IDegLira - a heavyweight contender in diabetes
Novo Nordisk has unveiled further data showing its diabetes combination of Victoza with new basal insulin degludec helped patients control blood sugar, lose weight and lower the risk of hypoglycaemia.
The product, known as IDegLira, is a once-daily combination of insulin degludec (IDeg) and Victoza (liraglutide), and has been identified as one of the most exciting prospects in the therapy area for some time.
The combination has been hailed as a potential new market leader since Novo first unveiled phase III data last summer, its combination of low risk of hypoglycaemia and weight loss giving it a 'holy grail' profile.
But FDA concerns about insulin degludec's cardiovascular effects have delayed its US approval, and approval of any combinations. The US regulator rejected insulin degludec in February 2013, asking for a dedicated cardiovascular outcomes trial to be completed.
This has been a major setback for the firm, but Europe's regulator raised no such concerns. The EMA granted insulin degludec marketing approval in January last year, where it is known as Tresiba and as Ryzodeg as a combination agent with insulin aspart.
Novo Nordisk filed for regulatory approval of IDegLira for the treatment of type 2 diabetes in the European Union on 31 May 2013, but hasn't yet received clearance for the combination.
The Copenhagen-headquartered company has unveiled further data from its DUAL trials today at the Diabetes UK conference in Liverpool.
While the DUAL I and II studies showed that IDegLira only produced a modest improvement in blood sugar lowering (1.9%) compared to either versus basal insulin degludec (IDeg) Tresiba or (Victoza) alone, they have shown data it produced impressive results in weight loss and lower risk of hypoglycaemia, two very important factors in managing the condition. The drug produced a significant mean weight loss of 2.7kg from baseline and a lower risk of hypoglycaemia, compared to IDeg alone (1.5 vs. 2.6 events/patient-year).
Professor Stephen Gough, lead trial investigator, University of Oxford and Oxford University Hospitals NHS Trust, comments: "Looking at the DUAL data, it's exciting to see the clinical advantages of insulin degludec and liraglutide combine into a single, once-daily injectable. A therapeutic option which helps patients reach their HbA1c targets, lowers their risk of hypoglycaemia and provides the added benefit of weight loss, is a great achievement in diabetes therapy; one which has the potential to significantly improve patient outcomes."
Research study suggests that many diabetes patients are suffering from hypoglycaemia, or dangerously low levels of blood sugar. One multinational survey of patients and doctors found 36% of respondents on basal insulin had experienced self-treated hypoglycaemia in the previous 30 days, as well as a risk of weight gain.
Fierce competition in diabetes market
The DUAL II study also showed a low incidence of gastrointestinal adverse events, an additional benefit the company will promote in its battle with competitors in the therapy area.
Foremost among these competitors is Sanofi, which markets the current market leading basal insulin Lantus. Sanofi has teamed up with Zealand Pharma to produce its basal insulin and GLP-1 combination, LixiLan.
This is the fixed ration combination of Lantus (insulin glargine) with Lyxumia (lixisenatide). However LixiLan has only just entered phase III trials, and won't be filed before late 2015. This could give Novo a chance to steal a march on its rival, potentially seizing market share from Lantus – but only in Europe. Novo Nordisk currently predict it will be 2016 or 2017 before insulin degludec gains US approval, giving Sanofi plenty of time to prepare its next-generation treatments as well.
Lilly's GLP-1 matches Victoza