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Insulin Glargine · OSIRIS

Opposing Step-by-step Insulin Reinforcement to Intensified Strategy

Ensayo de Sanofi en Diabetes tipo 2.

Más ensayos de: Diabetes tipo 2.

Fase

Fase 3

Estado

Completado

Participantes

811

previstos

Centros

18

Fin del objetivo primario

dic 2008

fecha real

Qué significa cada fase y cada estado.

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

Qué mide

HbA1c (From the beginning to the end of the study) (del registro, en inglés)

Cómo lo describe el promotor

En el documentoEn inglés, del registroPrimary objectives : * To show the non inferiority in terms of efficacy (HbA1c) of insulin glargine plus metformin combined with 1 to 3 bolus of insulin glulisine introduced progressively (Arm 2) compared with insulin glargine plus metformin combined with 3 bolus of insulin glulisine (Arm 1), in type 2 diabetes mellitus patients poorly controlled on basal insulin therapy with oral antidiabetic drugs. * To show the non inferiority in terms of efficacy (HbA1c) of insulin glargine plus metformin combined with 1 to 3 bolus of insulin glulisine introduced progressively (Arm 2) compared with insulin glargine plus metformin and insulin secretagogue (sulfonylurea or glinide) combined with 1 to 3 bolus of insulin glulisine introduced progressively (Arm 3), in type 2 diabetes mellitus patients poorly controlled on basal insulin therapy with oral antidiabetic drugs. Secondary objectives : * To compare between the 3 treatment groups: evolution of HbA1c over time, percentage of subjects with HbA1c \<= 7% at the end of the study, evolution of blood glucose profiles, incidence of hypoglycemia, insulin doses, evolution of body weight and treatment satisfaction.

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Ficha completa en ClinicalTrials.gov (NCT00174642), actualizada en sep 2009.