The U.S. Food and Drug Administration (FDA) has granted approval for Jardiance (empagliflozin) and Synjardy (empagliflozin and metformin hydrochloride) as supplementary treatments, in conjunction with diet and exercise, to enhance blood sugar control in children aged 10 and older with type 2 diabetes. This approval introduces a new class of orally administered medications for the management of pediatric type 2 diabetes. Previously, metformin was the only available oral therapy for treating children with type 2 diabetes, approved for pediatric use in 2000.
Dr. Michelle Carey, Associate Director for Therapeutic Review at the FDA’s Division of Diabetes, Lipid Disorders, and Obesity, acknowledges the limited treatment options for children with type 2 diabetes compared to adults, despite the disease’s more rapid progression in children. The recent approvals offer much-needed additional treatment choices for pediatric patients with type 2 diabetes.
Type 2 diabetes is the most prevalent form of diabetes, characterized by the body’s inadequate production or utilization of insulin, leading to elevated glucose levels in the blood. Data from the SEARCH for Diabetes in Youth study reveals a 4.8% annual increase in the incidence of type 2 diabetes in children from 2002 to 2015, with expectations of continued growth. In 2017, there were approximately 28,000 cases of type 2 diabetes among children in the United States, a number predicted to reach approximately 220,000 by 2060 if current trends persist, with a majority of cases occurring among minority racial and ethnic groups such as Non-Hispanic Blacks and Hispanics.
Empagliflozin, the active ingredient in Jardiance and Synjardy, functions by promoting the excretion of glucose in the urine. Synjardy also contains metformin.
To assess the safety and efficacy of empagliflozin in children, a double-blind, randomized, placebo-controlled trial involving 157 patients aged 10 to 17 years with poorly controlled type 2 diabetes was conducted. Participants were assigned randomly to one of three treatment groups for 26 weeks: empagliflozin, a DPP-4 inhibitor (linagliptin), or placebo. At the start of the trial, 51% of patients were solely taking metformin, 40% were on a combination of metformin and insulin, 3% were on insulin alone, and 6% were not using any other diabetes medications. The trial demonstrated that empagliflozin treatment yielded superior results in reducing hemoglobin A1c (a measure of average blood sugar) compared to the placebo at the 26-week mark. Patients treated with empagliflozin experienced an average decrease of 0.2% in hemoglobin A1c, while those on the placebo showed an average increase of 0.7%. Consequently, empagliflozin achieved a 0.8% decrease in hemoglobin A1c compared to the placebo. Additionally, empagliflozin-treated patients demonstrated reductions in fasting plasma glucose levels, which is a measurement of blood sugar after an eight-hour fast, compared to those on the placebo.
Common side effects observed in children treated with empagliflozin were generally similar to those reported in adults, although there was a higher risk of hypoglycemia (low blood sugar) among pediatric patients aged 10 and older taking empagliflozin, regardless of whether they were using other diabetes therapies.
