A randomized, placebo‐controlled trial to assess the efficacy and safety of sitagliptin in Japanese patients with type 2 diabetes and inadequate glycaemic control on ipragliflozin

Abstract

Aims To investigate the efficacy, safety and tolerability of sitagliptin 50 mg once daily (q.d.) added to ipragliflozin 50 mg q.d. monotherapy in Japanese patients with type 2 diabetes (T2D). Materials and Methods Japanese patients with T2D and HbA1c 7.0‐10.0% while treated with ipragliflozin 50 mg q.d. were randomized 1:1 to additional treatment with sitagliptin 50 mg q.d. (N=70) or matching placebo (N=71) for 24 weeks. The primary efficacy endpoint was change in HbA1c at Week 24. Secondary efficacy endpoints were changes in 2‐hour post‐meal glucose (2‐hr PMG), total PMG AUC_0‐2hr, and fasting plasma glucose (FPG). Results Baseline characteristics were similar between groups (mean age = 55.5 years and mean baseline HbA1c = 8.0%). After 24 weeks, the addition of sitagliptin provided significantly greater reduction in HbA1c compared to placebo (least squares (LS) mean difference (95% confidence interval) = ‐0.83% (‐1.05, ‐0.62), p0‐2hr, and FPG were ‐42.5 mg/dL, ‐67.0 mg•hr/dL, and ‐11.2 mg/dL, respectively (all p<0.001). The incidences of adverse events (AEs) overall and predefined AEs of clinical interest (symptomatic hypoglycemia, urinary tract infection, genital infection, hypovolemia, and polyuria/pollakiuria), were similar between groups. Conclusions In Japanese patients with T2D, sitagliptin 50 mg q.d. added to ipragliflozin 50 mg q.d. monotherapy provided significant improvement in glycemic control and was generally well tolerated.