Sanofi has reported positive results from the Phase III clinical trial of Toujeo for the treatment of children and adolescents with type 1 diabetes.
Toujeo comprises 300 units/ml of insulin glargine.
When compared to 100 units/ml of insulin glargine (Gla-100), Sanofi’s drug met the trial’s primary endpoint by demonstrating a comparable decrease in average blood sugar (HbA1c) and similar risk of low blood sugar events (hypoglycaemia) after 26 weeks.
The Phase III EDITION JUNIOR randomised, controlled trial showed that the proportion of patients who had severe hypoglycaemia and those with high blood sugar (hyperglycaemia) and ketosis was lower in the Toujeo arm.
The trial enrolled a total of 463 patients aged six to 17 who had previously received treatment for type 1 diabetes for a minimum of one year. Patients used their existing mealtime insulin during the study.
Data showed that the number of adverse events was comparable between patients treated with Toujeo and Gla-100. Based on the known profiles of both therapies, investigators did not report any unexpected safety concerns.
The trial involves an additional six-month safety follow-up period, which will report results separately.
Sanofi Development global head Dietmar Berger said: “Across the globe, between 50% and 80% of young people living with type 1 diabetes need more treatment options to help them achieve an average blood sugar level below 7.5%.
“By taking this step toward investigating an additional option for children and adolescents living with diabetes, we hope to provide another treatment for them and their physicians, to develop an individualised treatment plan that helps patients better manage their disease.”
Data has been presented at the International Society for Pediatric and Adolescent Diabetes 45th Annual Conference in Boston, Massachusetts, US.
Based on the results, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommended the expansion of Toujeo’s existing indication to include adolescents and children.
The final decision by the European Commission (EC) is expected in the coming months.