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): Injektionsreaktioner

Under de kliniska fas 3-studierna med Abasaglar (insulin glargin) var reaktioner på injektionsstället sällsynta och liknande mellan behandlingsgrupper, samt milda till måttliga i svårighetsgrad.

Injection Site Reactions

During the phase 3 clinical studies for Abasaglar compared with Lantus, injection site reactions were

  • infrequent

  • similar between treatment groups, and

  • mild to moderate in severity (Table 1).1,2

Table 1. Injection Site Reactions in Phase 3 Clinical Studies for Abasaglar 1-3

   

Abasaglar
(n=268)

Lantus
(n=267)

Abasaglar
(n=376)

Lantus
(n=380)

Patient population

T1DMa

T2DMb

Injection site reaction, n (%)c

7 (3)

3 (1)

13 (4)

11 (3)

Paind

6 (2)

2 (1)

10 (3)

5 (1)

Pruritus

2 (1)

1 (<1)

4 (1)

4 (1)

Rash

2 (1)

1 (<1)

3 (1)

3 (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 p>.05 for all treatment comparisons; treatment comparisons were not performed if there were <4 patients with events.

b Treatment comparisons were not performed.

c Data from patient questionnaires.

d Including burning sensation.

In the open-label study of patients with T1DM, Abasaglar and Lantus were administered via prefilled pens.1 No patient discontinued treatment due to injection site pain.3

In the double-blind study of patients with T2DM, Abasaglar and Lantus were administered via syringes.2 One patient in each treatment group discontinued treatment due to injection site pain.3

No patient in either study discontinued treatment due to pruritus or rash.3

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

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 09


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