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INSULIN GLARGINE · LanScape

Comparison of a Basal Plus One Insulin Regimen With a Biphasic Insulin Regimen in Type 2 Diabetes Patients

Ensayo de Sanofi en Diabetes tipo 2.

Más ensayos de: Diabetes tipo 2.

Fase

Fase 4

Estado

Completado

Participantes

463

previstos

Centros

74

Fin del objetivo primario

dic 2012

fecha real

Qué significa cada fase y cada estado.

Estudio de intervención, aleatorizado, abierto. Comenzó en jul 2009.

Qué mide

Glycosylated Haemoglobin (HbA1c) (At week 7 and week 32) (del registro, en inglés)

Cómo lo describe el promotor

En el documentoEn inglés, del registroThe primary objective is to demonstrate the non-inferiority at six months of a basal plus one insulin regimen (Lantus plus one injection of Apidra) compared with a biphasic insulin regimen (NovoMix 30) at controlling glycosylated haemoglobin (HbA1c) in type 2 diabetes. The secondary objective are: * To compare the proportion of patients in each treatment group reaching HbA1c target (\< 7%) at the end of the treatment period * To compare the rates of hypoglycaemia (total, severe, nocturnal) * To compare the change in body weight from visit 10 to visit 24 * To compare the change in diabetes specific quality of life and other patient reported outcomes from visit 10 to visit 24 * Diabetes Treatment Satisfaction Questionnaire - status and change (DTSQs+c) * Audit of Diabetes-Dependent Quality of Life (ADDQoL) questionnaire * Insulin Treatment Satisfaction Questionnaire (ITSQ) * EuroQoL 5 Dimensions (EQ5D) questionnaire * To record the change in the daily dose of insulin from visit 2 to visit 10 and visit 10 to visit 24

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Todos los de SNY, en su ficha.

Ficha completa en ClinicalTrials.gov (NCT00965549), actualizada en ene 2013.