Efficacy and safety of teneligliptin in combination with pioglitazone in J apanese patients with type 2 diabetes mellitus

Aim To confirm the efficacy and safety of teneligliptin in combination with pioglitazone in J apanese patients with type 2 diabetes mellitus inadequately controlled with pioglitazone monotherapy. Materials and Methods In an initial 12‐week, double‐blind, placebo controlled, parallel‐group study, patients ( n  = 204) were randomized to teneligliptin 20 mg or placebo once daily added to their stable pioglitazone therapy. This was followed by a 40‐week, open‐label period during which all patients received teneligliptin once daily. The primary end‐point was the change in hemoglobin A 1c ( H b A 1c ) from baseline to week 12. Results Patients in the teneligliptin group showed significantly greater reductions in H b A 1c compared with the placebo group at week 12 ( P  < 0.001). The changes in H b A 1c from baseline to week 12 were −0.9 ± 0.0% (least‐squares mean ± standard error) in the teneligliptin group and −0.2 ± 0.0% in the placebo group. The change in fasting plasma glucose from baseline to week 12 was greater in the teneligliptin group than in the placebo group ( P  < 0.001). The blood glucose lowering effects of teneligliptin were sustained throughout the 40‐week open‐label period. Adverse events and adverse drug reactions occurred slightly more frequently in the teneligliptin group than in the placebo group, although the incidence of hypoglycemia was low. Bodyweight was unchanged in the double‐blind period, but was slightly increased in the open‐label period. Conclusions Add‐on therapy with teneligliptin was effective and generally well tolerated throughout the study period in Japanese patients with type 2 diabetes mellitus inadequately controlled with pioglitazone monotherapy. This trial was registered with ClinicalTrials.gov (no. NCT 01026194).