Efficacy and safety of trelagliptin in Japanese patients with type 2 diabetes with severe renal impairment or end‐stage renal disease: Results from a randomized, phase 3 study

INTRODUCTION: To investigate the efficacy and safety of trelagliptin 25 mg in patients with type 2 diabetes mellitus with severe renal impairment or end‐stage renal disease. MATERIALS AND METHODS: This multicenter, randomized, phase 3 study comprised a 12‐week double‐blind phase followed by a 40‐week open‐label phase. Patients had type 2 diabetes mellitus with severe renal impairment (creatinine clearance <30 mL/min) or end‐stage renal disease (undergoing hemodialysis), and were receiving diet and/or exercise therapy with/without one antidiabetic drug. RESULTS: Patients were randomized to trelagliptin (A/A, n = 55) or placebo (P/A, n = 52; double‐blind phase). Both groups received trelagliptin in the open‐label phase. The least square mean change (95% confidence interval [CI]) from baseline in hemoglobin A1c at the end of the double‐blind phase was −0.71% (95% CI −0.885, −0.542) and 0.01% (95% CI −0.170, 0.183) in the A/A and P/A groups, respectively (intergroup least square means difference −0.72%, 95% CI −0.966, −0.473; P < 0.0001). Mean hemoglobin A1c decreased after trelagliptin treatment in the P/A group to similar levels observed in the A/A group and remained comparable in both groups versus baseline up to week 52. In the double‐blind phase, the incidence of treatment‐emergent adverse events (TEAEs) was 72.7% and 61.5% in the A/A and P/A group, respectively; most TEAEs were mild‐to‐moderate, except in one patient (P/A group), who experienced two severe TEAEs. The incidence of serious TEAEs was 7.3% and 3.8% in the A/A and P/A group, respectively. CONCLUSIONS: Once‐weekly trelagliptin 25 mg was efficacious, with no major safety concerns, and represents a meaningful treatment option in this patient population.