Posted by Michael Wonder on 05 Oct 2016
Saxagliptin and saxagliptin with metformin hydrochloride in type 2 diabetes mellitus: additional clinical benefits still not there
4 October 2016 - Study evaluations unsuitable for statements about the positive or negative effects over comparative therapies.
Saxagliptin hydrochloride (Onglyza) is approved for use by adults with type 2 diabetes mellitus in whom diet and exercise alone will not lower high blood sugar levels enough. The fixed-dose combination with metformin hydrochloride goes under the name Komboglyze. Both the monotherapy preparation as well as the fixed-dose combination passed early benefit assessments in 2013, The fixed-term decisions of the Federal Joint Committee (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 active substance and the combination has advantages or disadvantages for patients over appropriate comparator therapies. The conclusion is that neither the monothetherapy preparation or the fixed-dose combination have additional benefits.
