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NBI-6024

A Study to Evaluate NBI-6024 in Adult and Adolescent Patients With New Onset of Type 1 Diabetes Mellitus

Ensayo de NEUROCRINE BIOSCIENCES INC en Diabetes tipo 1.

Más ensayos de: Diabetes tipo 1.

Fase

Fase 1

Estado

Completado

Participantes

188

previstos

Centros

21

Fin del objetivo primario

abr 2006

fecha real

Qué significa cada fase y cada estado.

Estudio de intervención, aleatorizado, doble ciego. Comenzó en dic 2001.

Qué mide

To assess the effect of repeated administrations of NBI-6024 on endogenous insulin production as measured by C-peptide levels in adult and adolescent patients with new onset type 1 diabetes mellitus (monthly assessments, up to 24 months (end of study)) (del registro, en inglés)

Cómo lo describe el promotor

En el documentoEn inglés, del registroThis was a study designed to evaluate the efficacy of multiple doses of an investigational drug, NBI-6024, in adult (18 to 35 years of age) and adolescent (10 to 17 years of age) patients with new onset type 1 diabetes mellitus, on endogenous insulin production. A total of 188 patients were enrolled in the study. The study was divided into three periods: screening, treatment (comprising an induction phase and maintenance phase), and follow-up. NBI-6024 was generally well tolerated and exhibits a benign safety profile, as there were no significant safety issues with NBI-6024 treatment. In summary, NBI-6024 did not demonstrate statistically significant efficacy compared with placebo.

Más ensayos de NBIX

Todos los de NBIX, en su ficha.

Ficha completa en ClinicalTrials.gov (NCT00873561), actualizada en mar 2009.