@entity1 -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 XXXX with type 2 @entity6 .

@entity1 @entity9984 @entity6 @entity1017 @entity7965
AIMS: To conduct a @entity1 -level meta-analysis of the EDITION 1, 2 and 3 studies, which compared the efficacy and safety of new insulin glargine 300 U/ml ( @entity9984 -300) with insulin glargine 100 U/ml ( @entity9984 -100) in @entity1 with type 2 @entity6 (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 @entity1 -level meta-analysis of the studies enabled these endpoints to be examined over 6 months in a large population with T2DM ( @entity9984 -300, n = 1247; @entity9984 -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 @entity9984 -300 and @entity9984 -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 @entity9984 -300 than with @entity9984 -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 @entity1 with >= 1 hypoglycaemic event. Severe hypoglycaemia at any time (24 h) was rare ( @entity9984 -300: 2.3%; @entity9984 -100: 2.6%). Weight gain was low (<1 kg) in both groups, with @entity1017 with @entity9984 -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: @entity9984 -300 provides comparable glycaemic control to @entity9984 -100 in a large population with a broad clinical spectrum of T2DM, with consistently less hypoglycaemia at any time of day and @entity7965 .
