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Abasaglar ® (insulin glargin)
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None of the neoplasm events in the phase 3 ELEMENT-1, ELEMENT-2 and ELEMENT-5 clinical studies for Abasaglar were considered by the investigator to be possibly related to the study drug.1
In the phase 3 studies that compared Abasaglar with Lantus, there were no statistically significant differences in the incidence of neoplasms between treatment groups (Table 1. Neoplasms Reported in the ELEMENT-1 Clinical Study for Abasaglar ,Table 2. Neoplasms Reported in the ELEMENT-2 Clinical Study for Abasaglar and Table 3. Neoplasms Reported in the ELEMENT-5 Clinical Study for Abasaglar ).1
Table 1. Neoplasms Reported in the ELEMENT-1 Clinical Study for Abasaglar 1
|
Neoplasms, n (%) |
Abasaglar |
Lantus |
p-Value |
|
Neoplasms benign, malignant, and unspecified (including cysts and polyps) |
1 (0.4) |
5 (1.9) |
p=.123 |
|
Skin papilloma |
1 (0.4) |
1 (0.4) |
|
|
Gliomatosis cerebri |
0 (0.0) |
1 (0.4) |
|
|
Refractory cytopenia with unilineage dysplasia |
0 (0.0) |
1 (0.4) |
|
|
Squamous cell carcinoma |
0 (0.0) |
1 (0.4) |
|
|
Uterine leiomyoma |
0 (0.0) |
1 (0.4) |
|
Abbreviations: Abasaglar = Abasaglar® (insulin glargine) 100 units/mL; Lantus = Lantus® (insulin glargine) 100 units/mL.
Table 2. Neoplasms Reported in the ELEMENT-2 Clinical Study for Abasaglar1
|
Neoplasms, n (%) |
Abasaglar |
Lantus |
p-Value |
|
Neoplasms benign, malignant, and unspecified (including cysts and polyps) |
5 (1.3) |
3 (0.8) |
p=.503 |
|
Squamous cell carcinoma |
1 (0.3) |
1 (0.3) |
|
|
Adrenal adenoma |
1 (0.3) |
0 (0.0) |
|
|
Bladder cancer |
0 (0.0) |
1 (0.3) |
|
|
Fibroadenoma of breast |
1 (0.3) |
0 (0.0) |
|
|
Lung adenocarcinoma |
1 (0.3) |
0 (0.0) |
|
|
Lung carcinoma cell type unspecified recurrent |
1 (0.3) |
0 (0.0) |
|
|
Thyroid neoplasm |
0 (0.0) |
1 (0.3) |
|
Abbreviations: Abasaglar = Abasaglar® (insulin glargine) 100 units/mL; Lantus = Lantus® (insulin glargine) 100 units/mL.
Table 3. Neoplasms Reported in the ELEMENT-5 Clinical Study for Abasaglar1
|
Neoplasms, n (%) |
Abasaglar |
Lantus |
p-Value |
|
Neoplasms benign, malignant, and unspecified (including cysts and polyps) |
2 (<1) |
3 (1.2) |
.683 |
|
Benign neoplasm of thyroid gland |
0 (0) |
2 (<1) |
.244 |
|
Adenocarcinoma of colon |
1 (<1) |
0 (0) |
1 |
|
Adrenal adenoma |
1 (<1) |
0 (0) |
1 |
|
Chronic myeloid leukaemia |
0 (0) |
1 (<1) |
0.495 |
|
Skin papilloma |
1 (<1) |
0 (0) |
1 |
Abbreviations: Abasaglar = Abasaglar® (insulin glargine) 100 units/mL; Lantus = Lantus® (insulin glargine) 100 units/mL.
1. 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
Datum fӧr senaste ӧversyn 2018 M08 08