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
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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.