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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
Adult patients with inadequately controlled T1DM participated in the ELEMENT-1 study, a 24-week, open-label, active-controlled study with a 28-week extension, to evaluate the glucose lowering effect of once-daily Abasaglar with that of once-daily administration of Lantus, both in combination with mealtime insulin lispro.1
Results
Characteristics of the 535 randomized patients included
58% male
74.5% white
2% black or African American
4.5% American Indian or Alaskan native
3.9% Hispanic
a mean age of 41 years
a mean BMI of approximately 25.5 kg/m2
a mean duration of DM of 16.5 years, and
At week 24, treatment with Abasaglar provided a LSM reduction in HbA1c that was noninferior to that achieved with treatment with Lantus (Table 1).1
Table 1. Efficacy Results in Adult Patients With T1DM - ELEMENT-1 Study1
HbA1c, %a |
Abasaglar
+ Insulin Lispro |
Lantus
+ Insulin Lispro |
Baseline, mean |
7.75 |
7.79 |
LSM change from baseline |
-0.35 |
-0.46 |
LSM difference (95% CI) |
0.108 (-0.002, 0.219) |
|
Percentage of patients achieving HbA1c < 7% |
35 |
32 |
Abbreviations: 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.
a Data from LOCF; p>.05 for all 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. Data on file, Eli Lilly and Company and/or one of its subsidiaries.
Glossary
Abasaglar = Abasaglar® (insulin glargine) 100 units/mL
BMI = body mass index
DM = diabetes mellitus
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
GFR = glomerular filtration rate
HbA1c = glycated hemoglobin
Lantus = Lantus® (insulin glargine) 100 units/mL
LSM = least squares mean
T1DM = type 1 diabetes mellitus
Datum fӧr senaste ӧversyn 2019 M01 04