Similar efficacy and safety of <scp>LY2963016</scp> insulin glargine and insulin glargine ( <scp>L</scp> antus®) in patients with type 2 diabetes who were insulin‐naïve or previously treated with insulin glargine: a randomized, double‐blind controlled trial (the <scp>ELEMENT</scp> 2 study)

<jats:sec> <jats:title>Aims</jats:title> <jats:p> To compare the efficacy and safety of <jats:styled-content style="fixed-case">LY2963016</jats:styled-content> insulin glargine ( <jats:styled-content style="fixed-case">LY IGlar</jats:styled-content> ) and the reference product ( <jats:styled-content style="fixed-case">L</jats:styled-content> antus®) insulin glargine ( <jats:styled-content style="fixed-case">IGlar</jats:styled-content> ) in combination with oral antihyperglycaemic medications in patients with type 2 diabetes ( <jats:styled-content style="fixed-case">T2D</jats:styled-content> ). </jats:p> </jats:sec> <jats:sec> <jats:title>Methods</jats:title> <jats:p> This phase <jats:styled-content style="fixed-case">III</jats:styled-content> , randomized, double‐blind, 24‐week study enrolled patients with <jats:styled-content style="fixed-case">T2D</jats:styled-content> who were insulin‐naïve [glycated haemoglobin ( <jats:styled-content style="fixed-case">HbA1c</jats:styled-content> ) ≥7 and ≤11.0%] or previously on <jats:styled-content style="fixed-case">IGlar</jats:styled-content> ( <jats:styled-content style="fixed-case">HbA1c</jats:styled-content> ≤11%) and treated with ≥2 oral antihyperglycaemic medications. Patients were randomized to receive once‐daily <jats:styled-content style="fixed-case">LY IGlar</jats:styled-content> (n = 376) or <jats:styled-content style="fixed-case">IGlar</jats:styled-content> (n = 380) for 24 weeks. The primary efficacy outcome was to test the non‐inferiority (0.4% and then 0.3% margin) of <jats:styled-content style="fixed-case">LY IGlar</jats:styled-content> to <jats:styled-content style="fixed-case">IGlar</jats:styled-content> , as measured by change in <jats:styled-content style="fixed-case">HbA1c</jats:styled-content> from baseline to 24 weeks. </jats:p> </jats:sec> <jats:sec> <jats:title>Results</jats:title> <jats:p> Both treatment groups had similar and significant (p < 0.001) within‐group decreases in mean <jats:styled-content style="fixed-case">HbA1c</jats:styled-content> values from baseline. <jats:styled-content style="fixed-case">LY IGlar</jats:styled-content> met non‐inferiority criteria compared with <jats:styled-content style="fixed-case">IGlar</jats:styled-content> for change in <jats:styled-content style="fixed-case">HbA1c</jats:styled-content> from baseline [−1.29 vs −1.34%; respectively, least‐squares mean difference 0.052% (95% confidence interval −0.070 to 0.175); p > 0.05]. There were no treatment differences (p > 0.05) in fasting plasma glucose, proportion of patients reaching <jats:styled-content style="fixed-case">HbA1c</jats:styled-content> <7% or insulin dose at 24 weeks. Adverse events, allergic reactions, weight change, hypoglycaemia and insulin antibodies were similar between treatment groups. Similar findings were observed in patients who were insulin‐naïve or previously treated with <jats:styled-content style="fixed-case">IGlar</jats:styled-content> at baseline. </jats:p> </jats:sec> <jats:sec> <jats:title>Conclusions</jats:title> <jats:p> Both <jats:styled-content style="fixed-case">LY IGlar</jats:styled-content> and <jats:styled-content style="fixed-case">IGlar</jats:styled-content> , when used in combination with oral antihyperglycaemic medications, provided effective and similar glucose control with similar safety profiles in patients with <jats:styled-content style="fixed-case">T2D</jats:styled-content> . </jats:p> </jats:sec>