At the same time, sulphonyl ureas, a type of pill, may over-stimulate beta cells.

The programme has compared liraglutide with three widely used classes of antidiabetic drugs - sulfonylurea, glitazone or basal insulin - and the programme confirmed a statistically significant benefit of liraglutide on the primary endpoint, lowering of blood glucose (HbA1c), as well as on the secondary endpoint, weight loss.
 
Novo Nordisk expects to file for marketing approval of liraglutide in Japan in the third quarter of 2008.