Canagliflozin safe, tolerable in kids, adolescents, manufacturer study finds
A phase 3 trial found significantly greater reductions in HbA1c levels in children and adolescents 10 years of age and older who were randomized to canagliflozin versus placebo.
Canagliflozin appeared safe and effective for children and adolescents ages 10 years or older with type 2 diabetes, a manufacturer study found.
The phase 3 trial, conducted at 104 sites in 10 countries, randomized 171 young patients with an HbA1c level of 6.5% to 11% to canagliflozin, 100 mg, (n=84) or placebo (n=87) once daily. After week 12, those who still had an HbA1c level of 7% or higher and an estimated glomerular filtration rate of at least 60 mL/min/1.73 m2 were randomized again to either keep receiving 100 mg of canagliflozin or placebo or have their dose uptitrated to 300 mg. The study was funded and conducted by Johnson & Johnson. Results were published by Annals of Internal Medicine on Aug. 5.
At week 26, the canagliflozin group had a significantly greater reduction in HbA1c level (P=0.002). The proportion of participants who achieved an HbA1c level below 6.5% was also significantly greater with canagliflozin (36.3% vs. 14.0%). Treatment-emergent adverse events occurred in 77.4% and 74.7%; they were serious in 9.5% and 5.7%, respectively.
The results provide support for the use of canagliflozin in the clinical management of type 2 diabetes in children and adolescents aged 10 years or older, concluded the study authors.
An accompanying editorial noted that the observed HbA1c reductions were in the range of what has been seen in studies of glucagon-like peptide-1 receptor agonists in youth and offered guidance on how to think about prescribing the two drug classes. “Sodium–glucose cotransporter-2 inhibitors offer an oral option for youth not wanting injections. However, the aggressive nature of youth-onset [type 2 diabetes] means that combination medical therapy is often necessary,” the editorialists said.