Abasaglar ® (basal insulin glargine)

This information is intended for UK registered healthcare professionals only as a scientific exchange in response to your search for information. Please refer to the link for full prescribing information: Abasaglar Summary of Product Characteristics (SmPC)

Abasaglar® (insulin glargine): Immunogenicity in Phase 3 Studies

In the phase 3 studies, the majority of patients had no detectable antibodies throughout the studies or changes in total insulin antibody level.

Detailed Information

The development of antibody responses to insulin glargine differs in patients with T1DM compared with patients with T2DM. In phase 3 studies, the immunogenicity of Abasaglar was studied separately and compared with that of Lantus.1,2

In the main phase 3 studies, a greater proportion of patients with T1DM in the ELEMENT-1 study showed detectable antibodies to insulin glargine at baseline compared with patients with T2DM in the ELEMENT-2 study.1,2  This autoimmune condition has been previously described.3,4

In the phase 3 studies, ELEMENT-1, ELEMENT-2, and ELEMENT-5, antibody levels (percent binding) were similar between both treatment groups with no significant differences at any visit in the total study population.1,2,5

In the ELEMENT-1, ELEMENT-2, and ELEMENT-5 studies, the incidence of detectable antibodies and the median insulin antibody binding were similar between treatment groups (Table 1. Incidences of Detectable Antibodies and Percent Insulin Antibody Binding in the ELEMENT-1, ELEMENT-2, and ELEMENT-5 Studies   ).1,2,5

Table 1. Incidences of Detectable Antibodies and Percent Insulin Antibody Binding in the ELEMENT-1, ELEMENT-2, and ELEMENT-5 Studies1,2,5

Assessmenta

Abasaglar
(n=268)

Lantus
(n=267)

Abasaglar
(n=376)

Lantus
(n=380)

Abasaglar
(n=234)

Lantus
(n=239)

ELEMENT-1

ELEMENT-2

ELEMENT-5

Incidence of detectable antibodies, n (%)b   

24 weeks

80 (30)

90 (34)

56 (15)

40 (11)

68 (29)

66 (28)

52 weeks

107 (40)

105 (39)

N/A

N/A

N/A

N/A

Percent insulin antibody binding, medianc

24 weeks

1.17

1.10

1.07

0.65

1.76

0.81

52 weeks

0.92

0.89

N/A

N/A

N/A

N/A

Abbreviations: Abasaglar = Abasaglar® (insulin glargine) 100 units/mL; ELEMENT-1 = a prospEctive, randomized, open-LabEl coMparison of a long-acting basal insulin analog LY2963016 to Lantus® in combination with mealtime insulin lispro in adult patiENTs with type 1 diabetes mellitus; ELEMENT-2 = a prospEctive, randomized, doubLE-blind coMparison of a long-acting basal insulin analog LY2963016 to Lantus® in adult patiENTs with type 2 diabetes mellitus; ELEMENT-5 = a study of LY2963016 compared to LANTUS® in adult participants with type 2 diabetes mellitus; Lantus = Lantus® (insulin glargine) 100 units/mL; LOCF = last observation carried forward; N/A = not applicable.

a p>.05 for all within-study treatment comparisons.

b Data represents overall 24- and 52-week study periods and not LOCF.

c Data represents LOCF.

References

1. Blevins TC, Dahl D, Rosenstock J, et al. Efficacy and safety of LY2963016 insulin glargine compared with insulin glargine (Lantus®) in patients with type 1 diabetes in a randomized controlled trial: the ELEMENT 1 study. Diabetes Obes Metab. 2015;17(8):726-733. http://dx.doi.org/10.1111/dom.12496

2. Rosenstock J, Hollander P, Bhargava A, et al. Similar efficacy and safety of LY2963016 insulin glargine and insulin glargine (Lantus®) in patients with type 2 diabetes who were insulin-naïve or previously treated with insulin glargine: a randomized, double-blind controlled trial (the ELEMENT 2 study). Diabetes Obes Metab. 2015;17(8):734-741. http://dx.doi.org/10.1111/dom.12482

3. Eibl N, Spatz M, Fischer GF et al. Impaired primary immune response in type-1 diabetes: results from a controlled vaccination study. Clin Immunol 2002; 103:249–259. http://dx.doi.org/10.1006/clim.2002.5220

4. Centers for Disease Control and Prevention. National diabetes fact sheet. 2011. http://www.cdc.gov/diabetes/pubs/pdf/ndfs_2011.pdf. Accessed May 28, 2018.

5. Data on file, Eli Lilly and Company and/or one of its subsidiaries.

Glossary

Abasaglar = Abasaglar® (insulin glargine) 100 units/mL

ELEMENT-1 = a prospEctive, randomized, open-LabEl coMparison of a long-acting basal insulin analog LY2963016 to Lantus® in combination with mealtime insulin lispro in adult patiENTs with type 1 diabetes mellitus

ELEMENT-2 = a prospEctive, randomized, doubLE-blind coMparison of a long-acting basal insulin analog LY2963016 to Lantus® in adult patiENTs with type 2 diabetes mellitus

ELEMENT-5 = a prospEctive, randomized, open-LabEl coMparison of a long-acting basal insulin analog LY2963016 to Lantus® in adult patiENTs with type 2 diabetes mellitus

Lantus = Lantus® (insulin glargine) 100 units/mL

T1DM = type 1 diabetes mellitus

T2DM = type 2 diabetes mellitus

Date of Last Review: May 28, 2018

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