Cited 7 times in
Efficacy and safety of fixed-dose combination therapy with gemigliptin (50 mg) and rosuvastatin compared with monotherapy in patients with type 2 diabetes and dyslipidaemia (BALANCE): A multicentre, randomized, double-blind, controlled, phase 3 trial
DC Field | Value | Language |
---|---|---|
dc.contributor.author | 차봉수 | - |
dc.date.accessioned | 2019-12-18T00:51:56Z | - |
dc.date.available | 2019-12-18T00:51:56Z | - |
dc.date.issued | 2019 | - |
dc.identifier.issn | 1462-8902 | - |
dc.identifier.uri | https://ir.ymlib.yonsei.ac.kr/handle/22282913/173248 | - |
dc.description.abstract | AIM: To evaluate the efficacy and safety of a fixed-dose combination (FDC) of gemigliptin and rosuvastatin in patients with type 2 diabetes and dyslipidaemia. RESEARCH DESIGN AND METHODS: A total of 33 hospitals in Korea participated in this randomized, double-blind trial of diabetic patients with dyslipidaemia. A total of 290 participants were randomly assigned at a 1:1:1 ratio to receive an FDC of gemigliptin (50 mg) and rosuvastatin (20 mg) (GEMI/ROSU FDC group), gemigliptin (50 mg) (GEMI group) or rosuvastatin (20 mg) (ROSU group). Rosuvastatin was up-titrated from 5 to 20 mg/d throughout the study period. Primary efficacy measures were changes in HbA1c and LDL-C from baseline to Week 24 between the GEMI/ROSU FDC and ROSU groups and between the GEMI/ROSU FDC and GEMI groups, respectively. Secondary efficacy measures were changes in HbA1c and LDL-C between the GEMI/ROSU FDC and GEMI groups and between the GEMI/ROSU FDC and ROSU groups, respectively. RESULTS: After 24 weeks of treatment, a significant reduction in HbA1c from baseline was noted in the GEMI/ROSU FDC group (-0.81% of LS mean; P < 0.0001 vs ROSU group), in addition to a significant reduction in LDL-C concentration (-51.9% of LS mean percentage changes, P < 0.0001 vs GEMI group). HbA1c was significantly reduced from baseline in both the GEMI/ROSU FDC and GEMI groups, but the reduction in HbA1c was significantly greater in the GEMI group than in the GEMI/ROSU FDC group, despite receiving the same dose of gemigliptin. The decrease in LDL-C over time was similar between the GEMI/ROSU FDC and ROSU groups. There were no significant differences in adverse events among the groups. CONCLUSION: The FDC of gemigliptin and rosuvastatin is safe and is effective in reducing both blood glucose and LDL-C levels; thus, it could be a good therapeutic choice for type 2 diabetic patients with dyslipidaemia. | - |
dc.description.statementOfResponsibility | restriction | - |
dc.language | English | - |
dc.publisher | Wiley-Blackwell | - |
dc.relation.isPartOf | DIABETES OBESITY & METABOLISM | - |
dc.rights | CC BY-NC-ND 2.0 KR | - |
dc.subject.MESH | Aged | - |
dc.subject.MESH | Diabetes Mellitus, Type 2/complications | - |
dc.subject.MESH | Diabetes Mellitus, Type 2/drug therapy* | - |
dc.subject.MESH | Dipeptidyl-Peptidase IV Inhibitors*/adverse effects | - |
dc.subject.MESH | Dipeptidyl-Peptidase IV Inhibitors*/therapeutic use | - |
dc.subject.MESH | Double-Blind Method | - |
dc.subject.MESH | Dyslipidemias/complications | - |
dc.subject.MESH | Dyslipidemias/drug therapy* | - |
dc.subject.MESH | Female | - |
dc.subject.MESH | Glycated Hemoglobin A/analysis | - |
dc.subject.MESH | Humans | - |
dc.subject.MESH | Hydroxymethylglutaryl-CoA Reductase Inhibitors*/adverse effects | - |
dc.subject.MESH | Hydroxymethylglutaryl-CoA Reductase Inhibitors*/therapeutic use | - |
dc.subject.MESH | Male | - |
dc.subject.MESH | Middle Aged | - |
dc.subject.MESH | Piperidones*/adverse effects | - |
dc.subject.MESH | Piperidones*/therapeutic use | - |
dc.subject.MESH | Pyrimidines*/adverse effects | - |
dc.subject.MESH | Pyrimidines*/therapeutic use | - |
dc.subject.MESH | Rosuvastatin Calcium*/adverse effects | - |
dc.subject.MESH | Rosuvastatin Calcium*/therapeutic use | - |
dc.title | Efficacy and safety of fixed-dose combination therapy with gemigliptin (50 mg) and rosuvastatin compared with monotherapy in patients with type 2 diabetes and dyslipidaemia (BALANCE): A multicentre, randomized, double-blind, controlled, phase 3 trial | - |
dc.type | Article | - |
dc.contributor.college | College of Medicine (의과대학) | - |
dc.contributor.department | Dept. of Internal Medicine (내과학교실) | - |
dc.contributor.googleauthor | Ji Cheol Bae | - |
dc.contributor.googleauthor | Kyung Wan Min | - |
dc.contributor.googleauthor | Yong Hyun Kim | - |
dc.contributor.googleauthor | Kyoung‐Ah Kim | - |
dc.contributor.googleauthor | Eun‐Gyoung Hong | - |
dc.contributor.googleauthor | Cheol‐Young Park | - |
dc.contributor.googleauthor | Song Han | - |
dc.contributor.googleauthor | Bong‐Soo Cha | - |
dc.identifier.doi | 10.1111/dom.13491 | - |
dc.contributor.localId | A03996 | - |
dc.relation.journalcode | J00722 | - |
dc.identifier.eissn | 1463-1326 | - |
dc.identifier.pmid | 30084112 | - |
dc.identifier.url | https://onlinelibrary.wiley.com/doi/full/10.1111/dom.13491 | - |
dc.subject.keyword | DPP IV inhibitor | - |
dc.subject.keyword | dyslipidaemia | - |
dc.subject.keyword | statin | - |
dc.subject.keyword | type 2 diabetes | - |
dc.contributor.alternativeName | Cha, Bong Soo | - |
dc.contributor.affiliatedAuthor | 차봉수 | - |
dc.citation.volume | 21 | - |
dc.citation.number | 1 | - |
dc.citation.startPage | 103 | - |
dc.citation.endPage | 111 | - |
dc.identifier.bibliographicCitation | DIABETES OBESITY & METABOLISM, Vol.21(1) : 103-111, 2019 | - |
dc.identifier.rimsid | 64378 | - |
dc.type.rims | ART | - |
Items in DSpace are protected by copyright, with all rights reserved, unless otherwise indicated.