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. Issue 9 (16th June 2015)

• Record Type: Journal Article
• Authors: Ritzel, R.; Roussel, R.; Bolli, G. B.; Vinet, L.; Brulle‐Wohlhueter, C.; Glezer, S.; Yki‐Järvinen, H.
• Is Part Of: Diabetes, obesity & metabolism. Volume 17:Issue 9(2015:Sep.)
• Page Start: 859
• Page End: 867
• Publication Date: 2015-06-16
• Subjects: Diabetes -- Periodicals; Obesity -- Periodicals; Metabolism -- Disorders -- Periodicals; Clinical pharmacology -- Periodicals; 616.462
• DOI: 10.1111/dom.12485
• Languages: English
• ISSNs: 1462-8902

Abstract

<abstract abstract-type="main" id="dom12485-abs-0001"> <title> <x xml:space="preserve">Abstract</x> </title> <sec id="dom12485-sec-0001" sec-type="section"> <title>Aims</title> <p id="dom12485-para-0001">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 (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.</p> </sec> <sec id="dom12485-sec-0002" sec-type="section"> <title>Methods</title> <p id="dom12485-para-0002">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 (Gla‐300, n = 1247; Gla‐100, n = 1249).</p> </sec> <sec id="dom12485-sec-0003" sec-type="section"> <title>Results</title> <p id="dom12485-para-0003">No 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 (<1 kg) in both groups, with less gain with Gla‐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.</p> </sec> <sec id="dom12485-sec-0004" sec-type="section"> <title>Conclusion</title> <p id="dom12485-para-0004">Gla‐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.</p> </sec> </abstract>