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Dapagliflozin Approved for Treatment of T2D in Children: Daily Dose

Dapagliflozin Approved for Treatment of T2D in Children: Daily Dose / Image Credit: ©New Africa/AdobeStock
©New Africa/AdobeStock

Patient Care brings primary care clinicians a lot of medical news every day—it’s easy to miss an important study. The Daily Dose provides a concise summary of one of the website's leading stories you may not have seen.

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 A1c 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 A1c after 26 weeks for dapagliflozin or saxagliptin vs placebo.

The adjusted mean change in A1c 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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