Positive Ph III results for Novo Nordisk's degludec; US advocacy calls for Victoza's withdrawal

Danish diabetes specialist Novo Nordisk (NOV: N) says that its investigational ultra-long-acting insulin degludec showed a significant reduction in the rates of nocturnal hypoglycemia by 25%, compared to insulin glargine, according to two studies featured in the prestigious medical journal The Lancet.

The company noted recently that regulatory reviews of Degludec and DegludecPlus are on track. In the USA, a regulatory action date of July 29, 2012, has been issued by the US Food and Drug Administration. In Europe, the regulatory review is also progressing according to plan, it said (The Pharma Letter February 3). Degludec is potentially the biggest product up for approval this year, according to a recent report by EvaluatePharma, which forecast sales to reach $1.4 billion by 2016 (TPL January 20).

The two Phase III trials included a total of 1,635 participants and investigated insulin degludec compared to insulin glargine in a basal-bolus regimen in people with type 1 and type 2 diabetes. Both were “treat-to-target” studies, meaning patient insulin doses were adjusted systematically to allow them to achieve a targeted fasting glucose level. As a result, patients, successfully achieved comparable improvements in glucose control in both studies, allowing researchers to closely determine the differences in the rates of hypoglycemia.1