Cited 51 times in
Efficacy, safety, and tolerability of ipragliflozin in Asian patients with type 2 diabetes mellitus and inadequate glycemic control with metformin: Results of a phase 3 randomized, placebo-controlled, double-blind, multicenter trial
DC Field | Value | Language |
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dc.contributor.author | 차봉수 | - |
dc.date.accessioned | 2017-10-26T07:30:48Z | - |
dc.date.available | 2017-10-26T07:30:48Z | - |
dc.date.issued | 2016 | - |
dc.identifier.issn | 2040-1116 | - |
dc.identifier.uri | https://ir.ymlib.yonsei.ac.kr/handle/22282913/152127 | - |
dc.description.abstract | AIMS/INTRODUCTION: To determine the efficacy and safety of ipragliflozin in combination with metformin in Asian patients with type 2 diabetes mellitus. MATERIALS AND METHODS: This phase 3, multicenter, placebo-controlled, double-blind, parallel-group study was carried out at 18 sites in Korea and 12 sites in Taiwan. After an 8-week washout period for patients using drugs other than metformin and a 2-week run-in period, patients were randomized to either 50 mg ipragliflozin or a placebo for 24 weeks while continuing metformin. Efficacy outcomes included the changes in hemoglobin A1c, fasting plasma glucose (FPG) and bodyweight from baseline to the end of treatment (with last observation carried forward). Safety outcomes included treatment-emergent adverse events. RESULTS: Between November 2011 and January 2013, 171 patients were randomized to and administered ipragliflozin (n = 87) or a placebo (n = 83). The mean changes (standard deviation) in hemoglobin A1c were -0.94% (0.75%) and -0.47% (0.81%) in the ipragliflozin and placebo groups, respectively (between-group difference -0.46%, P < 0.001). The changes in fasting plasma glucose and bodyweight were also significantly greater in the ipragliflozin group, with between-group differences of -14.1 mg/dL and -1.24 kg, respectively (both P < 0.001). The most common treatment-emergent adverse events (ipragliflozin vs placebo) were upper respiratory tract infection (9.2% vs 12.0%) and urinary tract infection (6.9% vs 2.4%). CONCLUSIONS: These results show that ipragliflozin is effective and well tolerated when used in combination with metformin in Asian patients with type 2 diabetes mellitus. | - |
dc.description.statementOfResponsibility | open | - |
dc.language | English | - |
dc.publisher | Asian Association for the Study of Diabetes and Blackwell Pub. Asia | - |
dc.relation.isPartOf | JOURNAL OF DIABETES INVESTIGATION | - |
dc.rights | CC BY-NC-ND 2.0 KR | - |
dc.rights.uri | https://creativecommons.org/licenses/by-nc-nd/2.0/kr/ | - |
dc.subject.MESH | Asian Continental Ancestry Group | - |
dc.subject.MESH | Diabetes Mellitus, Type 2/drug therapy* | - |
dc.subject.MESH | Double-Blind Method | - |
dc.subject.MESH | Drug Therapy, Combination/adverse effects | - |
dc.subject.MESH | Female | - |
dc.subject.MESH | Glucosides/adverse effects | - |
dc.subject.MESH | Glucosides/therapeutic use* | - |
dc.subject.MESH | Humans | - |
dc.subject.MESH | Male | - |
dc.subject.MESH | Metformin/adverse effects | - |
dc.subject.MESH | Metformin/therapeutic use* | - |
dc.subject.MESH | Thiophenes/adverse effects | - |
dc.subject.MESH | Thiophenes/therapeutic use* | - |
dc.subject.MESH | Treatment Outcome | - |
dc.title | Efficacy, safety, and tolerability of ipragliflozin in Asian patients with type 2 diabetes mellitus and inadequate glycemic control with metformin: Results of a phase 3 randomized, placebo-controlled, double-blind, multicenter trial | - |
dc.type | Article | - |
dc.publisher.location | Japan | - |
dc.contributor.college | College of Medicine | - |
dc.contributor.department | Dept. of Internal Medicine | - |
dc.contributor.googleauthor | Chieh-Hsiang Lu | - |
dc.contributor.googleauthor | KyungWan Min | - |
dc.contributor.googleauthor | Lee-Ming Chuang | - |
dc.contributor.googleauthor | Satoshi Kokubo | - |
dc.contributor.googleauthor | Satoshi Yoshida | - |
dc.contributor.googleauthor | Bong-Soo Cha | - |
dc.identifier.doi | 10.1111/jdi.12422 | - |
dc.contributor.localId | A03996 | - |
dc.relation.journalcode | J01377 | - |
dc.identifier.eissn | 2040-1124 | - |
dc.identifier.pmid | 27330723 | - |
dc.subject.keyword | Asia | - |
dc.subject.keyword | Ipragliflozin | - |
dc.subject.keyword | Type 2 diabetes mellitus | - |
dc.contributor.alternativeName | Cha, Bong Soo | - |
dc.contributor.affiliatedAuthor | Cha, Bong Soo | - |
dc.citation.volume | 7 | - |
dc.citation.number | 3 | - |
dc.citation.startPage | 366 | - |
dc.citation.endPage | 373 | - |
dc.identifier.bibliographicCitation | JOURNAL OF DIABETES INVESTIGATION, Vol.7(3) : 366-373, 2016 | - |
dc.date.modified | 2017-10-24 | - |
dc.identifier.rimsid | 46907 | - |
dc.type.rims | ART | - |
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