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Aims/Introduction  To assess the efficacy and safety of sitagliptin compared with α‐glucosidase inhibitors in Japanese patients with type 2 diabetes inadequately controlled by metformin or pioglitazone alone.    Materials and Methods  In the present multicenter, randomized, open‐label, parallel‐group, active‐controlled, non‐inferiority trial, 119 patients aged 20–79 years with type 2 diabetes who had glycated hemoglobin 6.9–8.8% on stable metformin (500–1,500 mg/day) or pioglitazone (15–30 mg/day) alone were randomly assigned (1:1) to receive the addition of sitagliptin (50 mg/day) or an α‐glucosidase inhibitor (0.6 mg/day voglibose or 150 mg/day miglitol) for 24 weeks. The primary end‐point was change in glycated hemoglobin from baseline to week 12. All data were analyzed according to the intention‐to‐treat principle.    Results  After 12 weeks, reductions in adjusted mean glycated hemoglobin from baseline were −0.70% in sitagliptin and −0.21% in the α‐glucosidase inhibitor groups respectively; between‐group difference was −0.49% (95% confidence interval −0.66 to −0.32,  P  < 0.0001), meeting the predefined non‐inferiority criterion (0.25%) and showing statistical significance. This statistical significance also continued after 24 weeks. Although sitagliptin did not affect bodyweight, α‐glucosidase inhibitors decreased bodyweight significantly from baseline (−0.39 kg;  P  = 0.0079). Gastrointestinal disorders were significantly lower with sitagliptin than with an α‐glucosidase inhibitor (6 [10.3%] patients vs 23 [39.7%];  P  = 0.0003). Minor hypoglycemia occurred in two patients (3.5%) in each group.    Conclusions  Sitagliptin showed greater efficacy and better tolerability than an α‐glucosidase inhibitor when added to stable doses of metformin or pioglitazone. These findings support the use of sitagliptin in Japanese patients with type 2 diabetes inadequately controlled by insulin‐sensitizing agents. This trial was registered with  UMIN  (no. 4675).

journal of diabetes investigation

Efficacy and safety of the dipeptidyl peptidase‐4 inhibitor sitagliptin compared with alpha‐glucosidase inhibitor in Japanese patients with type 2 diabetes inadequately controlled on metformin or pioglitazone alone (Study for an Ultimate Combination Therapy to Control Diabetes with Sitagliptin‐1): A multicenter, randomized, open‐label, non‐inferiority trial