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

Sanofi · 2010
ClinicalTrials.gov · Datasets · License: Public Domain · 2010
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diabetes-mellitustype-2
Primary 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 \Percentage of patients who reach the target of HbA1c \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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