The US Food and Drug Administration (FDA) has recently granted approval for two drugs commonly used by adults with type 2 diabetes to be utilized in children aged ten and above. Jardiance (empagliflozin) and Synjardy (empagliflozin and metformin hydrochloride) are the latest medications to be added to the existing treatment options for pediatric type 2 diabetes, alongside metformin, which received approval back in 2000. This development broadens the pharmaceutical options available for young patients managing this condition.
According to Dr. Michelle Carey, associate director for therapeutic review for the division of diabetes, lipid disorders, and obesity in the FDA’s Center for Drug Evaluation and Research, “Children with type 2 diabetes have limited treatment options, even though the disease and symptom onset generally progress more rapidly in children.”
Type 2 diabetes, a chronic condition characterized by abnormal insulin production and usage, is rising in children. Between 2002 and 2015, the number of children diagnosed with this condition increased by 4.8% each year, as reported by the SEARCH for Diabetes in Youth study. Should this trend continue, there are projected to be 220,000 cases of type 2 diabetes in children by 2060. Interestingly, this increase is primarily observed in minority racial and ethnic groups.
To ensure the safety and efficacy of the newly approved drugs for pediatric type 2 diabetes, a comprehensive study was conducted involving 157 patients aged 10 to 17. A double-blind, randomized trial divided these patients into three treatment groups and monitored for 26 weeks.
The trial found that the medication containing the active ingredient empagliflozin significantly reduced hemoglobin A1c (HbA1C) levels, a key indicator of blood sugar control, compared to the placebo.
Using empagliflozin resulted in a 0.2% decrease in HbA1C levels among 52 patients, while the placebo group experienced a 0.7% increase. Pediatric patients using the drug had a higher likelihood of experiencing low blood sugar levels than those using a placebo, even when other diabetes therapies were involved.
In adults, the most common side effects of this medication are urinary tract infections and fungal infections in females. Patients also using metformin may experience diarrhea, nausea, and upset stomach.
Patients with type 1 diabetes or severe kidney problems are advised against using these medications due to the increased risk of diabetic ketoacidosis.