TitleComparable efficacy and safety between LY2963016 insulin glargine and insulin glargine (Lantus®) in Chinese patients with type 1 diabetes: a phase III, randomized, controlled trial
OBJECTIVE Compare the efficacy and safety of LY2963016 insulin glargine (LY IGlar) with the reference product (Lantus®) insulin glargine (IGlar) in Chinese patients with type 1 diabetes mellitus (T1DM).
MATERIALS AND METHODS This phase III, prospective, multicenter, open-label study enrolled patients with T1DM, age≥18 years, with hemoglobin A1c (HbA1c) ≤11.0%, were randomized to LY IGlar (n=137) or IGlar (n=135) in combination with premeal insulin lispro for 24 weeks. The treatment targets were to achieve HbA1c<7% and preprandial capillary blood glucose 79 to 126 mg/dL (4.4 to 7.0 mmol/L), avoiding hypoglycemia. The primary efficacy endpoint was testing the non-inferiority of LY IGlar to IGlar by a margin of 0.4% using mixed model repeated measure approach, as measured by change in HbA1c levels from baseline to the 24 weeks. Continuous laboratory measures were analyzed using analysis of covariance. For categorical measures, Fisher's exact test was used.
RESULTS The least-squares mean difference between treatments (LY IGlar - IGlar) in change from baseline was -0.12% (95% confidence interval [CIs]: -0.32%, 0.08%), meeting the noninferiority criteria. There were no clinically meaningful differences (p>0.05) in other efficacy outcomes, including proportions of patients achieving HbA1c<7.0% and HbA1c ≤6.5%, self-monitored blood glucose (SMBG) and insulin dose at week 24. Weight change, insulin antibodies, and all adverse events including allergic reactions and hypoglycemia, were also similar between two treatment groups (all p>0.05).
CONCLUSION LY IGlar and IGlar had equivalent efficacy in glycemic control and similar safety profiles in Chinese patients with T1DM, when used in combination with mealtime insulin lispro. This article is protected by copyright. All rights reserved.