Abasaglar ® (insulin glargin)

För fullständig produktresumé för Abasaglar® se FASS.

Denna information är endast avsedd för sjukvårdspersonal verksam i Sverige och som svar på din fråga. Informationen nedan är på engelska

Abasaglar® (insulin glargin): Byte från glargin 300 enheter/ml

Vid övergång från insulin glargin 300 enheter/ml till Abasaglar, är den rekommenderade initiala Abasaglar-dosen cirka 80% av den för 300 enheter/ml produkt.

Detailed Information

ABASAGLAR and Toujeo (insulin glargine 300 units/ml) are not bioequivalent and are not directly interchangeable. To reduce the risk of hypoglycemia, patients who are changing their basal insulin regimen from an insulin regimen with once daily insulin glargine 300 units/ml to a once daily regimen with ABASAGLAR should reduce their dose by approximately 20%.1

During the first weeks the reduction should, at least partially, be compensated by an increase in mealtime insulin, after this period the regimen should be adjusted individually. 1

Close metabolic monitoring is recommended during the switch and in the initial weeks thereafter. With improved metabolic control and resulting increase in insulin sensitivity a further adjustment in dose regimen may become necessary. Dose adjustment may also be required, for example, if the patient's weight or life-style changes, change of timing of insulin dose or other circumstances arise that increase susceptibility to hypoglycaemia or hyperglycaemia.1

Dosing in Phase 3 Studies of Insulin Glargine 300 Units/mL

In a phase 3a study that compared IG-300 with IG-100 in patients with T1DM, the mean basal insulin dose required to achieve a similar mean reduction in HbA1c between treatment groups was 18% higher in patients treated with IG-300 compared with those treated with IG-100.2

In 3 phase 3a studies that compared IG-300 with IG-100 in patients with T2DM, the mean basal insulin dose required to achieve similar levels of glycemic control between treatment groups was 10% to 17% higher in patients treated with IG-300 compared with those treated with IG-100.3-5

References

1. Abasaglar [summary of product characteristics]. Eli Lilly Nederland B.V., The Netherlands.

2. Home PD, Bergenstal RM, Bolli GB, et al. New insulin glargine 300 units/mL versus glargine 100 units/mL in people with type 1 diabetes: a randomized, phase 3a, open-label clinical trial (EDITION 4). Diabetes Care. 2015;38(12):2217-2225. http://dx.doi.org/10.2337/dc15-0249

3. Riddle MC, Bolli GB, Ziemen M, et al; EDITION 1 Study Investigators. New insulin glargine 300 units/mL versus glargine 100 units/mL in people with type 2 diabetes using basal and mealtime insulin: glucose control and hypoglycemia in a 6-month randomized controlled trial (EDITION 1). Diabetes Care. 2014;37(10):2755-2762. http://dx.doi.org/10.2337/dc14-0991

4. Yki-Järvinen H, Bergenstal R, Ziemen M, et al; EDITION 2 Study Investigators. New insulin glargine 300 units/mL versus glargine 100 units/mL in people with type 2 diabetes using oral agents and basal insulin: glucose control and hypoglycemia in a 6-month randomized controlled trial (EDITION 2). Diabetes Care. 2014;37(12):3235-3243. http://dx.doi.org/10.2337/dc14-0990

5. Bolli GB, Riddle MC, Bergenstal RM, et al; EDITION 3 Study Investigators. New insulin glargine 300 U/ml compared with glargine 100 U/ml in insulin-naïve people with type 2 diabetes on oral glucose-lowering drugs: a randomized controlled trial (EDITION 3). Diabetes Obes Metab. 2015;17(4):386-394. http://dx.doi.org/10.1111/dom.12438

Glossary

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

HbA1c = glycated hemoglobin

T1DM = type 1 diabetes mellitus

T2DM = type 2 diabetes mellitus

Datum fӧr senaste ӧversyn 2019 M07 10

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