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Abasaglar ® (insulin glargin)
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ABASAGLAR® (insulin glargine) : HbA1c Results in Patients in Patients with Type 2 Diabetes Mellitus
In patients with T2DM, at week 24, treatment with Abasaglar provided a LSM reduction in HbA1c that was noninferior to that achieved with Lantus.
Adult patients with T2DM participated in the ELEMENT-2 study, 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 with at least 2 OAMs with adequate or inadequate glycemic control (~40%).1
Results
Characteristics of the 759 randomized patients included
78.5% white
50% male
a mean age of approximately 59 years
a mean BMI of approximately 32 kg/m2, and
A total of 3 patients randomized to Abasaglar did not receive study drug and were not included in efficacy analysis.2
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 T2DM - ELEMENT-2 Study1
HbA1c, %a |
Abasaglar
+ OAMs |
Lantus
+ OAMs |
Baseline, mean |
8.34 |
8.31 |
LSM change from baseline |
-1.29 |
-1.34 |
LSM difference (95% CI) |
0.052 (-0.07, 0.175) |
|
Percentage of patients achieving HbA1c < 7% |
49 |
53 |
Abbreviations: 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; HbA1c = glycated hemoglobin; Lantus = Lantus® (insulin glargine) 100 units/mL; LOCF = last observation carried forward; LSM = least squares mean; OAM = oral antihyperglycemic medication; T2DM = type 2 diabetes mellitus.
a Data from LOCF; p>.05 for all treatment comparisons.
1. 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
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
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
GFR = glomerular filtration rate
HbA1c = glycated hemoglobin
Lantus = Lantus® (insulin glargine) 100 units/mL
OAM = oral antihyperglycemic medication
T2DM = type 2 diabetes mellitus
Datum fӧr senaste ӧversyn 2019 M01 04