• Sanofi : Positive results in Phase 3 trial for Toujeo® in children and adolescents with type 1 diabetes

    • December 6, 2019
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    Children and adolescents (aged 6 to 17 years) living with type 1 diabetes achieved comparable reduction in average blood sugar (HbA1c) and similar risk of low blood sugar events with Toujeo® (insulin glargine 300 Units/mL) compared to insulin glargine 100 Units/mL (Gla-100), according to results presented at the International Society for Pediatric and Adolescent Diabetes 45th Annual Conference in Boston, Massachusetts.

    The trial, EDITION JUNIOR, is the first randomized, controlled trial comparing Toujeo vs Gla-100 in this group of patients. The study met its primary endpoint with comparable reductions in average blood sugar over 6 months with both treatments and similar risk of low blood sugar events (hypoglycemia). The percentages of patients who experienced severe hypoglycemia and who experienced high blood sugar (hyperglycemia) with ketosis were numerically lower with Toujeo. As these are serious short-term complications, these findings are clinically important for people with type 1 diabetes.

    Based on these data, the European Medicines Agency’s Committee for Medicinal Products for Human Use adopted a positive opinion on October 17, recommending expanding the current indication for Toujeo in the Europe Union for the treatment of diabetes mellitus in adolescents and children (6 years and older).

     

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