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INSULIN GLARGINE · GALAPAGOS

Insulins Glargine and gluLisine strAtegy Versus Premixed Insulin strAteGy: a cOmparative Study

Ensayo de Sanofi en Diabetes tipo 2.

Más ensayos de: Diabetes tipo 2.

Fase

Fase 4

Estado

Completado

Participantes

934

previstos

Centros

96

Fin del objetivo primario

mar 2012

fecha real

Qué significa cada fase y cada estado.

Estudio de intervención, aleatorizado, abierto. Comenzó en feb 2010.

Qué mide

Percentage of patients with Glycosylated Haemoglobin (HbA1c) <7% with no documented symptomatic hypoglycemia (confirmed by a Plasma Glucose (PG) ≤ 56 mg/dL [3.1 mmol/L] (From baseline (visit 2, week 0) to visit 14 (week 24)) (del registro, en inglés)

Cómo lo describe el promotor

En el documentoEn inglés, del registroPrimary Objective: To demonstrate the superiority of a strategy with insulin glargine in comparison with a strategy including the premixed insulin in term of percentage of patients reaching HbA1c (glycosylated hemoglobin) below 7% at the end of treatment and who do not experience documented symptomatic hypoglycemia (confirmed by a Plasma Glucose (PG) below 56 mg/dL (3.1 mmol/L)) over a 24-week treatment period, in Type 2 diabetes patients failing lifestyle management and oral agents. Secondary Objectives: To assess the effect of insulin glargine in comparison with premixed insulin on : * Evolution of HbA1c level during the treatment period Percentage of patients who reach the target of HbA1c \< 7 % and who do not experience documented symptomatic hypoglycemia confirmed by a Plasma Glucose (PG) below 70 mg/dL (3.9 mmol/L) * Percentage of patients who reach the target of HbA1c \< 6.5% and who do not experience documented symptomatic hypoglycemia confirmed by a PG below 56 mg/dL (3.1 mmol/L) \>Percentage of patients who reach the target of HbA1c \< 6.5% and who do not experience documented symptomatic hypoglycemia confirmed by a PG below 70 mg/dL (3.9 mmol/L) \>Evolution of Fasting Plasma Glucose Evolution of 7-point plasma glucose profiles * Evolution of weight * Hypoglycemia occurrence * Dose of insulins * Evolution of liver function * Overall safety

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Todos los de SNY, en su ficha.

Ficha completa en ClinicalTrials.gov (NCT01121835), actualizada en abr 2013.