Abasaglar ® (insulin glargin)

För fullständig produktresumé för Abasaglar® se FASS.

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Abasaglar® (insulin glargine): Dosinitiering och titrering av patienter

Den rekommenderade startdosen av Abasaglar skiljer sig mellan patienter med T1DM eller T2DM. Hos patienter med T2DM användes ett Abasaglar-titreringsschema på 1 enhet per dygn.

Initiation of Abasaglar Therapy

The recommended initial dose of Abasaglar differs between patients with T1DM or T2DM (Table 1).1

Table 1. Initiation of  Abasaglar Therapy in Patients With T1DM or T2DM1

If treating patients with...

Then the recommended initial dose of Abasaglar is...

T1DM

approximately 1/3 of the total daily insulin requirement.

T2DM

0.2 units/kg or up to 10 units once daily.

Abbreviations: Abasaglar = Abasaglar® (insulin glargine) 100 units/mL; T1DM = type 1 diabetes mellitus; T2DM = type 2 diabetes mellitus.

In patients with T1DM, short- or rapid-acting, premeal insulin should be used to satisfy the remainder of the daily insulin requirements.1

In patients with T2DM, the amount and timing of short- or rapid-acting insulins and dosages of any antihyperglycemic medications may need to be adjusted.1

Titration of Abasaglar During a Phase 3 Clinical Study - ELEMENT-2

The ELEMENT-2 study, a randomized, double-blind, phase 3 study, compared the efficacy and safety of Abasaglar vs Lantus in patients with T2DM.2

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

Patients previously prescribed Lantus initiated Abasaglar or Lantus at the prestudy Lantus dose.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 less than or equal to 5.6 mmol/L (100 mg/dL) was achieved.2

In Korea and Taiwan, due to the availability of syringes only marked in 2-unit increments, patients followed a patient-driven titration schedule to increase their initial dose by 2 units every other day until an FBG concentration of less than or equal to 5.6 mmol/L (100 mg/dL) was achieved.4

Higher insulin dose increases were permitted if deemed necessary by the investigator, and insulin dose decreases were permitted if patients experienced hypoglycemia.4

Approximately 50% of patients in each treatment group injected their basal insulin in the daytime and approximately 50% of patients injected their dose in the evening or at bedtime.4

Titration of Insulin Glargine

In the Canadian INSIGHT, Implementing New Strategies with Insulin Glargine for Hyperglycemia Treatment, study with 405 insulin-naïve patients, introduction of insulin glargine and self-titration of the glargine dose by a simple protocol of 1 unit per day was 1.7 times more likely to safely achieve near-physiological control, defined as 2 consecutive HbA1c levels less than 6.5%, than conventional therapy with OAMs.3

References

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

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

4. Data on file, Eli Lilly and Company and/or one of its subsidiaries.

Glossary

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

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

FPG = fasting plasma 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 2018 M10 05

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