Efficacy and safety of GP40021 insulin lispro biphasic compared with Humalog Mix 25 in Type 2 diabetes mellitus patients.
J Comp Eff Res
; 10(1): 55-66, 2021 01.
Article
en En
| MEDLINE
| ID: mdl-33355484
ABSTRACT
Aim:
To compare safety (immunogenicity) and efficacy of a biosimilar insulin GP-Lis25 and a reference insulin Ly-Lis25 (Humalog Mix 25) in Type 2 diabetes mellitus (T2D) patients. Materials &methods:
This randomized open-label, 26-week clinical trial enrolled 210 T2D patients, randomized 11 to twice-daily GP-Lis25 or Ly-Lis25. The primary end point was immune response at 26th week. Noninferiority margin for HbA1c was 0.4%.Results:
Immune response frequency was similar in GP-Lis25 and Ly-Lis25 groups both at week 12 (p = 0.651) and 26 (p = 0.164). The difference of HbA1c change at week 26 was (95% CI) 0.01 (-0.27-0.28)%. Fasting plasma glucose, seven-point glucose profile and insulin dose were similar between groups. Safety did not differ between groups.Conclusion:
GP-Lis25 and Ly-Lis25 demonstrated similar safety and efficacy. ClincalTrials.gov identifier NCT04023344.Palabras clave
Texto completo:
1
Base de datos:
MEDLINE
Asunto principal:
Diabetes Mellitus Tipo 2
Tipo de estudio:
Clinical_trials
Límite:
Humans
Idioma:
En
Revista:
J Comp Eff Res
Año:
2021
Tipo del documento:
Article
País de afiliación:
Rusia