Abstract
INTRODUCTION: LY2963016 insulin glargine (LY IGlar) and Lantus(®) (IGlar), both with identical primary amino acid sequences, were compared in two phase 3 studies for intrapatient blood glucose variability. METHODS: ELEMENT-1 was a 52-week study in patients with type 1 diabetes (T1D), which included Japanese patients, and ELEMENT-2 was a 24-week study in non-Japanese patients with type 2 diabetes (T2D). In ELEMENT-1, 535 patients with T1D were evaluable (268 LY IGlar and 267 IGlar). Of these, 100 were Japanese patients (49 LY IGlar and 51 IGlar). In ELEMENT-2, 756 patients with T2D were evaluable (376 LY IGlar and 380 IGlar). We evaluated and compared intrapatient blood glucose variability of LY IGlar and IGlar in these studies from three different perspectives: intrapatient between-day fasting blood glucose variability, intrapatient between-day daily mean blood glucose variability, and intrapatient within-day blood glucose variability. RESULTS: Overall, evaluations of all three indices showed that intrapatient blood glucose variability was similar between LY IGlar and IGlar throughout the study periods both in the overall populations of patients with T1D and T2D and also in the subgroup of Japanese patients with T1D. CONCLUSION: Intrapatient blood glucose variability between LY IGlar and IGlar was shown to be similar in patients with T1D or T2D. CLINICAL TRIAL REGISTRATION: NCT01421147 (ELEMENT-1) and NCT01421459 (ELEMENT-2). FUNDING: Eli Lilly and Company (Indianapolis, IN, USA); Boehringer-Ingelheim (Ridgefield, CT, USA); Eli Lilly Japan K.K. (Kobe, Japan) and Nippon Boehringer Ingelheim Co., Ltd. (Tokyo, Japan).