sitagliptin/metformin (Janumet)

Following an abbreviated submission

sitagliptin 50 mg and metformin hydrochloride 1000 mg (Janumet® 50/1000): is accepted for restricted use within NHS Scotland.

Licensed indication under review: as an adjunct to diet and exercise to improve glycaemic control in patients with type 2 diabetes mellitus inadequately controlled on their maximal tolerated dose of metformin alone, or those already being treated with the combination of sitagliptin and metformin.

SMC restriction: restricted to use in patients for whom a combination of sitagliptin and metformin is an appropriate choice of therapy and only when the addition of sulphonylureas to metformin monotherapy is not appropriate. Sitagliptin represents an alternative to other agents such as thiazolidinediones.

Efficacy of sitagliptin when added to metformin, as assessed by measurement of HbA1c, is similar to sulphonylurea and thiazolidinedione drugs added at this stage in therapy. It appears to have minimal effects on body weight.