Ann Intern Med

Oral SGLT2 inhibitor outperforms placebo in pediatric diabetes trial

August 6, 2025

Canagliflozin demonstrated both efficacy and safety in lowering HbA1c in youth-onset T2DM, positioning it as a valuable addition to the limited treatment options for this growing population.

Study details: This phase 3, randomized, double-blind, placebo-controlled trial (NCT03170518) evaluated canagliflozin in 171 children and adolescents (≥10 years) with T2DM across 104 sites in ten countries. Participants received 100 mg canagliflozin or placebo daily, with potential uptitration to 300 mg at week 13 based on HbA1c and eGFR criteria. Primary endpoint was change in HbA1c from baseline to week 26.

Results: Canagliflozin significantly reduced HbA1c vs. placebo at week 26 (difference in least-squares means –0.76%; 95% confidence interval, –1.25 to –0.27; P=.002). A greater proportion of participants achieved HbA1c <6.5% with canagliflozin (36.3% vs. 14.0%). Adverse events were comparable between groups (77.4% vs. 74.7%), with a safety profile consistent with adult data. Hypoglycemia rates were low and similar across groups.

Source:

Nadgir U, et al. (2025, August 5). Ann Intern Med. Treatment With Canagliflozin Versus Placebo in Children and Adolescents With Type 2 Diabetes : A Randomized Clinical Trial. https://pubmed.ncbi.nlm.nih.gov/40759025/