medwireNews: Findings from the EDITION JUNIOR trial indicate that glargine-300 and glargine-100 have similar efficacy and safety when used with mealtime insulin in children and adolescents with type 1 diabetes.
The non-inferiority trial of 463 participants, aged 6 to 17 years, from 24 countries indicated that the second-generation basal insulin analog glargine 300 units/mL (Gla-300) offered similar glycemic control to the first-generation insulin analog glargine 100 units/mL (GLa-100) during half a year of treatment.
The treatment groups had a comparable reduction in glycated hemoglobin (HbA1c) from baseline to week 26, at a least squares (LS) mean of 0.4% in both. The LS mean between-group difference was 0.004%, with the upper boundary of the 95% confidence interval of 0.18% falling within the pre-specified 0.3% (3.3 mmol/mol) margin.
“Superiority of Gla-300 relative to Gla-100 was not demonstrated,” Thomas Danne (Hannover Medical School, Germany) and co-workers acknowledge in Diabetes Care, but they suggest that“Gla-300 may be a suitable therapeutic option in this age group.”
The secondary efficacy endpoint of achieving HbA1c target (<7.5% or 58 mmol/mol) at week 26 was also similar with Gla-300 and Gla-100, at 26.2% and 23.5%, respectively.
And the same was true for the secondary efficacy endpoint of fasting plasma glucose (FPG), which after 26 weeks dropped by an LS mean of 10.1 mg/dL (0.56 mmol/L) with Gla-300 and 9.9 mg/dL (0.55 mmol/L) with Gla-100.
The trial included young people who had been treated for type 1 diabetes for at least a year, all of whom had HbA1c levels between 7.5% (58 mmol/mol) and 11% (97 mmol/mol) at screening.
Participants in the open-label trial received a once-daily subcutaneous injection either in the morning or evening, at the same time each day for 26 weeks, which was titrated to a fasting self-monitored plasma glucose target of 9–130 mg/dL (5.0–7.2 mmol/L).
After this, there was a 26-week safety extension period and a 4-week follow-up period. Fast-acting mealtime insulin analogs were continued during the study.
“Of note, HbA1c and FPG levels remained similar between treatment groups during the 6-month safety extension period of the study,” the researchers report in Diabetes Care. “Consistent HbA1c reductions were also observed across most clinically relevant subgroups.”
The incidence of at least one severe or documented hypoglycemic event (<70 mg/dL or 3.9 mmol/L) did not vary between the groups during the 6-month treatment period, at 97.0% with Gla-300 and 97.8% with Gla100.
Similarly, the incidence of biochemical hyperglycemia with ketosis (self-monitored plasma glucose of at least 252 mg/dL or 14 mmol/L and ketones of more than 1.5 mmol/L) during the 26-week treatment period showed no significant difference.
Nonetheless, when the two participants with more than 30 events of hyperglycemia with ketosis were excluded, there was a trend toward fewer occurrences in the Gla-300 than Gla-100 group, at 0.50 versus 0.69 events per participant–year, respectively.
“Given the tendency toward a lower incidence of hyperglycemia with ketosis observed with Gla-300 versus Gla-100 in this study, future studies sufficiently powered to detect potential differences between these basal insulin analogs would be of interest to explore whether Gla-300 may provide a suitable therapy option in individuals at high risk of hyperglycemia and ketosis,” the researchers suggest.
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