American Diabetes Association
Browse

Efficacy and safety of insulin glargine 300 U/mL (Gla-300) vs insulin glargine 100 U/mL (Gla-100) in children and adolescents (6–17 years) with type 1 diabetes: results of the EDITION JUNIOR randomized controlled trial

Download (447.36 kB)
figure
posted on 2020-05-19, 18:14 authored by Thomas Danne, William V. Tamborlane, Oleg A. Malievsky, Denise R. Franco, Tomoyuki Kawamura, Marek Demissie, Elisabeth Niemoeller, Harmonie Goyeau, Marek Wardecki, Tadej Battelino
Objective: To compare efficacy and safety of insulin glargine 300 U/mL (Gla-300) and 100 U/mL (Gla-100) in children and adolescents (6–17 years) with type 1 diabetes.

Study Design: EDITION JUNIOR was a non-inferiority, international, open-label, two-arm, parallel-group, phase 3b trial. Participants were randomized 1:1 to Gla-300 or Gla-100, titrated to achieve fasting self-monitored plasma glucose levels of 90–130 mg/dL (5.0–7.2 mmol/L), with continuation of prior prandial insulin. The primary endpoint was between-group difference in HbA1c change from baseline to Week 26. Other assessments included change in fasting plasma glucose (FPG), hypoglycemia, hyperglycemia with ketosis and adverse events.

Results: In 463 randomized participants (Gla-300, n=233; Gla-100, n=230), comparable least squares (LS) mean (standard error) reductions in HbA1c were observed from baseline to Week 26 (−0.40 [0.06] % for both), with LS mean between-group difference of 0.004 % (95% CI: −0.17–0.18), confirming non-inferiority at the prespecified 0.3 % (3.3 mmol/mol) margin. Mean FPG change from baseline to Week 26 was also similar between groups. During the 6-month treatment period, incidence and event rates of severe or documented (≤70 mg/dL [≤3.9 mmol/L]) hypoglycemia were similar between groups. Incidence of severe hypoglycemia was 6.0% with Gla-300 and 8.8% with Gla-100 (relative risk 0.68 [95% CI: 0.35–1.30]). Incidence of any hyperglycemia with ketosis was 6.4% with Gla-300, 11.8% with Gla-100.

Conclusions: Gla-300 provided similar glycemic control and safety profiles to Gla-100 in children and adolescents with type 1 diabetes, indicating that Gla-300 is a suitable therapeutic option in this population.

Funding

The clinical trial considered in this analysis was sponsored by Sanofi, Paris, France.

History

Usage metrics

    Diabetes Care

    Exports

    RefWorks
    BibTeX
    Ref. manager
    Endnote
    DataCite
    NLM
    DC