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
DC Field | Value | Language |
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dc.contributor.author | Hong, Sang-Mo | - |
dc.contributor.author | Park, Cheol-Young | - |
dc.contributor.author | Hwang, Dong-Min | - |
dc.contributor.author | Han, Kyung Ah | - |
dc.contributor.author | Lee, Chang Beom | - |
dc.contributor.author | Chung, Choon Hee | - |
dc.contributor.author | Yoon, Kun-Ho | - |
dc.contributor.author | Mok, Ji-Oh | - |
dc.contributor.author | Park, Kyong Soo | - |
dc.contributor.author | Park, Sung-Woo | - |
dc.date.accessioned | 2021-08-11T15:23:54Z | - |
dc.date.available | 2021-08-11T15:23:54Z | - |
dc.date.issued | 2017-05 | - |
dc.identifier.issn | 1462-8902 | - |
dc.identifier.issn | 1463-1326 | - |
dc.identifier.uri | https://scholarworks.bwise.kr/sch/handle/2021.sw.sch/7628 | - |
dc.description.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. | - |
dc.format.extent | 10 | - |
dc.language | 영어 | - |
dc.language.iso | ENG | - |
dc.publisher | Blackwell Publishing Inc. | - |
dc.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 | - |
dc.type | Article | - |
dc.publisher.location | 미국 | - |
dc.identifier.doi | 10.1111/dom.12870 | - |
dc.identifier.scopusid | 2-s2.0-85013392379 | - |
dc.identifier.wosid | 000399367700007 | - |
dc.identifier.bibliographicCitation | Diabetes, Obesity and Metabolism, v.19, no.5, pp 654 - 663 | - |
dc.citation.title | Diabetes, Obesity and Metabolism | - |
dc.citation.volume | 19 | - |
dc.citation.number | 5 | - |
dc.citation.startPage | 654 | - |
dc.citation.endPage | 663 | - |
dc.type.docType | Article | - |
dc.description.isOpenAccess | N | - |
dc.description.journalRegisteredClass | scie | - |
dc.description.journalRegisteredClass | scopus | - |
dc.relation.journalResearchArea | Endocrinology & Metabolism | - |
dc.relation.journalWebOfScienceCategory | Endocrinology & Metabolism | - |
dc.subject.keywordPlus | BETA-CELL FUNCTION | - |
dc.subject.keywordPlus | DIPEPTIDYL PEPTIDASE-4 INHIBITOR | - |
dc.subject.keywordPlus | GLYCEMIC CONTROL | - |
dc.subject.keywordPlus | DPP-4 INHIBITOR | - |
dc.subject.keywordPlus | VILDAGLIPTIN | - |
dc.subject.keywordPlus | GLUCOSE | - |
dc.subject.keywordPlus | ASSOCIATION | - |
dc.subject.keywordPlus | COMBINATION | - |
dc.subject.keywordPlus | DA-1229 | - |
dc.subject.keywordPlus | MODEL | - |
dc.subject.keywordAuthor | combination therapy | - |
dc.subject.keywordAuthor | DPP-4 inhibitor | - |
dc.subject.keywordAuthor | evogliptin | - |
dc.subject.keywordAuthor | metformin | - |
dc.subject.keywordAuthor | sitagliptin | - |
dc.subject.keywordAuthor | type 2 diabetes mellitus | - |
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