Safety and efficacy of teneligliptin, a dipeptidyl peptidase-4 inhibitor, in monotherapy and in combination therapy with antihyperglycemic agents in patients with type 2 diabetes mellitus - An interim analysis of post-marketing surveillance, RUBY-

Objective: Safety and efficacy of the dipeptidyl peptidase-4 inhibitor teneligliptin were examined in clinical practice by post-marketing surveillance (RUBY) in patients with type 2 diabetes mellitus (T2DM) in monotherapy and combination therapies. Method: Interim analysis was conducted based on case report forms collected by June 28, 2017 in RUBY surveillance in Japanese patients with T2DM who started administration of teneligliptin. We analyzed safety by the number of concomitant antihyperglycemic agents for combination therapy, and the safety and efficacy of teneligliptin in add-on therapy with prior antihyperglycemic agents. Results: The number of subjects in safety analysis set was 10,532. Compared to the teneligliptin monotherapy group, as the number of concomitant drugs increased, the incidence of adverse drug reactions (ADRs), including hypoglycemia, was higher. The incidence of ADRs was 2.24% in monotherapy and 4.13% in add-on therapy with biguanides (BG), 1.57% with sulfonylureas (SU), 4.44% with crglucosidase inhibitors (α-Gl), 2.06% with thiazolidines (TZD), 2.47% with insulin, 2.29% with BG + SU, 1.27% with SU+α-GI, and 1.1996 with SU+TZD. The profile of ADRs was not deviated in any combination. HbAlc levels decreased significantly until 2 years after administration (-0.90% ±1.23% after 2 years) in monotherapy and also similarly decreased in all combination groups. Conclusion: It is considered that careful management to avoid ADRs, including hypoglycemia, are required when teneligliptin is used in combination with multiple antihyperglycemic agents. On the other hand, teneligliptin was generally well-tolerated and improved glycemic control in monotherapy and add-on therapies to 1 or 2 frequently use antihyperglycemic agents.