Abasaglar ® (insulin glargin)

För fullständig produktresumé för Abasaglar® se FASS.

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Abasaglar® (insulin glargin): Nattlig hypoglykemi

Fas 3-studier rapporterade en liknande frekvens av nattlig hypoglykemi mellan patienter som behandlades med Abasaglar och Lantus. Ingen studie har jämfört behandling av Abasaglar med IDeg.

Detailed Information

During the phase 3 clinical studies of Abasaglar, the rate of nocturnal hypoglycemia, defined as a BG concentration less than or equal to 3.9 mmol/L (≤70 mg/dL) between bedtime and waking, was similar between patients treated with Abasaglar or Lantus (Table 1).1,2

Table 1. Summary of Nocturnal Hypoglycemia in Phase 3 Clinical Studies for Abasaglar 1,2

 

Abasaglar
(n=268)

Lantus
(n=267)

Abasaglar
(n=376)

Lantus
(n=380)

Patient population

T1DM

T2DM

Nocturnal hypoglycemiaa

24 weeksb

18.3 (23.6)

18.4 (21.5)

7.6 (11.8)

8.1 (14.6)

52 weeksc

16.1 (20.2)

17.3 (19.5)

N/A

N/A

Abbreviations: Abasaglar = Abasaglar® (insulin glargine) 100 units/mL; BG = blood glucose; Lantus = Lantus® (insulin glargine) 100 units/mL; N/A = not applicable; T1DM = type 1 diabetes mellitus; T2DM = type 2 diabetes mellitus.

a Defined as BG ≤3.9 mmol/L (≤70 mg/dL) between bedtime and waking; data presented as mean (SD) events/patient/y; p>.05 for all within-study treatment comparisons.

b Data represents overall rate of nocturnal hypoglycemia during 24-week treatment period.

c Data represents overall rate of nocturnal hypoglycemia during 24-week treatment period and 28-week extension period.

Nocturnal Hypoglycemia of Insulin Glargine vs Insulin Degludec

No study has been conducted to assess the rate of nocturnal hypoglycemia in patients treated with Abasaglar compared with patients treated with IDeg.

Ratner et al conducted a meta-analysis that included 7 phase 3a, open-label, randomized, controlled studies

  • of 4330 patients with T1DM or T2DM treated with IGlar or IDeg

  • of 26 or 52 weeks in duration, and

  • that evaluated the rate, as episodes per patient year of exposure, of nocturnal hypoglycemia, defined as the number of confirmed episodes that occurred between 00:01 hours and 05:59 hours.3

During the maintenance period, defined as week 16 to the end of treatment, patients with T1DM or T2DM treated with IDeg had a significantly lower rate of nocturnal hypoglycemia compared with those treated with IGlar (Table 2).3

Over the entire treatment period, only in patients with T2DM was there a significantly lower rate of nocturnal hypoglycemia in patients treated with IDeg compared with those treated with IGlar (Table 2).3

Although not significant across the entire treatment period, in patients with T1DM, those treated with IDeg were noted with a 17% lower rate of nocturnal hypoglycemia compared with those treated with IGlar (Table 2).3

Table 2. Rates of Nocturnal Hypoglycemia From a Meta-Analysis of 7 Phase 3a Studies in Patients Treated With Insulin Glargine or Insulin Degludec3

Nocturnal Hypoglycemiaa

Estimated Rate Ratiob (95% CI)

T1DM

Maintenance periodc

0.75 (0.60;0.94)d

Entire treatment period

0.83 (0.69;1.00)

T2DM

Maintenance periodc

0.62 (0.49;0.78)d

Entire treatment period

0.68 (0.57;0.82)d

Abbreviations: IDeg = insulin degludec; IGlar = insulin glargine; T1DM = type 1 diabetes mellitus; T2DM = type 2 diabetes mellitus.

a Number of confirmed episodes that occurred between 00:01 h and 05:59 h.

b Episodes per patient-year of exposure; IDeg/IGlar.

c Week 16 to the end of treatment.

d Significantly lower risk with IDeg compared with IGlar.

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. Ratner RE, Gough SC, Mathieu C, et al. Hypoglycaemia risk with insulin degludec compared with insulin glargine in type 2 and type 1 diabetes: a pre-planned meta-analysis of phase 3 trials. Diabetes Obes Metab. 2013;15(2):175-184. http://dx.doi.org/10.1111/dom.12032

Glossary

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

BG = blood glucose

IDeg = insulin degludec

IGlar = insulin glargine

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

T1DM = type 1 diabetes mellitus

T2DM = type 2 diabetes mellitus

Datum fӧr senaste ӧversyn 2019 M11 25

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