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)

What were the Adverse Events in Abasaglar® (insulin glargine) Clinical Studies?

During the phase 3 clinical studies for Abasaglar, the incidence of adverse events, including allergic and injection site reactions, was similar between treatment groups.

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UK_cFAQ_BIV020_AEs_CLINICAL_STUDIES
en-GB

What were the Adverse Events in Abasaglar® (insulin glargine) Clinical Studies?

During the phase 3 clinical studies for Abasaglar, the incidence of adverse events, including allergic and injection site reactions, was similar between treatment groups.

What were the most frequent Adverse Events? 

In patients with type 1 diabetes mellitus (T1DM), Most adverse events (AE) were mild in severity. The most frequently reported AEs included

  • nasopharyngitis (16.4%)
  • upper respiratory tract infections (8.0%)
  • hypoglycemia (4.7%), and
  • diarrhea (4.1%).1

In patients with type 2 diabetes mellitus (T2DM), the most frequently reported AEs included

  • nasopharyngitis (5.7%)
  • upper respiratory tract infections (4.5%), and
  • diarrhea (3.0%).2

Comparative data related to AEs were similar between patients with T1DM or T2DM (Adverse Events in Phase 3 Clinical Studies for Abasaglar).1,2

Adverse Events in Phase 3 Clinical Studies for Abasaglar1,2

Assessment

Type 1 Diabetes

Type 2 Diabetes

Abasaglar
(n=268)

Lantus
(n=267)

Abasaglar
(n=376)

Lantus
(n=380)

AEa

167 (62)

166 (62)

196 (52)

184 (48)

AE possibly related to study drug

17 (6)

14 (5)

26 (7)

23 (6)

AE possibly related to study procedure

2 (1)

2 (1)

6 (2)

8 (2)

AE possibly related to study disease state of diabetes

21 (8)

16 (6)

19 (5)

18 (5)

Discontinuations due to an AE

2 (1)

6 (2)

6 (2)

11 (3)

SAEb

20 (8)

24 (9)

15 (4)

18 (5)

Deaths

0 (0)

1 (<1)

1 (<1)

1 (<1)

Abbreviations: Abasaglar = Abasaglar® (insulin glargine) 100 units/mL; AE = adverse event; Lantus = Lantus® (insulin glargine) 100 units/mL; SAE = serious adverse event.

aData presented as n (%) of patients; patients may be represented in multiple categories.

bA hypoglycemic event that required treatment or resuscitative action from another person.

What were the incidence and rate of Hypoglycemia?

The incidence and rate of hypoglycemia, including total, nocturnal, and severe hypoglycemia, were similar between treatment groups during phase 3 clinical studies for Abasaglar (Incidence and Rate of Hypoglycemia at 24 and 52 Weeks in the ELEMENT 1 Study, Incidence and Rate of Hypoglycemia at 24 Weeks in the ELEMENT 2 Study).1,2

Incidence and Rate of Hypoglycemia at 24 and 52 Weeks in the ELEMENT 1 Study1

Assessment

24 Weeks

52 Weeks

Abasaglar
(n=268)

Lantus
(n=267)

Abasaglar
(n=268)

Lantus
(n=267)

Incidence of hypoglycemia, %

Total

94

95

96

97

Nocturnal

82

80

86

88

Severe

2

3

4

4

Rate of hypoglycemia, mean (SD)a

Total

86.5 (77.3)

89.2 (80.1)

77.0 (68.7)

79.8 (74.5)

Nocturnal

18.3 (23.6)

18.4 (21.5)

16.1 (20.2)

17.3 (19.5)

Severe

0.06 (0.52)

0.09 (0.50)

0.07 (0.46)

0.08 (0.46)

Abbreviations: Abasaglar = Abasaglar® (insulin glargine) 100 units/mL; Lantus = Lantus® (insulin glargine) 100 units/mL.

aEvents/patient/y. Represents all events reported during the 24-week treatment and 52-week (treatment and extension) periods.

Incidence and Rate of Hypoglycemia at 24 Weeks in the ELEMENT 2 Study2

Assessment

Abasaglar
(n=376)

Lantus
(n=380)

Incidence of hypoglycemia, %

Total

79

78

Nocturnal

57

54

Severe

<1

<1

Rate of hypoglycemia, mean (SD)a

Total

21.3 (24.4)

22.3 (28.2)

Nocturnal

7.6 (11.8)

8.1 (14.6)

Severe

0.04 (0.66)

0.01 (0.16)

Abbreviations: Abasaglar= Abasaglar® (insulin glargine) 100 units/mL; Lantus = Lantus® (insulin glargine) 100 units/mL.

aEvents/patient/y. Represents all events reported during the 24-week treatment period.

What were the Allergic Events and Injection Site Reactions?

There was no significant difference in the incidence of allergic events or injection site reactions between treatment groups In the patients with T1DM or T2DM,  (Allergic Events in Phase 3 Clinical Studies for Abasaglar, Injection Site Reactions in Phase 3 Clinical Studies for Abasaglar).

The majority of the allergic events were reported as mild or moderate in severity, and none resulted in discontinuation of treatment.

Mild or moderate pain was the most commonly reported injection site AE.1,2

Allergic Events in Phase 3 Clinical Studies for Abasaglar1,2

Assessment

Type 1 Diabetes

Type 2 Diabetes

Abasaglar
(n=268)

Lantus
(n=267)

Abasaglar
(n=376)

Lantus
(n=380)

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)

NR

NR

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; NR = not reported.

aPatients may be counted in >1 category.

bAngioedema, macular rash, papular rash, photosensitivity reaction, pruritic rash, urticaria, vesicular rash.

cInduration, nodule, pruritus, reaction, swelling.

Injection Site Reactions in Phase 3 Clinical Studies for Abasaglar1-3

Assessment

Type 1 Diabetesa

Type 2 Diabetesb

Abasaglar
(n=268)

Lantus
(n=267)

Abasaglar
(n=376)

Lantus
(n=380)

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.

aTreatment comparisons were not performed if there were <4 patients with events.

bTreatment comparisons were not performed.

cData from patient questionnaires.

dIncluding burning sensation.

References

1Blevins 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. https://doi.org/10.1111/dom.12496

2Rosenstock 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. https://doi.org/10.1111/dom.12482

3Data on file, Eli Lilly and Company and/or one of its subsidiaries.

Date of Last Review: November 01, 2021


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