Abasaglar ® (insulin glargin)

För fullständig produktresumé för Abasaglar® se FASS.

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Abasaglar® (insulin glargin): Uppnående av HbA1c Mindre än 7%

Hos patienter med T1DM eller T2DM vid vecka 24, var procentandelen patienter som uppnådde HbA1c-nivåer mindre än 7% likartad mellan Abasaglar och Lantus behandlingsgrupper.

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, the percentage of patients who achieved HbA1c levels less than 7% was similar between treatment groups (Table 1).1,2

Table 1. Achievement of HbA1c Levels Less Than 7% at 24 Weeks 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

Percentage of patients achieving HbA1c <7%a

35

32

49

53

Abbreviations: Abasaglar = Abasaglar® (insulin glargine) 100 units/mL; HbA1c = glycated hemoglobin; Lantus = Lantus® (insulin glargine) 100 units/mL; LOCF = last observation carried forward; 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.

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 04


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