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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
Author(s) -
Ritzel R.,
Roussel R.,
Bolli G. B.,
Vinet L.,
BrulleWohlhueter C.,
Glezer S.,
YkiJärvinen H.
Publication year - 2015
Publication title -
diabetes, obesity and metabolism
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 2.445
H-Index - 128
eISSN - 1463-1326
pISSN - 1462-8902
DOI - 10.1111/dom.12485
Subject(s) - insulin glargine , medicine , confidence interval , type 2 diabetes , basal insulin , insulin , gastroenterology , diabetes mellitus , basal (medicine) , endocrinology , meta analysis , hypoglycemia
Aims To 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 ( G la‐300) with insulin glargine 100 U/ml ( G la‐100) in people with type 2 diabetes ( T2DM ) on basal and mealtime insulin, basal insulin and oral antihyperglycaemic drugs, or no prior insulin, respectively. Methods The 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 ( G la‐300, n = 1247; G la‐100, n = 1249). Results No significant study‐by‐treatment interactions across studies were found, enabling them to be pooled. The mean change in glycated haemoglobin was comparable for G la‐300 and G la‐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 G la‐300 than with G la‐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 ( G la‐300: 2.3%; G la‐100: 2.6%). Weight gain was low (<1 kg) in both groups, with less gain with G la‐300 [ LS mean difference −0.28 kg (95% CI −0.55 to −0.01); p = 0.039]. Both treatments were well tolerated, with similar rates of adverse events. Conclusion Gla‐300 provides comparable glycaemic control to G la‐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.