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insulin glulisine · VARIABILITE

Efficacy Study on the Control of Blood Glucose Concentration in Type 1 Diabetic Patients

Ensayo de Sanofi en Diabetes tipo 1.

Más ensayos de: Diabetes tipo 1.

Fase

Fase 3

Estado

Completado

Participantes

88

previstos

Centros

1

Fin del objetivo primario

sep 2008

fecha real

Qué significa cada fase y cada estado.

Estudio de intervención, aleatorizado, abierto. Comenzó en oct 2005.

Qué mide

Efficacy data : fasting blood glucose concentration (read daily during the last 2 months of each period) (del registro, en inglés)

Cómo lo describe el promotor

En el documentoEn inglés, del registro·Main objective: To compare the variability of fasting capillary blood glucose concentration, observed with insulin glargine combined with insulin glulisine and with insulin detemir combined with insulin glulisine, in type 1 diabetics. It is a non-inferiority study. ·Secondary objectives: Efficacy: * To compare the variability of blood glucose concentration before the evening meal, observed with insulin glargine combined with insulin glulisine and with insulin detemir combined with insulin glulisine, in type 1 diabetics. * To record the intra- and inter-daily variability using the MAGE and MODD indices \[1,2,3,4\] * To compare the glycaemic profiles (7 points) * To evaluate the HbA1c concentration, at the end of each period of treatment, weight change, the dose of insulin used and the number of daily injections. Tolerance: * To record undesirable events * To evaluate the safety in use from the record of episodes of hypoglycaemia (symptomatic, diurnal, nocturnal, severe).

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Todos los de SNY, en su ficha.

Ficha completa en ClinicalTrials.gov (NCT00271284), actualizada en dic 2009.