LISBON, Portugal—Sanofi’s longer-acting basal insulin Toujeo, a follow-up to its own long-dominant product Lantus, beat the older medication at holding off hypoglycemia, both by day and by night.
In two separate trials, one in patients already using insulin and another in those who’d never used it before, Toujeo held off precipitous drops in blood sugar better than Lantus did. It’s an advantage Sanofi could push as it works to build up Toujeo scripts—and fights off biosimilar versions of Lantus.
Presented at the European Association for the Study of Diabetes meeting on Wednesday, the analysis of the Edition 2 and Edition 3 trials covered 796 and 839 patients, respectively, split between Toujeo and Lantus. The results showed fewer incidents of hypoglycemia for Toujeo patients, particularly as doses were titrated.
"We think that those studies are making a strong case for the ability of Toujeo to bring patients to target with less hypoglycemia," Riccardo Perfetti, head of Sanofi's global diabetes medical affairs, said Wednesday. And that is against the gold standard people thought was unbeatable, which is Lantus."
It’s Toujeo’s “smoother” profile—essentially, less variability in activity over time—that “is associated with reduced daily glycemic variability and lower risk for hypoglycaemia, particularly in the second half of the night,” the researchers found.
In Edition 2, previous insulin users on Toujeo saw an average 0.333 rating on the Low Blood Glucose Index, compared with 0.507 for Lantus patients. Once patients reached a maintenance dose, the difference was smaller—0.410 versus 0.498.
In new-to-insulin patients, the nighttime comparison was 0.300 for Toujeo patients and 0.376 for Lantus patients as dosing was titrated, and 0.376 compared with 0.410 at a maintenance dose. The overnight figures were statistically significant but the daytime difference missed that significance slightly.
Those numbers fell in line with actual, documented symptomatic hypoglycemic events in both studies, the researchers found. “While Edition 2 and Edition 3 had different frequencies of hypoglycaemia, the LBGI identified patients at risk uniformly well across the two studies,” the abstract states.
Prior insulin users with an LBGI index of 1.1 or less posted hypoglycemic event rates of 0.63 per person, compared with 3.49 for those with LBGI levels greater than 1.1. For those new to insulin, the comparison was 0.25 per person compared with 1.06.
Hypoglycemia, particularly at night, is a feared risk of basal insulin therapy, and drugmakers have designed their next-gen treatments to hold off those side effects—and have been testing them to prove they do just that. Mining data in this vein can be important, given that payers in the U.S. increasingly tough on basal insulin pricing and coverage.
"Beyond just competing on rebates, you still want to also to compete on value, and that value is exemplified by clinical differentiaton," Stefan Oelrich, global head of Sanofi's diabetes franchise, said Wednesday. "It's going to even be a criteria just to preserve the volumes, not just your prices."
"Commoditization when comes to pricing is there," he added. "But I think there will Still be elements of differntiation needed, and I think that’s where the ompanies that have inveted into clincial differentiation will stand out."
Novo Nordisk, which is working to make a case for its own longer-acting basal insulin Tresiba, rolled out data at this year’s American Diabetes Association annual meeting backing up the med’s cardiovascular safety—and at the same time, cut the risk of severe hypoglycemia by 40% and nighttime hypoglycemia by 53%.
Also at ADA, Sanofi unveiled its own hypoglycemia study on Toujeo, based on real-world evidence gleaned on that drug, plus two Novo Nordisk basal insulins and Sanofi’s Lantus. Among at-risk seniors, those taking Toujeo were 57% less likely to experience hypoglycemia, the study found. The data was part of a push toward real-world evidence for Toujeo, with at least three more studies planned.
"We want to make sure that in the future we provide datasets, not an alternative but complementary, on how Toujeo may be able to make the lives of patients using basal insulin easier, more manageable and cost-effective," Perfetti said.
The idea, he said, is "not only to document Toujeo outcomes in randomized controlled studies, but to demonstrate in real like it makes a difference for patients."