Comparable efficacy and safety between LY2963016 insulin glargine and insulin glargine (Lantus) in Chinese patients with type 1 diabetes: A phase III, randomized, controlled trial
Diabetes, Obesity and Metabolism Jun 17, 2021
Yan X, Jiang S, Lou Y, et al. - Researchers undertook this phase III, prospective, multicenter, open-label study to compare LY2963016 insulin glargine (LY IGlar) vs reference product (Lantus) insulin glargine (IGlar), in terms of efficacy and safety among Chinese patients suffering from type 1 diabetes mellitus (T1DM). Participants had T1DM, age≥18 years, and hemoglobin A1c (HbA1c) ≤11.0%, and were randomly assigned to LY IGlar (n=137) or IGlar (n=135) in combination with premeal insulin lispro for 24 weeks. Testing the non-inferiority of LY IGlar to IGlar by a margin of 0.4% employing mixed model repeated measure approach, as determined by alteration in HbA1c levels from baseline to the 24 weeks, was the primary efficacy endpoint. They found that -0.12% was the least-squares mean difference between treatments (LY IGlar – IGlar) in change from baseline, meeting the noninferiority criteria. Findings revealed that equivalent efficacy in glycemic control as well as similar safety profiles were shown by LY IGlar and IGlar in Chinese patients with T1DM, when administered in combination with mealtime insulin lispro.
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