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Journal of diabetes investigation

Efficacy and safety of the dipeptidyl peptidase-4 inhibitor sitagliptin compared with alpha-glucosidase inhibitor in Japanese patients with typexa02 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.


PMID 25802726

Abstract

To assess the efficacy and safety of sitagliptin compared with α-glucosidase inhibitors in Japanese patients with typexa02 diabetes inadequately controlled by metformin or pioglitazone alone. In the present multicenter, randomized, open-label, parallel-group, active-controlled, non-inferiority trial, 119 patients aged 20-79xa0years with typexa02 diabetes who had glycated hemoglobin 6.9-8.8% on stable metformin (500-1,500xa0mg/day) or pioglitazone (15-30xa0mg/day) alone were randomly assigned (1:1) to receive the addition of sitagliptin (50xa0mg/day) or an α-glucosidase inhibitor (0.6xa0mg/day voglibose or 150xa0mg/day miglitol) for 24xa0weeks. The primary end-point was change in glycated hemoglobin from baseline to weekxa012. All data were analyzed according to the intention-to-treat principle. After 12xa0weeks, 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, Pxa0

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