التفاصيل البيبلوغرافية
| العنوان: |
Patient-level meta-analysis of the EDITION 1, 2 and 3 studies : glycaemic control and hypoglycaemia with new insulin glargine 300 U/ml versus glargine 100 U/ml in people with type 2 diabetes |
| المؤلفون: |
Ritzel, R., Roussel, R., Bolli, G. B., Vinet, L., Brulle-Wohlhueter, C., Glezer, S., Yki-Järvinen, Hannele |
| المساهمون: |
Clinicum, Hannele Yki-Järvinen Research Group, Department of Medicine |
| بيانات النشر: |
Wiley |
| سنة النشر: |
2017 |
| المجموعة: |
Helsingfors Universitet: HELDA – Helsingin yliopiston digitaalinen arkisto |
| مصطلحات موضوعية: |
basal insulin, insulin glargine, insulin therapy, GLUCOSE CONTROL, RISK, UNITS/ML, BASAL, General medicine, internal medicine and other clinical medicine |
| الوصف: |
AimsTo conduct a patient-level meta-analysis of the EDITION 1, 2 and 3 studies, which compared the efficacy and safety of new insulin glargine 300 U/ml (Gla-300) with insulin glargine 100 U/ml (Gla-100) in people with type 2 diabetes (T2DM) on basal and mealtime insulin, basal insulin and oral antihyperglycaemic drugs, or no prior insulin, respectively. MethodsThe EDITION studies were multicentre, randomized, open-label, parallel-group, phase IIIa studies, with similar designs and endpoints. A patient-level meta-analysis of the studies enabled these endpoints to be examined over 6 months in a large population with T2DM (Gla-300, n = 1247; Gla-100, n = 1249). ResultsNo significant study-by-treatment interactions across studies were found, enabling them to be pooled. The mean change in glycated haemoglobin was comparable for Gla-300 and Gla-100 [each -1.02 (standard error 0.03)%; least squares (LS) mean difference 0.00 (95% confidence interval (CI) -0.08 to 0.07)%]. Annualized rates of confirmed (3.9 mmol/l) or severe hypoglycaemia were lower with Gla-300 than with Gla-100 during the night (31% difference in rate ratio over 6 months) and at any time (24 h, 14% difference). Consistent reductions were observed in percentage of participants with 1 hypoglycaemic event. Severe hypoglycaemia at any time (24 h) was rare (Gla-300: 2.3%; Gla-100: 2.6%). Weight gain was low ( ConclusionGla-300 provides comparable glycaemic control to Gla-100 in a large population with a broad clinical spectrum of T2DM, with consistently less hypoglycaemia at any time of day and less nocturnal hypoglycaemia. ; Peer reviewed |
| نوع الوثيقة: |
article in journal/newspaper |
| وصف الملف: |
application/pdf |
| اللغة: |
English |
| العلاقة: |
This study was sponsored by Sanofi. The authors thank the study participants, trial staff, and investigators for their participation. The authors would also like to thank Cassandra Pessina (Sanofi) for critical review of the manuscript, and for assistance with management of the manuscript development. Editorial and writing assistance was provided by Rachel Wright of Fishawack Communications Ltd and was funded by Sanofi.; Ritzel , R , Roussel , R , Bolli , G B , Vinet , L , Brulle-Wohlhueter , C , Glezer , S & Yki-Järvinen , H 2015 , ' Patient-level meta-analysis of the EDITION 1, 2 and 3 studies : glycaemic control and hypoglycaemia with new insulin glargine 300 U/ml versus glargine 100 U/ml in people with type 2 diabetes ' , Diabetes, obesity and metabolism , vol. 17 , no. 9 , pp. 859-867 . https://doi.org/10.1111/dom.12485Test; http://hdl.handle.net/10138/208847Test; f35cc1b6-34ad-46c2-9fca-79888f9583a3; 84939572199; 000360215900006 |
| الإتاحة: |
http://hdl.handle.net/10138/208847Test |
| حقوق: |
cc_by_nc ; info:eu-repo/semantics/openAccess ; openAccess |
| رقم الانضمام: |
edsbas.168F2556 |
| قاعدة البيانات: |
BASE |
