One‐year sustained glycaemic control and less hypoglycaemia with new insulin glargine 300 <scp>U/ml</scp> compared with 100 <scp>U/ml</scp> in people with type 2 diabetes using basal plus meal‐time insulin: the <scp>EDITION 1</scp> 12‐month randomized trial, including 6‐month extension

<jats:sec> <jats:title>Aims</jats:title> <jats:p> To evaluate the maintenance of efficacy and safety of insulin glargine 300 U/ml ( <jats:styled-content style="fixed-case">Gla‐300</jats:styled-content> ) versus glargine 100 U/ml ( <jats:styled-content style="fixed-case">Gla‐100</jats:styled-content> ) in people with type 2 diabetes mellitus ( <jats:styled-content style="fixed-case">T2DM</jats:styled-content> ) using basal plus meal‐time insulin for 12 months in the <jats:styled-content style="fixed-case">EDITION</jats:styled-content> 1 trial. </jats:p> </jats:sec> <jats:sec> <jats:title>Methods</jats:title> <jats:p> <jats:styled-content style="fixed-case">EDITION</jats:styled-content> 1 was a multicentre, randomized, open‐label, two‐arm, phase <jats:styled-content style="fixed-case">IIIa</jats:styled-content> study. Participants completing the initial 6‐month treatment period continued to receive <jats:styled-content style="fixed-case">Gla‐300</jats:styled-content> or <jats:styled-content style="fixed-case">Gla‐100</jats:styled-content> , as previously randomized, once daily for a further 6‐month open‐label extension phase. Changes in glycated haemoglobin ( <jats:styled-content style="fixed-case">HbA1c</jats:styled-content> ) and fasting plasma glucose concentrations, insulin dose, hypoglycaemic events and body weight were assessed. </jats:p> </jats:sec> <jats:sec> <jats:title>Results</jats:title> <jats:p> Of 807 participants enrolled in the initial phase, 89% (359/404) assigned to <jats:styled-content style="fixed-case">Gla‐300</jats:styled-content> and 88% (355/403) assigned to <jats:styled-content style="fixed-case">Gla‐100</jats:styled-content> completed 12 months. Glycaemic control was sustained in both groups (mean <jats:styled-content style="fixed-case">HbA1c</jats:styled-content> : <jats:styled-content style="fixed-case">Gla‐300</jats:styled-content> , 7.24%; <jats:styled-content style="fixed-case">Gla‐100</jats:styled-content> , 7.42%), with more sustained <jats:styled-content style="fixed-case">HbA1c</jats:styled-content> reduction for <jats:styled-content style="fixed-case">Gla‐300</jats:styled-content> at 12 months: least squares mean difference <jats:styled-content style="fixed-case">Gla‐300</jats:styled-content> vs <jats:styled-content style="fixed-case">Gla‐100</jats:styled-content> : <jats:styled-content style="fixed-case">HbA1c</jats:styled-content> −0.17 [95% confidence interval ( <jats:styled-content style="fixed-case">CI</jats:styled-content> ) −0.30 to −0.05]%. The mean daily basal insulin dose at 12 months was 1.03 U/kg for <jats:styled-content style="fixed-case">Gla‐300</jats:styled-content> and 0.90 U/kg for <jats:styled-content style="fixed-case">Gla‐100</jats:styled-content> . Lower percentages of participants had ≥1 confirmed [≤3.9 mmol/l (≤70 mg/dl)] or severe hypoglycaemic event with <jats:styled-content style="fixed-case">Gla‐300</jats:styled-content> than <jats:styled-content style="fixed-case">Gla‐100</jats:styled-content> at any time of day [24 h; 86 vs 92%; relative risk 0.94 (95% <jats:styled-content style="fixed-case">CI</jats:styled-content> 0.89–0.99)] and during the night [54 vs 65%; relative risk 0.84 (95% <jats:styled-content style="fixed-case">CI</jats:styled-content> 0.75–0.94)], while the annualized rates of such hypoglycaemic events were similar. No between‐treatment differences in adverse events were apparent. </jats:p> </jats:sec> <jats:sec> <jats:title>Conclusion</jats:title> ...