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Efficacy and safety of evogliptin treatment in patients with type 2 diabetes: A multicentre, active-controlled, randomized, double-blind study with open-label extension (the EVERGREEN study)

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Author(s)
Gyuri KimSoo LimHyuk-Sang KwonIe B ParkKyu J AhnCheol-Young ParkSu K KwonHye S KimSeok W ParkSin G KimMin K MoonEun S KimChoon H ChungKang S ParkMikyung KimDong J ChungChang B LeeTae H KimMoon-Kyu Lee
Keimyung Author(s)
Kim, Hye Soon
Department
Dept. of Internal Medicine (내과학)
Journal Title
Diabetes, obesity & metabolism
Issued Date
2020
Volume
22
Issue
9
Keyword
continuous glucose monitoringdipeptidyl peptidase-4 inhibitorevogliptinglycaemicvariabilitylinagliptintype 2 diabetes
Abstract
Aim:
To investigate the efficacy and safety of evogliptin compared with linagliptin in patients with type 2 diabetes.

Materials and Methods:
In this 12‐week, multicentre, randomized, double‐blind, active‐controlled, and 12‐week open‐label extension study, a total of 207 patients with type 2 diabetes who had HbA1c levels of 7.0%‐10.0% were randomized 1: 1 to receive evogliptin 5 mg (n = 102) or linagliptin 5 mg (n = 105) daily for 12 weeks. The primary efficacy endpoint was the change from baseline HbA1c at week 12. The secondary endpoint was the change in the mean amplitude of glycaemic excursion (MAGE) assessed by continuous glucose monitoring. In the extension study conducted during the following 12 weeks, evogliptin 5 mg daily was administered to both groups: evogliptin/evogliptin group (n = 95) and linagliptin/evogliptin group (n = 92).

Results:
After 12 weeks of treatment, the mean change in HbA1c in the evogliptin group and in the linagliptin group was −0.85% and −0.75%, respectively. The between‐group difference was −0.10% (95% CI: −0.32 to 0.11), showing non‐inferiority based on a non‐inferiority margin of 0.4%. The change in MAGE was −24.6 mg/dL in the evogliptin group and −16.7 mg/dL in the linagliptin group. These values were significantly lower than the baseline values in both groups. However, they did not differ significantly between the two groups. In the evogliptin/evogliptin group at week 24, HbA1c decreased by −0.94%, with HbA1c values of <7.0% in 80.2% of the patients. The incidence and types of adverse events were comparable between the two groups for 24 weeks.

Conclusion:
In this study, the glucose‐lowering efficacy of evogliptin was non‐inferior to linagliptin. It was maintained at week 24 with a 0.94% reduction in HbA1c. Evogliptin therapy improved glycaemic variability without causing any serious adverse events in patients with type 2 diabetes.
Keimyung Author(s)(Kor)
김혜순
Publisher
School of Medicine (의과대학)
Citation
Gyuri Kim et al. (2020). Efficacy and safety of evogliptin treatment in patients with type 2 diabetes: A multicentre, active-controlled, randomized, double-blind study with open-label extension (the EVERGREEN study). Diabetes, obesity & metabolism, 22(9), 1527–1536. doi: 10.1111/dom.14061
Type
Article
ISSN
1463-1326
Source
https://dom-pubs.onlinelibrary.wiley.com/doi/full/10.1111/dom.14061
DOI
10.1111/dom.14061
URI
https://kumel.medlib.dsmc.or.kr/handle/2015.oak/43048
Appears in Collections:
1. School of Medicine (의과대학) > Dept. of Internal Medicine (내과학)
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