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- Title
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
- 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.
- Subjects
CD26 antigen; ENZYME inhibitors; SITAGLIPTIN; TYPE 2 diabetes treatment; METFORMIN; THERAPEUTICS
- Publication
Diabetes, Obesity & Metabolism, 2017, Vol 19, Issue 5, p654
- ISSN
1462-8902
- Publication type
Article
- DOI
10.1111/dom.12870