Sitagliptin does not appear to significantly improve glycemic control in pediatric patients 10 to 17 years of age with type 2 diabetes, according to a new Food and Drug Administration (FDA) drug safety communication.
The finding was based on data from three 20-week double-blind, placebo-controlled studies each with 34-week extensions. The trials evaluated the efficacy and safety of sitagliptin, a dipeptidyl peptidase-4 (DPP-4) inhibitor, in 410 pediatric patients aged 10 to 17 years with inadequately controlled type 2 diabetes, with or without insulin therapy. Results from these trials showed that sitagliptin did not have a significant impact in hemoglobin A1c (HbA1c) when compared with placebo.
In Study 1, the mean baseline HbA1c was 7.5%; 12% of patients were on insulin therapy. At week 20, the change from baseline in HbA1c in patients treated with sitagliptin (n=95) was 0.06% compared with 0.23% in patients treated with placebo (n=95), a difference of -0.17% (95% CI: -0.62-0.28).
In Studies 2 and 3, the mean baseline HbA1c was 8.0%; 15% of patients were on insulin and 72% were on metformin HCl (>1500mg daily). At week 20, the change from baseline in HbA1c in patients treated with sitagliptin (n=107) was -0.23% compared with 0.09% in patients treated with placebo (n=113), a difference of -0.33% (95% CI: -0.70-0.05).
As for rescue therapy, in the first 20 weeks, 5% of sitagliptin-treated patients received metformin (Study 1 only) and/or insulin (all 3 trials) vs 15% of patients in the placebo arm. The percentages of patients initiating rescue therapy were found to be similar between the groups from weeks 20 to 54. Results also showed that compared with placebo, pediatric patients had an increased risk of hypoglycemia episodes when they received sitagliptin together with insulin therapy.
Based on these findings, updates have been made to the prescribing information for Januvia (sitagliptin), Janumet (sitagliptin and metformin hydrochloride), and Janumet XR (sitagliptin and metformin HCl extended-release). The safety and effectiveness of these agents have not been established in pediatric patients.
For more information visit fda.gov.
New studies show diabetes drug not proven to improve blood sugar control in pediatric patients. [press release]. Silver Spring, MD: US Food and Drug Administration; December 4, 2020.