234 386

Cited 10 times in

Addition of Ipragliflozin to Metformin Treatment in Korean Patients with Type 2 Diabetes Mellitus: Subgroup Analysis of a Phase 3 Trial

DC Field Value Language
dc.contributor.author차봉수-
dc.date.accessioned2018-07-20T08:24:12Z-
dc.date.available2018-07-20T08:24:12Z-
dc.date.issued2017-
dc.identifier.issn2233-6079-
dc.identifier.urihttps://ir.ymlib.yonsei.ac.kr/handle/22282913/161155-
dc.description.abstractBACKGROUND: This is a subgroup analysis of Korean patients from a phase 3 clinical trial investigating the efficacy and safety of ipragliflozin in patients with type 2 diabetes mellitus inadequately controlled with metformin. METHODS: This multicenter, placebo-controlled, double-blind, parallel-group study was carried out between November 2011 and January 2013. Patients entered a 2-week placebo pretreatment period, followed by a 24-week treatment period with either ipragliflozin (50 mg/day) or placebo, while continuing metformin. Efficacy outcomes (glycosylated hemoglobin [HbA1c], fasting plasma glucose [FPG], and body weight) and safety outcomes (treatment-emergent adverse events [TEAEs]) were measured and compared between the two treatment groups for patients enrolled in all 18 study sites in Korea. RESULTS: Eighty-two Korean patients received ipragliflozin (n=43) or placebo (n=39) during the study period. Mean changes in HbA1c levels from baseline to the end of treatment were -0.97% in the ipragliflozin group and -0.31% in the placebo group, with an adjusted between-group difference of -0.60% (P<0.001). Compared to placebo, FPG and body weight also decreased significantly (both P<0.001) from baseline after treatment in the ipragliflozin group, with between-group differences of -21.4 mg/dL and -1.53 kg, respectively. Decreased weight was the most common TEAE in the ipragliflozin group (7.0%); there were no reports of genital and urinary tract infection. CONCLUSION: Ipragliflozin treatment in addition to metformin led to significant improvement in glycemic outcomes and reduction in body weight in Korean patients with type 2 diabetes mellitus, compared with metformin treatment alone; the safety profile was comparable in both groups.-
dc.description.statementOfResponsibilityopen-
dc.languageEnglish-
dc.publisherKorean Diabetes Association-
dc.relation.isPartOfDIABETES & METABOLISM JOURNAL-
dc.rightsCC BY-NC-ND 2.0 KR-
dc.rightshttps://creativecommons.org/licenses/by-nc-nd/2.0/kr/-
dc.titleAddition of Ipragliflozin to Metformin Treatment in Korean Patients with Type 2 Diabetes Mellitus: Subgroup Analysis of a Phase 3 Trial-
dc.typeArticle-
dc.contributor.collegeCollege of Medicine-
dc.contributor.departmentDept. of Internal Medicine-
dc.contributor.googleauthorKyung-Wan Min-
dc.contributor.googleauthorBon Jeong Ku-
dc.contributor.googleauthorJi-Hyun Lee-
dc.contributor.googleauthorMin-Seon Kim-
dc.contributor.googleauthorKyu-Jeung Ahn-
dc.contributor.googleauthorMoon-Kyu Lee-
dc.contributor.googleauthorSatoshi Kokubo-
dc.contributor.googleauthorSatoshi Yoshida-
dc.contributor.googleauthorHyun-Ji Cho-
dc.contributor.googleauthorBong-Soo Cha-
dc.identifier.doi10.4093/dmj.2017.41.2.135-
dc.contributor.localIdA03996-
dc.relation.journalcodeJ00720-
dc.identifier.eissn2233-6087-
dc.identifier.pmid28447440-
dc.subject.keywordAsia-
dc.subject.keywordDiabetes mellitus, type 2-
dc.subject.keywordIpragliflozin-
dc.subject.keywordKorea-
dc.subject.keywordMetformin-
dc.subject.keywordRandomized controlled trial-
dc.subject.keywordSodium-glucose cotransporter 2 inhibitor-
dc.contributor.alternativeNameCha, Bong Soo-
dc.contributor.affiliatedAuthorCha, Bong Soo-
dc.citation.volume41-
dc.citation.number4-
dc.citation.startPage135-
dc.citation.endPage145-
dc.identifier.bibliographicCitationDIABETES & METABOLISM JOURNAL, Vol.41(4) : 135-145, 2017-
dc.identifier.rimsid61080-
dc.type.rimsART-
Appears in Collections:
1. College of Medicine (의과대학) > Dept. of Internal Medicine (내과학교실) > 1. Journal Papers

qrcode

Items in DSpace are protected by copyright, with all rights reserved, unless otherwise indicated.