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): Injection Site Reactions

During the phase 3 clinical studies for Abasaglar, injection site reactions were infrequent, similar between treatment groups, and mild to moderate in severity.



Injection Site Reactions

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

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

Date of Last Review: September 09, 2019


Contact Lilly

Call or Email us

If you want to ask a Medical Information question or you want to report an adverse event or product complaint you can call us or email us at ukmedinfo@lilly.com

Available Mon - Fri, 8am - 4pm, excluding Bank Holidays

Or you can

Chat with Us If you have a question, you can chat online with a Lilly Medical Information professional.

Submit a question