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

Summary

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 \< 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

Timeline

Start

2010-02

Primary completion

2012-03

Completion

2012-03

Drugs

Indications