Merck & Co. has received a positive opinion from the EMEA’s Committee for Medicinal Products for Human Use (CHMP) for Januvia tablets and Janumet tablets recommending their use as add-on to insulin for the treatment of type 2 diabetes.
In the US, Januvia is indicated, as an adjunct to diet and exercise, to improve glycemic control in adult patients with type 2 diabetes. Janumet is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus when treatment with both sitagliptin and metformin is appropriate. The labeling for both Januvia and Janumet state that they have not been studied in combination with insulin.
In the US, a supplemental New Drug Application (sNDA) that is similar to the European proposal concerning the use Januvia and Janumet in combination with insulin has been accepted by the FDA and is currently under review. The use of Januvia and Janumet in combination with insulin is investigational in the US.
Sitagliptin is a selective, once-daily DPP-4 inhibitor that enhances a natural body system called the incretin system to help regulate blood sugar by increasing levels of active GLP-1 and GIP hormones, it inhibits DPP-4 over 24 hours. The fixed-dose combination of sitagliptin and metformin targets: insulin deficiency from pancreatic beta cells, hepatic insulin resistance, and overproduction of glucose by the liver.