Label Update Required for Diabetes Drugs Containing Sitagliptin

December 4, 2020 – The U.S. FDA has approved a label update for Merck’s Januvia® (sitagliptin), Janumet® (sitagliptin/metformin hydrochloride), and Janumet® XR (sitagliptin/metformin hydrochloride extended release). The labels for each product will reflect that drugs containing sitagliptin have not been proven to improve glycemic (blood sugar) control in pediatric patients age 10 to 17 who have type 2 diabetes.

In three clinical studies, patients 10 to 17 years of age who received sitagliptin did not experience significantly different results in their blood sugar levels compared to those who received a placebo. In one study, patients treated with sitagliptin had on average a 0.06% increase in HbA1c levels (a measure of blood sugar) compared to an average 0.23% increase in patients who received a placebo. In second and third studies, patients who received sitagliptin had an average 0.23% decrease in HbA1c levels compared to an average 0.09% increase for patients given a placebo.

Januvia, Janumet, and Janumet XR are approved as adjuncts to diet and exercise to improve glycemic control in adults who have type 2 diabetes mellitus.