Abasaglar ® (insulin glargin)

För fullständig produktresumé för Abasaglar® se FASS.

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Abasaglar® (insulin glargin): Allergi mot insulin glargin

Patienter med kända allergier mot insulin glargin uteslöts från kliniska studier med Abasaglar (insulin glargin).

Detailed Information

The phase 3 clinical study for Abasaglar in patients with T1DM excluded patients with a known hypersensitivity or allergy to insulin glargine or insulin lispro or their excipients.1

The phase 3 clinical study for Abasaglar in patients with T2DM excluded patients with a known hypersensitivity or allergy to Lantus or any of its excipients.1

During the phase 3 studies, the incidence of allergic reactions was low and similar between treatment groups (Table 1).2,3

In patients with T1DM, the allergic events were reported as mild in severity.2

In patients with T2DM, the allergic events were reported as mild or moderate in severity.3

 No patient in the phase 3 studies discontinued treatment due to an allergic event.2,3

Table 1. Allergic Events in Phase 3 Clinical Studies for Abasaglar2,3


Abasaglar
(n=268)

Lantus
(n=267)

Abasaglar
(n=376)

Lantus
(n=380)

Patient population

T1DM

T2DM

Special topic assessment of allergic reactions, n (%)a

20 (8)

11 (4)

21 (6)

27 (7)

Pruritus, rash, dermatitis, otherb

7 (3)

4 (2)

8 (2)

12 (3)

Arthralgia, arthritis, periarthritis

4 (2)

5 (2)

7 (2)

9 (2)

Injection sitec

6 (2)

2 (1)

5 (1)

4 (1)

Drug hypersensitivity and hypersensitivity

1 (<1)

1 (<1)

---

---

Allergic respiratory symptom, asthma, nasal edema

2 (1)

0 (0)

3 (1)

5 (1)

Abbreviations: Abasaglar = Abasaglar = ® (insulin glargine) 100 units/mL; Lantus = Lantus® (insulin glargine) 100 units/mL; T1DM = type 1 diabetes mellitus; T2DM = type 2 diabetes mellitus.

a Patients may be counted in more than 1 category; p>.05 for all within-study treatment comparisons.

b Angioedema, macular rash, papular rash, photosensitivity reaction, pruritic rash, urticaria, vesicular rash.

c Induration, nodule, pruritus, reaction, swelling.

References

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

2. 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

3. 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

Glossary

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

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

T1DM = type 1 diabetes mellitus

T2DM = type 2 diabetes mellitus

Datum fӧr senaste ӧversyn 2019 M09 12


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