AstraZeneca Announces Positive Phase III T2NOW Trial Results for Dapagliflozin in Pediatric and Adolescent Type 2 Diabetes

On October 4, AstraZeneca announced that the Phase III T2NOW study of dapagliflozin (brand name: Forxiga) for the treatment of type 2 diabetes in children and adolescents met its primary endpoint. Compared with placebo, the level of glycated hemoglobin (HbA1c) in patients treated with dapagliflozin was significantly reduced.

The press release shows that T2NOW is one of the largest pediatric Type 2 diabetes studies currently.

The T2NOW study is a 26-week randomized, double-blind, multicenter Phase III clinical trial designed to evaluate the efficacy and safety of dapagliflozin as an add-on therapy in children and adolescents with type 2 diabetes who are being treated with metformin, insulin, or both.

The study enrolled a total of 245 patients who were randomly assigned to receive 5mg dapagliflozin (n=81), 2.5mg saxagliptin (n=88), or placebo (n=76). At week 12, patients with HbA1c ≥7% in the dapagliflozin and saxagliptin groups were further randomized in a 1:1 ratio to either continue the same dose or increase to a higher dose (10mg dapagliflozin or 5mg saxagliptin).

The primary endpoint was the change in HbA1c at week 26, with secondary endpoints including changes in fasting plasma glucose (FPG) and the proportion of patients achieving HbA1c <7.0% (53 mmol/mol) at week 26. Safety was assessed over 52 weeks.

The results showed that, for the primary endpoint, at week 26, the adjusted mean reduction in HbA1c was 0.62% in the dapagliflozin group, compared with an increase of 0.41% in the placebo group, with a difference of 1.03%; in the saxagliptin group, the adjusted mean increase in HbA1c was 0.06%, compared with an increase of 0.5% in the placebo group, with a difference of 0.44%. Other secondary endpoints also showed statistically significant improvements.

Primary and Secondary Endpoints (Source: The New England Journal of Medicine)

In terms of safety, the safety of dapagliflozin in pediatric and adolescent patients with type 2 diabetes is consistent with that in adult patients.

Ruud Dobber, Executive Vice President of AstraZeneca's BioPharmaceuticals Business, said: "The T2NOW study results bring hope to children and adolescents with type 2 diabetes. The global burden of type 2 diabetes in children and adolescents is increasing, but treatment options are limited, and there is an urgent need for effective oral therapies."

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