Lilly Insulin Glargine Versus Lantus® in Insulin-Naïve and Insulin-Treated Adults with Type 2 Diabetes: A Randomized, Controlled Trial (ELEMENT 5)

• Published in: Diabetes therapy 2019-02, Vol.10 (1), p.189-203
• Main Authors: Pollom, Robyn K., Ilag, Liza L., Lacaya, Lyndon B., Morwick, Tina M., Ortiz Carrasquillo, Ramón
• Format: Article
• Language: English
• Subjects: Cardiology; Clinical trials; Diabetes; Drug therapy; Effectiveness; Endocrinology; Evidence-based medicine; Glucose; Hypoglycemia; Insulin; Internal Medicine; Medicine; Medicine & Public Health; Original Research
• ISSN: 1869-6953; 1869-6961
• DOI: 10.1007/s13300-018-0549-3

Introduction This study compared the efficacy and safety of similar U-100 insulin glargine products, namely, Lilly insulin glargine (LY IGlar; Basaglar ® ) and the reference insulin glargine product (IGlar; Lantus ® ), used once daily in combination with oral antihyperglycemic medications (OAMs) in adults with type 2 diabetes (T2D). Methods ELEMENT 5 was a phase III, randomized, multinational, open-label, treat-to-target, 24-week trial. Participants were insulin naïve (glycated hemoglobin [HbA1c] ≥ 7.0% to ≤ 11.0%) or on basal insulin (IGlar, neutral protamine Hagedorn or insulin detemir; HbA1c ≤ 11.0%) and taking ≥ 2 OAMs. The primary objective was to show  that LY IGlar is noninferior to IGlar in terms of HbA1c reduction (0.4% noninferiority margin). Results The study population ( N  = 493) was predominantly Asian (48%) or White (46%), with similar baseline characteristics between arms ( P  > 0.05). At 24 weeks, LY IGlar was noninferior to IGlar in terms of change in HbA1c level from baseline (− 1.25 vs. − 1.22%, respectively; least squares mean difference − 0.04%; 95% confidence interval − 0.22%, 0.15%). Other 24-week efficacy and safety results were also similar between treatments ( P  > 0.05), including insulin dose; percentage of patients having HbA1c of