FDA Alert

FDA Approves Two Medications to Treat Pediatric Patients With Type 2 Diabetes

Jessica Ganga

The FDA has approved two new medications to help manage type 2 diabetes and improve blood sugar control, alongside diet and exercise, in pediatric patients 10 years of age and older. The approvals of empagliflozin and empagliflozin and metformin hydrochloride provide a “new class” of oral medications for pediatric patients with type 2 diabetes.

“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 Evaluation and Research said in a press release.

Empagliflozin, the active ingredient in both medications, works by “increasing the excretion of glucose in the urine,” according to the press release.

The approval of empagliflozin follows a double-blind, placebo-controlled trial that evaluated 157 patients aged 10 to 17 years with inefficiently controlled type 2 diabetes. Participants received one of three treatments for 26 weeks: empagliflozin, a DPP-4 inhibitor (linagliptin), or placebo. Overall, the trial found after 26 weeks that treatment with empagliflozin was more effective in reducing hemoglobin A1c compared to placebo. The researchers observed that patients treated with empagliflozin (n = 52) had an average of 0.2% decrease in hemoglobin A1c compared with an average of 0.7% increase in hemoglobin A1c in patients taking placebo (n = 53).

Additionally, patients who received empagliflozin had reductions in fasting plasma glucose—blood sugar measurement that’s taken after not eating or drinking for at least 8 hours.

At the beginning of the trial, 51% of patients were taking metformin alone, 40% of patients were taking a combination of metformin and insulin, 3% of patients were taking insulin alone, and 6% of patients were not taking any other medications for diabetes.

The most common adverse events that occurred in pediatric patients treated with empagliflozin were common to those reported by adults (urinary tract infections and female fungal infections). Additionally, it was reported that pediatric patients had a higher risk of hypoglycemia, regardless of whether they were taking other therapies for diabetes.



FDA approves new class of medicines to treat pediatric type 2 diabetes. News release. US Food and Drug Administration; June 20, 2023. Accessed August 9, 2023.