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): Viktförändring

I de kliniska fas 3-studierna för Abasaglar var LSM-förändringen i kroppsvikt likartad mellan behandlingsgrupperna.

Detailed Information

In the phase 3 clinical studies that compared Abasaglar with Lantus, there were no significant differences between treatment groups for actual mean body weight at baseline or LSM weight change at the 24- and 52-week endpoints (Table 1).1,2

Table 1. Body Weight Assessment in Phase 3 Clinical Studies for Abasaglar 1,2


Abasaglar
(n=268)

Lantus
(n=267)

Abasaglar
(n=376)

Lantus
(n=380)

Patient population

T1DM

T2DM

Baseline body weight, kga

76 (17)

75 (15)

90 (20)

90 (19)

Weight change at 24-week endpoint, kgb

+0.36

+0.12

+1.8 (0.3)

+2.0 (0.3)

Weight change at 52-week endpoint, kgc

+0.71

+0.36

N/A

N/A

Abbreviations: Abasaglar = Abasaglar® (insulin glargine) 100 units/mL; Lantus = Lantus® (insulin glargine) 100 units/mL; LOCF = last observation carried forward; LSM = least squares mean; N/A = not applicable; T1DM = type 1 diabetes mellitus; T2DM = type 2 diabetes mellitus.

a Data presented as mean (SD); p>.05 for within-study treatment comparisons.

b Data presented as LSM or LSM (SE) and from LOCF; p>.05 for within-study treatment comparisons.

c Data presented as LSM and from LOCF; p>.05 for within-study treatment comparison.

Weight Gain With Insulin Therapies

Weight gain has occurred with some insulin therapies, including Abasaglar, and has been attributed to the anabolic effects of insulin and the decrease in glycosuria.1-3

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. 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

3. Heller S. Weight gain during insulin therapy in patients with type 2 diabetes mellitus. Diabetes Res Clin Pract. 2004;65(suppl):S23-S27. http://dx.doi.org/10.1016/j.diabres.2004.07.005

Glossary

Abasaglar = Abasaglar® (insulin glargine) 100 units/mL

Lantus = Lantus® (insulin glargine) 100 units/mL

LSM = least squares mean

Datum fӧr senaste ӧversyn 2019 M09 12


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