Abasaglar ® (insulin glargin)

För fullständig produktresumé för Abasaglar® se FASS.

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Abasaglar® (insulin glargine): Dosering i kliniska studier för patienter tidigare på Lantus®

I kliniska prövningar fick patienterna, som före studien fick Lantus, antingen Abasaglar eller Lantus med en dos som motsvarade deras Lantus-dos före studien.

Detailed Information

Patients With Type 1 Diabetes Mellitus

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

The study enrolled patients with T1DM who

  • presented with an HbA1c level ≤11% at screening

  • had received basal-bolus insulin therapy for at least 1 year, and

  • had received once-daily basal insulin as NPH, Lantus, or detemir for at least 3 months along with mealtime regular human insulin, insulin lispro, aspart, or glulisine.1

Abasaglar and Lantus treatments were initiated at the same dose and at the same time of day as the patient’s prestudy basal insulin.1

Insulin lispro was administered with meals at the same dose as the patient’s prestudy mealtime insulin.1

Insulin doses were adjusted to minimize or avoid hypoglycemia while pursuing glycemic targets that included

  • an HbA1c level <7%

  • an FPG concentration ≤6.0 mmol/L (≤108 mg/dL), and

  • a preprandial capillary BG concentration between 3.9 and 7.2 mmol/L (70-130 mg/dL).1

Insulin doses were adjusted between week 0 and week 12 with subsequent dose changes directed by safety issues such as hypoglycemia.1

Patients With Type 2 Diabetes Mellitus

The ELEMENT-2 study was a phase 3, prospective, multinational, multicenter, randomized, double-blind, 2-treatment group, parallel, 24-week study in patients with T2DM who were insulin naïve or received prior treatment with Lantus.2

The study enrolled patients with T2DM who had received stable doses of at least 2 OAMs for 12 weeks and who

  • were insulin-naïve and presented with an HbA1c level ≥7.0% and ≤11.0%, or

  • had received prior Lantus treatment and presented with an HbA1c level ≤11.0%.2

Patients previously prescribed Lantus initiated Abasaglar or Lantus at the prestudy Lantus dose.2

The initial dose of Abasaglar and Lantus for insulin-naïve patients was 10 units once daily.2

As described by Gerstein et al,3 patients followed a patient-driven titration schedule to increase their initial insulin dose by 1 unit daily until an FPG concentration of ≤5.6 mmol/L (≤100 mg/dL) was achieved.2

Insulin doses were adjusted between week 0 and week 12 with subsequent dose changes directed by safety issues such as hypoglycemia.2

Patients were to remain on their prestudy OAMs throughout the study.2

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. Gerstein HC, Yale JF, Harris SB, et al. A randomized trial of adding insulin glargine vs. avoidance of insulin in people with type 2 diabetes on either no oral glucose-lowering agents or submaximal doses of metformin and/or sulphonylureas. The Canadian INSIGHT (Implementing New Strategies with Insulin Glargine for Hyperglycaemia Treatment) study. Diabet Med. 2006;23(7):736-742. http://dx.doi.org/10.1111/j.1464-5491.2006.01881.x

Glossary

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

BG = blood glucose

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

ELEMENT-2 = a prospEctive, randomized, doubLE-blind coMparison of a long-acting basal insulin analog LY2963016 to Lantus® in adult patiENTs with type 2 diabetes mellitus

FBG = fasting blood glucose

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 2017 M04 27

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