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Insulin glargine · L2T3

Lantus Versus Levemir Treat-To-Target

Ensayo de Sanofi en Diabetes tipo 2.

Más ensayos de: Diabetes tipo 2.

Fase

Fase 4

Estado

Completado

Participantes

973

previstos

Centros

20

Fin del objetivo primario

jun 2008

fecha real

Qué significa cada fase y cada estado.

Estudio de intervención, aleatorizado, abierto. Comenzó en nov 2006.

Qué mide

HbA1c recorded (At baseline, week 12 and week 24) (del registro, en inglés)

Cómo lo describe el promotor

En el documentoEn inglés, del registroPrimary objective: To demonstrate the non-inferiority of insulin glargine in comparison to insulin detemir in term of percentage of patients who reach the target of HbA1c \< 7% at the end of the treatment period and do not experience symptomatic hypoglycemia, confirmed by plasma glucose (PG) ≤ 56 mg/dL (3.1 mmol/L) Secondary objectives: * To compare between the 2 treatment groups, the percentage of patients who reach the target of HbA1c \< 7% and \< 6.5% at the end of the treatment period * To compare the changes in HbA1c and fasting plasma glucose (FPG) * To compare the evolution of blood glucose profiles * To compare the day to day FPG variability, the insulin doses * To determine in each treatment group the biochemical and patient-related determinants of failure to reach HbA1c targets * To compare the overall incidence and rate of symptomatic hypoglycemia and nocturnal symptomatic hypoglycemia confirmed by PG ≤ 56 mg/dL (3.1 mmol/L) * To compare over the treatment period, the overall incidence and rate of symptomatic hypoglycemia and symptomatic nocturnal hypoglycemia (with PG ≤ 70 mg/dL \[3.9 mmol/L\]), of symptomatic day-time hypoglycemia (with PG ≤ 70 mg/dL and with PG ≤ 56 mg/dL), of severe hypoglycemia, of asymptomatic hypoglycemia with PG ≤ 56 mg/dL * To compare the overall safety: incidence of adverse events (including serious hypoglycemia and local tolerance at injection site), change in body weight, in waist circumference and in waist / hip ratio * To assess the quality of life and treatment satisfaction

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Todos los de SNY, en su ficha.

Ficha completa en ClinicalTrials.gov (NCT00405418), actualizada en sep 2009.