Insulin glargine 300 U/mL was found to be comparable to insulin glargine 100 U/mL in providing effective glycemic control in pediatric patients with type 1 diabetes, according to results from the EDITION JUNIOR trial.
The phase 3 study included 463 patients between 6 and 17 years of age with type 1 diabetes for at least 1 year and compared the efficacy of the 2 formulations of insulin glargine on change from baseline to month 6 in hemoglobin A1c (HbA1c). Results showed a mean reduction in HbA1c of 0.4% in both treatment arms (difference, 0.004%; 95% CI, -0.17 to 0.18).
As for safety, a similar percentage of patients in both groups experienced ≥1 event of severe and/or documented (≤70 mg/dL) hypoglycemia (97% and 97.8% for insulin glargine 300 U/mL and 100 U/mL, respectively). Numerically, the percentage of patients who experienced severe hypoglycemia or had ≥1 event of hyperglycemia with ketosis (ketones ≥1.5 mmol/L) was lower with insulin glargine 300 U/mL compared with insulin glargine 100 U/mL.
“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 individualized treatment plan that helps patients better manage their disease,” said Dietmar Berger, Global Head of Development at Sanofi.
Data from a 6 month safety follow-up period will be reported separately. Insulin glargine 300 U/mL (Toujeo) is currently only approved for use in adults. Safety and efficacy in the adolescent population is currently under regulatory review in the United States.
For more information visit sanofi.com.
This article originally appeared on MPR