UK-based AstraZeneca (AZ, NASDAQ: AZN) has announced promising results from the Phase III T2NOW study (NCT03199053) for its diabetes medication, Forxiga (dapagliflozin), in adolescents and children aged 10 to 17 with type 2 diabetes (T2D). Enrolling 256 patients, this study stands as one of the largest investigations into type 2 diabetes in children.
Significant Glycemic Improvements Observed
The results revealed that patients receiving dapagliflozin exhibited significantly lower levels of glycosylated hemoglobin (A1C) compared to those on placebo. Statistical significance was achieved at the primary endpoint and all secondary endpoints after 26 weeks, confirming that dapagliflozin can lead to clinically meaningful blood glucose improvements in the pediatric population. Safety outcomes in this demographic were consistent with those observed in adult T2D patients, aligning with the established safety profile of dapagliflozin.
Global Context and Rising Incidence of Pediatric T2D
The clinical trial was conducted across 23 countries and regions, although the Chinese Mainland did not participate, with Taiwan hosting two trial centers. The incidence and prevalence of T2D among children and adolescents are escalating globally, with approximately 41,600 new diagnoses reported in 2021. Historically, metformin has been the only oral medication approved for treating children with T2D since 2000, with restrictions for those under 10 years of age. In June 2023, the US Food and Drug Administration (FDA) expanded treatment options by approving empagliflozin and metformin combination therapies for children aged 10 and above, as an adjunct to diet and exercise for improved blood sugar control.-Fineline Info & Tech
