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Insulin Glargine

Tulip Study: Testing the Usefulness of Lantus When Initiated Prematurely In Patients With Type 2 Diabetes

Ensayo de Sanofi en Diabetes tipo 2.

Más ensayos de: Diabetes tipo 2.

Fase

Fase 4

Estado

Completado

Participantes

390

previstos

Centros

6

Qué significa cada fase y cada estado.

Estudio de intervención, aleatorizado, abierto. Comenzó en abr 2003.

Qué mide

Percentage of subjects achieving HbA1c < 7% at the end of the study. (del registro, en inglés)

Cómo lo describe el promotor

En el documentoEn inglés, del registroPrimary objective: The primary objective of this trial is: * To evaluate the efficacy of initiating Lantus in combination with oral antidiabetics drugs compared to oral antidiabetic treatment optimised by enhancing hygienic and dietary measures in type 2 diabetics whose blood glucose control is acceptable but not optimal on maximum oral treatment, based on the number of patients achieving a HbA1c value \< 7% at the end of treatment. Secondary objectives: The secondary objectives of this trial are to compare between the two treatment groups: * The variation in HbA1c between baseline and end of trial. * The frequency of episodes of symptomatic hypoglycaemia (diurnal and nocturnal), severe hypoglycaemia (diurnal and nocturnal) and asymptomatic hypoglycaemia. * Mean blood glucose levels at different times of the day. * The variation in weight and lipid in each group between baseline and end of trial. * The incidence of adverse events.

Más ensayos de SNY

Todos los de SNY, en su ficha.

Ficha completa en ClinicalTrials.gov (NCT00174681), actualizada en ene 2011.