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): HbA1c resultat hos patienter med diabetes typ 2

Hos patienter med T2DM, vid vecka 24, gav behandling med Abasaglar en LSM-minskning av HbA1c, vilken inte var lägre än den som uppnåddes med Lantus.

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

  • 67.5% with a GFR >90 mL/min/1.73m2.1,2

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
(n=376)

Lantus + OAMs
(n=380)

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.

References

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


Kontakta Medicinsk Information på Lilly

Kontakta oss på telefon

Kontorstid vardagar 9.00-17.00

Eller så kan du

Klicka för att chatta är tillgänglig

Skriv din fråga till oss