New Phase III data presented this week at the 46th Annual Meeting of the European Association for the Study of Diabetes (EASD) in Stockholm, Sweden, found that German independent drug major Boehringer Ingelheim’s investigational linagliptin therapy resulted in significant reductions in blood sugar as measured by hemoglobin A1c (HbA1c) when compared to placebo, both when added to sulfonylurea (SU) in inadequately controlled type 2 diabetes (T2D) patients, and when administered as monotherapy in T2D patients for whom metformin is inappropriate.
In addition, new pharmacokinetic (PK) data demonstrate that decreases in renal function had minor effect on the elimination of linagliptin. These findings support the study conclusion that a dose adjustment may not be required in T2D patients with varying degrees of renal impairment (RI) when treated with linagliptin.
Results from this PK study show that minor changes were observed in linagliptin exposure in study participants with RI (a 1.4-fold increase in exposure at steady state in T2D patients with severe RI compared with T2D patients with normal renal function). As a result of these findings, the study authors suggest that no dose adjustment is required in T2D patients with varying degrees of RI when treated with linagliptin.
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