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Abasaglar ® (insulin glargin)
Denna information är endast avsedd för sjukvårdspersonal verksam i Sverige och som svar på din fråga. Informationen nedan är på engelska
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 |
Lantus
+ Insulin Lispro |
Abasaglar
+ OAMs |
Lantus
+ OAMs |
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.
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