Linagliptin is authorized for the treatment of type 2 diabetes in monotherapy only when metformin is not tolerated.
Its use is approved in a two-drug combined therapy with metformin or insulin, and in triple therapy with metformin and sulphonylureas or with metformin and insulin.
Regarding efficacy only a 0.6% reduction vs placebo in HbA1c was shown, which is of limited magnitude. Its effect on morbidity and mortality has not been evaluated.
In one trial the combination of linagliptin + metformin was statistically inferior to glimepiride + metformin.
There is no evidence that linagliptin offers significant advantages with respect to other gliptins in terms of efficacy and safety. No dose adjustments are required in renal impairment, unlike sitagliptin, saxagliptin and vildagliptin.
There are no data on long term safety. The possible risks are related to the immune and cardiovascular system and the possibility of developing pancreatitis.