Abasaglar ® (insulin glargin)

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Abasaglar® (insulin glargin): Biverkningar i kliniska studier

I kliniska fas 3-prövningar av Abasaglar var incidensen av allvarliga biverkningar, allergiska reaktioner, samt reaktioner vid injektionsstället jämförbar i olika grupper.

Detailed information

In patients with T1DM, most AEs 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 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 (Table 1).1,2

Table 1. Adverse Events in Phase 3 Clinical Studies for Abasaglar1,2

      

Abasaglar
(n=268)

Lantus
(n=267)

Abasaglar
(n=376)

Lantus
(n=380)

Patient population

T1DM

T2DM

AEsa

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 - DM

21 (8)

16 (6)

19 (5)

18 (5)

Discontinuations due to an AE

2 (1)

6 (2)

6 (2)

11 (3)

SAEsb

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; DM = diabetes mellitus; Lantus = Lantus® (insulin glargine) 100 units/mL; SAE = serious adverse event; T1DM = type 1 diabetes mellitus; T2DM = type 2 diabetes mellitus.

a Data presented as n (%) of patients; patients may be represented in multiple categories. p>.05 for all within-study treatment comparisons.

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

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 (Table 2) (Table 3).1,2

Table 2. Incidence and Rate of Hypoglycemia at 24 and 52 Weeks in the ELEMENT-1 Study1


Abasaglar
(n=268)

Lantus
(n=267)

Abasaglar
(n=268)

Lantus
(n=267)

Assessmenta

24 Weeks

52 Weeks

Incidence of hypoglycemia, %

Total

94

95

96

97

Nocturnal

82

80

86

88

Severe

2

3

4

4

Rate of hypoglycemia, mean (SD)b

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

a p>.05 for all treatment comparisons.

b Events/patient/year. Represents all events reported during the 24-week treatment and 52-week (treatment and extension) periods.

Table 3. Incidence and Rate of Hypoglycemia at 24 Weeks in the ELEMENT-2 Study2

Assessmenta

Abasaglar
(n=376)

Lantus
(n=380)

Incidence of hypoglycemia, %

Total

79

78

Nocturnal

57

54

Severe

<1

<1

Rate of hypoglycemia, mean (SD)b

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

a p>.05 for all treatment comparisons.

b Events/patient/year. Represents all events reported during the 24-week treatment period.

Allergic Events and Injection Site Reactions

In the patients with T1DM or T2DM, there was no significant difference in the incidence of allergic events or injection site reactions between treatment groups (Table 4) (Table 5). 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

Table 4. Allergic Events in Phase 3 Clinical Studies for Abasaglar1,2


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

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

c Induration, nodule, pruritus, reaction, swelling.

Table 5. Injection Site Reactions in Phase 3 Clinical Studies for Abasaglar1-3

   

Abasaglar
(n=268)

Lantus
(n=267)

Abasaglar
(n=376)

Lantus
(n=380)

Patient population

T1DMa

T2DMb

Injection site reactionc, n (%)

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.

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

AE = adverse event

T1DM = type 1 diabetes mellitus

T2DM = type 2 diabetes mellitus

Datum fӧr senaste ӧversyn 2019 M01 09

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