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ADA: Lantus Losing Its Superiority to Newer Treatments

Diabetes patients stand to benefit from two experimental insulin therapies that could eventually replace Sanofi’s global leader Lantus, according to results from large clinical trials…. 

Both treatments are basal insulins, which help diabetics keep blood sugar levels under control between meals and throughout the day.

Sanofi’s experimental new drug Toujeo is being positioned to succeed Lantus when it loses patent protection early next year. Eli Lilly and Co is working on a drug similar to Lantus.

Late-stage studies of Toujeo showed that patients with type 2 diabetes were 31% less likely at nighttime to have potentially dangerous declines in blood sugar than those taking Lantus, the world’s most prescribed insulin, researchers said on Saturday.

Dr. Geremia Bolli, a professor at the University of Perugia, Italy, who helped lead one of the studies, added that, “Low blood sugar events, especially at night, are a big deal because they are frightening and are a barrier to use of insulin.” He presented his findings at the American Diabetes Association Scientific sessions in San Francisco.

Toujeo has the same active ingredient as Lantus, called insulin glargine, but in a three-fold higher concentration, Bolli said. Its activity level does not jump overnight, as is the case with Lantus.

The hypoglycemia data came from a combined review of three Phase III studies sponsored by Sanofi. The studies also showed that Toujeo and Lantus were similarly effective in controlling overall blood sugar and are the basis for Sanofi’s recently filed U.S. marketing application for Toujeo. The new drug is also awaiting approval in Europe.

In a fourth late-stage study involving patients with type 1 diabetes – the less common, inherited form of the disease – rates of hypoglycemia and overall blood sugar control were similar for Toujeo and Lantus.

While France’s Sanofi develops the successor to its most popular insulin, Lantus, a potential rival from U.S. drugmaker Eli Lilly proved just as effective and safe as Lantus for patients with type 1 and type 2 diabetes, including similar incidence of hypoglycemia.

Results for the Lilly drug, which has the same molecular formula as Lantus, were based on six studies sponsored by Lilly and its partner Boehringer Ingelheim.

Completed clinical trials for this new insulin glargine product show that it works similarly in the body and produces clinical results similar to Lantus.

Although awaiting approval in the United States, Europe and Japan, its U.S. launch could be delayed until mid-2016 by an ongoing patent dispute with Sanofi.

Lilly is also developing its own new basal insulin, called peglispro, which in clinical trial results released earlier this year, proved more effective than Lantus in reducing blood sugar levels for patients with type 2 diabetes. It also caused significantly fewer episodes of overnight hypoglycemia.

Lilly expects to seek U.S. and European approvals early next year for the drug. But patients taking peglispro had seriously elevated liver enzymes, a sign of potential liver toxicity, which could give Toujeo an advantage.

Practice Pearls:

  • There were 31% less risk for nighttime hypos with Toujeo.
  • Rates of hypoglycemia and overall blood sugar control were similar for Toujeo and Lantus.
  • Toujeo has the same active ingredient as Lantus, called insulin glargine, but in a three-fold higher concentration.

American Diabetes Association 2014 Scientific Sessions; June 16, 2014.