Clinical study of repaglinide efficacy and safety in type 2 diabetes mellitus patients with blood glucose levels inadequately controlled by sitagliptin

摘要

Aims/Introduction The aim of the present study was to evaluate the long-term efficacy and safety of adding repaglinide in patients with type 2 diabetes mellitus whose blood glucose levels were not sufficiently controlled by treatment with a dipeptidyl peptidase-4 inhibitor, sitagliptin, in addition to diet and exercise therapies. Materials and Methods This was a multicenter, uncontrolled, dose-titration study with a treatment period of 52?weeks. The primary end-point was the change in glycated hemoglobin levels from baseline. Results The glycated hemoglobin level was 7.43?±?0.57% (mean?±?standard deviation) at baseline, and decreased to 6.93?±?0.91% at the end of the study. The mean changes in glycated hemoglobin levels at 4?weeks and at the end of the study were ?0.44?±?0.28% and ?0.50?±?0.82%, respectively. The glycated hemoglobin-lowering effect was maintained for 52?weeks. The rate of adverse events was 86.0% (86/100), and there were 352 adverse events. The rate of adverse drug reactions was 21.0% (21/100). Hypoglycemia was reported in 5.0% (5/100) of patients, but there was no incidence of ‘major hypoglycemia’. Conclusions Combination therapy with repaglinide and sitagliptin was considered effective for a long term without clinical safety problems in patients with type 2 diabetes mellitus.