Assuntos
Medicamentos Biossimilares , Diabetes Mellitus/tratamento farmacológico , Custos de Medicamentos , Insulina Glargina , Medicamentos Biossimilares/classificação , Medicamentos Biossimilares/economia , Medicamentos Biossimilares/uso terapêutico , Aprovação de Drogas , Setor de Assistência à Saúde/tendências , Humanos , Hipoglicemiantes/classificação , Hipoglicemiantes/economia , Hipoglicemiantes/uso terapêutico , Insulina Glargina/classificação , Insulina Glargina/economia , Insulina Glargina/uso terapêutico , Análise de Séries Temporais Interrompida , Marketing , Estados UnidosRESUMO
Aim: To compare safety (immunogenicity) and efficacy of GP40061 insulin glargine (GP-Gla) and Lantus® (Sanofi glargine, Sa-Gla) in people with diabetes mellitus. Materials & methods: This randomized open-label, 26-week clinical trial enrolled 180 Type 1 diabetes mellitus patients (HbA1c 6.5-12.0%), randomized 1:1 to once daily GP-Gla (n = 90) or Sa-Gla (n = 90). The primary end point was immune response at 26th week. Results: The frequency of immune response was similar in GP-Gla and Sa-Gla (p = 1.000). Groups were similar in terms of other safety end points. Mean HbA1c change from baseline was -0.66% for GP-Gla and -0.77% for Sa-Gla, and did not differ between groups (p = 0.326). Insulin doses, fasting plasma glucose and seven-point glucose profiles were similar between groups. Conclusion: GP-Gla and Sa-Gla demonstrated similar safety and efficacy. ClinicalTrials.gov Identifier: NCT04022993.