Abasaglar® (insulin glargin): Studie på patienter med diabetes typ 1

Detailed Information

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 

• 73.5% with a GFR >90 mL/min/1.73m².^1,2

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 T1DM - ELEMENT-1 Study¹

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.

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. 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