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Insulin aspart · GEMELLI1

Comparison of SAR341402 to NovoLog/NovoRapid in Adult Patients With Diabetes Mellitus Also Using Insulin Glargine

Ensayo de Sanofi en Type 1 Diabetes Mellitus-Type 2 Diabetes Mellitus (del registro, en inglés).

Fase

Fase 3

Estado

Completado

Participantes

597

previstos

Centros

82

Fin del objetivo primario

jul 2018

fecha real

Qué significa cada fase y cada estado.

Estudio de intervención, aleatorizado, abierto. Comenzó en ago 2017.

Qué mide

Change in Glycated Hemoglobin A1c (HbA1c) From Baseline to Week 26 (del registro, en inglés) (inicio y semana 26)

Cómo lo describe el promotor

En el documentoEn inglés, del registroPrimary Objective: To demonstrate non-inferiority of SAR341402 versus NovoLog/NovoRapid in glycated hemoglobin A1c (HbA1c) change from baseline to Week 26 in participants with type 1 or type 2 diabetes mellitus (T1DM or T2DM) also using Lantus®. Secondary Objectives: * To assess the immunogenicity of SAR341402 and NovoLog/NovoRapid in terms of positive/negative status and anti-insulin antibody (AIA) titers during the course of the study. * To assess the relationship of AIAs with efficacy and safety. * To assess the efficacy of SAR341402 and NovoLog/NovoRapid in terms of proportion of participants reaching HbA1c lesser than (\<) 7.0% and change in HbA1c, fasting plasma glucose (FPG), and self-measured plasma glucose (SMPG) profiles from baseline to Week 26 and Week 52 (only Week 52 for HbA1c). * To assess safety of SAR341402 and NovoLog/NovoRapid.

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Todos los de SNY, en su ficha.

Ficha completa en ClinicalTrials.gov (NCT03211858), actualizada en mar 2022.