Empagliflozin Approved for Pediatric Patients With Type 2 Diabetes

The Food and Drug Administration (FDA) has approved Jardiance^® (empagliflozin) and Synjardy^® (empagliflozin and metformin hydrochloride) as adjuncts to diet and exercise to improve glycemic control in children 10 years of age and older with type 2 diabetes mellitus (T2DM). 

Empagliflozin is a sodium-glucose co-transporter 2 (SGLT2) inhibitor. Its approval for pediatric use was based on efficacy and safety data from the phase 3 DINAMO trial (ClinicalTrials.gov Identifier: NCT03429543), which included 157 patients 10 to 17 years of age with inadequately controlled T2DM. Patients were randomly assigned 1:1:1 to receive empagliflozin 10mg, linagliptin 5mg, or placebo orally once daily for 26 weeks. At week 12, empagliflozin-treated patients who did not achieve an HbA1c of less than 7% were re-randomized to remain on 10mg or increased to 25mg. 

Results showed that empagliflozin (pooled 10mg and 25mg doses) in addition to other baseline therapies (diet, exercise, metformin and/or insulin) reduced HbA1c by 0.8% at week 26 compared with placebo (95% CI, -1.5, -0.2; P =.0116). Treatment with linagliptin did not achieve statistical significance in HbA1c reduction when compared with placebo.

The overall safety profile of empagliflozin was generally consistent with previous findings in adults with T2DM. In pediatric patients aged 10 years and older, the risk of hypoglycemia was higher with empagliflozin regardless of insulin use.

“Compared to adults, children with type 2 diabetes have limited treatment options, even though the disease and symptom onset generally progress more rapidly in children,” said Michelle Carey, MD, MPH, associate director for therapeutic review for the Division of Diabetes, Lipid Disorders, and Obesity in the FDA’s Center for Drug Evaluation and Research. “Today’s approvals provide much-needed additional treatment options for children with type 2 diabetes.”