Cited 13 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 |
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dc.contributor.author | 차봉수 | - |
dc.date.accessioned | 2018-07-20T08:24:12Z | - |
dc.date.available | 2018-07-20T08:24:12Z | - |
dc.date.issued | 2017 | - |
dc.identifier.issn | 2233-6079 | - |
dc.identifier.uri | https://ir.ymlib.yonsei.ac.kr/handle/22282913/161155 | - |
dc.description.abstract | BACKGROUND: 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.statementOfResponsibility | open | - |
dc.language | English | - |
dc.publisher | Korean Diabetes Association | - |
dc.relation.isPartOf | DIABETES & METABOLISM JOURNAL | - |
dc.rights | CC BY-NC-ND 2.0 KR | - |
dc.rights | https://creativecommons.org/licenses/by-nc-nd/2.0/kr/ | - |
dc.title | Addition of Ipragliflozin to Metformin Treatment in Korean Patients with Type 2 Diabetes Mellitus: Subgroup Analysis of a Phase 3 Trial | - |
dc.type | Article | - |
dc.contributor.college | College of Medicine | - |
dc.contributor.department | Dept. of Internal Medicine | - |
dc.contributor.googleauthor | Kyung-Wan Min | - |
dc.contributor.googleauthor | Bon Jeong Ku | - |
dc.contributor.googleauthor | Ji-Hyun Lee | - |
dc.contributor.googleauthor | Min-Seon Kim | - |
dc.contributor.googleauthor | Kyu-Jeung Ahn | - |
dc.contributor.googleauthor | Moon-Kyu Lee | - |
dc.contributor.googleauthor | Satoshi Kokubo | - |
dc.contributor.googleauthor | Satoshi Yoshida | - |
dc.contributor.googleauthor | Hyun-Ji Cho | - |
dc.contributor.googleauthor | Bong-Soo Cha | - |
dc.identifier.doi | 10.4093/dmj.2017.41.2.135 | - |
dc.contributor.localId | A03996 | - |
dc.relation.journalcode | J00720 | - |
dc.identifier.eissn | 2233-6087 | - |
dc.identifier.pmid | 28447440 | - |
dc.subject.keyword | Asia | - |
dc.subject.keyword | Diabetes mellitus, type 2 | - |
dc.subject.keyword | Ipragliflozin | - |
dc.subject.keyword | Korea | - |
dc.subject.keyword | Metformin | - |
dc.subject.keyword | Randomized controlled trial | - |
dc.subject.keyword | Sodium-glucose cotransporter 2 inhibitor | - |
dc.contributor.alternativeName | Cha, Bong Soo | - |
dc.contributor.affiliatedAuthor | Cha, Bong Soo | - |
dc.citation.volume | 41 | - |
dc.citation.number | 4 | - |
dc.citation.startPage | 135 | - |
dc.citation.endPage | 145 | - |
dc.identifier.bibliographicCitation | DIABETES & METABOLISM JOURNAL, Vol.41(4) : 135-145, 2017 | - |
dc.identifier.rimsid | 61080 | - |
dc.type.rims | ART | - |
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