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Insulin glargine

Insulin Glargine During and After the Period of Fasting in Ramadan

Ensayo de Sanofi en Diabetes tipo 2.

Más ensayos de: Diabetes tipo 2.

Fase

Fase 4

Estado

Completado

Participantes

450

previstos

Fin del objetivo primario

feb 2006

fecha real

Qué significa cada fase y cada estado.

Estudio de intervención, no aleatorizado, abierto. Comenzó en may 2005.

Qué mide

Hypoglycaemic events (severe, symptomatic, asymptomatic, nocturnal) before, during and after Ramadan (del registro, en inglés)

Cómo lo describe el promotor

En el documentoEn inglés, del registroPrimary Objectives : * To compare the number of hypoglycaemic events (severe, symptomatic, asymptomatic, nocturnal) in patients with type 2 diabetes treated with insulin glargine (Lantus®) and glimepiride (Amaryl®), before, during and after the period of fasting in Ramadan. Secondary Objectives : * To assess glycaemic control before, during and after Ramadan in terms of HbA1c, FBG, and 8-point blood glucose profile (FBG and 8-point blood glucose profile will be collected with a blood glucose monitor through a monthly patient diary). * To assess the relationship between hypoglycaemia events during Ramadan and blood glucose control prior and during Ramadan. * To assess patient satisfaction * To document adverse events (all serious adverse events, non serious adverse events) throughout the study (all events will be collected through the monthly patient diary).

Más ensayos de SNY

Todos los de SNY, en su ficha.

Ficha completa en ClinicalTrials.gov (NCT00258804), actualizada en jun 2011.