- Article
- Source: Campus Sanofi
- 23 Oct 2023
T1 Evidence in Children
Prescribing Information Toujeo (insulin glargine 300 units/mL)
Prescribing Information Lantus (insulin glargine 100 units/mL)
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Toujeo® is indicated for the treatment of diabetes mellitus in adults, adolescents and children from the age of 6 years. Discover the Toujeo® Evidence in T1DM below and get access to patient supporting tools and materials for children with T1DM who have been prescribed Toujeo®.
Randomised, Open Label Clinical Trial
Toujeo vs Insulin Glargine 100 U/mL
6 month, randomised, open label, double-arm, parallel group, non-inferiority study in 463 patients with T1DM.
Objective: To demonstrate non-inferiority of Toujeo® vs insulin glargine 100 U/mL (a standard of care) in change of HbA1c from baseline to Week 26 in children/adolescents aged >6 years with T1DM.
Meta Analysis
Toujeo® vs Insulin Glargine 100 U/mL
Post-hoc meta-analysis of three EDITION 6-month, Phase III, randomised clinical trials in a broad population including children aged 6+.
Post-hoc meta-analysis aim:Exploring the risk for severe hypoglycaemia with Toujeo® vs insulin glargine 100 units/mL in the pool of studied patients with T1DM.
Edition 4 (549 adults), Edition Junior (463 children), Edition JP (245 adults).
MAT-XU-2205636 (v5.0) Date of Preparation: October 2023