Dapagliflozin Approved for Treatment of T2D in Children: Daily Dose

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Last week, we reported on the US Food and Drug Administration (FDA) approval of dapagliflozin (Farxiga; AstraZeneca) for youths aged 10 years and older with uncontrolled type 2 diabetes (T2D) to improve glycemic control.

The approval

The once-daily, oral, sodium-glucose cotransporter 2 (SGLT2) inhibitor was approved for use in this younger population based on data from the pediatric T2NOW phase 3 trial (NCT03199053). The trial, described as one of the largest pediatric T2D phase 3 trials to date, was designed to evaluate the safety and efficacy of dapagliflozin as add-on treatment in children and adolescents with T2D with persistent hyperglycemia.

Study participants were assigned randomly 1:1:1 to 5 mg of dapagliflozin (n = 81), 2.5 mg of saxagliptin (Onglyza; AstraZeneca) (n = 88), or placebo (n = 76). Participants in the dapagliflozin and saxagliptin treatment groups with A_1c of 7% or greater at week 12 were then randomly assigned 1:1 at week 14 to either continue the original dose of active treatment drug or to titrate to a higher dose (10 mg of dapagliflozin or 5 mg of saxagliptin). The trial’s primary endpoint was change in A_1c after 26 weeks for dapagliflozin or saxagliptin vs placebo.

The adjusted mean change in A_1c at 26 weeks was for dapagliflozin was –1.03% (95% CI, –1.57 to –0.49; P < .001) and −0.44% (95% CI, −0.93 to 0.05; [P = .078]) for saxagliptin compared with placebo. Adverse events and serious adverse events occurred in 72.8% and 8.6%, respectively, of participants who received dapagliflozin, 69.3% and 8.0% of patients who received saxagliptin, and 71.1% and 6.6% of participants who received placebo.

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