4 October 2016 - For other questions, an additional benefit has not been established.

Sitagliptin phosphate monohydrate (Januvia) is approved for use by certain adults with type 2 diabetes mellitus in whom the use of diet and exercise alone does not lower high blood sugar levels enough. The fixed-dose combination with metformin hydrochloride goes under the names of Janumet and Velmetia. Both the monotherapy preparation as well as the fixed-dose combination passed early benefit assessments in 2013. The fixed-term decisions of the G-BA has ended. The deadline has been extended by one year.

The manufacturer has submitted new dossiers after the deadline. The IQWiG has re-examined whether the medicine has advantages or disadvantages for patients over the appropriate comparator therapies. For the free and the fixed dose combination of sitagliptin phosphate monohydrate and metformin hydrochloride, there is evidence of some non-quantifiable, some significant added value over a sulphonylurea. For all other applications, an additional clinical benefit has not been established.

Read IQWiG press release [German]