US Food and Drug Administration has recently approved labelling changes in Sitagliptin drug stating that sitagliptin and its combination with metformin (Januvia, Janumet and janumet XR) are not proven to improve blood sugar control in pediatric patients age 10 to 17 with type 2 diabetes. They further added that the drugs are approved to improve blood sugar control in adults age 18 and older with type 2 diabetes in their press release on December 4, 2020.
FDA made these changes based on the evidence from three double-blind, placebo-controlled studies which 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 the hemoglobin A1c (HbA1c) level when compared with placebo.
Study 1 results reported patients treated with sitagliptin (n=95) had, on average of 0.06% increase in HbA1c levels while patients taking the placebo (n=95) had an average of 0.23% increase. Study 2 and 3 results showed the change from baseline at week 20, in HbA1c on patients treated with sitagliptin (n=107) was -0.23% whereas for placebo (n=113) it was 0.09%.
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. Common side effects in pediatric patients were generally similar to those reported in adults, including nasopharyngitis (cold) and upper respiratory tract infection. The risk of hypoglycemia was found to be higher in pediatric patients when they received sitagliptin together with insulin therapy compared to placebo.
Based on these findings the FDA has made updates on the labelling information of Sitagliptin (Januvia, Janumet, Janumet XR). Further studies are required to establish the safety and effectiveness of Sitagliptin in the paediatric population. However, Sitagliptin (Januvia, Janumet, Janumet XR) are approved to improve glycemic control in adults age 18 and older with type 2 diabetes.
For further information:
https://www.fda.gov/drugs/drug-safety-and-availability/new-studies-show-diabetes-drug-not-proven-improve-blood-sugar-control-pediatric-patients