USA: In an Intention-to-treat analysis of children, adolescents, and young adults with type 2 diabetes who received dapagliflozin with the standard of care treatment there was no significant change in HbA1c concentration between groups. In a prespecified sensitivity analysis of protocol-compliant, the study population showed a significant difference in HbA1c concentration. The researchers did not identify any new safety signals and there was a low risk of severe hypoglycaemia.

These are the findings from a study which was conducted with an aim to assess the efficacy and safety of dapagliflozin as add-on therapy in children, adolescents, and young adults with type 2 diabetes receiving metformin, insulin, or both. The study findings, published in The Lancet Diabetes & Endocrinology, are significant as there are not much treatment options for young people with type 2 diabetes.
For this purpose, the researchers undertook a multicentre, placebo-controlled, double-blind, randomised phase 3 study at 30 centres in five countries (Hungary, Israel, Mexico, Russia, and the USA). It included 72 participants aged 10–24 years with type 2 diabetes and HbA1c concentration of 6·5–11% (48–97 mmol/mol). They were randomly assigned in the ratio of 1:1 to receive oral dapagliflozin 10 mg (n=39) or placebo (n=33) during a 24 week double-blind period. This was followed by a 28 week open-label safety extension in which all participants received dapagliflozin.
Between-group differences in change in HbA1c concentration from baseline to 24 weeks (intention-to-treat analysis) was the primary outcome. Also, they assessed a prespecified sensitivity analysis of the primary outcome in the per-protocol population, which included only protocol-compliant participants.
Based on the study, the researchers reported the following findings:
In the intention-to-treat analysis, after 24 weeks, mean change in HbA1c concentration was −0·25% for dapagliflozin and 0·50% for placebo.
The between-group difference was −0·75%.
In a sensitivity analysis in the per-protocol population (34 in the dapagliflozin group and 26 in the placebo group) after 24 weeks, mean change was −0·51% for dapagliflozin and 0·62% for placebo.
The between-group difference was −1·13%.
Adverse events occurred in 69% dapagliflozin-assigned participants and 58% placebo-assigned participants over 24 weeks, and in 74% participants who received dapagliflozin over 52 weeks.
Hypoglycaemia occurred in 28% dapagliflozin-assigned and 18% placebo-assigned participants who received dapagliflozin over 24 weeks and in 33% who received dapagliflozin over 52 weeks; none were considered as serious adverse events. No adverse events of diabetic ketoacidosis occurred.
"Change in HbA1c concentration was not significant in the intention-to-treat analysis of children, adolescents, and young adults with type 2 diabetes receiving dapagliflozin in addition to standard-of-care treatment," wrote the authors.
Reference:
The study titled, "Efficacy and safety of dapagliflozin in children and young adults with type 2 diabetes: a prospective, multicentre, randomised, parallel group, phase 3 study," was published in The Lancet Diabetes & Endocrinology.
DOI: https://doi.org/10.1016/S2213-8587(22)00052-3