FDA Approves Dapagliflozin For Pediatric Patients With Type 2 Diabetes


The indication is for the improvement of glycemic control in pediatric patients aged 10 and older with type 2 diabetes and comes after positive results from the phase 3 T2NOW clinical trial.

The FDA has approved dapagliflozin (Farxiga; AstraZeneca) to improve glycemic control in pediatric patients aged 10 years and older who have type 2 diabetes (T2D). Previously, the drug was approved by the FDA as an adjunct to diet and exercise to improve glycemic control in adult patients with T2D.1

Dapagliflozin -- Image credit: luchschenF | stock.adobe.com

Image credit: luchschenF | stock.adobe.com

Dapagliflozin is a first-in-class, oral, once-daily sodium-glucose cotransporter 2 (SGLT2) inhibitor. In addition to its indications for T2D, it is also approved for the treatment of heart failure across the full ventricular ejection fraction range and chronic kidney disease in adult patients. Additional research has also demonstrated that dapagliflozin has shown efficacy in preventing and delaying cardiorenal disease while also protecting the organs, which is significant because of the underlying links between the kidneys, heart, and pancreas.1

The approval for pediatric patients with T2D came after positive results from T2NOW, a randomized, double-blind, placebo-controlled phase 3 clinical trial (NCT03199053) that assessed the efficacy and safety of dapagliflozin as an add-on treatment in children and adolescents aged 10 to 17 years with T2D who were receiving either metformin or insulin alone, or a combination of both. Patients were randomly assigned to receive a 5-mg once-daily oral dose of dapagliflozin (n = 81), a 2.5-mg once-daily oral dose of saxagliptin (n = 88), or placebo n = 76). Patients who had hemoglobin A1c (HbA1c) levels less than 7% at week 12 remained on their previously assigned randomized treatment. Further, patients receiving dapagliflozin with week-12 HbA1c levels of 7% or higher were randomly assigned again to either continue on the low dose of dapagliflozin (5 mg) or up titrate to a higher dose treatment of 10 mg. Similarly, patients receiving saxagliptin underwent the same protocol as their counterparts receiving dapagliflozin; however, the low dose for this group was 2.5 mg and the high dose was 5 mg.1-3

About the Trial

Trial Name: Study to Evaluate Safety and Efficacy of Dapagliflozin and Saxagliptin in Patients With Type 2 Diabetes Mellitus (T2DM) Aged 10 to Below 18 Years Old

ClinicalTrials.gov ID: NCT03199053

Sponsor: AstraZeneca

Completion Date: January 3, 2024

The primary end point for the trial was the change in A1c after 26 weeks compared with placebo. Secondary end points included the change in fasting plasma glucose and the proportion of patients with A1c levels of 7% or higher at baseline who achieved A1c of 7% or less after 26 weeks.1

According to the findings, dapagliflozin, compared with placebo, demonstrated significant reductions in A1c. The adjusted mean change in A1c was -0.62% for those receiving dapagliflozin versus +0.41% for those receiving placebo, which is a difference of -1.03% (95% CI: -1.57-0.49; p < .001). Further, at week 26, dapagliflozin achieved statistical significance in the primary endpoint and in all secondary endpoints compared with placebo.1

Adverse events (AEs) and occurred in 72.8%, 69.3%, and 71.1% of patients receiving dapagliflozin, saxagliptin, and placebo, respectively. Serious AEs were also observed in 8.6%, 8.0%, and 6.6% of patients, respectively, in these treatment groups. Severe hypoglycemia had occurred in 4.9%, 4.5%, and 7.9% of patients in each group, respectively. Over 52 weeks, the most common AE reported by patients was headache (dapagliflozin: 14.8%; placebo: 5.3%); however, most occurrences were mild and none were serious or resulted in discontinuation of the trial.3

“The prevalence of T2D continues to rise in children and adolescents, yet oral treatment options have remained limited for this population,” said Ruud Dobber, Executive Vice President, BioPharmaceuticals Business Unit, AstraZeneca, in a news release. “Today’s approval represents an important milestone for pediatric patients living with T2D in the US, extending this medicine’s potential benefits to even more patients facing high unmet needs and reinforcing AstraZeneca’s commitment to delivering innovative treatments across cardiovascular, renal and metabolic diseases.”1


1. AstraZeneca. Farxiga approved in the US for the treatment of paediatric type-2 diabetes. News release. June 12, 2024. Accessed June 12 2024. https://www.astrazeneca.com/media-centre/press-releases/2024/farxiga-approved-in-the-us-for-the-treatment-of-paediatric-type-2-diabetes.html
2. Study to Evaluate Safety and Efficacy of Dapagliflozin and Saxagliptin in Patients With Type 2 Diabetes Mellitus (T2DM) Aged 10 to Below 18 Years Old. ClinicalTrials.gov identifier: NCT03199053. Updated April 17, 2024. Accessed June 12, 2024. https://clinicaltrials.gov/study/NCT03199053
3. Shehadeh, N, Barrett, T, Galassetti, P, et al. Dapagliflozin or Saxagliptin in Pediatric Type 2 Diabetes. NEJM Evid. 2023;2(12) doi:10.1056/EVIDoa2300210
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