Canagliflozin lowers HbA1c levels in children with T2DM

Treatment with canagliflozin significantly reduces haemoglobin A1c (HbA1c) in children and adolescents with type 2 diabetes mellitus (T2DM), with a safety profile comparable to that seen in adults, results of a phase III trial have shown.

The trial included 171 participants, who were randomized to receive either canagliflozin (n=84) or placebo (n=87). HbA1c from baseline decreased significantly with canagliflozin compared with placebo at week 26 (difference in least-squares means, –0.76 percent, 95 percent confidence interval [CI], –1.25 to –0.27; p=0.002).

In addition, more participants on canagliflozin than on placebo achieved HbA1c levels <6.5 percent (36.3 percent vs 14.0 percent; difference, 22.3 percentage points, 95 percent CI, 10.5–34.1).

Treatment-emergent adverse events (TEAEs) occurred in 77.4 percent of participants treated with canagliflozin and 74.7 percent on placebo, while serious TEAEs occurred in 9.5 percent and 5.7 percent, respectively. Common AEs seen in this paediatric population were similar to those in adults.

Moreover, hypoglycaemia occurred in 11.9 percent of patients who received canagliflozin and in 10.3 percent of those treated with placebo.

This phase III, randomized, placebo-controlled trial was conducted in 104 sites across 10 countries. Children and adolescents aged 10 years or older with T2DM (HbA1c ≥6.5 percent to ≤11 percent) were included. They were randomized to canagliflozin 100 mg or placebo once daily.

Participants with readings of 7 percent or higher for HbA1c and at least 60 mL/min/1.73 m2 for estimated glomerular filtration rate at week 12 were again randomized at week 13 to either keep receiving canagliflozin 100 mg (or placebo) or have their dose uptitrated to 300 mg (or placebo). The treatment lasted for 52 weeks.