316 692

Cited 4 times in

A 32-Week Randomized Comparison of Stepwise Insulin Intensification of Biphasic Insulin Aspart (BIAsp 30) Versus Basal-Bolus Therapy in Insulin-Naïve Patients with Type 2 Diabetes

DC Field Value Language
dc.contributor.author이병완-
dc.date.accessioned2019-02-12T16:42:21Z-
dc.date.available2019-02-12T16:42:21Z-
dc.date.issued2018-
dc.identifier.urihttps://ir.ymlib.yonsei.ac.kr/handle/22282913/167096-
dc.description.abstractINTRODUCTION: This 32-week, open-label, randomized, parallel-group, multinational trial aimed to compare the efficacy and safety of stepwise insulin intensification of biphasic insulin aspart 30 (BIAsp 30) relative to stepwise intensification of a basal-bolus regimen in insulin-naïve adults with type 2 diabetes (T2D) who continued pretrial treatment with metformin and sulfonylurea. METHODS: Adults with T2D were randomized into one of two treatment arms for 32 weeks: (1) BIAsp 30 once daily (OD), with the possibility of stepwise treatment intensification up to BIAsp 30 three times daily (TID); (2) insulin glargine OD, with the possibility of stepwise treatment intensification with insulin aspart up to TID. The primary endpoint was change from baseline in HbA1c after 32 weeks. RESULTS: After 32 weeks, the estimated mean change in HbA1c from baseline was statistically significantly lower in the BIAsp 30 arm (- 1.18%) versus basal-bolus (- 1.36%) [estimated treatment difference 0.18%; 95% confidence interval (95% CI) 0.01; 0.36; p < 0.05]. The proportion of patients with HbA1c below 7.0% was statistically significantly lower with BIAsp 30 (42.9%) compared with basal-bolus (56.9%) (odds ratio 0.58; 95% CI 0.37; 0.89; p = 0.01). The overall rate of severe or blood glucose (BG)-confirmed hypoglycemic events was numerically lower for BIAsp 30 compared with basal-bolus, and a statistically significantly lower rate in nocturnal severe or BG-confirmed hypoglycemia in the BIAsp 30 arm relative to basal-bolus was observed: estimated rate ratio 0.32 (95% CI 0.13; 0.79), p = 0.0131. The proportion of patients with adverse events was similar in both treatment arms. CONCLUSION: Insulin intensification with BIAsp 30 and basal-bolus showed an improvement in glycemic control; the change in HbA1c was statistically significantly lower for BIAsp 30 compared to basal-bolus. Basal-bolus treatment was accompanied by a numerically, and statistically significantly, higher rate of overall and nocturnal severe or BG-confirmed hypoglycemia, respectively, compared with BIAsp 30. FUNDING: Novo Nordisk A/S. TRIAL REGISTRATION: ClinicalTrials.gov identifier, NCT02453685.-
dc.description.statementOfResponsibilityopen-
dc.languageEnglish-
dc.publisherSpringer Healthcare-
dc.relation.isPartOfDIABETES THERAPY-
dc.rightsCC BY-NC-ND 2.0 KR-
dc.rightshttps://creativecommons.org/licenses/by-nc-nd/2.0/kr/-
dc.titleA 32-Week Randomized Comparison of Stepwise Insulin Intensification of Biphasic Insulin Aspart (BIAsp 30) Versus Basal-Bolus Therapy in Insulin-Naïve Patients with Type 2 Diabetes-
dc.typeArticle-
dc.contributor.collegeCollege of Medicine (의과대학)-
dc.contributor.departmentDept. of Internal Medicine (내과학교실)-
dc.contributor.googleauthorSultan Linjawi-
dc.contributor.googleauthorByung-Wan Lee-
dc.contributor.googleauthorO¨ mu¨r Tabak-
dc.contributor.googleauthorSusanna Lo¨vdahl-
dc.contributor.googleauthorShanti Werther-
dc.contributor.googleauthorSalahedeen Abusnana-
dc.identifier.doi10.1007/s13300-017-0334-8-
dc.contributor.localIdA02796-
dc.relation.journalcodeJ02908-
dc.identifier.eissn1869-6953-
dc.identifier.pmid29129018-
dc.subject.keywordBIAsp 30-
dc.subject.keywordBasal–bolus-
dc.subject.keywordStepwise insulin intensification-
dc.subject.keywordType 2 diabetes-
dc.contributor.alternativeNameLee, Byung Wan-
dc.contributor.affiliatedAuthor이병완-
dc.citation.volume9-
dc.citation.number1-
dc.citation.startPage1-
dc.citation.endPage11-
dc.identifier.bibliographicCitationDIABETES THERAPY, Vol.9(1) : 1-11, 2018-
dc.identifier.rimsid58078-
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.