Sitagliptin does not control blood sugar in paediatric patients with T2D, warns FDA
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.
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