<a><b>Objective</b>:
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.</a>
<p><b>Study Design:</b> 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 HbA<sub>1c</sub>
change from baseline to Week 26. Other assessments included change in fasting
plasma glucose (FPG), hypoglycemia, hyperglycemia with ketosis and adverse
events. </p>
<p><b>Results: </b>In 463
randomized participants (Gla-300, n=233; Gla-100, n=230), comparable least
squares (LS) mean (standard error) reductions in HbA<sub>1c</sub> 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. </p>
<p><b>Conclusions: </b>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.</p>
Effects of insulin degludec and insulin glargine on day-to-day fasting plasma glucose variability in individuals with type 1 diabetes: a multicentre, randomised, crossover study
