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Deprecated: Implicit conversion from float 263.2 to int loses precision in C:\Inetpub\vhosts\kidney.de\httpdocs\pget.php on line 534 Diabetes+Obes+Metab 2017 ; 19 (12): 1681-7 Nephropedia Template TP
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Efficacy and safety of evogliptin monotherapy in patients with type 2 diabetes and moderately elevated glycated haemoglobin levels after diet and exercise #MMPMID28448688
Park J; Park SW; Yoon KH; Kim SR; Ahn KJ; Lee JH; Mok JO; Chung CH; Han KA; Koh GP; Kang JG; Lee CB; Kim SH; Kwon NY; Kim DM
Diabetes Obes Metab 2017[Dec]; 19 (12): 1681-7 PMID28448688show ga
Aims: To evaluate the efficacy and safety of evogliptin, a newly developed dipeptidyl peptidase?4 inhibitor, in patients with type 2 diabetes (T2D) inadequately controlled by diet and exercise. Materials and Methods: In this randomized, double?blind, placebo?controlled, parallel?group, multicentre, phase III study, 160 patients with T2D were assigned to either evogliptin 5 mg or placebo for 24 weeks. The primary endpoint was the mean change in glycated haemoglobin (HbA1c) from baseline to week 24. Results: The mean baseline HbA1c levels were similar in the evogliptin and the placebo groups (7.20% ± 0.56% vs 7.20% ± 0.63%, respectively). At week 24, evogliptin significantly reduced HbA1c levels from baseline compared with placebo (?0.23% vs 0.05%, respectively, P < .0001). Additionally, the proportion of patients achieving HbA1c <6.5% was significantly higher in the evogliptin group than in the placebo group (33.3% vs 15.2%; P = .008). The overall incidence of adverse events, including hypoglycaemia, was similar in the 2 groups. Conclusions: In this 24?week study, once?daily evogliptin monotherapy significantly improved glycaemic control and was well tolerated in patients with T2D.