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 |
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dc.contributor.author | 이병완 | - |
dc.date.accessioned | 2019-02-12T16:42:21Z | - |
dc.date.available | 2019-02-12T16:42:21Z | - |
dc.date.issued | 2018 | - |
dc.identifier.uri | https://ir.ymlib.yonsei.ac.kr/handle/22282913/167096 | - |
dc.description.abstract | INTRODUCTION: 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.statementOfResponsibility | open | - |
dc.language | English | - |
dc.publisher | Springer Healthcare | - |
dc.relation.isPartOf | DIABETES THERAPY | - |
dc.rights | CC BY-NC-ND 2.0 KR | - |
dc.rights | https://creativecommons.org/licenses/by-nc-nd/2.0/kr/ | - |
dc.title | 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.type | Article | - |
dc.contributor.college | College of Medicine (의과대학) | - |
dc.contributor.department | Dept. of Internal Medicine (내과학교실) | - |
dc.contributor.googleauthor | Sultan Linjawi | - |
dc.contributor.googleauthor | Byung-Wan Lee | - |
dc.contributor.googleauthor | O¨ mu¨r Tabak | - |
dc.contributor.googleauthor | Susanna Lo¨vdahl | - |
dc.contributor.googleauthor | Shanti Werther | - |
dc.contributor.googleauthor | Salahedeen Abusnana | - |
dc.identifier.doi | 10.1007/s13300-017-0334-8 | - |
dc.contributor.localId | A02796 | - |
dc.relation.journalcode | J02908 | - |
dc.identifier.eissn | 1869-6953 | - |
dc.identifier.pmid | 29129018 | - |
dc.subject.keyword | BIAsp 30 | - |
dc.subject.keyword | Basal–bolus | - |
dc.subject.keyword | Stepwise insulin intensification | - |
dc.subject.keyword | Type 2 diabetes | - |
dc.contributor.alternativeName | Lee, Byung Wan | - |
dc.contributor.affiliatedAuthor | 이병완 | - |
dc.citation.volume | 9 | - |
dc.citation.number | 1 | - |
dc.citation.startPage | 1 | - |
dc.citation.endPage | 11 | - |
dc.identifier.bibliographicCitation | DIABETES THERAPY, Vol.9(1) : 1-11, 2018 | - |
dc.identifier.rimsid | 58078 | - |
dc.type.rims | ART | - |
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