Higher proportion of participants achieved HbA1c levels below 6.5 percent with canagliflozin versus placebo
WEDNESDAY, Aug. 6, 2025 (HealthDay News) — Canagliflozin is associated with a clinically meaningful reduction in hemoglobin A1c (HbA1c) for children and adolescents with type 2 diabetes mellitus (T2DM), according to a study published online Aug. 5 in the Annals of Internal Medicine.
Ulhas Nadgir, M.D., from Sutter Medical Group in Sacramento, California, and colleagues assessed the safety and efficacy of canagliflozin in children and adolescents aged 10 years or older with T2DM in a phase 3 randomized, placebo-controlled multicenter study conducted in 104 sites in 10 countries. Participants were randomly assigned to canagliflozin (100 mg) or placebo once daily (84 and 87 individuals, respectively); at week 13, participants with week 12 readings of 7 percent or higher for HbA1c and at least 60 mL/min/1.73 m2 for estimated glomerular filtration rate were randomly assigned to continue receiving 100 mg canagliflozin (or placebo) or to have their dose uptitrated to 300 mg (or placebo).
The researchers found that the HbA1c reduction from baseline was significantly greater with canagliflozin versus placebo at week 26 (difference in least-squares means, −0.76 percent). A higher proportion of participants achieved HbA1c levels below 6.5 percent with canagliflozin versus placebo (36.3 versus 14.0 percent, respectively). Among those who received canagliflozin and placebo, treatment-emergent adverse events occurred in 77.4 and 74.7 percent, respectively, and serious treatment-emergent adverse events occurred in 9.5 and 5.7 percent, respectively.
“The data from this trial provide support for the use of canagliflozin in the clinical management of T2DM in children and adolescents aged 10 years or older,” the authors write.
The study was funded by Johnson & Johnson, the manufacturer of canagliflozin.
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