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J Comp Eff Res ; 11(18): 1337-1347, 2022 12.
Artigo em Inglês | MEDLINE | ID: mdl-36511777

RESUMO

Aim: To evaluate the safety and efficacy of insulin Aspart-Mix biosimilar candidate GP40081 (GP-Asp30) compared with NovoMix® 30 (NN-Asp30). Materials & methods: In a randomized open-label, active-controlled, 26-week non-inferiority clinical trial 264 patients with Type 2 diabetes mellitus were randomized 1:1 to receive once-daily GP-Asp30 or NN-Asp30. The primary safety end point was the immune response rate. Efficacy outcomes were a mean change in HbA1c (primary), frequency of achieving a glycemic g fasting plasma glucose levels, 7-point glucose profiles, and insulin doses. Results: The immune response developed in 10/126 (8%) participants in the GP-Asp30 group and in 10/125 (8%) participants in the NN-Asp30 group (p = 1.000). The mean difference in HbA1c change between groups was 0.12 (95%CI [-0.14, 0.38]). Other secondary efficacy and safety outcomes weren't statistically different between the two groups. Conclusion: GP-Asp30 demonstrated similar safety and efficacy compared with NN-Asp30 and may be considered a biosimilar insulin.


Assuntos
Medicamentos Biossimilares , Diabetes Mellitus Tipo 2 , Hipoglicemiantes , Insulina Aspart , Humanos , Medicamentos Biossimilares/uso terapêutico , Insulinas Bifásicas , Glicemia , Diabetes Mellitus Tipo 2/tratamento farmacológico , Hemoglobinas Glicadas , Hipoglicemiantes/uso terapêutico , Insulina/uso terapêutico , Insulina Aspart/uso terapêutico , Insulina Isófana
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