Tresiba safer than insulin glargine, says Novo Nordisk

Diabetics treated with Novo Nordisk's basal insulin Tresiba have a lower risk of developing low blood sugar compared to Sanofi's Lantus, according to a new trial.

The SWITCH 2 study found that type 2 diabetics taking Tresiba (insulin degludec) were less likely to have symptoms of low blood sugar (hypoglycaemia) compared to those taking Lantus (insulin glargine), the most-prescribed basal insulin product.

Tresiba was as good as Lantus at reducing haemoglobin A1c levels - a marker for glucose control. However, the rate of symptomatic hypoglycaemia was 186 events per 100 patient years for Novo Nordisk's drug, a 30% reduction on the 265 events per 100 patient years seen with insulin glargine.

Similarly, nocturnal low blood sugar episodes were reduced 42% with Tresiba compared to Lantus, although there was no significant difference between the two drugs in the rate of severe hypoglycaemic episodes.

Hypoglycaemia is one of the biggest concerns for diabetics and, taken together, the results could give Novo Nordisk additional power as it tries to wrest market share away from $7bn-a-year Lantus.

Moreover, it could also differentiate Tresiba from biosimilar copies of Sanofi's drug that are starting to reach the market and threaten to disrupt the basal insulin category.

Novo Nordisk had been held back in its efforts to compete with Lantus by a delay to US approval of Tresiba, with the FDA rejecting its marketing application for the drug in 2013, although it has been launched in most other major markets.

Last October however the Danish drugmaker finally won US approval for Tresiba and combination product Ryzodeg (insulin degludec and insulin aspart), prompting analysts at Sydbank to increase their peak sales predictions for the franchise to around $3bn.

In some markets the drug has achieved solid gains in market share - for example in Japan it now claims around one third of the basal insulin market almost three years after its launch in 2013.

A second phase III trial of Tresiba in type 1 diabetes patients - called SWITCH 1  - is due to generate results in the next few weeks, according to Novo Nordisk and if positive will reinforce the hypoglycaemia data. Tresiba has a hypoglycaemia claim on the label in some other markets, but not as yet in the US.

Novo Nordisk has another important US launch in the offing this year as it is anticipating approval shortly for Xultophy (insulin degludec plus liraglutide) - a combination basal insulin/GLP-1 agonist that could have equal earning power to Tresiba.

The combination has already started rolling out in Europe and some other world markets.