Abasaglar ® (insulin glargin)

För fullständig produktresumé för Abasaglar® se FASS.

Denna information är endast avsedd för sjukvårdspersonal verksam i Sverige och som svar på din fråga. Informationen nedan är på engelska

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

Hos patienter med T1DM gav Abasaglar en genomsnittlig sänkning av HbA1c som inte var sämre än för Lantus.

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

HbA1c, %a 

Abasaglar + Insulin Lispro
(n=268)

Lantus + Insulin Lispro
(n=267)

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.

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

Datum fӧr senaste ӧversyn 2019 M01 04


Kontakta Medicinsk Information på Lilly

Kontakta oss på telefon

Kontorstid vardagar 9.00-17.00

Eller så kan du

Skriv din fråga till oss