FDA Approves Insulin Glargine Injection for Pediatric Patients with Diabetes


The approval was based on a phase 3 EDITION JUNIOR trial evaluating children and adolescents, aged 6 to 17 years, living with type 1 diabetes.

Officials with the FDA have approved an expanded indication for insulin glargine injection (Toujeo, Sanofi) 300 Units/ml as a long-acting insulin to improve blood sugar control in adult and pediatric patients, age 6 years and older, with diabetes.1

The drug was previously approved by the agency for improving blood sugar control only in adults aged 18 years and older.1

The approval was based on a phase 3 EDITION JUNIOR trial evaluating children and adolescents, aged 6 to 17, living with type 1 diabetes and existing phase III clinical trial data from adults with type 1 and type 2 diabetes (EDITION trial program). 1

The EDITION JUNIOR was the first randomized, controlled trial comparing insulin glargine injection 300 units/ml vs. insulin glargine 100 Units/ml. The study results were presented at the International Society of Pediatric and Adolescent Diabetes 45th Annual Conference in Boston, MA.2

The EDITION JUNIOR study included 463 children and adolescents (aged 6 to 17 years) treated for type 1 diabetes for at least one year and with comparable reduction in average blood sugar between 7.5% and 11.0% at screening. Participants continued to use their existing mealtime insulin. The trial demonstrated that participants with insulin glargine 300 units/ml experienced numerically lower severe hypoglycemia and hyperglycemia compared with those who were assigned to 100 units/ml.2

Insulin glargine injection is a long-acting man-made insulin used to control high blood sugar in adults and children who are 6 years of age or older with diabetes mellitus. The injection contains 3 times as much insulin in 1ml as standard insulin (100 units/ml). 1

The most common adverse effects reported with insulin glargine injection is hypoglycemia. Additional allergic reactions may occur, including a rash over the whole body, shortness of breath, swelling of face, tongue or throat, or trouble breathing. 1


  • FDA Approval of Sanofi’s Toujeo for Pediatric Patients [email]. Ruder Finn. Sent November 26, 2019. Accessed November 26, 2019.
  • Danne T et al., “Insulin Glargine 300 U/mL (Gla-300) provides effective glycemic control in youths with type 1 diabetes (T1D): the EDITION JUNIOR study,” Poster presentation P240, ISPAD 45th Annual Conference, Boston MA; October 31, 2019. http://www.professionalabstracts.com/ispad2019/Iplanner/#/presentation/216. Accessed November 26, 2019.

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