AstraZeneca (AZ) has shared positive results from a late-stage trial evaluating its oral SGLT2 inhibitor Forxiga (dapagliflozin) in children and adolescents with type 2 diabetes (T2D).

T2D is the most common type of diabetes, accounting for over 90% of cases worldwide, and its prevalence in children and adolescents is increasing globally.

The disease is characterised by pathophysiologic defects leading to elevated glucose levels, which over time contribute to further disease progression.

“Despite the growing global burden of T2D among children and adolescents, the treatment options available are currently limited,” said Ruud Dobber, executive vice president, BioPharmaceuticals Business Unit, AZ.

"It is well documented that some patients find injectable therapies challenging, making the need for effective oral treatment alternatives paramount,” he added.

AZ’s phase 3 T2NOW, which is one of the largest paediatric T2D studies performed to date, assessed the efficacy and safety of Forxiga as an add-on treatment in children and adolescents with T2D who were receiving metformin, insulin or both.

The study met its primary endpoint and treatment with Forxiga was associated with a significant reduction in A1C, a marker of average blood sugar, compared with patients receiving placebo after 26 weeks.

The safety results in this patient population were reported to be consistent with those in adults with T2D and in line with the known safety profile for Forxiga.

Statistical significance was also seen in all secondary endpoints versus placebo at week 26, which AZ said establishes that Forxiga can “provide clinically meaningful improvements in glycaemia for children and adolescents with T2D”.

Naim Shehadeh, professor of endocrinology, Rambam Health Care Campus in Israel, said: “The significant decrease in A1C that we observed in patients receiving Forxiga may indicate a reduction in the progression of disease and its complications.

"This is an important treatment consideration as children and adolescents with T2D often experience earlier onset of complications and faster advancement of disease compared to adults with the same condition.”

Forxiga, which is sometimes sold under the brand name ‘Farxiga’, is approved in more than 120 countries alongside diet and exercise to improve glycaemic control in adults with T2D. The drug is also approved in certain markets, including the EU, for paediatric patients aged ten years and older with T2D.

Beyond its T2D indication, Forxiga is approved to treat heart failure with reduced ejection fraction and chronic kidney disease in more than 100 countries.

https://www.pmlive.com/pharma_news/astrazenecas_forxiga_shows_promise_in_paediatric_type_2_diabetes_trial_1501616