Abasaglar ® (insulin glargin)

För fullständig produktresumé för Abasaglar® se FASS.

Denna information är endast avsedd för sjukvårdspersonal verksam i Sverige och som svar på din fråga. Informationen nedan är på engelska

Abasaglar® (insulin glargin): Cancerincidens

Ingen av cancerincidenserna i kliniska fas 3-studier ansågs relaterade till studiemedicinen.

Detailed Information

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
(n=268)

Lantus
(n=267)

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
(n=376)

Lantus
(n=380)

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
(n=249) 

Lantus
(n=244) 

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.

References

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


Kontakta Medicinsk Information på Lilly

Kontakta oss på telefon

Kontorstid vardagar 9.00-17.00

Eller så kan du

Skriv din fråga till oss