Abasaglar ® (insulin glargin)

För fullständig produktresumé för Abasaglar® se FASS.

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Abasaglar® (insulin glargin): ELEMENT-1-studieresultat vid 12 veckor

Den statistiskt signifikanta skillnaden vid 12 veckor var inte längre statistiskt signifikant vid 24, 36 eller 52 veckor.

Clinical study in patients with type 1 Diabetes Mellitus : ELEMENT-1

At week 12, the LSM HbA1c level was significantly higher in patients treated with Abasaglar compared with those treated with Lantus; however, the significance was not maintained at 24, 36, and 52 weeks.

The ELEMENT-1 study was a phase 3, prospective, multinational, multicenter, randomized, open-label, 2-treatment group, parallel, 52-week study (24-week treatment period with a 28-week extension period) in patients with T1DM on basal-bolus insulin therapy.1

Objectives

The primary objective of the study was to determine that once-daily Abasaglar was noninferior to once-daily Lantus, both in combination with preprandial insulin lispro administered 3 times a day, as assessed by change in HbA1c from baseline to the 24-week primary endpoint.1

A secondary objective of the study was to compare Abasaglar treatment with Lantus treatment, in combination with premeal insulin lispro, regarding HbA1c levels at 6, 12, 24, 36, and 52 weeks.1

Results

The LSM change in HbA1c from baseline to week 24 (LOCF) was similar between treatment groups, thus demonstrating noninferiority of Abasaglar treatment compared with Lantus treatment and of Lantus treatment compared with Abasaglar treatment. Both treatment groups demonstrated significant improvement in HbA1c from baseline to week 52 (p<.001).1

The LSM HbA1c levels were similar between treatment groups at weeks 6, 24, 36 and 52; however, at week 12, patients treated with Abasaglar were noted with a significantly higher LSM HbA1c level compared to those treated with Lantus (7.42% vs 7.31%, p=.03).1

The basal insulin dose titrations from baseline to week 18 were less aggressive in the Abasaglar treatment group compared with the Lantus treatment group, which according to the authors, may have resulted

  • from the investigators' lack of experience with Abasaglar, and

  • in the difference in HbA1c levels at week 12 between patients treated with Abasaglar and those treated with Lantus.1

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

Glossary

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

HbA1c = glycated hemoglobin

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

LOCF = last observation carried forward

LSM = least squares mean

T1DM = type 1 diabetes mellitus

Datum fӧr senaste ӧversyn 2018 M05 01


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