Novo Nordisk, Sanofi Announce Positive Data In Heated Competition for Insulin Market Share

Novo Nordisk has announced new data on its development of a next-generation insulin that could help the company stave off biosimilar and follow-on insulin competition. Meanwhile, Sanofi announced that its own insulin met its main objective in a head-to-head study versus Novo Nordisk’s product.

On December 5, 2017, the Denmark-based drug maker announced data showing that switching to insulin degludec (Tresiba), from a different basal insulin benefits patients with diabetes even if their blood sugar was well controlled on their previous insulin therapy.

The data arise from a post-hoc analysis of the EU-TREAT study, a European, multi-center, real-world evidence study investigating the effect of switching to insulin degludec—a basal insulin with a long duration (over 42 hours) of action and a flat and stable action profile—from another basal insulin in people with type 1 (n = 1717) and type 2 (n = 2550) diabetes.

In patients with type 2 diabetes whose blood sugar levels were controlled with basal insulin prior to the switch, insulin degludec significantly reduced the rate of hypoglycemia while maintaining blood sugar control; results show a 67% reduction in the rate of hypoglycemic events—with an 11% lower dose of insulin—over 6 months after switching.

In patients who had uncontrolled type 1 or type 2 diabetes, switching to insulin degludec was associated with significantly improved glycemic control without an increase in the risk of hypoglycemia or an increase in the dose of insulin. These results were sustained for up to 12 months after switching. Patients who had type 1 diabetes and had controlled blood sugar levels had a 16% lower rate of hypoglycemia over 6 months with a 13% lower dose of insulin.

"This new analysis shows that people with diabetes who have switched to [insulin degludec] in the real world benefit from this change, regardless of whether they did so to improve blood glucose control or reduce the risk of [hypoglycemia]," said Mads Krogsgaard Thomsen, executive vice president and chief science officer at Novo Nordisk. "This confirms that the benefits of Tresiba seen in clinical trials are being reproduced in clinical practice."

Meanwhile, Sanofi, maker of the insulin glargine injection Toujeo, announced that its product met its main objective in a head-to-head clinical trial—the BRIGHT study—that compared Toujeo to Tresiba. Sanofi indicated that it will present full results of the study, which followed 929 adults with type 2 diabetes, in 2018. “We believe that these first comparative clinical data assessing similarity and difference not only in efficacy, but also in the important safety aspect, such as low blood sugar events, can support physicians in their treatment decisions," said Riccardo Perfetti, head of the global diabetes medical team at ‎Sanofi.

In the race to control insulin market share, cost may play the deciding role, however. A study published in Diabetes Therapy suggests that Novo Nordisk’s insulin degludec could prove to be more cost effective than insulin glargine, Sanofi’s Toujeo, or the EU-approved insulin glargine biosimilar Abasaglar (also approved as a follow-on insulin, Basaglar, in the United States). The cost-utility study (which was funded by Novo Nordisk) used a short-term model to evaluate the costs and effects of treatment with insulin degludec versus insulin glargine over a 12-month period in patients with type 1 and type 2 diabetes from the perspective of the United Kingdom’s National Health Service. The study considered the recent reduction in the price of insulin degludec and the addition of Toujeo and the biosimilar insulin glargine to the market, and found that insulin degludec is likely to be highly cost effective compared to the alternatives.