Add on Dapagliflozin exhibits inconsequential antidiabetic effect in kids with type 2 diabetes
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
Disclaimer: This website is primarily for healthcare professionals. The content here does not replace medical advice and should not be used as medical, diagnostic, endorsement, treatment, or prescription advice. Medical science evolves rapidly, and we strive to keep our information current. If you find any discrepancies, please contact us at corrections@medicaldialogues.in. Read our Correction Policy here. Nothing here should be used as a substitute for medical advice, diagnosis, or treatment. We do not endorse any healthcare advice that contradicts a physician's guidance. Use of this site is subject to our Terms of Use, Privacy Policy, and Advertisement Policy. For more details, read our Full Disclaimer here.
NOTE: Join us in combating medical misinformation. If you encounter a questionable health, medical, or medical education claim, email us at factcheck@medicaldialogues.in for evaluation.