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HOE901-U300 · EDITION IV

Comparison of a New Formulation of Insulin Glargine With Lantus in Patients With Type 1 Diabetes Mellitus

Ensayo de Sanofi en Diabetes tipo 1.

Más ensayos de: Diabetes tipo 1.

Fase

Fase 3

Estado

Completado

Participantes

549

previstos

Centros

147

Fin del objetivo primario

sep 2013

fecha real

Qué significa cada fase y cada estado.

Estudio de intervención, aleatorizado, abierto. Comenzó en sep 2012.

Qué mide

Change In HbA1c From Baseline to Month 6 Endpoint (del registro, en inglés) (inicio y mes 6)

Cómo lo describe el promotor

En el documentoEn inglés, del registroPrimary Objective: * To compare the efficacy of a new formulation of insulin glargine and Lantus (overall, regardless the injection time) in terms of change of HbA1c from baseline to endpoint (scheduled Month 6) in participants with type 1 diabetes mellitus Secondary Objective: * To compare HOE901-U300 and Lantus when given in the morning or in the evening in terms of: * Change of HbA1c from baseline to endpoint (scheduled Month 6) * Change from baseline to endpoint (Month 6) in fasting plasma glucose (FPG), plasma glucose prior to injection of study drug, plasma glucose at 03:00 hours, mean plasma glucose (8-point profiles), glucose variability, treatment satisfaction and health related quality of life in participants with Type 1 Diabetes Mellitus (T1DM) * Reaching target HbA1c values and controlled plasma glucose (all and reaching target without hypoglycemia) * Frequency of occurrence and diurnal distribution of hypoglycemia by category of hypoglycemia (symptomatic, asymptomatic, nocturnal, severe, probable and relative) * Safety and tolerability of HOE901-U300 including development of anti-insulin antibody (AIAs) during the 12-month study period

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Todos los de SNY, en su ficha.

Ficha completa en ClinicalTrials.gov (NCT01683266), actualizada en may 2015.