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INSULIN GLARGINE · DINAMO

Evaluation of the Safety and Efficacy of Insulin Glargine + Glulisine or Insulin Regular + NPH Insulin (Isophane Insulin) Use in Type 2 Diabetes Mellitus Patients With Moderate Renal Failure.

Ensayo de Sanofi en Diabetes tipo 2.

Más ensayos de: Diabetes tipo 2.

Fase

Fase 4

Estado

Completado

Participantes

72

previstos

Centros

10

Fin del objetivo primario

oct 2013

fecha real

Qué significa cada fase y cada estado.

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

Qué mide

Proportion of patients that reach the target of HbA1c ≤7% without confirmed nocturnal hypoglycaemia in each treatment group and the respective CI 90%. (From visit 1 (Day 1) to visit 13 (Day 169)) (del registro, en inglés)

Cómo lo describe el promotor

En el documentoEn inglés, del registroPrimary Objective: \>To obtain an estimation for both treatment groups of the proportion of patients that reach the target of HbA1c \<= 7% without confirmed nocturnal hypoglycaemia in each treatment group. Secondary Objectives: * Glycemic control, measured by HbA1c and FPG (fasting plasma glucose) at baseline and after each period of treatment. * Incidence of confirmed symptomatic and nocturnal hypoglycemia. * Incidence of confirmed severe hypoglycemia (\< 36mg/dL or need of help to recover). \>Weight variation for each period of treatment. * Creatinine clearance at baseline and after each period of treatment. * Overall safety: Incidence of adverse events.

Más ensayos de SNY

Todos los de SNY, en su ficha.

Ficha completa en ClinicalTrials.gov (NCT01122979), actualizada en nov 2013.