Abasaglar ® (insulin glargin)

För fullständig produktresumé för Abasaglar® se FASS.

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Abasaglar® (insulin glargin): primär slutpunkt i kliniska studier

Vid vecka 24 i båda fas 3-studierna gav Abasaglar-behandlingen en genomsnittlig HbA1c-sänkning som inte var sämre än för jämförelsepreparatet insulin glargin.

Detailed Information

Clinical Studies - Type 1 and Type 2 Diabetes Mellitus

Adult patients with inadequately controlled T1DM participated in a 24-week, open-label, active-controlled study with a 28-week extension to evaluate the glucose lowering effect of once-daily Abasaglar compared with that of once-daily administration of Lantus, both in combination with mealtime insulin lispro.1

Adult patients with T2DM participated in a double-blind, active-controlled study to evaluate the glucose lowering effect of once-daily Abasaglar plus OAMs compared with that of Lantus administered once daily along with OAMs. Patients were

  • insulin naïve (~60%) and had failed to achieve adequate glycemic control on at least 2 OAMs, or

  • already on Lantus along with at least 2 OAMs with adequate or inadequate glycemic control (~40%).2

Results

At week 24, treatment with Abasaglar provided a mean reduction in HbA1c that was noninferior to that achieved with Lantus (Table 1. Efficacy Results in Adult Patients With T1DM or T2DM in Phase 3 Clinical Studies of Abasaglar  ).1,2

Table 1. Efficacy Results in Adult Patients With T1DM or T2DM in Phase 3 Clinical Studies of Abasaglar1,2


Abasaglar + Insulin Lispro 
(n=268)

Lantus + Insulin Lispro
(n=267)

Abasaglar  + OAMs 
(n=376)

Lantus + OAMs 
(n=380)

Patient population

T1DM

T2DM

HbA1c, %a

Baseline, mean

7.75

7.79

8.34

8.31

LSM change from baselineb

-0.35

-0.46

-1.29

-1.34

LSM difference
(95% CI)b

0.108
(-0.002, 0.219)

0.052
(-0.07, 0.175)

Abbreviations: Abasaglar = Abasaglar® (insulin glargine) 100 units/mL; HbA1c = glycated hemoglobin; Lantus = Lantus® (insulin glargine) 100 units/mL; LOCF = last observation carried forward; LSM = least squares mean; OAM = oral antihyperglycemic medication; T1DM = type 1 diabetes mellitus; T2DM = type 2 diabetes mellitus.

a Data from LOCF; p>.05 for all within-study treatment comparisons.

b At week 24.

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

Glossary

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

HbA1c = glycated hemoglobin

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

OAM = oral antihyperglycemic medication

T1DM = type 1 diabetes mellitus

T2DM = type 2 diabetes mellitus

Datum fӧr senaste ӧversyn 2019 M02 01

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