Calendario›SNY›Insulin glulisine

Insulin glulisine

OPAL - Insulin Glulisine, Diabetes Mellitus

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

Fase

Fase 3

Estado

Completado

Participantes

396

previstos

Centros

1

Fin del objetivo primario

sep 2006

fecha real

Qué significa cada fase y cada estado.

Estudio de intervención, aleatorizado, abierto. Comenzó en jul 2004.

Qué mide

Change in HbA1c. (from baseline to study endpoint.) (del registro, en inglés)

Cómo lo describe el promotor

En el documentoEn inglés, del registroPrimary objective: The primary study objective is to compare efficacy of Insulin glulisine, once a day at breakfast vs. Insulin glulisine given once a day at main meal in combination with insulin glargine + OAD in terms of change in HbA1c, from baseline to endpoint for the individual patient. The aim of the study is to demonstrate two-sided equivalence between the two therapy regimens receiving two different injection timing of Insulin glulisine. Secondary objective: Secondary study objectives are to compare efficacy and safety of Insulin glulisine, once a day at breakfast vs. Insulin glulisine given once a day at main meal in combination with insulin glargine + OAD in terms of: * Change of fasting-, pre-/2h-postprandial-, mean daily and nocturnal blood glucose (baseline to endpoint) * Change of fasting plasma glucose (baseline to endpoint) * Response rate: Responders will be those patients with HbA1c smaller than 7.0% at study endpoint * Insulin dose (rapid-acting, basal and total daily doses) * Weight, body-mass index * Hypoglycemic events * Adverse events

Más ensayos de SNY

Todos los de SNY, en su ficha.

Ficha completa en ClinicalTrials.gov (NCT00272012), actualizada en dic 2009.