Efficacy and safety of LY2963016 insulin glargine compared with insulin glargine (Lantus®) in patients with type 1 diabetes in a randomized controlled trial: the ELEMENT 1 study. Issue 8 (23rd June 2015)

• Record Type: Journal Article
• Authors: Blevins, T. C.; Dahl, D.; Rosenstock, J.; Ilag, L. L.; Huster, W. J.; Zielonka, J. S.; Pollom, R. K.; Prince, M. J.
• Is Part Of: Diabetes, obesity & metabolism. Volume 17:Issue 8(2015:Aug.)
• Page Start: 726
• Page End: 733
• Publication Date: 2015-06-23
• Subjects: Diabetes -- Periodicals; Obesity -- Periodicals; Metabolism -- Disorders -- Periodicals; Clinical pharmacology -- Periodicals; 616.462
• DOI: 10.1111/dom.12496
• Languages: English
• ISSNs: 1462-8902

Abstract

<abstract abstract-type="main" id="dom12496-abs-0001"> <title> <x xml:space="preserve">Abstract</x> </title> <sec id="dom12496-sec-0001" sec-type="section"> <title>Aims</title> <p id="dom12496-para-0001">To compare the efficacy and safety of LY2963016 insulin glargine (LY IGlar) and the reference product (Lantus®) insulin glargine (IGlar) in patients with type 1 diabetes (T1D).</p> </sec> <sec id="dom12496-sec-0002" sec-type="section"> <title>Methods</title> <p id="dom12496-para-0002">This phase III, randomized, open‐label, 52‐week study enrolled patients with T1D [glycated haemoglobin (HbA1c) ≤11%] being treated with basal (once‐daily) and bolus insulin. Patients were randomized to receive once‐daily LY IGlar (n = 268) or IGlar (n = 267) in combination with mealtime insulin lispro for 52 weeks. The primary efficacy outcome was to test the non‐inferiority (0.4% and then 0.3% margin) of LY IGlar to IGlar as measured by change in HbA1c from baseline to 24 weeks.</p> </sec> <sec id="dom12496-sec-0003" sec-type="section"> <title>Results</title> <p id="dom12496-para-0003">Both treatment groups had similar and significant (p < 0.001) within‐group decreases in mean HbA1c values from baseline. LY IGlar met the non‐inferiority criteria compared with IGlar for change in HbA1c from baseline to 24 weeks [−0.35 vs −0.46%, least‐squares mean difference 0.108% (95% confidence interval −0.002 to 0.219), p > 0.05]. There were no significant (p > 0.05) treatment differences in other efficacy measures, including proportion of patients reaching HbA1c <7%, daily mean blood glucose, and insulin dose at 24 and 52 weeks. At 52 weeks, similar findings were observed between LY IGlar and IGlar for safety outcomes, including adverse events, allergic reactions, hypoglycaemia, weight change and insulin antibodies.</p> </sec> <sec id="dom12496-sec-0004" sec-type="section"> <title>Conclusions</title> <p id="dom12496-para-0004">Both LY IGlar and IGlar, when used in combination with mealtime insulin lispro, provided effective and similar glucose control and similar safety profiles.</p> </sec> </abstract>