With Lantus Under Pressure From Follow-on, Sanofi Releases Phase 3 Results for Toujeo in Pediatric Population

Sanofi released phase 3 results this week for its long-acting insulin glargine (Toujeo) when used in pediatric patients with type 1 diabetes (T1D) aged 6 to 17.

The company said the patients achieved comparable reduction in average blood sugar (HbA1c) and had a similar risk of low blood sugar events with insulin glargine 300 units/mL compared to insulin glargine 100 units/mL (its older formulation, Lantus).

Toujeo, which received FDA approval in February 2015, is actually a competitor with Novo Nordisk’s ultra—long-acting insulin degludec, marketed as Tresiba. Both are taken once a day and have a longer window of effectiveness. Thus, ultra–long-acting insulins offer people with diabetes some flexibility on when they can take their daily dose without being at risk of hypoglycemia.

The trial, EDITION JUNIOR, is the first randomized, controlled trial comparing Toujeo versus Lantus in younger patients. The study compared the insulins in 463 children and adolescents treated for T1D for at least 1 year and with HbA1c between 7.5% and 11.0% at screening. Participants (Toujeo, n = 233; Lantus, n = 228) continued to use their existing mealtime insulin. Over the same period, a comparable number of patients experienced 1 or more anytime (24 hour) hypoglycemia events.

Numerically fewer patients using Toujeo experienced severe hypoglycemia, or experienced one or more episodes of high blood sugar (hyperglycemia) with ketosis compared with those using Lantus (226 for Toujeo and 223 for Lantus).

The number of adverse events (AE) was comparable between the 2 treatment groups (65.2% versus 65.8% of patients reported any treatment-emergent AE). No unexpected safety concerns were reported.

The study met its primary end point with comparable reductions in average blood sugar over 6 months, and the percentages of patients who experienced severe hypoglycemia and who experienced hyperglycemia with ketosis were numerically lower with Toujeo, but did not achieve statistical significance. The company said the results are still “clinically important.” These results were presented at the International Society for Pediatric and Adolescent Diabetes 45th Annual Conference in Boston, Massachusetts.

"We know that living with type 1 diabetes means dealing with highs and lows in blood sugar, which are worrying and present substantial challenges for young people," said Thomas Danne, MD, director of the Department of General Pediatrics and Endocrinology/Diabetology at the Children's Hospital On the Bult, Hannover Medical School, Germany, in a statement. "In addition to the trial demonstrating safety and efficacy, the percentage of patients with severe hypoglycemia, and the percentage with hyperglycemia with ketosis, were numerically lower with Toujeo."

Lantus, the originator insulin glargine, is under pressure from follow-on competition, given the commercialization of Boehringer Ingelheim’s Basaglar, the first FDA-approved insulin glargine follow-on, which launched in 2016 after a lengthy patent litigation with Sanofi.