Similar Intrapatient Blood Glucose Variability with LY2963016 and Lantus® Insulin Glargine in Patients with Type 1 (T1D) or Type 2 Diabetes, Including a Japanese T1D Subpopulation

Hiroshi Nishiyama, Tomotaka Shingaki, Yumi Suzuki, Liza L Ilag, Hiroshi Nishiyama, Tomotaka Shingaki, Yumi Suzuki, Liza L Ilag

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).

Keywords: Blood glucose variability; Insulin glargine; Japanese subgroup; LY2963016; Type 1 diabetes; Type 2 diabetes.

Figures

Fig. 1
Fig. 1
Intrapatient between-day FBG variability. a All patients with T1D. b Japanese patients with T1D. c Patients with T2D. Intrapatient between-day FBG variability calculated using standard deviation of FBG from SMBG (standard deviation of 3 values per visit) (bar graph; left axis). To display dispersion, mean FBG is also shown (line graph; right axis). Treatment comparisons at each visit were analyzed using ANCOVA: *p < 0.05 LY IGlar vs IGlar. For a and b, data from weeks 2, 18, 30, 44, and week 24 (LOCF) are not shown. No statistical significance was observed at these visits or endpoints. ANCOVA analysis of covariance, BL baseline, FBG fasting blood glucose, IGlar Lantus insulin glargine, LOCF last observation carried forward, LS least-squares, LY IGlar LY2963016 insulin glargine, N number of patients with data, SMBG self-monitored blood glucose, T1D type 1 diabetes, T2D type 2 diabetes
Fig. 2
Fig. 2
Intrapatient between-day daily mean BG variability. a All patients with T1D. b Japanese patients with T1D. c Patients with T2D. Intrapatient between-day daily mean BG variability calculated using standard deviation of daily mean BG from 7-point SMBG profiles (standard deviation of 3 values per visit) (bar graph; left axis). To display dispersion, daily mean BG is also shown (line graph; right axis). Treatment comparisons at each visit were analyzed using ANCOVA; not significant at all visits. For a and b, data from weeks 2, 18, 30, 44, and week 24 (LOCF) are not shown. No statistical significance was observed at these visits or endpoints. ANCOVA analysis of covariance, BG blood glucose, BL baseline, IGlar Lantus insulin glargine, LOCF last observation carried forward, LS least-squares, LY IGlar LY2963016 insulin glargine, N number of patients with data, SMBG self-monitored blood glucose, T1D type 1 diabetes, T2D type 2 diabetes
Fig. 3
Fig. 3
Intrapatient within-day BG variability. a All patients with T1D. b Japanese patients with T1D. c Patients with T2D. Intrapatient within-day daily mean BG variability calculated using mean of daily BG standard deviations from 7-point SMBG profiles (mean of 3 values per visit) (bar graph; left axis). To display dispersion, daily mean BG is also shown (line graph; right axis). Treatment comparisons at each visit were analyzed using ANCOVA; not significant at all visits. For a and b, data from weeks 2, 18, 30, 44, and week 24 (LOCF) are not shown. No statistical significance was observed at these visits or endpoints. ANCOVA analysis of covariance, BG blood glucose, BL baseline, LOCF last observation carried forward, LS least-squares, N number of patients with data, SMBG self-monitored blood glucose, T1D type 1 diabetes, T2D type 2 diabetes

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