Novo's Xultophy beats basal-bolus insulin at cutting hypoglycemia, spurring weight loss

Novo Nordisk
Novo Nordisk's new insulin-GLP-1 combo, Xultophy, is up against Sanofi's Soliqua.

SAN DIEGONovo Nordisk is in a tough market race against Sanofi with combo product Xultophy, which hit the market after the French drugmaker’s Soliqua. New basal-bolus topping data, though, could give the med a leg up.

Xultophy—which marries Novo's newest basal insulin, Tresiba, with its top-selling GLP-1 med Victoza—beat a "gold-standard" insulin therapy at helping Type 2 diabetes patients avoid hypoglycemia and weight gain, common side effects of insulin. And it did that while matching the older basal-bolus treatment's ability to cut blood-sugar levels, a new study showed.

Presented on Saturday at the American Diabetes Association’s annual meeting, the trial pitted Xultophy against basal-bolus therapy with Sanofi's standard basal insulin, Lantus, and Novo's own mealtime insulin NovoLog. Xultophy took 66% of patients down below a 7% A1C target, similar to the 67% of patients who reached the mark with the basal-bolus duo.

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But Xultophy also managed to reduce severe hypoglycemic events by 89% and spur a median weight reduction of 2.06 lbs, versus the 5.81-lb median weight gain basal-bolus patients experienced, the study showed.

In other words, switching to Xultophy didn’t come along with the increases in hypoglycemia and weight that are usually “one of the tradeoffs” for basal insulin patients who need to add bolus therapy for improved glycemic control, Todd Hobbs, M.D., Novo’s North American chief medical officer, said in an interview. “That’s where I think the real advantage of this combination is,” he added.

But it’s not the only advantage. A basal-bolus regimen involves at least one shot of basal insulin along with several injections of faster-acting bolus insulin every day, compared with just one daily injection of Xultophy, marking a serious advantage for Xultophy in the convenience department, Hobbs noted.

Basal-bolus is “kind of the gold standard for the best efficacy” in terms of getting glucose down, “so to take that on with one injection a day with this combination productwe were optimistic that we could do this, but we were very happy with the results,” he said.

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And as a separate analysis showed, despite a higher drug price for Xultophy, the total annual cost of taking one patient below the 7% target for A1C, a key measure of blood glucose, without weight gain or hypoglycemia was actually far lower with the combo med at $28,849 than it was with basal-bolus, a charge that rang up at $220,562.

Novo will take as many points as it can get in Xultophy’s column. Though it won FDA approval the same day as did Sanofi’s Soliquaa combo of Lantus and GLP-1 med Adlyxinit fell behind Sanofi’s product on the launch calendar, giving its rival a head start.

That’s not to say the Danish drugmaker is worried about how its entrant stacks up, though. While there’s no head-to-head data comparing the two combos, the way Hobbs sees it, Xultophy gets the edge when “you look at the components.” In particular, in pitting Victoza against Adlyxin, the Sanofi med is “a very short-acting GLP-1 that really affects one meal a day. … And Victoza, being a longer-acting, easily once-a-day profile, affects all the meals,” he said.

Sanofi, unsurprisingly, sees things differently. “The value of the combination that we have” is that Lantus, which “is a product that a physician knows, is the chief mediator of fasting glucose control,” Riccardo Perfetti, M.D., Ph.D., Sanofi’s VP of global medical affairs for its diabetes franchise, said in an interview. And as for Adlyxin, it “specifically corrects” meal-related glucose excursions, meaning the combo “addresses two problems” and is “really fixing glucose levels throughout the day.”

The French drugmaker, meanwhile, had some positive data of its own to trumpet on Saturday. In a new analysis of Type 2 diabetes patients who had switched over from treatment with between 15 and 40 units of daily basal insulin, Soliqua lowered mean blood sugar levels by between 1.09% and 2.41%.