FDA Approves First SGLT2 Inhibitor for Use in Children With Type 2 Diabetes


Jardiance and Synjardy approved as an addition to diet and exercise to improve blood sugar control in children aged 10 years and older with type 2 diabetes.

The FDA has approved empagliflozin (Jardiance) plus empagliflozin and metformin hydrochloride (Synjardy) as an addition to diet and exercise to improve blood sugar control in children aged 10 years and older with type 2 diabetes (T2D). The FDA noted that these approvals offer a new class of oral medications that treat pediatric T2D. Prior to the FDA action, the only other oral therapy FDA-approved for children with T2D was metformin, which was initially approved for pediatric use in 2000.

“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,” 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, said in a press release. “Today’s approvals provide much-needed additional treatment options for children with type 2 diabetes.”

Empagliflozin is the active ingredient in both Jardiance and Synjardy and works by increasing the excretion of glucose in the urine. Empagliflozin is a sodium-glucose transporter 2 (SGLT2) inhibitor initially approved by the FDA in August 2014 for treating T2D in combination with diet modifications and exercise. SGLT2 is located in the proximal tubule reabsorbs glucose from the glomerular filtrate. Empagliflozin inhibits SGLT2, thereby lowering glucose reabsorption back into the circulation to reduce blood glucose levels. Synjardy was initially approved by the FDA in 2015 as an addition to diet and exercise to improve glucose control in adults with T2D. Empagliflozin as a component of Synjardy is FDA-approved to lower the risk of cardiovascular death in adults with T2D and established cardiovascular disease and to reduce the risk of cardiovascular death and hospitalization for heart failure in adults with heart failure.

The FDA action was based on results from the DINAMO phase 3 trial (NCT03429543), which showed empagliflozin was associated with a statistically significant reduction in the primary endpoint of change from baseline in A1c levels at 26 weeks compared with the placebo. Investigators included individuals aged 10 to 17 years old with T2D.

Additionally, investigators found that when added to other baseline treatments, including diet, exercise, insulin, and/or metformin, empagliflozin in the 10- and 25-mg dosages reduced A1c levels by 0.84% compared with the placebo at week 26.

The reduction in A1c levels in individuals treated with linagliptin (Tradjenta) from Boehringer Ingelheim was not statistically significant compared with the placebo. Investigators also reported a numerical reduction of 0.34%.

The safety profile in this study was consistent with the previously known safety profile of empagliflozin. Investigators enrolled individuals aged 10 to 17 years older with T2D who were previously treated with insulin or metformin. Of the 262 individuals screened, investigators assigned 158 to start empagliflozin 10 mg, linagliptin 5 mg, or the placebo, once daily.

Individuals in the empagliflozin group who did not have A1c levels below 7% by week 12 were re-randomized to either remain on 10 mg or increase to the 25-mg dosage. At week 26, individuals who were in the placebo group were reassigned to empagliflozin 10 or 25 mg or linagliptin 5 mg. The safety profile was assessed until week 52.

Common adverse effects (AEs) in children administered empagliflozin were generally similar to AEs observed in adults, other than a greater risk of hypoglycemia among pediatric patients 10 years and older taking empagliflozin compared to placebo, regardless of use of other diabetes drugs. The most common AEs in adults include urinary tract infections and female fungal infections. The most common AEs in patients administered metformin include diarrhea, nausea, and upset stomach.

Jardiance and Synjardy are not recommended for patients with type 1 diabetes due to an elevated risk of diabetic ketoacidosis. The combination is also not recommended to improve blood sugar control in patients with severe kidney problems and should not be administered to those who previously experienced a serious allergic reaction to them.


FDA Approves New Class of Medicines to Treat Pediatric Type 2 Diabetes. FDA. News release. June 21, 2023. https://content.govdelivery.com/accounts/USFDA/bulletins/3611410

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