14 Jun 2024 • Dapagliflozin, an oral sodium-glucose cotransporter-2 (SGLT2) inhibitor, previously used in type 2 diabetes in adults as an adjunct to diet and exercise is now approved by the FDA for use in the pediatric population in the US, aged 10 years and older with type 2 diabetes, to improve glycemic control. 

This decision comes after successful outcomes from the phase 3 T2NOW clinical trial, the largest phase 3 trials for pediatric type 2 diabetes, and the T2GO phase 3 clinical trial. 

After 26 weeks of Dapagliflozin in the 10- to 17-year-old group, there were significant reductions in HbA1C levels with an adjusted mean change of -0.62% compared to 0.41% in the placebo group, a difference of -1.03%. The manufacturer-recommended starting dose is 5 mg orally once daily. 

Dapagliflozin's approval for extended use in the pediatric population with type 2 diabetes is being seen as an important milestone in the US.

Source:AJMC| Read full story