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Efficacy and Safety of Enavogliflozin versus Dapagliflozin as Add-on to Metformin in Patients with Type 2 Diabetes Mellitus: A 24-Week, Double-Blind, Randomized Trial
DC Field | Value | Language |
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dc.contributor.author | 이병완 | - |
dc.date.accessioned | 2024-05-30T06:47:07Z | - |
dc.date.available | 2024-05-30T06:47:07Z | - |
dc.date.issued | 2023-11 | - |
dc.identifier.issn | 2233-6079 | - |
dc.identifier.uri | https://ir.ymlib.yonsei.ac.kr/handle/22282913/199333 | - |
dc.description.abstract | Background: Enavogliflozin is a novel sodium-glucose cotransporter-2 inhibitor currently under clinical development. This study evaluated the efficacy and safety of enavogliflozin as an add-on to metformin in Korean patients with type 2 diabetes melli-tus (T2DM) against dapagliflozin. Methods: In this multicenter, double-blind, randomized, phase 3 study, 200 patients were randomized to receive enavogliflozin 0.3 mg/day (n= 101) or dapagliflozin 10 mg/day (n= 99) in addition to ongoing metformin therapy for 24 weeks. The primary ob-jective of the study was to prove the non-inferiority of enavogliflozin to dapagliflozin in glycosylated hemoglobin (HbA1c) change at week 24 (non-inferiority margin of 0.35%) (Clinical trial registration number: NCT04634500). Results: Adjusted mean change of HbA1c at week 24 was -0.80% with enavogliflozin and -0.75% with dapagliflozin (difference, -0.04%; 95% confidence interval, -0.21% to 0.12%). Percentages of patients achieving HbA1c <7.0% were 61% and 62%, respec-tively. Adjusted mean change of fasting plasma glucose at week 24 was -32.53 and -29.14 mg/dL. An increase in urine glucose-creatinine ratio (60.48 vs. 44.94, P< 0.0001) and decrease in homeostasis model assessment of insulin resistance (-1.85 vs. -1.31, P=0.0041) were significantly greater with enavogliflozin than dapagliflozin at week 24. Beneficial effects of enavogliflozin on body weight (-3.77 kg vs. -3.58 kg) and blood pressure (systolic/diastolic, -5.93/-5.41 mm Hg vs. -6.57/-4.26 mm Hg) were comparable with those of dapagliflozin, and both drugs were safe and well-tolerated. Conclusion: Enavogliflozin added to metformin significantly improved glycemic control in patients with T2DM and was non-inferior to dapagliflozin 10 mg, suggesting enavogliflozin as a viable treatment option for patients with inadequate glycemic con-trol on metformin alone. | - |
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.subject.MESH | Blood Glucose | - |
dc.subject.MESH | Diabetes Mellitus, Type 2* | - |
dc.subject.MESH | Glycated Hemoglobin | - |
dc.subject.MESH | Humans | - |
dc.subject.MESH | Hypoglycemic Agents / adverse effects | - |
dc.subject.MESH | Metformin* / adverse effects | - |
dc.subject.MESH | Sodium-Glucose Transporter 2 Inhibitors* / adverse effects | - |
dc.title | Efficacy and Safety of Enavogliflozin versus Dapagliflozin as Add-on to Metformin in Patients with Type 2 Diabetes Mellitus: A 24-Week, Double-Blind, Randomized Trial | - |
dc.type | Article | - |
dc.contributor.college | College of Medicine (의과대학) | - |
dc.contributor.department | Dept. of Internal Medicine (내과학교실) | - |
dc.contributor.googleauthor | Kyung Ah Han | - |
dc.contributor.googleauthor | Yong Hyun Kim | - |
dc.contributor.googleauthor | Doo Man Kim | - |
dc.contributor.googleauthor | Byung Wan Lee | - |
dc.contributor.googleauthor | Suk Chon | - |
dc.contributor.googleauthor | Tae Seo Sohn | - |
dc.contributor.googleauthor | In Kyung Jeong | - |
dc.contributor.googleauthor | Eun-Gyoung Hong | - |
dc.contributor.googleauthor | Jang Won Son | - |
dc.contributor.googleauthor | Jae Jin Nah | - |
dc.contributor.googleauthor | Hwa Rang Song | - |
dc.contributor.googleauthor | Seong In Cho | - |
dc.contributor.googleauthor | Seung-Ah Cho | - |
dc.contributor.googleauthor | Kun Ho Yoon | - |
dc.identifier.doi | 10.4093/dmj.2022.0315 | - |
dc.contributor.localId | A02796 | - |
dc.relation.journalcode | J00720 | - |
dc.identifier.eissn | 2233-6087 | - |
dc.identifier.pmid | 36756676 | - |
dc.subject.keyword | Dapagliflozin | - |
dc.subject.keyword | Diabetes mellitus, type 2 | - |
dc.subject.keyword | Hypoglycemic agents | - |
dc.subject.keyword | Metformin | - |
dc.subject.keyword | Randomized controlled trial | - |
dc.subject.keyword | Sodium-glucose transporter 2 inhibitors | - |
dc.contributor.alternativeName | Lee, Byung Wan | - |
dc.contributor.affiliatedAuthor | 이병완 | - |
dc.citation.volume | 47 | - |
dc.citation.number | 6 | - |
dc.citation.startPage | 796 | - |
dc.citation.endPage | 807 | - |
dc.identifier.bibliographicCitation | DIABETES & METABOLISM JOURNAL, Vol.47(6) : 796-807, 2023-11 | - |
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