News on SGLT2 inhibitor for diabetes management

T2NOW Phase III study results were presented at the 59th Annual Meeting of the European Association for the Study of Diabetes (EASD) congress

On 4th October, AstraZeneca presented a study result from the T2NOW Phase III trial at the EASD congress, Germany. The result demonstrated a significant reduction in A1C for patients treated with dapagliflozin compared to that with a placebo.

T2NOW was a randomized, double-blind, placebo-controlled Phase III trial designed to evaluate the efficacy and safety of dapagliflozin as an add-on treatment in children and adolescents with Type-2 Diabetes (T2D) receiving metformin, insulin or both.

The results demonstrated that the adjusted mean change in A1C at week 26, was −0.62% for dapagliflozin versus +0.41% for placebo, a difference of −1.03% (95% CI: -1.57-0.49; p<0.001). Statistical significance was achieved in the primary endpoint and in all secondary endpoints versus placebo at week 26, suggesting that dapagliflozin can provide clinically meaningful improvements in glycemia for children and adolescents with T2D.

Adverse events (AEs) and serious AEs occurred in 72.8% and 8.6% of patients receiving dapagliflozin, respectively. Whereas, for patients receiving a placebo, the AEs and Serious AEs occurred in 71.1% and 6.6% respectively. Severe hypoglycemia occurred in 4.9% of patients receiving dapagliflozin, and 7.9% of patients in placebo group. Over 52 weeks, the most common AE was headache (dapagliflozin 14.8% vs. 5.3% in placebo).

The safety results in this patient population were consistent with those in adults with T2D, in line with the well-established safety profile for dapagliflozin.

Dapagliflozin is a first-in-class, oral, once-daily sodium-glucose cotransporter 2 (SGLT2) inhibitor. Dapagliflozin is approved for pediatric patients aged 10 years and above with T2D in the EU and other countries based on the T2GO study.Dapagliflozin is currently not approved for use in pediatric patients with T2D in the US.

Full-text article can be found here. DOI: 10.1056/EVIDoa2300210

Clinical trial: NCT03199053