TYPE 2 diabetes mellitus (T2D) in children and adolescents remains a growing concern, with treatment options significantly more limited than in adults. Canagliflozin, a sodium–glucose cotransporter-2 (SGLT2) inhibitor, has been approved for use in adults, but its safety and efficacy in younger populations have not been fully established. A recent Phase 3 trial sought to fill this gap by evaluating canagliflozin in paediatric patients with T2D. Notably, the study demonstrated that canagliflozin significantly reduced HbA1c levels after 26 weeks of treatment compared to placebo.
The randomised, double-blind, placebo-controlled trial was conducted across 104 centres in 10 countries. A total of 171 participants aged 10 years or older with HbA1c levels between 6.5% and 11% were enrolled. Participants were initially randomised to receive either 100 mg of canagliflozin or placebo daily. At week 13, those with HbA1c levels remaining above 7% and satisfactory kidney function were further randomised to continue on 100 mg or escalate to 300 mg (or matching placebo). The study’s primary endpoint was change in HbA1c from baseline to week 26, with safety and additional efficacy measures assessed over a 52-week period.
By week 26, the reduction in HbA1c was significantly greater in the canagliflozin group than in the placebo group, with a least-squares mean difference of −0.76% (95% CI: −1.25–−0.27; p=0.002). Additionally, 36.3% of those receiving canagliflozin achieved HbA1c levels below 6.5%, compared to 14.0% in the placebo group, an absolute difference of 22.3 percentage points (95% CI: 10.5–34.1). Adverse events were common but similar between groups (77.4% with canagliflozin vs 74.7% with placebo), and serious adverse events were slightly more frequent in the canagliflozin group (9.5% vs 5.7%). Rates of hypoglycaemia were low and comparable (11.9% vs 10.3%).
These findings suggest that canagliflozin can offer a clinically meaningful improvement in glycaemic control for young people with T2D, with a safety profile broadly consistent with adult use. However, the study’s limitations, including a relatively small sample size and 52-week duration, highlight the need for further long-term data. Nevertheless, the results support consideration of canagliflozin as an additional treatment option in paediatric diabetes care.
Reference
Nadgir U et al. Treatment With Canagliflozin Versus Placebo in Children and Adolescents With Type 2 Diabetes: A Randomized Clinical Trial. Ann Intern Med. 2025;DOI: 10.7326/ANNALS-24-04017.
