Novo Nordisk's Tresiba misses main mark in head-to-head tilt with Sanofi's Toujeo

Tresiba (insulin degludec) missed its primary endpoint in the Conclude study, Novo said in a Thursday presentation at the European Association for the Study of Diabetes (EASD) annual meeting, failing to significantly cut down the number of hypoglycemic events when compared against Toujeo in the trial’s 36-week maintenance period.

Novo Nordisk’s Tresiba is battling it out with Sanofi’s Toujeo in the next-gen insulin category. And while the Danish drugmaker had been hoping to show its contender could top Sanofi’s rival in a head-to-head showdown, it didn't quite get there.

As Novo was quick to point out, investigators did record fewer hypoglycemic events in the study’s Tresiba arm, with results "trending in the right direction" despite missing the statistical significance threshold. The miss "was actually driven by one or two patients with a lot of hypos," the company’s chief scientific officer, Mads Krogsgaard Thomsen, said.

Nocturnal hypoglycemias are "worrisome because they may happen when you’re alone at night, when you’re asleep in your bed," Thomsen said.

But the companies disagree on how important Novo’s results will be given that Tresiba missed its primary superiority target. "When it comes to teasing apart the two second-generation basal analogs, Novo has a failed trial. It’s difficult to draw any conclusions from that," David Werner, Sanofi’s global head of insulins, said ahead of Novo’s expanded results presentation.

He added that with his company’s own head-to-head study, called Bright, "we have shown that" Tresiba and Toujeo "have more similarities than differences," and that the "bigger question out there" is why both drugs in the class aren’t getting more play against older rivals.

Thomsen, on the other hand, shot down the idea that the two products were similar, pointing to older Tresiba-favoring studies and stressing that "one always has to look at the totality of the evidence that exists."

What the Conclude data "can help to do is open up the eyes of those physicians who maybe haven’t used" Tresiba much before, if at all, he said, calling them a "manifestation of insulin degludec being the safest insulin available."

Novo also pointed to Tresiba’s ability to reduce the rate of severe hypoglycemia by 80% against Toujeo and pare down the rate of nocturnal hypoglycemia by 37% during that same 36-week period.

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