2 December 2013 - Saxagliptin hydrochloride (Onglyza) has been approved also as monotherapy in Germany since July 2013 for certain adults with type 2 diabetes mellitus. It is an option when drug treatment is needed, but the drug metformin is not tolerated or cannot be used.

In an early benefit assessment pursuant to the Act on the Reform of the Market for Medicinal Products (AMNOG), the German Institute for Quality and Efficiency in Health Care (IQWiG) examined whether saxagliptin offers an added benefit over the current standard therapy. Such an added benefit cannot be derived from the dossier, however, as the manufacturer did not submit any suitable data.
For more details, go to: https://www.iqwig.de/en/press/press_releases/press_releases/added_benefit_of_saxagliptin_as_monotherapy_is_not_proven.5347.html