Efficacy and safety of adding evogliptin versus sitagliptin for metformin-treated patients with type 2 diabetes: A 24-week randomized, controlled trial with open label extension
- Authors
- Hong, Sang-Mo; Park, Cheol-Young; Hwang, Dong-Min; Han, Kyung Ah; Lee, Chang Beom; Chung, Choon Hee; Yoon, Kun-Ho; Mok, Ji-Oh; Park, Kyong Soo; Park, Sung-Woo
- Issue Date
- May-2017
- Publisher
- Blackwell Publishing Inc.
- Keywords
- combination therapy; DPP-4 inhibitor; evogliptin; metformin; sitagliptin; type 2 diabetes mellitus
- Citation
- Diabetes, Obesity and Metabolism, v.19, no.5, pp 654 - 663
- Pages
- 10
- Journal Title
- Diabetes, Obesity and Metabolism
- Volume
- 19
- Number
- 5
- Start Page
- 654
- End Page
- 663
- URI
- https://scholarworks.bwise.kr/sch/handle/2021.sw.sch/7628
- DOI
- 10.1111/dom.12870
- ISSN
- 1462-8902
1463-1326
- Abstract
- Aims: This trial consisted of a 24-week multicentre, randomized, double-blind, double-dummy, active-controlled study and a 52-week open label extension study to assess the efficacy and safety of evogliptin, a novel dipeptidyl peptidase-4 inhibitor, compared to sitagliptin in patients with type 2 diabetes who have inadequate glycaemic control with metformin alone. Methods: Adult patients with type 2 diabetes mellitus (N = 222) with HbA1c 6.5% to 11% who were receiving stable doses of metformin (>= 1000 mg/d) were randomized 1: 1 to add-on evogliptin 5 mg (N = 112) or sitagliptin 100 mg (N = 110) once daily for 24 weeks. The primary efficacy analysis consisted of a comparison of the change from baseline HbA1c at week 24. Non-inferiority was concluded if the upper limit of the 2-sided 95% confidence interval for the HbA1c difference between treatments was < 0.35%. Results: Mean changes in HbA1c following addition of evogliptin or sitagliptin were -0.59% and -0.65%, respectively. The between-group difference was 0.06% (2-sided 95% confidence interval, -0.10 to 0.22), demonstrating non-inferiority. After the 52-week treatment, evogliptin caused a persistently decreased level of HbA1c (-0.44% +/- 0.65%, P <.0001). In general, both treatments were well tolerated, with incidences and types of adverse events comparable between the two groups. Hypoglycaemic events, mostly mild, were reported in 0.9% of patients treated with evogliptin and in 2.8% of patients treated with sitagliptin for 24 weeks. Conclusions: Evogliptin 5 mg added to metformin therapy effectively improved glycaemic control and was non-inferior to sitagliptin and well tolerated in patients with type 2 diabetes mellitus that was inadequately controlled by metformin alone.
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